Docstoc

Ballot

Document Sample
Ballot Powered By Docstoc
					                                                               V3 Ballot Submission/Resolution Form

                            BALLOT TITLE:        HL7 Implementation Guide for Clinical Document Architecture, Release 2: Consent Directives, Release 1
                                                 (CDAR2_IG_CONSENTDIR_R1_D2_2010MAY) - 2nd DSTU Ballot


                          BALLOT CYCLE:          MAY 2010
                      SUBMITTED BY NAME:         Chirag Bhatt
                     SUBMITTED BY EMAIL:         cbhatt@feinfo.com
                                                 443-270-5135
                     SUBMITTED BY PHONE:
           SUBMITTED BY ORGANIZATION (if         FEI.com
                             applicable):
                      SUBMISSION DATE:           May 8, 2010
                SUBMITTED BY IDENTIFIER:
                  OVERALL BALLOT VOTE:           Affirmative




  If you submit an overall affirmative vote, please make sure you have not included negative line
                                    items on the Ballot worksheet
                                                 Enter Ballot Comments (Line Items)                             Instructions




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Submitter]                                1                                                                   March 2003
                                                               V3 Ballot Submission/Resolution Form

                            BALLOT TITLE:        HL7 Implementation Guide for Clinical Document Architecture, Release 2: Consent Directives, Release 1
                                                 (CDAR2_IG_CONSENTDIR_R1_D2_2010MAY) - 2nd DSTU Ballot


                          BALLOT CYCLE:          MAY 2010
                      SUBMITTED BY NAME:         Chirag Bhatt
                     SUBMITTED BY EMAIL:         cbhatt@feinfo.com
                                                 443-270-5135
                     SUBMITTED BY PHONE:
           SUBMITTED BY ORGANIZATION (if         FEI.com
                             applicable):
                      SUBMISSION DATE:           May 8, 2010
                SUBMITTED BY IDENTIFIER:
                  OVERALL BALLOT VOTE:           Affirmative




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Submitter]                                2                                                                   March 2003
                                                                V3 Ballot Submission/Resolution Form


                                                                   Ballot Comment Submission

                                                Vote
                                                and
Number     Ballot WG     Chapter     Section    Type       Existing Wording                 Proposed Wording   Comments
         1 CBCC                                  A-Q       (Comments entered on Submitter                      Some part of document uses term
                                                           Tab)                                                “Client” whereas some examples
                                                                                                               and other part uses term “Patient”.
                                                                                                               Since all HL7 standard and CDA
                                                                                                               uses the term “Patient”, should it be
                                                                                                               consistently referred as Patient

         2 CBCC                                      A-Q   (Comments entered on Submitter                      It is not clear if person information
                                                           Tab)                                                is optional under
                                                                                                               clinicalDocument/informationRecip
                                                                                                               ient in header or
                                                                                                               participantRole/playingEntity.
                                                                                                               Many times the consent directive is
                                                                                                               not targetted for specific person
                                                                                                               receipient so it should be optional.

         3 CBCC                                      A-Q   (Comments entered on Submitter                      There should be way to explicitly
                                                           Tab)                                                revoke previously defined consent.
                                                                                                               It may be possible to submti RPLC
                                                                                                               document with revised
                                                                                                               documentationOf->serviceEvent-
                                                                                                               >EffectiveTime-high value.




         4 CBCC                                      A-Q   (Comments entered on Submitter                      This consent directive can also be
                                                           Tab)                                                extended to support the following
                                                                                                               business cases ((may be it can
                                                                                                               already support but I may have
                                                                                                               missed):
         5 CBCC                                      A-Q   (Comments entered on Submitter                      a) Patient is at provider B and signs
                                                           Tab)                                                the consent, provider B should be
                                                                                                               able to submit that consent directive
                                                                                                               to provider A that patient previously
                                                                                                               visited and receive patient history
                                                                                                               in return as allowed by the consent
                                                                                                               directive.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                          3                                                          March 2003
                                                                V3 Ballot Submission/Resolution Form

        6 CBCC                                       A-Q   (Comments entered on Submitter                                    b) Patient gives bi-directional (2-
                                                           Tab)                                                              way) consent to Provider A for a
                                                                                                                             referral to Provider B. As a result,
                                                                                                                             Provider A can later request the
                                                                                                                             patient information/progress notes
                                                                                                                             etc. from provider B without having
                                                                                                                             patient sign another consent.

        7 StructDocs     2           2.1.9       Neg-Mi Missing                         CONF-CD-nn: If the current           The conformance statement was
                                                                                        document is replacing a prior        removed. However, reconcilliation
                                                                                        documents, then the value of         package for Version 1 accepted as
                                                                                        ClinicalDocument/relatedDocument/    Persuasive motion to use the
                                                                                        parentDocument SHALL be present,     languge stated here. (number 170
                                                                                        and SHALL contain a                  on the amalgamated sheet).
                                                                                        parentDocument element with the
                                                                                        typeCode "RPLC"
        8 StructDocs     3           3           Neg-Mj CONF-CD-13: A Consent Directive A Consent Directive document shall   Don't understand why
                                                        SHALL have a structuredBody     have either a:                       nonXMLBody was removed for this
                                                        element                         • structuredBody element or          version, esp. when Figure 15 shows
                                                                                        • nonXMLBody element                 an example of its use, and the
                                                                                                                             language immediately below the
                                                                                                                             figure states "If the structuredBody
                                                                                                                             element of a Consent Directive is
                                                                                                                             used..." So if the intent was indeed
                                                                                                                             to remove the nonXMLBody option,
                                                                                                                             there should be an explanation as to
                                                                                                                             why and the language made
                                                                                                                             consistent.




        9 StructDocs     1           1.3         Neg-Mi ge the existing                                                      Text at top right corner of page 8 in
                                                        le document                                                          PDF is cut off; can't tell what it
                                                                                                                             means to say.

       10 CBCC           1           1.8.2           A-Q   If approved in January 2010                                       Should this be changed to May
                                     Future                                                                                  2010?
                                     Work
       11 CBCC           2           Figure 13       A-Q   Originator                                                        Should Level Seven Healthcare, Inc.
                                                                                                                             appear twice here?




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                          4                                                                        March 2003
                                                                 V3 Ballot Submission/Resolution Form

       12 CBCC                                       A-C   action vs. action / operation                                              Is there a specific time to use 'just
                                                                                                                                     "action" ' or 'just "action /
                                                                                                                                     operation" ' it seems that where
                                                                                                                                     'action' is used 'action / operation ' is
                                                                                                                                     also applicable
       13 CBCC           1.1 Purpose            Neg-Mi Privacy policies define how            Privacy policies define how            There are a few concepts that
                                                       Individually Identifiable Health       Individually Identifiable Health       require more explaination:
                                                       Information (IIHI) is to be collected, Information (IIHI) is to be collected, 1) client. We need to help the reader
                                                       accessed, used and disclosed. A        accessed, used and disclosed. A        understand that we define client as a
                                                       Consent Directive is a record of a     Privacy Consent Directive is a         broader term that is inclusive of
                                                       healthcare client’s privacy policy,    record of a client’s (e.g., patient,   patient and consumer. I would rather
                                                       which is in accordance with            consumer) privacy policy. A            we use 'consumer'.
                                                       governing jurisdictional and           Privacy Consent Directive grants or 2) Need to introduce the concept of
                                                       organizational privacy policies that withholds authorization to collect, preferences
                                                       grant or withhold consent to IIHI. In access, use, or disclose IIHI about     3) Need to be specific that we are
                                                       addition, Consent Directives provide the client. A client may                 only working on 'privacy' types of
                                                       the ability for a healthcare client to author/publish their privacy           consent directives. I prefix 'privacy'
                                                       delegate authority to a Substitute     preferences as a self-declared         consistently
                                                       Decision Maker who may act on          Privacy Consent Directive.             4) Need to be specific that an
                                                       behalf of that individual.             Effective Privacy Consent              effective consent is between the
                                                                                              Directives are a bilateral agreement consumer and a data holder
                                                                                              between the client and an
                                                                                              individual/organization that is in
                                                                                              accord with law, regulation and
                                                                                              organizational policies with regard
                                                                                              to their content. In addition, Privacy
                                                                                              Consent Directives provide the
                                                                                              ability for a healthcare client to
                                                                                              delegate authority to a Substitute
                                                                                              Decision Maker who may act on
                                                                                              behalf of that individual.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                              5                                                                                March 2003
                                                              V3 Ballot Submission/Resolution Form

       14 CBCC           1.1                    Neg-Mi The guide supports backward            The guide supports backward             The wet signature and PDF are not
                                                       compatibility by allowing a scanned    compatibility by incorporating the      there for backward compatibility,
                                                       document with wet signatures to be     IHE Basic Patient Privacy Consents      they are there for specific reasons
                                                       sent in the unstructured body of a     (BPPC) mechanism of                     that we need to express. Backward
                                                       CDA document.                          acknowledging a Privacy Policy          compatibility is there through the
                                                                                              identifier and extending this with      use of the BPPC mechanism that we
                                                                                              privacy policy attributes captured in   extend here.
                                                                                              the CDA document according to this
                                                                                              CDA-IG specification. This guide
                                                                                              allows for the capture in the
                                                                                              unstructured body of a CDA
                                                                                              document of a scanned document to
                                                                                              support manual interpretation of the
                                                                                              meaning of the privacy consent
                                                                                              directive and to support capture of
                                                                                              the clients wet signature.
       15 CBCC           1.1                    Neg-Mi The CDA IG for Consent Directives                                              Do we really mean that we are
                                                       is intended to provide multiple                                                offering multiple representations? I
                                                       representations for expressing                                                 thought we were making ONE
                                                       privacy preferences and for                                                    representation that can be used
                                                       exchanging privacy policies that can                                           multiple ways?
                                                       be enforced by consuming systems.

       16 CBCC           1.1                    Neg-Mi Different templates will be assigned                                           Which meaning of the word
                                                       to different kinds of consents                                                 'template' are we using here? We
                                                                                                                                      need to be more clear. There is the
                                                                                                                                      meaning of a 'cda' template, for
                                                                                                                                      which I think we are defining one of
                                                                                                                                      those, right? Where a cda template
                                                                                                                                      is a specific set of requirements that
                                                                                                                                      a cda document can claim is
                                                                                                                                      compliant to.
                                                                                                                                      Or is this use of the word 'template'
                                                                                                                                      meaning the 'template policies'
                                                                                                                                      which is another work item we are
                                                                                                                                      running in HL7 to define a catalog
                                                                                                                                      of policies that can have a well-
                                                                                                                                      known identifier.
       17 CBCC           1.5                    Neg-Mi                                                                                Are we not defining a cda template
                                                                                                                                      for compliance to this CDA-IG?
                                                                                                                                      Thus don't we need to define a
                                                                                                                                      specific template id value?




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                            6                                                                                March 2003
                                                                 V3 Ballot Submission/Resolution Form

       18 CBCC           1.6                         A-S   The conformance statements are         The conformance statements are      Although we will be numbering
                                                           numbered sequentially and listed       numbered and listed within the body them sequentially, this wording
                                                           within the body of the DSTU as         of the DSTU as follows:             seems to imply that they will appear
                                                           follows:                                                                   sequentially. This is usually only the
                                                                                                                                      case for the first draft, as later drafts
                                                                                                                                      and later versions will have the
                                                                                                                                      numbers out of sequence due to
                                                                                                                                      insertion/deletion of requirements.
                                                                                                                                      Meaning that once a requirement is
                                                                                                                                      assigned a number it will stay that
                                                                                                                                      number. Thus I simply removed the
                                                                                                                                      unnecessary and likely confusing
                                                                                                                                      'sequentially' word.


       19 CBCC           1.7                         A-S   A client is a person who is enrolled   A client is a person who is enrolled   We need to explain this context as
                                                           and eligible to receive healthcare     and eligible to receive healthcare     many don't understand it
                                                           services.                              services. The term Client is used as
                                                                                                  a more broad term that is inclusive
                                                                                                  of patient and consumer. The more
                                                                                                  broad use recognizes that a privacy
                                                                                                  consent directive may be declared
                                                                                                  prior to any treatment relationship
                                                                                                  and is likely in effect well beyond
                                                                                                  the episode of care completion.

       20 CBCC           1.7                         A-S   Consent, Consent Directive                                                    We need to be more clear and
                                                                                                                                         always explain that we are
                                                                                                                                         specailizing only 'privacy' type
                                                                                                                                         consents. Thus I recommend we
                                                                                                                                         always and consistently prefix
                                                                                                                                         'consent' with 'privacy consent'.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                                7                                                                               March 2003
                                                                 V3 Ballot Submission/Resolution Form

       21 CBCC           1.8         Figure 3   Neg-Mj                                                                            This is the first place where this
                                                                                                                                  comment applies, but the comment
                                                                                                                                  applies later as well. I agree that the
                                                                                                                                  Consenter, Patient, and
                                                                                                                                  PrividerOrganization are identified
                                                                                                                                  in the CDA header. I do NOT agree
                                                                                                                                  that the role attributes of a consent
                                                                                                                                  directive should come from or be
                                                                                                                                  recorded in the CDA header. The
                                                                                                                                  role attributes of a consent directive
                                                                                                                                  are more appropriate to be encoded
                                                                                                                                  in the CDA body as data.
                                                                                                                                  From my read of section 2 this is
                                                                                                                                  consistent with the above, so it only
                                                                                                                                  requires the shading for HDR be
                                                                                                                                  shrunk.
       22 CBCC           1.8.1                       A-S   clinical content                                                       It is confusing to see the word
                                                                                                                                  'clinical content'. I presume this is a
                                                                                                                                  cut-paste, and we should specialize
                                                                                                                                  this to a privacy consent content?

       23 CBCC           1.8.2                       A-S                                                                          Should we not also indicate that we
                                                                                                                                  are working on a catalog of privacy
                                                                                                                                  policies that could be used?

       24 CBCC           2.1.3                       A-S   The author of the document         This element identifies the author of Need to explain what the author
                                                           (assignedAuthor) need not be the   the Privacy Consent Document. The element is before explaining what
                                                           author of the policy (author).     author of the document                else it can be.
                                                                                              (assignedAuthor) need not be the
                                                                                              author of the policy (author).




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                            8                                                                             March 2003
                                                               V3 Ballot Submission/Resolution Form

       25 CBCC           2.1.4                  Neg-Mi This may be the custodian of the IIHI                                             This sentence indicates that there
                                                       as well, but this specification allows                                            may be different purposes of the
                                                       for the custodian of the IIHI and                                                 custodian, but does not explain how
                                                       custodian of the consent to be                                                    one would determine which
                                                       different.                                                                        meaning is given.
                                                                                                                                         I do not think we should override
                                                                                                                                         this element with the purpose of
                                                                                                                                         identifying the custodian of the IIHI
                                                                                                                                         that this privacy consent directive
                                                                                                                                         rules over. The normal meaning of
                                                                                                                                         custodian should not be modified.
                                                                                                                                         Rather we should add an element to
                                                                                                                                         indicate the custodian of the IIHI
                                                                                                                                         that the consent document rules
                                                                                                                                         over. We can re-use the coding of
                                                                                                                                         custodian, but need a new element.


       26 CBCC           2.1.5                  Neg-Mi Information Recipient providers and                                               We should not override the meaning
                                                       users specify the recipients of the                                               of this element.
                                                       Consent Directive. In the case of                                                 I am unclear on what this is trying to
                                                       consultations and referrals, the                                                  say. I can imaging that we are trying
                                                       Consent Directive recipient may be                                                to identify a party to whom we are
                                                       the same person/entity as the                                                     sending IIHI that is ruled by this
                                                       intended recipient of the client’s IIHI                                           consent. This meaning does not
                                                       that is disclosed as a result of the                                              come through in this paragraph. I
                                                       authorization provided using the                                                  also don't understand how this
                                                       Consent Directive.                                                                concept would work. Further I don't
                                                                                                                                         see a use-case where this assignment
                                                                                                                                         of privacy policy to someone else is
                                                                                                                                         needed or would be allowed.
                                                                                                                                         Recommend this be removed until
                                                                                                                                         we have more clear need.
       27 CBCC           2.1.6                  Neg-Mi Each Consent Directive shall              The legalAuthenticator is as defined    Our meaning is not that different
                                                       identify and may record the               in CDA. For a Privacy Consent           than the CDA meaning of this
                                                       signature of the consenter. The           Document this element may be            element. We should only explain
                                                       consenter is either the client or their   either the client or their Substitute   that the legal authenticator in the
                                                       representative (e.g., Substitute          Decision Maker. If necessary, the       case of a privacy consent directive is
                                                       Decision Maker). The                      Signatures section may provide the      often times the client or their legal
                                                       legalAuthenticator is either the client   signature associated with the           guardian.
                                                       or their Substitute Decision Maker.       consenter’s signature.
                                                       If necessary, the Signatures section
                                                       may provide the signature associated
                                                       with the consenter’s signature.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                               9                                                                                March 2003
                                                             V3 Ballot Submission/Resolution Form

       28 CBCC           2.1.8                  Neg-Mi                         CONF-CD-10:                       The @code value is the policy id as
                                                                               ClinicalDocument/documen          found in the access control decision
                                                                               tationOf/serviceEvent/co          database. This is the key value that
                                                                               de/@code attribute SHALL be       is used to identify the policy rule
                                                                               present and indicate the OID of   (language) that this consent
                                                                               the externally identified and     document is acknowledging.
                                                                               defined privacy policy
                                                                               corresponding to the “Privacy
                                                                               Policy Acknowledgement
                                                                               Document”.

       29 CBCC           2.1.8                  Neg-Mi                         CONF-CD-11:                       The @code/System value is the
                                                                               ClinicalDocument/documen identifier of the assigning authority
                                                                               tationOf/serviceEvent/co of the policy identified in @code
                                                                               de/@codeSystem attribute
                                                                               SHALL be present and indicate
                                                                               the assigning authority of the
                                                                               externally identified and defined
                                                                               privacy policy corresponding to
                                                                               the “Privacy Policy
                                                                               Acknowledgement Document”.

       30 CBCC           2.1.8                  Neg-Mi                         CONF-CD-12:                       The @code/SystemName value is
                                                                               ClinicalDocument/documen the descriptive name of the policy
                                                                               tationOf/serviceEvent/co identified in @code.
                                                                               de/@codeSystemName
                                                                               attribute MAY be present and be
                                                                               a descriptive text of the privacy
                                                                               policy being acknowledged.

       31 CBCC           3.3.1                  Neg-Mi Digital Signatures                                        Digital Signatures would
                                                                                                                 encapsulate the CDA document.
                                                                                                                 Have Digital signature as a
                                                                                                                 standalone header level (e.g. 3.3.2)
                                                                                                                 and in there explain how XML
                                                                                                                 digital signature can encapsulate the
                                                                                                                 CDA consent document according
                                                                                                                 to local policy.

       32 CBCC                                       A-C                                                         no comments




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                            10                                                                         March 2003
                                                                V3 Ballot Submission/Resolution Form

       33 CBCC           3                      Neg-Mj                                                                             The use of Preconditions throughout
                                                                                                                                   this section to include a code is
                                                                                                                                   valid only if the code itself
                                                                                                                                   expresses the precondition in full.
                                                                                                                                   Typical codes that expressing the
                                                                                                                                   results of an observation need to be
                                                                                                                                   associated with more than just the
                                                                                                                                   result of the observation, e.g.,
                                                                                                                                   Diagnosis=Heart Attack, not "Heart
                                                                                                                                   Attack". Else you have the answer
                                                                                                                                   (the test to perform) without the
                                                                                                                                   question against which to judge the
                                                                                                                                   precondition.

       34 CBCC           4                      Neg-Mi                                                                             Please include references to BPPC
                                                                                                                                   from IHE.

       35 CBCC                       3.2             A-S   CONF-CD-14: A Consent                                                     Can we provide a more definitive
                                                           Directive SHALL contain the                                               description of the required sections,
                                                           sections described hereunder.                                             referencing a table or list, for
                                                                                                                                     example? As it reads, I'm not sure
                                                                                                                                     how the statement could be
                                                                                                                                     validated.
       36 CBCC                       3.2             A-S   CONF-CD-15: requires templateID suggest or require a LOINC section If the template ID and title are
                                                           and title; no requirement for section code                                required with no section code, is it
                                                           code                                                                      possible that people will rely on
                                                                                                                                     these to convey semantics instead of
                                                                                                                                     the code?
       37 CBCC                                             Comments received from Walter Suarez (see separate attachement)**No Vote and Type were indicated**
       38 CBCC                       1.1             A-S   A Consent Directive is a record of a A Consent Directive is a record of a
                                                           healthcare client’s privacy policy,   healthcare client’s health
                                                           which is in accordance with           information privacy policy, which
                                                           governing jurisdictional and          is in accordance with governing
                                                           organizational privacy policies that jurisdictional and organizational
                                                           grant or withhold consent to IIHI.    privacy policies that grant or
                                                                                                 withhold consent to IIHI.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                            11                                                                             March 2003
                                                                 V3 Ballot Submission/Resolution Form

       39 CBCC                       1.1             A-S                                                                               Consider adding the five categories
                                                                                                                                       of consent described in ONC’s
                                                                                                                                       Consent Directives Document
                                                                                                                                       released March 31, 2010




       40 CBCC                       1.1             A-S   The CDA IG for Consent Directives       The CDA IG for Consent Directives
                                                           is intended to provide multiple         is intended to provide multiple
                                                           representations for expressing          representations for expressing
                                                           privacy preferences and for             health information privacy
                                                                                                   preferences and for
       41 CBCC                       1.1             A-S   Different templates will be assigned                                        Missing completion of statement?
                                                           to different kinds of consents                                              Need to add clarification to this
                                                                                                                                       statement
       42 CBCC                       1.1             A-S   Code system names will be added to                                          Need to clarify what it is referred to
                                                           future versions of the DSTU.                                                by ‘Code System Names’


       43 CBCC                       1.1             A-S   Scope: this specification applies to                                        I believe a statement like this would
                                                           consent directives that applied to                                          be helpful to clarify the scope of
                                                           health information maintained in                                            applicability of this specification
                                                           electronic health records (EHRs),
                                                           personal health records (PHRs),
                                                           Health Information Exchange
                                                           systems (HIEs) and other forms of
                                                           electronics collection and
                                                           maintenance of health information.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                                12                                                                            March 2003
                                                                 V3 Ballot Submission/Resolution Form

       44 CBCC                       1.7             A-S   Client: A client is a person who is                                         By establishing the definition of
                                                           enrolled and eligible to receive                                            ‘Client’ as is noted here, and
                                                           healthcare services.                                                        utilizing this term across the entire
                                                                                                                                       document, the specification is,
                                                                                                                                       unnecessarily constraint to enrollees
                                                                                                                                       of some form or a plan, rather than
                                                                                                                                       individuals that receive care from
                                                                                                                                       providers, whether they are or not
                                                                                                                                       enrolled in a plan. What about
                                                                                                                                       individuals that receive charity care
                                                                                                                                       or out-of-pocket paying individuals?

       45 CBCC                       1.8             A-S   The Consent Directive                 This Consent Directive
                                                           Implementation Guide provides a       Implementation Guide provides a
                                                           mechanism to record a client’s        mechanism to record a client’s
                                                           privacy consent(s) and to share those health information privacy
                                                           consent directives between those      consent(s) and to share those
                                                           entities that are custodians of the   consent directives between those
                                                           client's health records including     entities that are custodians of the
                                                           Individually Identifiable Health      client's health records including
                                                           Information (IIHI).                   Individually Identifiable Health
                                                                                                 Information (IIHI).
       46 CBCC                       1.8.2           A-Q   For example, there is no way include For example, there is no way to        What is an ‘electronic’ signature? Is
                                                           an electronic signature with the      include an electronic (digital?)      it the pasting of a wet signature in a
                                                           identity of an author, authenticator, signature with the identity of an     document? Or is it a digital
                                                           or legal authenticator in the         author, authenticator, or legal       signature encoding?
                                                           document header that is often         authenticator in the document
                                                           mandatory for legally binding         header that is often mandatory for
                                                           documents                             legally binding documents




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                               13                                                                             March 2003
                                                                 V3 Ballot Submission/Resolution Form

       47 CBCC           1.1 Purpose            Neg-Mi Privacy policies define how                 Privacy policies define how              Consent is already complicated
                                                       Individually Identifiable Health            Individually Identifiable Health         enough. Use simple sentences to
                                                       Information (IIHI) is to be collected,      Information (IIHI) is to be collected,   explain it. The term "client" and
                                                       accessed, used and disclosed. A             accessed, used and disclosed. A          "healthcare client" are new to many
                                                       Consent Directive is a record of a          Consent Directive is a record of a       of your readers. A more familiar
                                                       healthcare client’s privacy policy,         client’s (e.g., a patient’s) privacy     term or phrase is "patient or their
                                                       which is in accordance with                 policy. It grants or withholds           representative".
                                                       governing jurisdictional and                authorization to perform these
                                                       organizational privacy policies that        functions. Effective Consent
                                                       grant or withhold consent to IIHI. In       Directives are in accord with law,
                                                       addition, Consent Directives provide        regulation and organizational
                                                       the ability for a healthcare client to      policies with regard to their content.
                                                       delegate authority to a Substitute          In addition, Consent Directives
                                                       Decision Maker who may act on               provide the ability for a healthcare
                                                       behalf of that individual.                  client to delegate authority to a
                                                                                                   Substitute Decision Maker who may
                                                                                                   act on behalf of that individual.
       48                1.1                         A-T   Consent Directive examples include      Consent Directive examples include: Use a bulleted list to make this
                                                           basic Opt-In/Opt-Out to clinical use;   * basic Opt-In/Opt-Out to clinical    section more readable.
                                                           Opt-Out of sharing outside of local     use;
                                                           event use, allowing emergency           * Opt-Out of sharing outside of local
                                                           override; limit access to functional    event use,
                                                           roles (e.g., direct care providers);    * allowing emergency override;
                                                           specific document is marked as          * limit access to functional roles
                                                           available in emergency situations;      (e.g., direct care providers);
                                                           allow specific documents to be used     * specific document is marked as
                                                           for specific research projects and      available in emergency situations;
                                                           others.                                 * allow specific documents to be
                                                                                                   used for specific research projects
                                                                                                   and others.

       49                1.1                         A-T   The CDA IG for Consent Directives       The CDAImplementation Guide for Simplify and be more direct. Yes, it
                                                           is intended to provide multiple         Consent Directives provides          indends to, but also does, so use the
                                                           representations for expressing          multiple representations for         most active verb.
                                                           privacy preferences and for             expressing privacy preferences and
                                                           exchanging privacy policies that can    for exchanging privacy policies that
                                                           be enforced by consuming systems.       can be enforced by consuming
                                                                                                   systems.
       50                1.1                    Neg-Mi expressing privacy preferences and                                               The distinction between these two is
                                                       for exchanging privacy policies                                                  fine enough that it deserves some
                                                                                                                                        introduction.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                                14                                                                              March 2003
                                                                 V3 Ballot Submission/Resolution Form

       51                1.2                    Neg-Mi The audience for this document                The audience for this document            Policy makers need to understand
                                                       includes software developers and              includes software developers,             technical capabilities or they will
                                                       consultants                                   system architects, policy makers and      establish policies that cannot be
                                                                                                     analysts.                                 implemented using this technology.
                                                                                                                                               The term "consultant" usually
                                                                                                                                               describes a business relationship,
                                                                                                                                               not a functional activity. A
                                                                                                                                               consultant may be hired to perform
                                                                                                                                               any functional role in the
                                                                                                                                               development of a system. Remove
                                                                                                                                               it.

       52                Page 9                 Neg-Mi                                                                                         Page 9 content in the Word
                                                                                                                                               document and in the PDF obscured
                                                                                                                                               different parts of the document, so I
                                                                                                                                               could eventually read all of the
                                                                                                                                               content. It needs to be fixed in both
                                                                                                                                               so that all content can be read and
                                                                                                                                               commented on.

       53                Figure 1               Neg-Mi                                                                                         If you are going to use UML, use the
                                                                                                                                               right diagramming nomenclature to
                                                                                                                                               represent dependencies.

       54                1.4                    Neg-Mi The requirements of this Draft                                                          Not applicable to this section, and
                                                       Standard for Trial Use (DSTU) are                                                       simple restated: "We will follow
                                                       on track to become normative after a                                                    HL7 Policy and Procedures." Strike
                                                       trial period and will be subject to                                                     it.
                                                       change under the policies for DSTU
                                                       as specified by the HL7 Governance
                                                       and Operations Manual.

       55                Throughout             Neg-Mi CDA R2                                                                                  This is inconsistently rendered
                                                       CDA Release 2 (R2)                                                                      throughout the document. I would
                                                       Clinical Document Architecture                                                          suggest introducing it by it's full
                                                       (CDA)                                                                                   title once, and introducing the
                                                       Clinical Document Architecture                                                          acronym, which then be used
                                                       (CDA) Release 2 (R2)                                                                    consistently throughout the
                                                       CDA Release 2                                                                           document subsequently.

       56                1.5                         A-T   In this specification all templates are   In this specification all templates are
                                                           backed up by use case and                 traceable to use case and
                                                           information requirements                  information requirements
                                                           documented in the Composite               documented in the Composite
                                                           Privacy Consent Directive Domain          Privacy Consent Directive Domain
                                                           Analysis Model (CPCD DAM).                Analysis Model (CPCD DAM).




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                               15                                                                                    March 2003
                                                              V3 Ballot Submission/Resolution Form

       57                1.5                    Neg-Mi While in the most general forms of This implementation guide asserts         Not necessary and interferes with
                                                       CDA exchange, an originator need when templateIds are required for           the key statement: This guide tells
                                                       not apply a templateId for every       conformance.                          you what is needed for
                                                       template that an object in an instance                                       conformance.
                                                       document conforms to, this
                                                       implementation guide asserts when
                                                       templateIds are required for
                                                       conformance.
       58                1.5.2                  Neg-Mj                                                                           This section describes receiver
                                                                                                                                 responsibilities in the general case
                                                                                                                                 for all templates, but says nothing
                                                                                                                                 about the responsibilities of
                                                                                                                                 receivers with respect to this guide.
                                                                                                                                 Given that exchange of consent
                                                                                                                                 implies certain receiver
                                                                                                                                 responsibilities, I’d like to see those
                                                                                                                                 explicitly listed here.
       59                1.6.3                  Neg-Mi                                                                           You reference the guide, and then
                                                                                                                                 redefine the terms in your own
                                                                                                                                 words. I like your words, but do
                                                                                                                                 they mean the same as the guide?
       60                1.6.4                   A-T Instead of the traditional dotted      This document uses XPath notation The use of Xpath notation is now
                                                       notation used by HL7 to represent    in conformance statements and        the tradition in CDA
                                                       RIM classes, this document uses      elsewhere to identify the Extensible Implementation Guides.
                                                       XPath notation in conformance        Markup Language (XML) elements
                                                       statements and elsewhere to identify and attributes within the CDA
                                                       the Extensible Markup Language       document instance to which various
                                                       (XML) elements and attributes        constraints are applied.
                                                       within the CDA document instance
                                                       to which various constraints are
                                                       applied.
       61                1.7                    Neg-Mi                                                                           The term client may be common
                                                                                                                                 usage in certain programs, but the
                                                                                                                                 more common term is patient.
                                                                                                                                 Wouldn't it be easier to use that
                                                                                                                                 term?
       62                Figure 3               Neg-Mj                                                                           Even at 800% I cannot read the text.
                                                                                                                                 Use better graphics and a better way
                                                                                                                                 to identify content appearing in the
                                                                                                                                 CDA Header.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                           16                                                                            March 2003
                                                              V3 Ballot Submission/Resolution Form

       63                1.8                    Neg-Mi BPPC                                          Introduced for the first time here
                                                                                                     with no reference, description, link
                                                                                                     or other content. What is this thing?
                                                                                                     (I read the word document first, and
                                                                                                     didn't see the obscured content that
                                                                                                     does appear in the PDF). Even so, it
                                                                                                     needs better introduction here.

       64                1.8                    Neg-Mj In RMO-DP terms,                              Huh? That came out of the blue.
                                                                                                     Introduce please, or better yet, use
                                                                                                     HL7 SAIF terms. I know that you
                                                                                                     just said, but 95% of your audience
                                                                                                     just got lost.
       65                1.8         Figure 3   Neg-Mi                                               Figure 3 is badly introduced and
                                                                                                     placed in this document, move to
                                                                                                     after the pentultimate (next to last)
                                                                                                     paragraph.
       66                1.8.1                  Neg-Mi                                               Are level 1 and 2 constraints
                                                                                                     optional or required? Not stated
                                                                                                     here, but is stated for level 3.
       67                1.8.1                  Neg-Mi many additional distinctions in               I cannot parse what this phrase
                                                       reusability could be defined                  means. After a minute of thought it
                                                                                                     occurs to me that you are talking
                                                                                                     about levels. Levels were originally
                                                                                                     defined in section 1.2.2 in CDA
                                                                                                     Release 2, which might be a helpful
                                                                                                     reference.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                       17                                                  March 2003
                                                              V3 Ballot Submission/Resolution Form

       68                1.8.1                  Neg-Mj Conformance to the DSTU carries               This belongs in a conformance
                                                       with it an implicit adherence to              section, not in the SCOPE.
                                                       Level 1, which asserts header
                                                       element constraints. Conformance
                                                       to the DSTU at Level 1 (whether
                                                       specified or implicit) asserts header
                                                       element constraints but allows a non-
                                                       XML body or an XML body that
                                                       may or may not conform to
                                                       additional templates defined herein.
                                                       Likewise, conformance to the DSTU
                                                       at Level 2 does not require
                                                       conformance to entry-level
                                                       templates, but does assert
                                                       conformance to header- and section-
                                                       level templates. In all cases, required
                                                       clinical content must be present. For
                                                       example, a CDA Discharge
                                                       Summary carrying the templateId
                                                       that asserts conformance with Level
                                                       1 may use a PDF or HTML format
                                                       for the body of the document that
                                                       contains the required clinical
                                                       content.
       69                1.8.2                  Neg-Mi                                               Strike this, it is not applicable to
                                                                                                     DSTU or Normative Track content,
                                                                                                     nor binding on committees
                                                                                                     publishing this material.

       70                1.8.2       Figure 4   Neg-Mi                                               A picture should be worth a
                                                                                                     thousand words. This one fails to
                                                                                                     convey the 20 that could more
                                                                                                     simply state: This DSTU is based on
                                                                                                     CDA Release 2.0. The final
                                                                                                     standard is expected to be based
                                                                                                     upon CDA Release 3.0.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                           18                                             March 2003
                                                                V3 Ballot Submission/Resolution Form

       71                2                      Neg-Mi NOTE: Elements reused here may                                     Cannot parse this note on first
                                                       be further constrained within this                                 reading. Rereading: What we write
                                                       implementation guide. For example,                                 herein constrains the document, and
                                                       general constraints limit the                                      stuff we reuse from elsewhere
                                                       document type code to the LOINC®                                   carries its own baggage too. All of
                                                       document type vocabulary.                                          it applies. The note needs to be
                                                       However, whenever header sections                                  simplified.
                                                       below do not contain additional
                                                       conformance statements, General
                                                       Header Constraints apply.

       72                2                      Neg-Mi The Consent Directive document                                     Delete this as it duplicates content
                                                       requires two document level-two                                    in section 2.1
                                                       templateIds: one asserts use of the
                                                       General Header Constraints template
                                                       and the other asserts conformance
                                                       with the specific constraints of the
                                                       Consent Directive

       73                2                           A-T   CONF-CD-1: A document                                          Move to section 2.1
                                                           conforming to the CDA General
                                                           Header template SHALL include the
                                                           ClinicalDocument/templateId
                                                           “2.16.840.1.113883.10.20.3”.
       74                Figure 5                    A-T                                                                  Move before first constraint in 2.1.

       75                2.1                         A-T                                                                  Remove this heading level and
                                                                                                                          move everything underneath it
                                                                                                                          upwards.
       76                2.1                    Neg-Mj 2.1.1.1 ClinicalDocument/templateId 2.1.1.1                        If you represent an XPath with a
                                                                                           /ClinicalDocument/templateId   leading /, then your IMPLICIT
                                                                                                                          context becomes an EXPLICIT
                                                                                                                          context: The root of the document.

       77                2.1.2                  Neg-Mj The attributes Patient and                                         Do not use the term attribute. These
                                                       patientRole refer to the healthcare                                are not attributes in the RIM.
                                                       client whose IIHI is referenced in                                 patientRole is a Role Class, and
                                                       document.                                                          patient is an Entity Class. These are
                                                                                                                          not attributes in XML either.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                             19                                                                 March 2003
                                                              V3 Ballot Submission/Resolution Form

       78                2.1.3                  Neg-Mi CONF-CD-4:                                    This RIM attribute describes the
                                                       ClinicalDocument/author/functionC             functional role of the author. If that
                                                       ode/ MAY be present to specify                role is as substitute decision maker,
                                                       function/relationship of the author to        there is no “workaround” being
                                                       the client who is the record target.          done, it’s simple the correct use of
                                                       This element may be used as a                 the RIM attribute.
                                                       workaround to specify the client’s
                                                       relationship to the Substitute
                                                       Decision Maker – if one is involved
                                                       in the creation of the consent
                                                       directive.
       79                2.1.4                  Neg-Mi 2.1.4 ClinicalDocument/custodian              This section adds not constraints.
                                                       This element of the header identifies         The second sentence is merely
                                                       the custodian of the Consent                  confusing. Recommend this be
                                                       Directive document. This may be the           struck, or rewritten to clarify what
                                                       custodian of the IIHI as well, but this       you are trying to say.
                                                       specification allows for the
                                                       custodian of the IIHI and custodian
                                                       of the consent to be different.


       80                2.2                    Neg-Mi                                               This is no different from best
                                                                                                     practice for CDA, not sure why this
                                                                                                     is necessary here. Strike this
                                                                                                     section?
       81                3                      Neg-Mj The IHE Basic Patient Privacy                 This is incorrect. It uses XDS-SD
                                                       Consents specifies the contents of            which uses the nonXMLBody,
                                                       the consent directive document as an          which you demonstrate in the very
                                                       observationMedia.                             next chunk of text!




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                           20                                               March 2003
                                                              V3 Ballot Submission/Resolution Form

       82                                       Neg-Mj includes one of the following in                                       I would prefer that this document
                                                       addition to a formatted narrative                                      reference "assertions described
                                                       representation of a Consent                                            using prevailing standards" rather
                                                       Directive:                                                             than "prevailing, platform-specific
                                                       1) An interoperable representation of                                  assertions". The latter opens the
                                                       a client’s privacy preferences using                                   Consent document to the use of
                                                       HL7-based sections and entries that                                    proprietary content for computable
                                                       enables the exchange of consent                                        representations, which is not
                                                       directives between entities using                                      desirable in an HL7 implementation
                                                       dissimilar security frameworks to                                      guide.
                                                       enforce the assertions made by the
                                                       consenter.                                                          The use of two different formats to
                                                       2) An equivalent representation                                     represent the information
                                                       using prevailing, platform-specific                                 perpetuates the belief that an HL7
                                                       assertions to enable the exchange of                                model must be represented in HL7
                                                       computable consent directives across                                XML generated through the XML
                                                       similar systems using a common                                      ITS. XML Schemas are rarely
                                                       security infrastructure. This                                       normative artifacts in messages
                                                       representation will use a well-                                     creating using the HL7 methodology
                                                       defined assertion language                                          (the HDF). The models are what is
                                                       corresponding to the appropriate                                    normative.
                                                       access control markup or digital                                    A much more appropriate and useful
                                                       rights management technology used                                   approach would be to show how the
                                                       by the implementers.                                                HL7 model of consent is represented
                                                                                                                           by developing "profiles" of the
                                                                                                                           prevailing standards to reflect the
                                                                                                                           HL7 modeling restrictions found in
                                                                                                                           the Consent DAM. This would
                                                                                                                           support briding of information
                                                                                                                           between HL7 models and the
                                                                                                                           standards used in implementations
       83                                       Neg-Mj CONF-CD-17: The entry element     CONF-CD-17: The entry element     Consent is an ACT that has
                                                       SHALL include an act element with SHALL include an act element with occurred at the time this document
                                                       templateId of                     templateId of                     is created. The definition of that act
                                                       “2.16.840.1.113883.3.445.5” and a “2.16.840.1.113883.3.445.5” and a is described in the components of
                                                       moodCode of “DEF” to specify the moodCode of “EVN” to specify the the act, but the act itself is an
                                                       structure of a Consent Directive. execution of Consent Directive.   EVENT. It should also have an
                                                                                                                           effectiveTime attribute which
                                                                                                                           indicates the effective time of the
                                                                                                                           consent (start and stop date), as an
                                                                                                                           interval of time. The low value
                                                                                                                           must be present, the high value
                                                                                                                           could be unknown or absent.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                         21                                                                       March 2003
                                                              V3 Ballot Submission/Resolution Form

       84                                       Neg-Mj CONF-CD-18: The act element             CONF-CD-18: The act element          CDA says acts SHALL contain a
                                                       SHOULD include a code element to        SHALL include a code element to      code element.
                                                       specify the purpose of use for which    specify the purpose of use for which
                                                       the data consent is applicable.         the data consent is applicable.

       85                                       Neg-Mj CONF-CD-19: This section                CONF-CD-19: This section              This representation would indicate
                                                       SHOULD include one or more              SHOULD include one or more            that the person or organization
                                                       entry/act/informant/[@typeCode=’I       entry/act/informant/[@typeCode=’D     supplying the information about the
                                                       NF’] elements with a templateId of      IST’] elements with a templateId of   consent was the custodian of the
                                                       “2.16.840.1.113883.3.445.6” to          “2.16.840.1.113883.3.445.6” to        IIHI, which need not be the case.
                                                       represent the custodian of the          represent the distributor of the      The distributor (DIST) of
                                                       referenced IIHI. This may be            referenced IIHI. This may be          information used in the act is what
                                                       different than the custodian of the     different than the custodian of the   is relevant.
                                                       document identified in the header.      document identified in the header.

       86                                       Neg-Mj CONF-CD-25: This                        CONF-CD-25: This                      The “action allowed” may be to
                                                       entryRelationship SHALL include an      entryRelationship SHALL include       view, store or redisclose. Of these,
                                                       observation element with default        an act element with default           the term observation is only
                                                       classCode=“OBS” and                     classCode=“ACT” and                   pertinent to “view”, and even there
                                                       moodCode=“DEF”.                         moodCode=“DEF”.                       is not properly an HL7 Observation
                                                                                                                                     class. This should be an Act, not an
                                                                                                                                     observation.
       87                                       Neg-Mi CONF-CD-26: This observation       CONF-CD-26: This act element               Defaults are things not transmitted.
                                                       element SHOULD include a           SHOULD include a @negationId               Since CDA does not specify a
                                                                                          attribute with a value of “false”
                                                       @negationId attribute with a default                                          "default" (although it should have),
                                                       value of “false” indicating that the
                                                                                          indicating that the action specified       you need to be specific about the
                                                       action specified is enabled, and a is enabled, and a value of “true” if       reciever responsibility when the
                                                       value of “true” if the action is not
                                                                                          the action is not allowed by the           content is not sent.
                                                       allowed by the Consent Directive.  Consent Directive. When the
                                                       By default, the value is “false” for
                                                                                          negationInd attribute is not
                                                       negationInd.                       transmitted, the reciever must
                                                                                          behave as is negationInd is false.
       88                                       Neg-Mj CONF-CD-27: This section           CONF-CD-27: This act SHALL                 I believe you meant for this to apply
                                                       SHOULD include a code element      include a code element with default        the the observation[act] above, in
                                                       with default of                    of                                         which case, a code is required by
                                                       codeSystem="2.16.840.1.113883.5.4 codeSystem="2.16.840.1.113883.5.            CDA (whether it be an act or an
                                                       " to specify the Consent Directive 4" to specify the Consent Directive        observation).
                                                       operation or action [DYNAMIC].     operation or action [DYNAMIC].

       89                                       Neg-Mj CONF-CD-34: The component               CONF-CD-34: The component              CDA requires it.
                                                       element SHOULD include an               element SHALL include an act/code
                                                       act/code element to specify the         element to specify the Privacy
                                                       Privacy Policy or regulation that is    Policy or regulation that is basis for
                                                       basis for requesting the                requesting the authorizations
                                                       authorizations specified in the         specified in the Consent Directive.
                                                       Consent Directive.
       90



53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                            22                                                                             March 2003
                                                     V3 Ballot Submission/Resolution Form

       91
       92
       93
       94
       95
       96
       97
       98
       99
      100
      101
      102
      103
      104
      105
      106
      107
      108
      109
      110
      111
      112
      113
      114
      115
      116
      117
      118
      119
      120
      121
      122
      123
      124
      125
      126
      127
      128
      129
      130
      131
      132
      133
      134
      135
      136
      137



53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    23                    March 2003
                                                     V3 Ballot Submission/Resolution Form

      138
      139
      140
      141
      142
      143
      144
      145
      146
      147
      148
      149
      150
      151
      152
      153
      154
      155
      156
      157
      158
      159
      160
      161
      162
      163
      164
      165
      166
      167
      168
      169
      170
      171
      172
      173
      174
      175
      176
      177
      178
      179
      180
      181
      182
      183
      184



53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    24                    March 2003
                                                     V3 Ballot Submission/Resolution Form

      185
      186
      187
      188
      189
      190
      191
      192
      193
      194
      195
      196
      197
      198
      199
      200
      201
      202
      203
      204
      205
      206
      207
      208
      209
      210
      211
      212
      213
      214
      215
      216
      217
      218
      219
      220
      221
      222
      223
      224
      225
      226
      227




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    25                    March 2003
                                                     V3 Ballot Submission/Resolution Form




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    26                    March 2003
                                                                        V3 Ballot Submission/Resolution Form


                                                                       Committee Resolution




                                                                                                                                Against


                                                                                                                                              Abstain
                                                                                                                                                         Change     Substantive




                                                                                                                      For
Disposition                      Disposition Comment                                  Responsible Person                                                 Applied      Change      Submitted By
Considered - Question Answered   "Patient" is a role played in the context of a       serafina versaggi          6          0             0             Yes        No
                                 specific encounter. We decided to use "client" for
                                 all other cases. The defintion will also be expanded
                                 in response to other submitters comments.                                                                                                        Chirag Bhatt



Considered - Question Answered   That information referenced in the comment is part Serafina Versaggi            6          0             0                  No         No
                                 of the CDA R2 specification and it intended to be
                                 used wihtout any constratints - we will add a
                                 reference to CDA IG wording.
                                                                                                                                                                                  Chirag Bhatt
                                 This is stated in section 1.8 just above 1.8.1.



Considered - Question Answered   The is a way to show that a consent was revoked by Serafina Versaggi            6          0             0                  Yes        No
                                 changing the "statusCode" of the
                                 ClinicalDocument instances to "aborted". The
                                 status (indicated by
                                 ClinicalDocument/statusCode/@code) of the                                                                                                        Chirag Bhatt
                                 consent may be"active" for valid consent, that is in
                                 effect. "completed" if the consent directive has
                                 expired normall, or "aborted" if the was revoked.
                                 We will add this clarification to the IG.

Considered - Question Answered   These use cases are supported by this IG without      Ioana Singureanu          6          0             0             No         No
                                 the need for extensions. We could illustrate this
                                 fact by creating instances of consent directives as                                                                                              Chirag Bhatt
                                 CDA documents that conform to this IG.

Considered - Question Answered   We could develop example Consent Directives that Serafina Versaggi to coordinate 6         0             0             No         No
                                 illustrate this use case.                        with Chirag


                                                                                                                                                                                  Chirag Bhatt




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                                   27                                                                                          March 2003
                                                                      V3 Ballot Submission/Resolution Form

Considered - Question Answered   We could develop example Consent Directives that Serafina Versaggi to coordinate 6   0   0   No         No
                                 illustrate this use case.                        with Chirag


                                                                                                                                                   Chirag Bhatt




Not related                      This comment was deemed as "not related" because Ioana Singureanu               6    0   0   No         No
                                 it references a constraint that was removed from
                                 this balloted version of this IG. That constraint was
                                 deemed as redunant since this IG is not modifying                                                                 Doug Pratt
                                 the default header.



Persuasive with mod              The suggeted wording contradicts the intent of this Serafina Versaggi           6    0   0        Yes        No
                                 IG to specify a structured representation of consent
                                 directives. Other IGs (e.g. Unstructured Document)
                                 specify how to use nonXMLBody to store a
                                 scanned document of any kind. If a system cannot
                                 support structured consents they will not use this
                                 IG but Unstructured Documents or IHE BPPC. In
                                 addition to structured entries the structuredBody
                                 is intended support scanned document images.                                                                      Doug Pratt
                                 To eliminate any confusion, we will revise the
                                 diagram in Figure 15 to make it clear that only
                                 the structureBody is in scope.
                                 Since the implementers need to make a choice of
                                 nonXML or structured body, this IG provides
                                 only for a structuredBody.


Persuasive                       Fix publication                                     Ioana Singureanu            11   0   0        Yes        No
                                                                                                                                                   Doug Pratt


Persuasive                       Fix publication                                     Ioana Singureanu            11   0   0        Yes        No
                                                                                                                                                   Freida Hall

Considered - Question Answered   It is both the custodian and originator organization. Ioana Singureanu          11   0   0        No         No
                                                                                                                                                   Freida Hall




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                                   28                                                           March 2003
                                                                       V3 Ballot Submission/Resolution Form

Considered - Question Answered   "action" is used in privacy and "operation" is used   Ioana Singureanu    11   0   0   No    No
                                 in security policies.
                                                                                                                                   Freida Hall


Persuasive                       Accept proposed wording                               Serafina Versaggi   11   0   0   Yes   No




                                                                                                                                   John Moehrke




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                                   29                                           March 2003
                                                                    V3 Ballot Submission/Resolution Form

Persuasive                   Accept proposed wording                               Serafina Versaggi   11   0   0         Yes        No




                                                                                                                                          John Moehrke




Not persuasive               This statement will be modified to reflect scanned    Serafina Versaggi   11   0   0   Yes         No
                             documents and structured content.

                                                                                                                                          John Moehrke



Persuasive with mod          This statement will be removed, no longer             Serafina Versaggi   11   0   0         Yes        No
                             applicable.




                                                                                                                                          John Moehrke




Not persuasive               Template identifier are specified in sections 2, 3,   Ioana Singureanu    11   0   0   No          No
                             Appendix B
                                                                                                                                          John Moehrke




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                               30                                                      March 2003
                                                     V3 Ballot Submission/Resolution Form

Persuasive                   Remove "sequentially"           Serafina Versaggi   11   0   0   Yes   No




                                                                                                         John Moehrke




Persuasive                   Add proposed wording.           Serafina Versaggi   11   0   0   Yes   No




                                                                                                         John Moehrke




Persuasive with mod          See #44                         Serafina Versaggi   11   0   0   Yes   No


                                                                                                         John Moehrke




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                         31                                           March 2003
                                                                         V3 Ballot Submission/Resolution Form

Persuasive with mod              Remove the "header" rectangle because it is           Serafina Versaggi   11   0   0   Yes   No
                                 imprecise in this context.




                                                                                                                                   John Moehrke




Persuasive                       replace all occurrences with "privacy consent         Serafina Versaggi   11   0   0   Yes   No
                                 content"
                                                                                                                                   John Moehrke
                                 only once occurrence

Considered - Question Answered   This section is intended to specific future work      Ioana Singureanu    11   0   0   No    No
                                 affecting this artifact. Is the catalog intended to
                                                                                                                                   John Moehrke
                                 change this IG?

Considered - Question Answered   These CDA R2 and RIM concepts are already             Ioana Singureanu    11   0   0   No    No
                                 defined. We should not repeat that info.
                                                                                                                                   John Moehrke




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                                   32                                           March 2003
                                                                  V3 Ballot Submission/Resolution Form

Persuasive                   Remove the reference to IIHI, use default CDA   Ioana Singureanu    11   0   0        Yes        No
                             header.




                                                                                                                                   John Moehrke




Not persuasive               The meaning is not overriden, this usage note   Ioana Singureanu    11   0   0   No         No
                             provider information to implementers on
                             instantiating these documents.




                                                                                                                                   John Moehrke




Persuasive with mod          Add the suggested wording remove redunant       Serafina Versaggi   11   0   0        Yes        No
                             statements.




                                                                                                                                   John Moehrke




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                         33                                                     March 2003
                                                                     V3 Ballot Submission/Resolution Form

Persuasive with mod               Accept proposed wording                          Serafina Versaggi   11   0   0   Yes   No




                                                                                                                               John Moehrke




Persuasive with mod               Accept proposed wording                          Serafina Versaggi   11   0   0   Yes   No




                                                                                                                               John Moehrke




Persuasive with mod               Accept proposed wording                          Serafina Versaggi   11   0   0   Yes   No




Persuasive                        The CDA IG will be updated to reflect the        Serafina Versaggi   11   0   0   Yes   No
                                  recommendation that the XML digital signatures
                                  wrapper wraps the CDA document according to
                                  local policy
                                                                                                                               John Moehrke




Considered - No action required                                                    Ioana Singureanu    11   0   0   No    No   Jonathan D.
                                                                                                                               Belanger




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                               34                                           March 2003
                                                                                      V3 Ballot Submission/Resolution Form

                Persuasive with mod              We investigated HQMF as a example for dealing     Serafina Versaggi     11   0   0        No         No
                                                 with related diagnosis and preconditions in DEF
                                                 mood, but there is no way to leverage HQMF
                                                 because it is not a CDA Implementation Guide and
                                                 we do not the HQMF constructs available in CDA
                                                 R2 which is why we have this use of PreCondition.
                                                                                                                                                           Keith W. Boone




                Not persuasive                   IHE BPPC is already referenced in                   Serafina Versaggi   11   0   0   No         No
                                                 Acknowledgements, Approach, and References                                                                Keith W. Boone
                                                 sections.
                Considered - Question Answered   The resulting assertion is child()/[@title="Consent Ioana Singureanu    11   0   0        Yes        No
                                                 Directive Details"]
                                                                                                                                                           Liora Alschuler



                Considered - Question Answered   The semantics are specified in the header as       Ioana Singureanu     11   0   0        No         No
                                                 LOINC.The sections simply elaborate.
                                                                                                                                                           Liora Alschuler


e were indicated**                                                                                                                                         Walter Suarez
                Persuasive                       Accept proposed wording                            Serafina Versaggi    5    0   1        Yes        No


                                                                                                                                                           Walter Suarez




               53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                                  35                                                        March 2003
                                                                   V3 Ballot Submission/Resolution Form

Persuasive                   We will add it as US-specific examples "Core           Serafina Versaggi   5   0   1   Yes   No
                             consent options (abbreviated) for electronic
                             exchange include the following:
                             • No consent. Health information of patients is
                             automatically included—patients cannot opt out;
                             • Opt-out. Default is for health information of
                             patients to be included automatically, but the
                             patient can opt out completely;
                             • Opt-out with exceptions. Default is for health
                             information of patients to be included, but the
                             patient can opt out completely or allow only select                                               Walter Suarez
                             data to be included;
                             • Opt-in. Default is that no patient health
                             information is included; patients must actively
                             express consent to be included, but if they do so
                             then their information must be all in or all out; and
                             • Opt-in with restrictions. Default is that no patient
                             health information is made available, but the
                             patient may allow a subset of select data to be
                             included."

Persuasive                   Accept proposed wording                              Serafina Versaggi     5   0   1   Yes   No

                                                                                                                               Walter Suarez


Persuasive with mod          Duplicate, the statement will be removed, no longer Serafina Versaggi      5   0   1   Yes   No
                             applicable since we added the template identifiers.                                               Walter Suarez

Persuasive with mod          Duplicate, the statement will be removed, no longer Serafina Versaggi      5   0   1   Yes   No
                             applicable since we added references to coding
                                                                                                                               Walter Suarez
                             systems for dynamic and static vocab constraints
                             and examples.
Persuasive                   Accept proposed wording                             Ioana Singureanu       5   0   1   Yes   No




                                                                                                                               Walter Suarez




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                                36                                           March 2003
                                                                      V3 Ballot Submission/Resolution Form

Persuasive                       Duplicate comment, the definition will be           Serafina Versaggi    5   0   1   Yes   No
                                 expanded.




                                                                                                                                 Walter Suarez




Persuasive                       Accept proposed wording                             Serafina Versaggi    5   0   1   Yes   No




                                                                                                                                 Walter Suarez




Considered - Question Answered   Any type of signature (scanned wet, digital) is      Serafina Versaggi   5   0   1   Yes   No
                                 included in "electronic" signature. We will reword
                                 as "For example, there is no way include an
                                 electronic signature (e.g. digital signature,
                                 scanned wet signature) with the identity of an                                                  Walter Suarez
                                 author, authenticator, or legal authenticator in the
                                 document header that is often mandatory for legally
                                 binding documents. CDA R2 allows us to indicate
                                 if a signature is on record or if it is imminent."




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                                  37                                           March 2003
                                                                 V3 Ballot Submission/Resolution Form

Persuasive                   Simplify wording                                   Serafina Versaggi   11   0   0   Yes   No

                             Amended per Item 13




                                                                                                                            Keith W. Boone




Persuasive                   Use proposed punctuation                           Serafina Versaggi   11   0   0   Yes   No

                             Used verbiage suggested by Walter Suarez instead
                             which included bulleted list



                                                                                                                            Keith W. Boone




Persuasive                                                                      Serafina Versaggi   11   0   0   Yes   No


                                                                                                                            Keith W. Boone



Persuasive with mod          Use the following wording: "representing consent   Serafina Versaggi   11   0   0   Yes   No
                             directives in a standard form for exchange…"                                                   Keith W. Boone




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                            38                                             March 2003
                                                                     V3 Ballot Submission/Resolution Form

Persuasive with mod            The DAM DSTU is intended to communicate with Serafina Versaggi          11   0   0   Yes   No
                               business stakeholders/policy makers. Include
                               software developers, system architects, and
                               analysts

                                                                                                                               Keith W. Boone




Persuasive with mod            Fix rendering on page 14, not 9.                    Ioana Singureanu    11   0   0   Yes   No



                                                                                                                               Keith W. Boone




Pending input from submitter   What is the problem with fig. 1                                         11   0   0
                                                                                                                               Keith W. Boone
                               Asked Keith for larification - no response as yet

Persuasive with mod            The DAM on which this is based is an HL7 DSTU. Serafina Versaggi        11   0   0   Yes   No



                                                                                                                               Keith W. Boone




Persuasive                     Clinical Document Architecture Release 2 (CDA       Serafina Versaggi   11   0   0   Yes   No
                               R2) once and reference it CDA R2.


                                                                                                                               Keith W. Boone




Persuasive                                                                         Serafina Versaggi   11   0   0   Yes   No


                                                                                                                               Keith W. Boone




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                               39                                             March 2003
                                                                 V3 Ballot Submission/Resolution Form

Persuasive                   Remove redundant wording                      Serafina Versaggi   11   0   0        Yes        No



                                                                                                                                 Keith W. Boone




Persuasive                   add clarfication                              Serafina Versaggi   11   0   0        Yes        No



                                                                                                                                 Keith W. Boone




Persuasive                   Remove the redefinition..                     Serafina Versaggi   11   0   0        Yes        No
                                                                                                                                 Keith W. Boone


Persuasive                   Remove boilerplate since Xpath is now the     Serafina Versaggi   11   0   0        Yes        No
                             tradition



                                                                                                                                 Keith W. Boone




Not persuasive                                                             Ioana Singureanu    11   0   0   No         No

                                                                                                                                 Keith W. Boone


Persuasive                   Keep the diagram use vector graphics format   Serafina Versaggi   11   0   0        Yes        No
                                                                                                                                 Keith W. Boone




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                       40                                                       March 2003
                                                                   V3 Ballot Submission/Resolution Form

Persuasive                   Pub issue                                         Serafina Versaggi   11   0   0   No    No

                             BPPC defined earlier in the publication
                                                                                                                           Keith W. Boone




Persuasive                   Remove clause (RM-ODP)                            Serafina Versaggi   11   0   0   Yes   No

                                                                                                                           Keith W. Boone


Persuasive                   Move the diagram                                  Serafina Versaggi   11   0   0   Yes   No
                                                                                                                           Keith W. Boone


Persuasive                   They are required, add that detail.               Serafina Versaggi   11   0   0   Yes   No
                                                                                                                           Keith W. Boone

Persuasive                   Fix the paragraph, add reference to CDA R2 1.2.2. Serafina Versaggi   11   0   0   Yes   No


                                                                                                                           Keith W. Boone




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                           41                                             March 2003
                                                                 V3 Ballot Submission/Resolution Form

Persuasive                   Move to Conformance                                Serafina Versaggi   11   0   0        Yes        No




                                                                                                                                      Keith W. Boone




Not persuasive               This is relevant to the Normative track. We want   Ioana Singureanu    11   0   0   No         No
                             to go normative with CDA R3.
                                                                                                                                      Keith W. Boone


Not persuasive                                                                  Ioana Singureanu    11   0   0   No         No


                                                                                                                                      Keith W. Boone




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                            42                                                       March 2003
                                                                  V3 Ballot Submission/Resolution Form

Persuasive with mod          Remove the note, redundant                         Serafina Versaggi   5   0   1   Yes   No




                                                                                                                           Keith W. Boone




Persuasive                                                                      Serafina Versaggi   5   0   1   Yes   No



                                                                                                                           Keith W. Boone




Persuasive                                                                      Serafina Versaggi   6   0   0   Yes   No

                                                                                                                           Keith W. Boone


Persuasive                                                                      Serafina Versaggi   6   0   0   Yes   No
                                                                                                                           Keith W. Boone
Persuasive                                                                      Serafina Versaggi   6   0   0   Yes   No
                                                                                                                           Keith W. Boone

Persuasive                                                                      Serafina Versaggi   5   0   1   Yes   No

                                                                                                                           Keith W. Boone


Persuasive with mod          Propsed wording "The classes of Patient and        Serafina Versaggi   5   0   1   Yes   No
                             patientRole describe the healthcare client whose
                             IIHI is referenced in document."
                                                                                                                           Keith W. Boone




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                            43                                            March 2003
                                                                    V3 Ballot Submission/Resolution Form

Persuasive with mod          Clarify this is a workaround to the fact that the    Serafina Versaggi    5   0   1   Yes   No
                             /ClinicaDocument/author does not support a
                             function code.

                             Strike the last sentence that this element may be
                             used as a workaround....                                                                         Keith W. Boone




Persuasive with mod          Duplicate comment - include implementation           Ioana Singureanu     5   0   1   Yes   No
                             guidance onl



                                                                                                                              Keith W. Boone




Persuasive with mod          Duplicate comment - include implementation           Serafina Versaggi    5   0   1   Yes   No
                             guidance only
                                                                                                                              Keith W. Boone


Persuasive with mod          In addition to structured content, this specification Serafina Versaggi   5   0   1   Yes   No
                             allows for a scanned image of a of the consent
                                                                                                                              Keith W. Boone
                             directive document to be included as an
                             observationMedia instance.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                               44                                            March 2003
                                                                  V3 Ballot Submission/Resolution Form

Not persuasive with mod      We will add a statement to indicate how other        Serafina Versaggi   6   0   0   Yes         No
                             SDOs should use the Privacy domain analysis
                             model to create profiles - reference OASIS XSPA

                             We will reiterate (as stated in the Privacy Policy
                             DAM) that for encoding capabiities, formal policy
                             languages should be used.

                             This document is trying to express the parameters
                             that would be used by a privacy policy language




                                                                                                                                        Keith W. Boone




Persuasive                   Accept proposed wording                              Serafina Versaggi   6   0   0         Yes        No




                                                                                                                                        Keith W. Boone




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                              45                                                       March 2003
                                                                 V3 Ballot Submission/Resolution Form

Persuasive                   Per POCD_MT000040.xsd                              Serafina Versaggi   5   0   1   Yes   No

                                                                                                                           Keith W. Boone


Persuasive with mod          The informant is indeed the custodian of the       Serafina Versaggi   6   0   0   Yes   No
                             protected information. Disclosing informtion
                             produced by someone else is "redisclosure" -
                             typically not allowed.
                                                                                                                           Keith W. Boone
                             CONF-CD-19: This section SHOULD include one
                             or more entry/act/participant/[@typeCode=’CST’]
                             Need to populate down if necessary


Persuasive                   Accept proposed wording                            Serafina Versaggi   6   0   0   Yes   No


                                                                                                                           Keith W. Boone



Persuasive                   Replace last sentence with "When the negationInd   Serafina Versaggi   6   0   0   Yes   No
                             attribute is not transmitted, the receiver must
                             behave as if negationInd is false."

                             Accept proposed wording                                                                       Keith W. Boone




Persuasive                   Accept proposed wording                            Serafina Versaggi   6   0   0   Yes   No


                                                                                                                           Keith W. Boone



Persuasive                   Per POCD_MT000040.xsd                              Serafina Versaggi   6   0   0   Yes   No


                                                                                                                           Keith W. Boone




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                            46                                            March 2003
                                                     V3 Ballot Submission/Resolution Form




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    47                    March 2003
                                                     V3 Ballot Submission/Resolution Form




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    48                    March 2003
                                                     V3 Ballot Submission/Resolution Form




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    49                    March 2003
                                                     V3 Ballot Submission/Resolution Form




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    50                    March 2003
                                                             V3 Ballot Submission/Resolution Form


                                        Ballot Comment Tracking


                                  On Behalf of       Submitter
Organization    On behalf of      Email              Tracking ID Referred To   Received From   Notes




FEI.com




FEI.com




FEI.com




FEI.com




FEI.com




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                                    51               March 2003
                                                           V3 Ballot Submission/Resolution Form




FEI.com




Siemens




Siemens



Siemens

US Department of Matthew Greene   matthew.greene2@va.gov
Veterans Affairs

US Department of Matthew Greene   matthew.greene2@va.gov
Veterans Affairs




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                          52                    March 2003
                                                          V3 Ballot Submission/Resolution Form



                                   Suzanne.Gonzales-Webb@va.gov
                   Suzanne Gonzales-Webb
US Department of
Veterans Affairs




GE Healthcare




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                         53                    March 2003
                                                     V3 Ballot Submission/Resolution Form




GE Healthcare




GE Healthcare




GE Healthcare




GE Healthcare




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    54                    March 2003
                                                     V3 Ballot Submission/Resolution Form




GE Healthcare




GE Healthcare




GE Healthcare




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    55                    March 2003
                                                     V3 Ballot Submission/Resolution Form




GE Healthcare




GE Healthcare



GE Healthcare




GE Healthcare




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    56                    March 2003
                                                     V3 Ballot Submission/Resolution Form




GE Healthcare




GE Healthcare




GE Healthcare




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    57                    March 2003
                                                     V3 Ballot Submission/Resolution Form




GE Healthcare




GE Healthcare




GE Healthcare




GE Healthcare




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    58                    March 2003
                                                     V3 Ballot Submission/Resolution Form




GE Healthcare


GE Healthcare




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    59                    March 2003
                                                     V3 Ballot Submission/Resolution Form




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    60                    March 2003
                                                     V3 Ballot Submission/Resolution Form




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    61                    March 2003
                                                     V3 Ballot Submission/Resolution Form




GE Healthcare




GE Healthcare




GE Healthcare


GE Healthcare




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    62                    March 2003
                                                     V3 Ballot Submission/Resolution Form




GE Healthcare




GE Healthcare



GE Healthcare




GE Healthcare




GE Healthcare




GE Healthcare



53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    63                    March 2003
                                                     V3 Ballot Submission/Resolution Form




GE Healthcare




GE Healthcare



GE Healthcare




GE Healthcare




GE Healthcare



GE Healthcare




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    64                    March 2003
                                                     V3 Ballot Submission/Resolution Form




GE Healthcare




GE Healthcare



GE Healthcare


GE Healthcare




GE Healthcare




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    65                    March 2003
                                                     V3 Ballot Submission/Resolution Form




GE Healthcare




GE Healthcare




GE Healthcare




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    66                    March 2003
                                                     V3 Ballot Submission/Resolution Form




GE Healthcare




GE Healthcare




GE Healthcare

GE Healthcare


GE Healthcare




GE Healthcare




GE Healthcare




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    67                    March 2003
                                                     V3 Ballot Submission/Resolution Form




GE Healthcare




GE Healthcare



GE Healthcare



GE Healthcare




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    68                    March 2003
                                                     V3 Ballot Submission/Resolution Form




GE Healthcare




GE Healthcare




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    69                    March 2003
                                                     V3 Ballot Submission/Resolution Form




GE Healthcare




GE Healthcare




GE Healthcare




GE Healthcare




GE Healthcare




GE Healthcare




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    70                    March 2003
                                                     V3 Ballot Submission/Resolution Form




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    71                    March 2003
                                                     V3 Ballot Submission/Resolution Form




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    72                    March 2003
                                                     V3 Ballot Submission/Resolution Form




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    73                    March 2003
                                                     V3 Ballot Submission/Resolution Form




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Ballot]                    74                    March 2003
                                                 Ballot Submission/Resolution Instructions

                                                                                                                                   Return to Ballot
  How to Use this Spreadsheet
 Submitting a ballot:

 SUBMITTER WORKSHEET:
 Please complete the Submitter worksheet noting your overall ballot vote. Please note if you have any negative line items, the ballot is considered
 negative overall. For Organization and Benefactor members, the designated contact must be one of your registered voters to conform with
 ANSI guidelines.

 BALLOT WORKSHEET:
 Please complete all lavender columns as described below - columns in turquoise are for the committees to complete when reviewing ballot
 comments.
 Several columns utilize drop-down lists of valid values, denoted by a down-arrow to the right of the cell. Some columns utilize a filter which
 appears as a drop down in the gray row directly below the column header row.
 If you need to add a row, please do so near the bottom of the rows provided.
 If you encounter issues with the spreadsheet, please contact Karen VanHentenryck (karenvan@hl7.org) at HL7 Headquarters.

 Resolving a ballot:
 Please complete all green columns as described below - columns in blue are for the ballot submitters.
 You are required to send resolved ballots back to the ballot submitter, as denoted by the Submitter worksheet.

 Submitting comments on behalf of another person:
 You can cut and paste other peoples comments into your spreadsheet and manually update the column titled "On behalf of" or you
 can use a worksheet with the amalgamation macro in it (available from HL7 Inc. or HL7 Canada (hl7canada@cihi.ca)). The
 amalgamation worksheet contains the necessary instructions to automatically populate the 'submitter', 'organization' and
 'on behalf of' columns. This is very useful for organizational members or international affiliates who have one representative
 for ballot comments from a number of different people.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Instructions]                                                                                              August, 2002
                                           Ballot Submission/Resolution Instructions

  Column Headers
                                             Ballot Submitter (sections in lavender)

 Number                  This is an identifier used by HL7 Committees. Please do not alter.
 Ballot WG               Select the WG from the drop down list that will best be able to resolve the ballot comment.

                         In some situations, the ballot comment is general in nature and can best be resolved by a non-chapter
                         specific WG. This can include MnM (Modeling and Methodology) & INM (Infrastructure and
                         Management). Enter these WGs if you feel the ballot can best be resolved by these groups. In some
                         situations, chapter specific WGs such as OO (Observation and Orders) and FM (Financial Management)
                         will refer ballot comments to these WGs if they are unable to resolve the ballot comment. An explanation
                         of the 'codes' used to represent the Ballot WGs as well as the Ballots they are responsible for is included in
                         the worksheet titled 'CodeReference'
 Artifact                The type of Artifact this Change affects.
                         HD            Hierarchical Message Definition
                         AR            Application Roles
                         RM            Refined Message Information Model
                         IN            Interaction
                         TE            Trigger Event
                         MT            Message Type
                         DM            Domain Message Information Model
                         ST            Storyboard
                         ??            Other


 Section                 Section of the ballot, e.g., 3.1.2. Note: This column can be filtered by the committee, for example, to
                         consider all ballot line items reported against section 3.1.2.
 Ballot                  A collection of artifacts including messages, interactions, & storyboards that cover a specific interest area.
                         Examples in HL7 are Pharmacy, Medical Devices, Patient Administration, Lab Order/Resulting, Medical
                         Records, and Claims and Reimbursement.

                         Select from the drop down list the specific ballot that the comment pertains to. An explanation of the
                         'codes' used to represent the Ballots as well as the Ballot WGs that are are responsible for them is
                         included in the worksheet titled 'CodeReference'. Please refer to the list of available ballots on the HL7
                         site for more descriptive information on current, open ballots.
 Pubs                    If the submitter feels that the issue being raised directly relates to the formatting or publication of this
                         document rather than the content of the document, flag this field with a "Y" value, otherwise leave it blank
                         or "N".


53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Instructions]                                                                                  August, 2002
                                           Ballot Submission/Resolution Instructions

 Vote/Type               Negative Votes:

                         1. (Neg-Mj) Negative Vote with reason , Major. Use this in the situation where the content of the material is
                         non-functional, incomplete or requires correction before final publication. All Neg-Mj votes must be
                         resolved by committee.

                         2. (Neg-Mi) Negative Vote with reason, Minor Type. Use this when the comment needs to be resolved, but
                         is not as significant as a negative major.

                         Affirmative Votes:

                         3. (A-S) Affirmative Vote with Comment - Suggestion. Use this if the committee is to consider a
                         suggestion such as additional background information or justification for a particular solution.

                         4. (A-T) Affirmative Vote with Comment - Typo. If the material contains a typo such as misspelled words,
                         enter A-T.

                         5. (A-Q) Affirmative Vote with Question.

                         6. (A-C) Affirmative Vote with Comment.
 Existing Wording        Copy and Paste from ballot materials.
 Proposed Wording        Denote desired changes.

                         Reason for the Change. In the case of proposed wording, a note indicating where the changes are in the
 Comments
                         proposed wording plus a reason would be beneficial for the WG reviewing the ballot.
 In Person Resolution    Submitters can use this field to indicate that they would appreciate discussing particular comments in
 Required?               person during a WG Meeting. Co-Chairs can likewise mark this field to indicate comments they think
                         should be discussed in person. Please note that due to time constraints not all comments can be reviewed
                         at WGMs.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Instructions]                                                                                 August, 2002
                                           Ballot Submission/Resolution Instructions

                                         Committee Resolution (sections in turquoise)
 Comment Grouping        This is a free text field that WGs can use to track similar or identical ballot comments. For example, if a
                         committee receives 10 identical or similar ballot comments the WG can place a code (e.g. C1) in this
                         column beside each of the 10 ballot comments. The WG can then apply the sort filter to view all of the
                         similar ballot comments at the same time.
 Disposition             The instructions for selecting dispositions were too large for this section and have been moved to the
                         worksheet titled "Instructions Cont.."




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Instructions]                                                                               August, 2002
                                             Ballot Submission/Resolution Instructions

 Withdraw                 Withdraw
 (Negative Ballots        This code is used when the submitter agrees to "Withdraw" the negative line item. The Process
 Only)                    Improvement Committee is working with HL7 Headquarters to clarify the documentation on 'Withdraw" in
                          the HL7 Governance and Operations Manual. To help balloters and co-chairs understand the use of
                          "Withdraw", the following example scenarios have been included as examples of when "Withdraw" might
                          be used: 1) the WG has agreed to make the requested change, 2) the WG has agreed to make the
                          requested change, but with modification; 3) the WG has found the requested change to be persuasive but
                          out-of scope for the particular ballot cycle and encourages the ballotter to submit the change for the next
                          release; 4) the WG has found the requested change to be non-persuasive and has convinced the
                          submitter. If the negative ballotter agrees to "Withdraw" a negative line item it must be recorded in the
                          ballot spreadsheet.

                          The intent of this field is to help manage negative line items, but the WG may elect to manage affirmative
                          suggestions and typos using this field if they so desire.

                          This field may be populated based on the ballotter's verbal statement in a WGM, in a teleconference or
                          in a private conversation with a WG co-chair. The intention will be documented in minutes as appropriate
                          and on this ballot spreadsheet. The entry must be dated if it occurs outside of a WGM or after the
                          conclusion of WGM.

                          The field will be left unpopulated if the ballotter elects to not withdraw or retract the negative line item.

                          Note that a ballotter often withdraws a line item before a change is actually applied. The WG is obliged
                          to do a cross check of the Disposition field with the Change Applied field to ensure that they have
                          finished dealing with the line item appropriately.

                          Retract
                          The ballotter has been convinced by the WG to retract their ballot item. This may be due to a
                          decision to make the change in a future version or a misunderstanding about the content.

                       NOTE: If the line item was previously referred, but withdrawn or retracted once the line item is dealt with
                       in the subsequent WG update the disposition as appropriate when the line item is resolved.
 Disposition Committee If the Disposition is "Refer", then select the WG that is ultimately responsible for resolving the ballot
                       comment. Otherwise, leave the column blank. If the Disposition is "Pending" for action by another WG,
                       select the appropriate WG.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Instructions]                                                                                  August, 2002
                                            Ballot Submission/Resolution Instructions

 Disposition Comment Enter a reason for the disposition as well as the context. Some examples from the CQ WG include:
                     20030910 CQ WGM: The request has been found Not Persuasive because....
                     20031117 CQ Telecon: The group agreed to the proposed wording.
                     20031117 CQ Telecon: Editor recommends that proposed wording be accepted.


 Responsible Person       Identifies a specific person in the WG (or disposition WG) that will ensure that any accepted changes are
                          applied to subsequent materials published by the WG (e.g. updating storyboards, updating DMIMs, etc.).

 For, Against, Abstain    In the event votes are taken to aid in your line item resolutions, there are three columns available for the
                          number of each type of vote possible, for the proposed resolution, against it or abstain from the vote.
 Change Applied           A Y/N indicator to be used by the WG chairs to indicate if the Responsible Person has indeed made the
                          proposed change and submitted updated materials to the committee.
                          A Y/N indicator to be used by the WG chairs to indicate if the line item is a substantive change.
 Substantive Change       NOTE: This is a placeholder in V3 pending definition of substantive change by the ArB.
                          This column is auto filled from the Submitter Worksheet. It is used to refer back to the submitter for a
                          given line item when all the ballot line items are combined into a single spreadsheet or database. For
                          Organization and Benefactor members, the designated contact must be one of your registered voters to
 Submitted By             conform with ANSI guidelines.
                          This column is auto filled from the Submitter Worksheet. Submitter's should enter the name of the
                          organization that they represent with respect to voting if different from the organization that they are
                          employed by. It is used to link the submitter's name with the organization they are voting on behalf of for a
 Organization             given line item when all the ballot line items are combined into a single spreadsheet or database.
                        This column is autofilled from the Submitter Worksheet. It is used to track the original submitter of the line
                        item. Many International Affiliates, Organizational, and Benefactor balloters pool comments from a variety
 On Behalf Of           of reviewers, which can be tracked using this column.
                        This column is autofilled from the Submitter Worksheet. It is used to track the email address of the original
                        submitter of the line item. Many International Affiliates, Organizational, and Benefactor balloters pool
 On Behalf Of Email     comments from a variety of reviewers, which can be tracked using this column.
 Submitter Tracking ID #Internal identifier (internal to the organization submitting the ballot). This should be a meaningful number
                        to the organization that allows them to track comments. This can be something as simple as the
                        reviewer’s initials followed by a number for each comment, i.e. JD-1, or even more complex such as
                        ‘001XXhsJul03’ where ‘001’ is the unique item number, ‘XX’ is the reviewer's initials, ‘hs’ is the company


 Referred To              Use this column to indicate the WG you have referred this ballot comment to.



53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Instructions]                                                                                  August, 2002
                                          Ballot Submission/Resolution Instructions

 Received From           Use this column to indicate the WG from which you have received this ballot comment.
                         This is a free text field that WGs can use to add comments regarding the current status of referred or
 Notes                   received item.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Instructions]                                                                          August, 2002
                                         Ballot Submission/Resolution Instructions




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Instructions]                             August, 2002
                                         Ballot Submission/Resolution Instructions




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Instructions]                             August, 2002
                                             Ballot Submission/Resolution Instructions

                                                                                                         Back to ballot           Back to instructions
Ballot instructions continued...
For the column titled "Disposition" please select one of the following:

Applicable to All Ballot Comments (Affirmative and Negative)
1. Persuasive. The WG has accepted the ballot comment as submitted and will make the appropriate change in the next ballot cycle. At this point the
comment is considered withdrawn and the corresponding cell from the column titled ‘Withdrawn’ should be marked appropriately. Section 14.08.01.03
of the HL7 Governance and Operations Manual (GOM) states that if a ballot comment is to be withdrawn that “…the Work Group effecting reconciliation
agrees without objection that the poistion expressed by the negative response is persuasive” and therefore WGs must take a vote to accept the
comment as persuasive.

2. Persuasive with Mod. The WG believes the ballot comment has merit, but has changed the proposed solution given by the voter. Example
scenarios include, but are not limited to;
-The WG has accepted the intent of the ballot comment, but has changed the proposed solution
-The WG has accepted part of the ballot comment, and will make a change to the standard; the other part is not persuasive
-The WG has accepted part of the ballot comment, and will make a change to the standard; the other part may be persuasive but is out of scope
The standard will be changed accordingly in the next ballot cycle. The nature of, or reason for, the modification is reflected in the Disposition Comments.
At this point the comment is considered withdrawn and the corresponding cell from the column titled ‘Withdrawn’ should be marked appropriately.
Section 14.08.01.03 of the HL7 Governance and Operations Manual (GOM) states that if a ballot comment is to be withdrawn that “…the Work Group
effecting reconciliation agrees without objection that the poistion expressed by the negative response is persuasive” and therefore WGs must take a
vote to accept the comment as persuasive.

3. Not Persuasive. The WG does not believe the ballot comment has merit or is unclear. Section 14.08.01.02 of the HL7 GOM states that “Approval of
a motion to declare a negative response not persuasive shall require an affirmative vote of at least sixty percent (60%) of the combined affirmative and
negative votes cast by the Work Group during reconciliation.” A change will not be made to the standard or proposed standard. The WG must indicate a
specific reason why the ballot comment is rejected in the Disposition Comments. The ballot submitter has the option to appeal this decision following
HL7 procedures as defined in section 14.12 of the HL7 GOM.
Example scenarios include, but are not limited to;
- the submitter has provided a recommendation or comment that the WG does not feel is valid
- the submitter has not provided a recommendation/solution; the submitter is encouraged to submit a proposal for a future ballot
- the recommendation/solution provided by the submitter is not clear; the submitter is encouraged to submit a proposal for a future ballot

4. Not Persuasive with Mod. The comment was considered non-persuasive by the WG; however, the WG has agreed to make a modification to the
material based on this comment. For example, adding additional explanatory text. Additional changes suggested by the non-persuaive comment will
not be made to the standard or proposed standard. The WG must indicate a specific reason why the ballot comment is rejected in the Disposition
Comments. The ballot submitter has the option to appeal this decision following HL7 procedures as defined in section 14.12 of the HL7 GOM.

5. Not Related. The WG has determined that the ballot comment is not relevant to the domain at this point in the ballot cycle. Section 14.08.01.01 of
the HL7 GOM states that “Approval of a motion to declare a negative response not related shall require an affirmative vote of at least sixty percent
(60%) of the combined affirmative and negative votes cast by the Work Group during reconciliation.” Example scenarios include, but are not limited to;


53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Instructions Cont..]                                                                                August, 2002
                                            Ballot Submission/Resolution Instructions
(60%) of the combined affirmative and negative votes cast by the Work Group during reconciliation.” Example scenarios include, but are not limited to;
- the submitter is commenting on a portion of the standard, or proposed standard, that is not part of the current ballot
- the submitter's comments may be persuasive but beyond what can be accomplished at this point in the ballot cycle without creating potential
controversy.
- the submitter is commenting on something that is not part of the domain

6. Referred and Tracked. This should be used in circumstances when a comment was submitted to your WG in error and should have been submitted
to another WG. If you use this disposition you should also select the name of the WG you referred the comment to under the Column "Referred To".

7. Pending Input from Submitter. This should be used when the WG has read the comment but didn't quite understand it or needs to get more input
from the submitter. By selecting "Pending Input from Submitter" the WG can track and sort their dispositions more accurately.

8. Pending Input from other WG. The WG has determined that they cannot give the comment a disposition without further input or a final decision
from another WG. This should be used for comments that do belong to your WG but require a decision from another WG, such as ArB or MnM.

Applicable only to Affirmative Ballot Comments
9. Considered for future use. The WG, or a representative of the WG (editor or task force), has reviewed the item and has determined that no change
will be made to the standard at this point in time. This is in keeping with ANSI requirements. The reviewer should comment on the result of the ballot
comment consideration. An Example comment is included here:
- the suggestion is persuasive, but outside the scope of the ballot cycle; the submitter is encouraged to submit a proposal to the WG using the agreed
upon procedures.

10. Considered-Question answered. The WG, or a representative of the WG (editor or task force), has reviewed the item and has answered the
question posed. In so doing, the WG has determined that no change will be made to the standard at this point in time. This is in keeping with ANSI
requirements.

11. Considered-No action required. Occasionally people will submit an affirmative comment that does not require an action. For example, some WG's
have received comments of praise for a job well done. This comment doesn't require any further action on the WG's part, other than to keep up the
good work.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Instructions Cont..]                                                                             August, 2002
                                                          Ballot Submission/Resolution Instructions




     int the

econciliation




 Comments.




           of

st indicate a




                53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Instructions Cont..]                       August, 2002
                                                         Ballot Submission/Resolution Instructions




en submitted


more input




t no change




 some WG's




               53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Instructions Cont..]                       August, 2002
                                                               V3 Ballot Submission/Resolution Form


  Note on entering large bodies of text:
  ------------------------------------------------------------------
  When entering a large body of text in an Excel spreadsheet cell:

  1) The cell is pre-set to word wrap

  2) You can expand the column if you would like to see more of the available data

  3) There is a limit to the amount of text you can enter into a "comment" text column so keep things brief.
     -For verbose text, we recommend a separate word document; reference the file name here and include it (zipped) with your ballot.

  4) To include a paragraph space in your lengthly text, use Alt + Enter on your keyboard.

  5) To create "bullets", simply use a dash "-" space for each item you want to
  "bullet" and use two paragraph marks between them (Alt + Enter as described
  above).
  ------------------------------------------------------------------




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Format Guidelines]                         88                                                March 2003
                                                            V3 Ballot Submission/Resolution Form




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Format Guidelines]                89                    March 2003
                                                             V3 Ballot Submission/Resolution Form


 Note: This section is a placeholder for Q&A/Helpful Hints for ballot resolution. (These notes are from Cleveland Co-Chair meeting; needs to be edited, or replaced by use cases)

 Marked ballots
 Issue For second and subsequent membership ballots HL7 ballots only the substantive changes that were added since the last ballot, with the instructions that ballots returned on unmarked ite
 “not related”. How do you handle obvious errors that were not marked, for example, the address for an external reference (e.g. DICOM) is incorrect?
 Response You can correct the obvious typographical errors as long as it is not a substantive change, even if it is unmarked. We recommend conservation interpretation of “obvious error” as y
 make a change that will questioned, or perceived to show favoritism. If you are unclear if the item is an “obvious error” consult the TSC Chair or ARB.
 Comment With the progression of ballots from Committee - > Membership the closer you get to final member ballot, the more conservative you should be in adding content. In the early stag
 ballot, it may be acceptable to adding new content (if endorsed by the committee) as wider audiences will review/critique in membership ballot. The Bylaws require two levels of ballot for n
 to Section 14.01). Exceptions must approved by the TSC Char.

 Non-persuasive
 Issue Use with discretion· Attempt to contact the voter before you declare their vote non-persuasive· Fixing a problem (e.g. typo) in effect makes the negative vote non-persuasive.· In all case
 be informed of the TC’s action.
 Response The preferred outcome is for the voter to withdraw a negative ballot; It is within a chair’s prerogative to declare an item non-persuasive. However, it does not make sense to declar
 without attempting to contact the voter to discuss why you are declaring non-persuasive. If you correct a typo, the item is no longer (in effect) non-persuasive once you have adopted their re
 change, however the voter should then willingly withdraw their negative as you have made their suggestion correction.. In all cases, you must inform the voter.
 Comment


 Non-related
 Issue Use with discretion· Used, for example, if the ballot item is out of scope, e.g. on a marked ballot the voter has submitted a comment on an area not subject to vote.· Out of scope items
 Response
 Comment


 Non-standard ballot responses are received
 Issue The ballot spreadsheet allows invalid combination, such as negative typo.
 Response Revise the ballot spreadsheets to support only the ANSI defined votes, plus “minor” and “major” negative as requested by the committees for use as a management tool. Question w
 Suggestion will be retained
 Comment Separate Affirmative/Abstain and Negative ballots will be created. Affirmative ballots will support: naffirmativenaffirmative with commentnaffirmative with comment
 comment – suggestionnabstainNegative ballots will support:nnegative with reason – majornnegative with reason – minorNote: “major” “minor” need definition

 Substantive changes must be noted in ballot reconciliation
 Issue Who determines whether a ballot goes forward?
 Response Substantive changes in a member ballot will result in a subsequent ballot. These should be identified on the ballot reconciliation form. (Refer to Bylaws 15.07.03). The TSC Chair
 whether the ballot goes forward to another member ballot, or back to committee ballot.
 Comment · Co-chairs and Editors need a working knowledge of “substantive change” as defined on the Arb website.·

 What Reconciliation Documentation Should Be Retained?
 Issue · By-Laws Section 14.04.01 states: “All comments accompanying affirmative ballots shall be considered by the Technical Committee.” This means each line item must be reviewed. Y
 disposition "considered" to mark affirmative comments that have been reviewed. Committees are encouraged to include in the comment section what they thing of the affirmative comment a


53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Co-Chair Guidelines]                        90                                                                              March 2003
                                                              V3 Ballot Submission/Resolution Form

 disposition "considered" to mark affirmative comments that have been reviewed. Committees are encouraged to include in the comment section what they thing of the affirmative comment a
 they think action should be taken, and by who.
 Response ·
 Comment


 How do you handle negatives without comment?
 Issue How do you handle a negative ballot is submitted without comments?
 Response The co-chair attempts to contact the voter, indicating “x” days to respond. If there is no response, the vote becomes 'not persuasive' and the co-chair must notify the ballotter of this


 Appeals
 Issue How are appeals handled?
 Response · Negative votes could be appealed to the TSC or Board· Affirmative votes cannot be appealed
 Comment

 Some information is not being retained
 Issue · The disposition of the line item as to whether or not a change request has been accepted needs to be retained. · The status of the line item as it pertains to whether or not the respondent
 the line item is a separate matter and needs to be recorded in the column titled "withdrawn'

 Some information is not being retained
 Issue By-Laws Section 14.04.01 states: “All comments accompanying affirmative ballots shall be considered by the Technical Committee.”· There is divided opinion as to whether or not Tec
 Committee’s need to review all line items in a ballot.· Should there be a statement on the reconciliation document noting what the TC decided?
 Response “. . .considered” does not mean the committee has to take a vote on each line item. However, a record needs to be kept as to the disposition. There are other ways to review, e.g. se
 committee for review offline, and then discuss in conference call. The review could be asynchronous, then coordinated in a conference call. The ballot has to get to a level where the committ
 the item. The committee might utilize a triage process to manage line items.
 Comment Action Item: Add to the ballot spreadsheet a checkoff for “considered; this would not require, but does not prohibit, documentation of the relative discussion.

 Withdrawing Negatives
 To withdraw a negative ballot or vote, HQ must be formally notified. Typically, the ballotter notifies HQ in writing of this intent. If, however, the ballotter has verbally expressed the intention
 entire negative ballot in the TC meeting, this intent must be documented in the minutes. The meeting minutes can then be sent via e-mail to the negative voter with a note indicating that this i
 that he/she withdrew their negative as stated in the attached meeting minutes and that their vote will be considered withdrawn unless they respond otherwise within five (5) days.

 The ballotter may also submit a written statement to the TC. The submitter's withdrawal must be documented and a copy retained by the co-chairs and a copy sent to HL7 HQ by email or fax.

 Two weeks (14 days) prior to the scheduled opening of the next ballot, the co-chairs must have shared the reconciliation package or disposition of the negative votes with the negative balloter
 balloters then have 7 days to withdraw their negative vote. If, 7 days prior to the scheduled opening of the next ballot the negative vote is not withdrawn, it will go out
 with the subsequent ballot as an outstanding negative.


 Changes applied are not mapped to a specific response
 Issue Changes are sometimes applied to the standard that are not mapped directly to a specific ballot response , due to editing requirements
 Response: A column to record substantive changes and to track whether the change has been applied was added.


53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Co-Chair Guidelines]                          91                                                                               March 2003
                                                               V3 Ballot Submission/Resolution Form

 Response: A column to record substantive changes and to track whether the change has been applied was added.

 Asking for negative vote withdrawal:
 Please include the unique ballot ID in all requests to ballot submitters. E.g. if asking a ballot submitter to withdraw a negative please use the ballot ID to reference the ballot.


 The following sections contain known outstanding issues. These have not been resolved because they require a 'ruling' on interpretations of the Bylaws and the Policies and Procedures
 updating of those documents. If you ever in doubt on how to proceed on an item, take a proposal for a method of action, then take a vote on that proposal of action and record it in the sp
 the minutes.

 Tracking duplicate ballot issues is a challenge
 Issue Multiple voters submit the same ballot item.
 Response While items may be “combined” for purposes of committee review, each ballot must be responded to independently.
 Comment


 Editorial license
 Issue There is divided opinion as to the boundaries of "editorial license".
 Response
 Comment


 Divided opinion on what requires a vote
 Issue
 Response · Do all negative line items require inspection/vote of the TC? – Yes, but you can group· Do all substantive line items require inspection/vote of the TC? Yes· How should non
 be evaluated for potential controversy that would require inspection and vote of the TC? Prerogative of Chair, if so empowered
 Comment


 Ballet Reconciliation Process Suggestion
 Issue It might be useful to map the proposed change to the ARB Substantive Change document. This would involve encoding the ARB document and making allowances for “Guideline Not F
 Response ARB is updating their Substantive Change document; this process might elicit additional changes.
 Comment Action Item? This would require an additional column on the spreadsheet

 How are line item dispositions handled?
 Issue Line items are not handled consistently
 Response · A Withdrawn negative is counted as an affirmative (this is preferable to non-persuasive.)· A Not related remains negative in the ballot pool for quorum purposes, but does not imp
 e.g. it does not count as a negative in the 90% rule.· A Not persuasive remains negative in the ballot pool for quorum purposes, but does not impede the ballot, e.g. it does not count as a negat
 rule.· Every negative needs a response; not every negative needs to be “I agree with your proposed change.” The goal is to get enough negatives resolved in order to get the ballot to pass, wh
 quality standard.
 Comment

 How should negative line items in an “Affirmative Ballot” be handled?

53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Co-Chair Guidelines]                          92                                                                                March 2003
                                                               V3 Ballot Submission/Resolution Form


 How should negative line items in an “Affirmative Ballot” be handled?
 Issue Affirmative Ballots are received that contained negative line items. The current practice is to err on the side of caution and treat the negative line item as a true negative (i.e. negative ba
 Response · If a member votes “Affirm with Negative line item” the negative line item is treated as a comment but the ballot overall is affirmative.· Action Item: This must be added to the Ba
 Comment Revising the ballot spreadsheet to eliminate invalid responses will minimize this issue. Note on the ballot spread

 Difference Between Withdraw and Retract
 If a ballot submitter offers to withdraw the negative line item the ‘negative’ still counts towards the total number of affirmative and negative votes received for the ballot (as it currently seems
 bylaws). If the submitter offers to retract their negative then it does not count towards the overall affirmative and negative votes received for the ballot.




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Co-Chair Guidelines]                          93                                                                                March 2003
                                                            V3 Ballot Submission/Resolution Form




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Co-Chair Guidelines]              94                    March 2003
                                                                           V3 Ballot Submission/Resolution Form


, or replaced by use cases)


lots returned on unmarked items will be found

etation of “obvious error” as you do not want to

ing content. In the early stages of committee
uire two levels of ballot for new content (refer



       persuasive.· In all cases, the voter must

does not make sense to declare non-persuasive
nce you have adopted their recommended




to vote.· Out of scope items




management tool. Question will be removed.

ive with comment – typonaffirmative with




ws 15.07.03). The TSC Chair will determine




ne item must be reviewed. You can use the
of the affirmative comment and whether or not


               53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Co-Chair Guidelines]              95                    March 2003
                                                                            V3 Ballot Submission/Resolution Form

 of the affirmative comment and whether or not




 ust notify the ballotter of this disposition.




whether or not the respondent has withdrawn



 nion as to whether or not Technical

e other ways to review, e.g. send to the
 to a level where the committee could vote on




erbally expressed the intention to withdraw the
 th a note indicating that this is confirmation
hin five (5) days.

nt to HL7 HQ by email or fax.

otes with the negative balloters. The negative




                53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Co-Chair Guidelines]              96                    March 2003
                                                                           V3 Ballot Submission/Resolution Form




 the Policies and Procedures as well as
 action and record it in the spreadsheet and in




C? Yes· How should non-substantive changes




owances for “Guideline Not Found”.




m purposes, but does not impede the ballot,
g. it does not count as a negative in the 90%
er to get the ballot to pass, while producing a




               53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Co-Chair Guidelines]              97                    March 2003
                                                                            V3 Ballot Submission/Resolution Form



 true negative (i.e. negative ballot).
 This must be added to the Ballot Instruction



he ballot (as it currently seems to state in the




                53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Co-Chair Guidelines]              98                    March 2003
                                                            V3 Ballot Submission/Resolution Form




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Co-Chair Guidelines]              99                    March 2003
Ballot Committee Code   Ballot Committee Name Ballot Code Name

InM                     Infrastructure and      CT
                        Messaging               XML-ITS DataTypes

                                                XML-ITS Structures

                                                Datatypes Abstract
                                                MT
                                                TRANSPORT
                                                UML-ITS DataTypes

                                                CI, AI, QI
                                                MI

CBCC                    Community Based         MR
                        Collaborative Care


CDS                     Clinical Decision Support DS

CS                      Clinical Statement      CS

FM                      Financial Management    AB
                                                CO
                                                CR

II                      Imaging Integration     DI
                                                II

M and M                 Modelling and           RIM
                        Methodology             Refinement
                                                CPP
                                                MIF
                                                HDF

MedRec                  Medical Records (now    MR
                        merged with SD)

OO                      Orders and Observations BB
                                                CG
                                                CP
                                                LB
                                                ME
                                                OB
                                                OR
                                                RX
                                                SP
                                      TD


PA           Patient Administration   PA
                                      MM
                                      SC

PC           Patient Care             PC

PM           Personnel Management     PM

PHER         Public Health /          IZ
             Emergency Response       PH
                                      RR

Publishing   Publishing               V3 Help Guide (ref)
                                      Backbone (ref)

RCRIM        Regulated Clinical Research Information Management
                                      RP
                                      RT

Sched        Scheduling               SC

StructDocs   Structured Documents     CD
                                      QM

Vocab        Vocabulary               Vocabulary (ref)
                                      Glossary (ref)

ArB          Architectural Review Board
Attach       Attachments
CCOW         Clinical Context Object Workgroup
Ed           Education
Meaning

Version 3: (CMET) Common Message Elements, Release 1, 2, 3
Version 3: XML Implementation Technology Specification - Data Types, Release
1
Version 3: XML Implementation Technology Specification - Structures, Release 1

Version 3: Data Types - Abstract Specification, Release 1
Version 3: Shared Messages, Release 1, 2
Version 3: Transport Protocols
Version 3: UML Implementation Technology Specification - Data Types, Release
1
Version 3: Infrastructure Management, Release 1
Version 3: Master File/Registry Infrastructure, Release 1

Version 3: Medical Records: Composite Privacy Consent Directive, Release 1


Version 3: Clinical Decision Support, Release 1

Version 3: Clinical Statement Pattern, Release 1

Version 3: Accounting and Billing, Release 1,2
Version 3: Coverage, Release 1 (virtual CMET domain)
Version 3: Claims and Reimbursement, Release 1, 2, 3, 4

Version 3: Diagnostic Imaging, Release 1
Version 3: Imaging Integration, Release 1

Version 3: Reference Information Model, Release 1, 2
Version 3: Refinement, Extensibility and Conformance, Release 1, 2
Version 3: Core Principles and Properties
Version 3: Model Interchange Format
Version 3: HL7 Development Framework, Release 1

Version 3: Medical Records, Release 1, 2


Version 3: Blood Tissue Organ, Release 1
Version 3: Clinical Genomics, Release 1
Version 3: Common Product Model, Release 1
Version 3: Laboratory, Release 1
Version 3: Medication, Release 1
Version 3: Observations, Release 1
Version 3: Orders, Release 1
Version 3: Pharmacy, Release 1
Version 3: Specimen, Release 1
Version 3: Therapeutic Devices, Release 1


Version 3: Patient Administration, Release 1, 2
Version 3: Material Management, Release 1
Version 3: Scheduling, Release 1

Version 3: Care Provision, Release 1

Version 3: Personnel Management, Release 1

Version 3: Immunization, Release 1
Version 3: Public Health, Release 1
Version 3: Regulated Reporting, Release 1

Version 3: Guide
Version 3: Backbone

Version 3: Regulated Products, Release 1
Version 3: Regulated Studies, Release 1

Version 3: Scheduling, Release 1, 2

Version 3: Clinical Document Architecture, Release 1, 2
Version 3: Quality Measures, Release 1

Version 3: Vocabulary
Version 3: Glossary
Type of Document

Domain

Foundation

Foundation
Foundation
Domain
Foundations

Foundation
Domains
Domain



Domain

Domain

Domain

Domain
Domain
Domain

Domain
Domain

Foundation
Foundation
Foundation
Foundation
Foundation



Domain

Domain
Domain
Domain
Domain
Domain
Domain
Domain
Domain
Domain
Domain



Domain
Domain
Domain

Domain

Domain

Domain
Domain
Domain

Reference
Reference

Domain
Domain

Domain

Domain
Domain

Foundation
Reference
                                                            V3 Ballot Submission/Resolution Form

This page reserved for HL7 HQ. DO NOT EDIT.




                      Affirmative Negative



If you submit an overall affirmative vote, please make sure you have not included negative line items on the Ballot worksheet
Please be sure that your overall negative vote has supporting negative comments with explanations on the Ballot worksheet
You have indicated that you will be attending the Working Group Meeting and that you would like to discuss at least one of your comments with the responsible Committee during that time. Ple




Yes                   No


                                                                              Consi Consi            Pendi Pendi
                                                                              dered - dered -        ng      ng
                                                                     Consider No      Questi         input input
                                                                     ed for   action on              from from
                      Persuasive Not      Not persuasive     Not     future   requir Answe           submit other
Persuasive            with mod persuasive with mod           related use      ed      red            ter     WG
                                                                                              Referred and tracked

HD
AR
RM
IN
TE
MT
DM
ST
??




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Setup]                                     106                                                                          March 2003
                                                    V3 Ballot Submission/Resolution Form

                                                         ArB,Atta
                                                         ch,Cardi
                                                         o,CBCC,
                                                         CCOW,
                                                         CDS,CG
                                                         ,CIC,Clin
                                                         ical
                                                         Stateme
                                                         nt,Confo
                                                         rm,Ed,E
                                                         HR,FM,II
                                                         ,Implem
                                                         entation,
                                                         InM,ITS,
                                                         Lab,M
                                                         and M,M
                                                         and M/
                                                         CMETs,
                                                         M and
                                                         M/
                                                         Templat
                                                         es,M
                                                         and M/
                                                         Tooling,
                                                         MedRec,
                                                         OO,PA,
                                                         PC,PHE
                                                         R,PM,P
                                                         S,PSC,P
                                                         ublishing
                                                         ,RCRIM,
                                                         RX,Sche
                                                         d,Securit




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Setup]                    107                   March 2003
                                                                           V3 Ballot Submission/Resolution Form




Committee during that time. Please note that due to time constraints not all comments can be reviewed at WGMs and that it is your responsibility to find out when this ballot comment can be scheduled for dis




              53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Setup]                                     108                                                                             March 2003
                                                    V3 Ballot Submission/Resolution Form




53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Setup]                   109                    March 2003
                                                                 V3 Ballot Submission/Resolution Form




omment can be scheduled for discussion.




             53836d3e-8bd6-446c-ba22-2ad5dcac7167.xlsx [Setup]                   110                    March 2003

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:0
posted:5/14/2013
language:Latin
pages:110
yaofenji yaofenji
About