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                             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:        Liora Alschuler
                     SUBMITTED BY EMAIL:        Liora Alschuler

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                             applicable):
                      SUBMISSION DATE:
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.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:        Liora Alschuler
                     SUBMITTED BY EMAIL:        Liora Alschuler

                     SUBMITTED BY PHONE:
           SUBMITTED BY ORGANIZATION (if
                             applicable):
                      SUBMISSION DATE:
                SUBMITTED BY IDENTIFIER:
                  OVERALL BALLOT VOTE:          Affirmative




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Submitter]                                2                                                                  March 2003
                                                                   V3 Ballot Submission/Resolution Form


                                                                                          Ballot Comment Submission

                                                                                                   Vote
                                                                                                   and
Number     Ballot WG      Artifact   Artifact ID     Chapter       Section     Ballot   Pubs       Type    Existing Wording                        Proposed Wording
         1 CBCC                                                    3.2                               A-S   CONF-CD-14: A Consent
                                                                                                           Directive SHALL contain the
                                                                                                           sections described hereunder.



         2                                                         3.2                              A-S    CONF-CD-15: requires templateID suggest or require a LOINC section
                                                                                                           and title; no requirement for section code
                                                                                                           code


         3 CBCC                                      1             1.8.2                            A-Q    If approved in January 2010
                                                                   Future
                                                                   Work
         4 CBCC                                      2             Figure 13                        A-Q    Originator


         5 CBCC                                                                                     A-C    action vs. action / operation




         6 CBCC                                      1.1 Purpose                                   Neg-Mi Privacy policies define how              Privacy policies define how
                                                                                                          Individually Identifiable Health         Individually Identifiable Health
                                                                                                          Information (IIHI) is to be collected,   Information (IIHI) is to be collected,
                                                                                                          accessed, used and disclosed. A          accessed, used and disclosed. A
                                                                                                          Consent Directive is a record of a       Consent Directive is a record of a
                                                                                                          healthcare client’s privacy policy,      client’s (e.g., a patient’s) privacy
                                                                                                          which is in accordance with              policy. It grants or withholds
                                                                                                          governing jurisdictional and             authorization to perform these
                                                                                                          organizational privacy policies that     functions. Effective Consent
                                                                                                          grant or withhold consent to IIHI.       Directives are in accord with law,
                                                                                                          In addition, Consent Directives          regulation and organizational
                                                                                                          provide the ability for a healthcare     policies with regard to their content.
                                                                                                          client to delegate authority to a        In addition, Consent Directives
                                                                                                          Substitute Decision Maker who may        provide the ability for a healthcare
                                                                                                          act on behalf of that individual.        client to delegate authority to a
                                                                                                                                                   Substitute Decision Maker who
                                                                                                                                                   may act on behalf of that individual.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                                             3                                                                                            March 2003
                                                              V3 Ballot Submission/Resolution Form

         7                                           1.1                              A-T     Consent Directive examples include     Consent Directive examples include:
                                                                                              basic Opt-In/Opt-Out to clinical       * basic Opt-In/Opt-Out to clinical
                                                                                              use; Opt-Out of sharing outside of     use;
                                                                                              local event use, allowing emergency    * Opt-Out of sharing outside of
                                                                                              override; limit access to functional   local 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.

         8                                           1.1                              A-T     The CDA IG for Consent Directives      The CDAImplementation Guide for
                                                                                              is intended to provide multiple        Consent Directives provides
                                                                                              representations for expressing         multiple representations for
                                                                                              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.
         9                                           1.1                             Neg-Mi expressing privacy preferences and
                                                                                            for exchanging privacy policies

       10                                            1.2                             Neg-Mi The audience for this document           The audience for this document
                                                                                            includes software developers and         includes software developers,
                                                                                            consultants                              system architects, policy makers
                                                                                                                                     and analysts.




       11                                            Page 9                Yes       Neg-Mi




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                                                                  V3 Ballot Submission/Resolution Form

       12                                            Figure 1                          Neg-Mi



       13                                            1.4                               Neg-Mi The requirements of this Draft
                                                                                              Standard for Trial Use (DSTU) are
                                                                                              on track to become normative after
                                                                                              a trial period and will be subject to
                                                                                              change under the policies for DSTU
                                                                                              as specified by the HL7 Governance
                                                                                              and Operations Manual.

       14                                            Throughout                        Neg-Mi CDA R2
                                                                                              CDA Release 2 (R2)
                                                                                              Clinical Document Architecture
                                                                                              (CDA)
                                                                                              Clinical Document Architecture
                                                                                              (CDA) Release 2 (R2)
                                                                                              CDA Release 2

       15                                            1.5                                A-T     In this specification all templates are   In this specification all templates
                                                                                                backed up by use case and                 are 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).

       16                                            1.5                               Neg-Mi While in the most general forms of This implementation guide asserts
                                                                                              CDA exchange, an originator need when templateIds are required for
                                                                                              not apply a templateId for every    conformance.
                                                                                              template that an object in an
                                                                                              instance document conforms to, this
                                                                                              implementation guide asserts when
                                                                                              templateIds are required for
                                                                                              conformance.
       17                                            1.5.2                             Neg-Mj




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       18                                            1.6.3                           Neg-Mi




       19                                            1.6.4                            A-T     Instead of the traditional dotted      This document uses XPath notation
                                                                                              notation used by HL7 to represent      in conformance statements and
                                                                                              RIM classes, this document uses        elsewhere to identify the Extensible
                                                                                              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.

       20                                            1.7                             Neg-Mi




       21                                            Figure 3                        Neg-Mj



       22                                            1.8                             Neg-Mi BPPC




       23                                            1.8                             Neg-Mj In RMO-DP terms,




       24                                            1.8        Figure 3             Neg-Mi



       25                                            1.8.1                           Neg-Mi




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       26                                            1.8.1                        Neg-Mi many additional distinctions in
                                                                                         reusability could be defined




       27                                            1.8.1                        Neg-Mj Conformance to the DSTU carries
                                                                                         with it an implicit adherence to
                                                                                         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.

       28                                            1.8.2                        Neg-Mi




       29                                            1.8.2   Figure 4             Neg-Mi




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                            7                                                  March 2003
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       30                                            2                               Neg-Mi NOTE: Elements reused here may
                                                                                            be further constrained within this
                                                                                            implementation guide. For
                                                                                            example, general constraints limit
                                                                                            the document type code to the
                                                                                            LOINC® document type
                                                                                            vocabulary. However, whenever
                                                                                            header sections below do not
                                                                                            contain additional conformance
                                                                                            statements, General Header
                                                                                            Constraints apply.
       31                                            2                               Neg-Mi The Consent Directive document
                                                                                            requires two document level-two
                                                                                            templateIds: one asserts use of the
                                                                                            General Header Constraints
                                                                                            template and the other asserts
                                                                                            conformance with the specific
                                                                                            constraints of the Consent Directive

       32                                            2                                A-T    CONF-CD-1: A document
                                                                                             conforming to the CDA General
                                                                                             Header template SHALL include the
                                                                                             ClinicalDocument/templateId
                                                                                             “2.16.840.1.113883.10.20.3”.
       33                                            Figure 5                         A-T

       34                                            2.1                              A-T


       35                                            2.1                             Neg-Mj 2.1.1.1 ClinicalDocument/templateId 2.1.1.1
                                                                                                                                /ClinicalDocument/templateId



       36                                            2.1.2                           Neg-Mj The attributes Patient and
                                                                                            patientRole refer to the healthcare
                                                                                            client whose IIHI is referenced in
                                                                                            document.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                               8                                                                             March 2003
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       37                                            2.1.3                        Neg-Mi CONF-CD-4:
                                                                                         ClinicalDocument/author/functionC
                                                                                         ode/ MAY be present to specify
                                                                                         function/relationship of the author
                                                                                         to the client who is the record target.
                                                                                         This element may be used as a
                                                                                         workaround to specify the client’s
                                                                                         relationship to the Substitute
                                                                                         Decision Maker – if one is involved
                                                                                         in the creation of the consent
                                                                                         directive.
       38                                            2.1.4                        Neg-Mi 2.1.4 ClinicalDocument/custodian
                                                                                         This element of the header identifies
                                                                                         the custodian of the Consent
                                                                                         Directive document. This may be
                                                                                         the custodian of the IIHI as well, but
                                                                                         this specification allows for the
                                                                                         custodian of the IIHI and custodian
                                                                                         of the consent to be different.

       39                                            2.2                          Neg-Mi



       40                                            3                            Neg-Mj The IHE Basic Patient Privacy
                                                                                         Consents specifies the contents of
                                                                                         the consent directive document as
                                                                                         an observationMedia.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                            9                                                    March 2003
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       41                                                                  Neg-Mj includes one of the following in
                                                                                  addition to a formatted narrative
                                                                                  representation of a Consent
                                                                                  Directive:
                                                                                  1) An interoperable representation
                                                                                  of a client’s privacy preferences
                                                                                  using HL7-based sections and
                                                                                  entries that enables the exchange of
                                                                                  consent directives between entities
                                                                                  using dissimilar security
                                                                                  frameworks to enforce the assertions
                                                                                  made by the consenter.
                                                                                  2) An equivalent representation
                                                                                  using prevailing, platform-specific
                                                                                  assertions to enable the exchange of
                                                                                  computable consent directives
                                                                                  across similar systems using a
                                                                                  common security infrastructure.
                                                                                  This representation will use a well-
                                                                                  defined assertion language
                                                                                  corresponding to the appropriate
                                                                                  access control markup or digital
                                                                                  rights management technology used
                                                                                  by the implementers.




       42                                                                  Neg-Mj CONF-CD-17: The entry element          CONF-CD-17: The entry element
                                                                                  SHALL include an act element with      SHALL include an act element with
                                                                                  templateId of                          templateId of
                                                                                  “2.16.840.1.113883.3.445.5” and a      “2.16.840.1.113883.3.445.5” and a
                                                                                  moodCode of “DEF” to specify the       moodCode of “EVN” to specify the
                                                                                  structure of a Consent Directive.      execution of Consent Directive.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    10                                                                                     March 2003
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       43                                                                  Neg-Mj CONF-CD-18: The act element            CONF-CD-18: The act element
                                                                                  SHOULD include a code element to       SHALL include a code element to
                                                                                  specify the purpose of use for which   specify the purpose of use for which
                                                                                  the data consent is applicable.        the data consent is applicable.

       44                                                                  Neg-Mj CONF-CD-19: This section               CONF-CD-19: This section
                                                                                  SHOULD include one or more             SHOULD include one or more
                                                                                  entry/act/informant/[@typeCode=’I      entry/act/informant/[@typeCode=’D
                                                                                  NF’] elements with a templateId of     IST’] elements with a templateId of
                                                                                  “2.16.840.1.113883.3.445.6” to         “2.16.840.1.113883.3.445.6” to
                                                                                  represent the custodian of the         represent the distributor of the
                                                                                  referenced IIHI. This may be           referenced IIHI. This may be
                                                                                  different than the custodian of the    different than the custodian of the
                                                                                  document identified in the header.     document identified in the header.


       45                                                                  Neg-Mj CONF-CD-25: This                       CONF-CD-25: This
                                                                                  entryRelationship SHALL include        entryRelationship SHALL include
                                                                                  an observation element with default    an act element with default
                                                                                  classCode=“OBS” and                    classCode=“ACT” and
                                                                                  moodCode=“DEF”.                        moodCode=“DEF”.


       46                                                                  Neg-Mi CONF-CD-26: This observation           CONF-CD-26: This act element
                                                                                  element SHOULD include a               SHOULD include a @negationId
                                                                                  @negationId attribute with a default   attribute with a value of “false”
                                                                                  value of “false” indicating that the   indicating that the action specified
                                                                                  action specified is enabled, and a     is enabled, and a value of “true” if
                                                                                  value of “true” if the action is not   the action is not allowed by the
                                                                                  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.

       47                                                                  Neg-Mj CONF-CD-27: This section               CONF-CD-27: This act SHALL
                                                                                  SHOULD include a code element          include a code element with default
                                                                                  with default of                        of
                                                                                  codeSystem="2.16.840.1.113883.5.4      codeSystem="2.16.840.1.113883.5.
                                                                                  " to specify the Consent Directive     4" to specify the Consent Directive
                                                                                  operation or action [DYNAMIC].         operation or action [DYNAMIC].




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    11                                                                                        March 2003
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       48                                                                       Neg-Mj CONF-CD-34: The component              CONF-CD-34: The component
                                                                                       element SHOULD include an              element SHALL include an
                                                                                       act/code element to specify the        act/code element to specify the
                                                                                       Privacy Policy or regulation that is   Privacy Policy or regulation that is
                                                                                       basis for requesting the               basis for requesting the
                                                                                       authorizations specified in the        authorizations specified in the
                                                                                       Consent Directive.                     Consent Directive.
       49                                            3                          Neg-Mj




       50                                            4                          Neg-Mi




       51 StructDocs      ??        CDAR2_CD_I 2         2.1.9        No        Neg-Mi Missing                                CONF-CD-nn: If the current
                                    G                                                                                         document is replacing a prior
                                    _D2_2010MA                                                                                documents, then the value of
                                    Y                                                                                         ClinicalDocument/relatedDocument/
                                                                                                                              parentDocument SHALL be
                                                                                                                              present, and SHALL contain a
                                                                                                                              parentDocument element with the
                                                                                                                              typeCode "RPLC"




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       52 StructDocs      ??        CDAR2_CD_I 3             3            No         Neg-Mj CONF-CD-13: A Consent Directive A Consent Directive document
                                    G                                                       SHALL have a structuredBody     shall have either a:
                                    _D2_2010MA                                              element                         • structuredBody element or
                                    Y                                                                                       • nonXMLBody element




       53 StructDocs      ??        CDAR2_CD_I 1             1.3          Yes        Neg-Mi ge the existing
                                    G                                                       le document
                                    _D2_2010MA
                                    Y
       54 CBCC                                 1.1 Purpose                           Neg-Mi Privacy policies define how              Privacy policies define how
                                                                                            Individually Identifiable Health         Individually Identifiable Health
                                                                                            Information (IIHI) is to be collected,   Information (IIHI) is to be collected,
                                                                                            accessed, used and disclosed. A          accessed, used and disclosed. A
                                                                                            Consent Directive is a record of a       Privacy Consent Directive is a
                                                                                            healthcare client’s privacy policy,      record of a client’s (e.g., patient,
                                                                                            which is in accordance with              consumer) privacy policy. A
                                                                                            governing jurisdictional and             Privacy Consent Directive grants or
                                                                                            organizational privacy policies that     withholds authorization to collect,
                                                                                            grant or withhold consent to IIHI.       access, use, or disclose IIHI about
                                                                                            In addition, Consent Directives          the client. A client may
                                                                                            provide the ability for a healthcare     author/publish their privacy
                                                                                            client to delegate authority to a        preferences as a self-declared
                                                                                            Substitute Decision Maker who may        Privacy Consent Directive.
                                                                                            act on behalf of that individual.        Effective Privacy Consent
                                                                                                                                     Directives are a bilateral agreement
                                                                                                                                     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.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                              13                                                                                            March 2003
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       55                                            1.1                         Neg-Mi The guide supports backward            The guide supports backward
                                                                                        compatibility by allowing a scanned    compatibility by incorporating the
                                                                                        document with wet signatures to be     IHE Basic Patient Privacy Consents
                                                                                        sent in the unstructured body of a     (BPPC) mechanism of
                                                                                        CDA document.                          acknowledging a Privacy Policy
                                                                                                                               ientifier and extending this with
                                                                                                                               privacy policy attributes captured in
                                                                                                                               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.


       56                                            1.1                         Neg-Mi The CDA IG for Consent Directives
                                                                                        is intended to provide multiple
                                                                                        representations for expressing
                                                                                        privacy preferences and for
                                                                                        exchanging privacy policies that can
                                                                                        be enforced by consuming systems.

       57                                            1.1                         Neg-Mi Different templates will be assigned
                                                                                        to different kinds of consents




       58                                            1.5                         Neg-Mi




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       59                                            1.6                         A-S   The conformance statements are         The conformance statements are
                                                                                       numbered sequentially and listed       numbered and listed within the
                                                                                       within the body of the DSTU as         body of the DSTU as follows:
                                                                                       follows:




       60                                            1.7                         A-S   A client is a person who is enrolled   A client is a person who is enrolled
                                                                                       and eligible to receive healthcare     and eligible to receive healthcare
                                                                                       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.


       61                                            1.7                         A-S   Consent, Consent Directive




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       62                                            1.8     Figure 3              Neg-Mj




       63                                            1.8.1                          A-S     clinical content




       64                                            1.8.2                          A-S




       65                                            2.1.3                          A-S     The author of the document         This element identifies the author of
                                                                                            (assignedAuthor) need not be the   the Privacy Consent Document. The
                                                                                            author of the policy (author).     author of the document
                                                                                                                               (assignedAuthor) need not be the
                                                                                                                               author of the policy (author).




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       66                                            2.1.4                         Neg-Mi This may be the custodian of the
                                                                                          IIHI as well, but this specification
                                                                                          allows for the custodian of the IIHI
                                                                                          and custodian of the consent to be
                                                                                          different.




       67                                            2.1.5                         Neg-Mi Information Recipient providers and
                                                                                          users specify the recipients of the
                                                                                          Consent Directive. In the case of
                                                                                          consultations and referrals, the
                                                                                          Consent Directive recipient may be
                                                                                          the same person/entity as the
                                                                                          intended recipient of the client’s
                                                                                          IIHI that is disclosed as a result of
                                                                                          the authorization provided using the
                                                                                          Consent Directive.




       68                                            2.1.6                         Neg-Mi Each Consent Directive shall              The legalAuthenticator is as defined
                                                                                          identify and may record the               in CDA. For a Privacy Consent
                                                                                          signature of the consenter. The           Document this element may be
                                                                                          consenter is either the client or their   either the client or their Substitute
                                                                                          representative (e.g., Substitute          Decision Maker. If necessary, the
                                                                                          Decision Maker). The                      Signatures section may provide the
                                                                                          legalAuthenticator is either the          signature associated with the
                                                                                          client or their Substitute Decision       consenter’s signature.
                                                                                          Maker. If necessary, the Signatures
                                                                                          section may provide the signature
                                                                                          associated with the consenter’s
                                                                                          signature.



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       69                           CONF-CD-10 2.1.8                               Neg-Mi




       70                           CONF-CD-11 2.1.8                               Neg-Mi



       71                           CONF-CD-12 2.1.8                               Neg-Mi


       72                                            3.3.1                         Neg-Mi Digital Signatures




       73 CBCC                                                                      A-C




       74 CBCC                                                                      A-C




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       75 CBCC                                                             A-C




       76 CBCC                                                             A-C




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       77 CBCC                                       1.1                   A-S


                                                                                                                   A Consent Directive is a
                                                                                 A Consent Directive is a          record of a healthcare
                                                                                 record of a healthcare client’s   client’s health information
                                                                                 privacy policy, which is in       privacy policy, which is in
                                                                                 accordance with governing         accordance with governing
                                                                                 jurisdictional and                jurisdictional and
                                                                                 organizational privacy            organizational privacy
                                                                                 policies that grant or            policies that grant or
                                                                                 withhold consent to IIHI. In      withhold consent to IIHI. In
                                                                                 addition, Consent Directives      addition, Consent Directives
                                                                                 provide the ability for a         provide the ability for a
                                                                                 healthcare client to delegate     healthcare client to delegate
                                                                                 authority to a Substitute         authority to a Substitute
                                                                                 Decision Maker who may act        Decision Maker who may act
                                                                                 on behalf of that individual.     on behalf of that individual.
       78                                            1.1                   A-S




       79                                            1.1                   A-S                                     The CDA IG for Consent
                                                                                 The CDA IG for Consent            Directives is intended to
                                                                                 Directives is intended to         provide multiple
                                                                                 provide multiple                  representations for expressing
                                                                                 representations for expressing    health information privacy
                                                                                 privacy preferences and for       preferences and for
                                                                                 exchanging privacy policies       exchanging privacy policies
                                                                                 that can be enforced by           that can be enforced by
                                                                                 consuming systems.                consuming systems.
       80                                            1.1                   A-S   Different templates will be
                                                                                 assigned to different kinds of
                                                                                 consents
       81                                            1.1                   A-S   Code system names will be
                                                                                 added to future versions of the
                                                                                 DSTU




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    20                                                                            March 2003
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       82                                            1.1                   A-S
                                                     last
                                                     paragraph
                                                                                                               Scope: this specification
                                                                                                               applies to consent directives
                                                                                                               that applied to health
                                                                                                               information maintained in
                                                                                                               electronic health records
                                                                                                               (EHRs), personal health
                                                                                                               records (PHRs), Health
                                                                                                               Information Exchange
                                                                                                               systems (HIEs) and other
                                                                                                               forms of electronics
                                                                                                               collection and maintenance
                                                                                                               of health information .
       83                                            1.5                   A-S   In this specification all     In this specification all
                                                                                 templates are backed up by    templates are backed up by
                                                                                 use case and information      use cases and information
                                                                                 requirements documented in    requirements documented in
                                                                                 the Composite Privacy         the Composite Privacy
                                                                                 Consent Directive Domain      Consent Directive Domain
                                                                                 Analysis Model (CPCD          Analysis Model (CPCD
                                                                                 DAM).                         DAM).
       84                                            1.7                   A-S   Client
                                                                                 A client is a person who is
                                                                                 enrolled and eligible to
                                                                                 receive healthcare services




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    21                                                                       March 2003
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       85                                                                  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       health information privacy
                                                                                 those consent directives between      consent(s) and to share those
                                                                                 those entities that are custodians of consent directives between those
                                                                                 the 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).
       86                                                                  A-Q   For example, there is no way          For example, there is no way to
                                                                                 include an electronic signature with include an electronic (digital?)
                                                                                 the identity of an author,            signature with the identity of an
                                                                                 authenticator, or legal authenticator author, authenticator, or legal
                                                                                 in the document header that is often authenticator in the document
                                                                                 mandatory for legally binding         header that is often mandatory for
                                                                                 documents                             legally binding documents
       87
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    22                                                                                     March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    23                    March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    24                    March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    25                    March 2003
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                                                                                                                                 Committee Resolution

                                      In person
                                      resolution   Comment                                                  Disposition




                                                                                                                                                                                    For
Comments                              requested    grouping   Disposition                       Withdrawn   Committee     Disposition Comment            Responsible Person
Can we provide a more definitive                              Considered - Question Answered                              The resulting assertion is
description of the required sections,                                                                                     child()/[@title="Consent
referencing a table or list, for                                                                                          Directive Details"]
example? As it reads, I'm not sure
how the statement could be
validated.
If the template ID and title are                              Considered - Question Answered                              The semantics are
required with no section code, is it                                                                                      specified in the header as
possible that people will rely on                                                                                         LOINC.
these to convey semantics instead
of the code?
Should this be changed to May         No                      Persuasive                                                  Fix publication
2010?

Should Level Seven Healthcare,        No                      Considered - Question Answered                              It is both the custodian and
Inc. appear twice here?                                                                                                   originator organization.

 Is there a specific time to use 'just No                     Considered - Question Answered                              "action" is used in privacy
"action" ' or 'just "action /                                                                                             and "operation" is used in
operation" ' it seems that where                                                                                          security policies.
'action' is used 'action / operation '
is also applicable
Consent is already complicated         Yes
enough. Use simple sentences to
explain it. The term "client" and
"healthcare client" are new to many
of your readers. A more familiar
term or phrase is "patient or their
representative".




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                                             26                                                                             March 2003
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Use a bulleted list to make this       No
section more readable.




Simplify and be more direct. Yes,      No
it indends to, but also does, so use
the most active verb.




The distinction between these two Yes
is fine enough that it deserves some
introduction.
Policy makers need to understand     Yes
technical capabilities or they will
establish policies that cannot be
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.

Page 9 content in the Word            Yes
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.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    27                    March 2003
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If you are going to use UML, use       Yes
the right diagramming
nomenclature to represent
dependencies.
Not applicable to this section, and    Yes
simple restated: "We will follow
HL7 Policy and Procedures."
Strike it.




This is inconsistently rendered        Yes
throughout the document. I would
suggest introducing it by it's full
title once, and introducing the
acronym, which then be used
consistently throughout the
document subsequently.

                                       No




Not necessary and interferes with      Yes
the key statement: This guide tells
you what is needed for
conformance.




This section describes receiver         Yes
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.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    28                    March 2003
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You reference the guide, and then       Yes
redefine the terms in your own
words. I like your words, but do
they mean the same as the guide?

The use of Xpath notation is now        No
the tradition in CDA
Implementation Guides.




The term client may be common           Yes
usage in certain programs, but the
more common term is patient.
Wouldn't it be easier to use that
term?
Even at 800% I cannot read the          Yes
text. Use better graphics and a
better way to identify content
appearing in the CDA Header.
Introduced for the first time here      Yes
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.
Huh? That came out of the blue.         Yes
Introduce please, or better yet, use
HL7 SAIF terms. I know that you
just said, but 95% of your audience
just got lost.
Figure 3 is badly introduced and        Yes
placed in this document, move to
after the pentultimate (next to last)
paragraph.
Are level 1 and 2 constraints           Yes
optional or required? Not stated
here, but is stated for level 3.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    29                    March 2003
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I cannot parse what this phrase      Yes
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.
This belongs in a conformance        Yes
section, not in the SCOPE.




Strike this, it is not applicable to Yes
DSTU or Normative Track content,
nor binding on committees
publishing this material.

A picture should be worth a         Yes
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.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    30                    March 2003
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Cannot parse this note on first        Yes
reading. Rereading: What we
write herein constrains the
document, and stuff we reuse from
elsewhere carries its own baggage
too. All of it applies. The note
needs to be simplified.




Delete this as it duplicates content   Yes
in section 2.1




Move to section 2.1                    No




Move before first constraint in 2.1.   No

Remove this heading level and          No
move everything underneath it
upwards.
If you represent an XPath with a       Yes
leading /, then your IMPLICIT
context becomes an EXPLICIT
context: The root of the document.

Do not use the term attribute.       Yes
These are not attributes in the RIM.
 patientRole is a Role Class, and
patient is an Entity Class. These
are not attributes in XML either.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    31                    March 2003
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This RIM attribute describes the       Yes
functional role of the author. If that
role is as substitute decision maker,
there is no “workaround” being
done, it’s simple the correct use of
the RIM attribute.




This section adds not constraints.     Yes
The second sentence is merely
confusing. Recommend this be
struck, or rewritten to clarify what
you are trying to say.




This is no different from best      Yes
practice for CDA, not sure why this
is necessary here. Strike this
section?
This is incorrect. It uses XDS-SD Yes
which uses the nonXMLBody,
which you demonstrate in the very
next chunk of text!




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    32                    March 2003
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I would prefer that this document   Yes
reference "assertions described
using prevailing standards" rather
than "prevailing, platform-specific
assertions". The latter opens the
Consent document to the use of
proprietary content for computable
representations, which is not
desirable in an HL7 implementation
guide.

The use of two different formats to
represent the information
perpetuates the belief that an HL7
model must be represented in HL7
XML generated through the XML
ITS. XML Schemas are rarely
normative artifacts in messages
creating using the HL7
methodology (the HDF). The
models are what is normative.
A much more appropriate and
useful approach would be to show
how the 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 that has
Consent is an ACT                    Yes
occurred at the time this document
is created. The definition of that
act is described in the components
of the act, but the act itself is an
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.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    33                    March 2003
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CDA says acts SHALL contain a        Yes
code element.



This representation would indicate Yes
that the person or organization
supplying the information about the
consent was the custodian of the
IIHI, which need not be the case.
The distributor (DIST) of
information used in the act is what
is relevant.



The “action allowed” may be to       Yes
view, store or redisclose. Of these,
the term observation is only
pertinent to “view”, and even there
is not properly an HL7 Observation
class. This should be an Act, not an
observation.
Defaults are things not transmitted. Yes
Since CDA does not specify a
"default" (although it should have),
you need to be specific about the
reciever responsibility when the
content is not sent.




I believe you meant for this to apply Yes
the the observation[act] above, in
which case, a code is required by
CDA (whether it be an act or an
observation).




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    34                    March 2003
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CDA requires it.                     Yes




The use of Preconditions              Yes            Not persuasive                           In order to avoid extending
throughout this section to include a                                                          the CDA R2 XSDs the
code is valid only if the code itself                                                         project team used
expresses the precondition in full.                                                           preconditions to specify
Typical codes that expressing the                                                             attributes of the health
results of an observation need to be                                                          information referenced in
associated with more than just the                                                            the consent but missing in
result of the observation, e.g.,                                                              the CDA R2 structure.
Diagnosis=Heart Attack, not "Heart                                                            (Nov 17th 2009 SDWG
Attack". Else you have the answer                                                             conference). The "Future
(the test to perform) without the                                                             use" section specifies that
question against which to judge the                                                           this IG contains
precondition.                                                                                 workarounds that will be
                                                                                              redundant in CDA R3.
Please include references to BPPC    Yes             Not persuasive                           IHE BPPC is already
from IHE.                                                                                     referenced in
                                                                                              Acknowledgements,
                                                                                              Approach, and References
                                                                                              sections.
The conformance statement was     No                 Not related                              This comment is not
removed. However, reconcilliation                                                             related because it
package for Version 1 accepted as                                                             references a constraint that
Persuasive motion to use the                                                                  was removed as redunant.
languge stated here. (number 170                                                              Since this IG is not
on the amalgamated sheet).                                                                    modifying the default
                                                                                              header; this constraint was
                                                                                              redundant.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                      35                                                   March 2003
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Don't understand why                 No              Persuasive with mod                      Will revise the diagram in
nonXMLBody was removed for                                                                    Figure 15 to make it clear
this version, esp. when Figure 15                                                             that only the structureBody
shows an example of its use, and                                                              is in scope.
the language immediately below the                                                            Since the implementers
figure states "If the structuredBody                                                          need to make a choice of
element of a Consent Directive is                                                             nonXML or structured
used..." So if the intent was indeed                                                          body, this IG provides only
to remove the nonXMLBody                                                                      for a structuredBody. The
option, there should be an                                                                    structuredBody is intended
explanation as to why and the                                                                 support scanned document
language made consistent.                                                                     images as well as entries.

Text at top right corner of page 8 in                Persuasive                               Fix publication
PDF is cut off; can't tell what it
means to say.

There are a few concepts that          Yes           Persuasive                               Accept proposed wording
require more explaination:
1) client. We need to help the
reader understand that we define
client as a broader term that is
inclusive of patient and consumer. I
would rather we use 'consumer'.
2) Need to introduce the concept of
preferences
3) Need to be specific that we are
only working on 'privacy' types of
consent directives. I prefix 'privacy'
consistently
4) Need to be specific that an
effective consent is between the
consumer and a data holder




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                         36                                               March 2003
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The wet signature and PDF are not     Yes            Persuasive                               Accept proposed wording
there for backward compatibility,
they are there for specific reasons
that we need to express. Backward
compatibility is there through the
use of the BPPC mechanism that
we extend here.




Do we really mean that we are        Yes             Not persuasive                           This statement will be
offering multiple representations? I                                                          removed, no longer
thought we were making ONE                                                                    applicable.
representation that can be used
multiple ways?


Which meaning of the word             Yes            Persuasive with mod                      This statement will be
'template' are we using here? We                                                              removed, no longer
need to be more clear. There is the                                                           applicable.
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.
Are we not defining a cda template    Yes            Not persuasive                           Template identifier are
for compliance to this CDA-IG?                                                                specified in sections 2, 3,
Thus don't we need to define a                                                                Appendix B
specific template id value?




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                         37                                               March 2003
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Although we will be numbering          No            Persuasive                               Remove "sequentially"
them sequentially, this wording
seems to imply that they will appear
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.


We need to explain this context as   Yes             Persuasive                               Add proposed wording.
many don't understand it




We need to be more clear and                         Persuasive with mod                      See #44
always explain that we are
specailizing only 'privacy' type
consents. Thus I recommend we
always and consistently prefix
'consent' with 'privacy consent'.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                         38                                         March 2003
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This is the first place where this      Yes          Persuasive with mod                      Remove the "header"
comment applies, but the comment                                                              rectangle because it is
applies later as well. I agree that the                                                       imprecise in this context.
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.


It is confusing to see the word         Yes          Persuasive                               replace all occurences with
'clinical content'. I presume this is a                                                       "privacy consent content"
cut-paste, and we should specialize
this to a privacy consent content?

Should we not also indicate that we No               Considered - Question Answered           This section is intended to
are working on a catalog of privacy                                                           specific future work
policies that could be used?                                                                  affecting this artifact. Is
                                                                                              the catalog intended to
                                                                                              change this IG?
Need to explain what the author        No            Considered - Question Answered           These CDA R2 and RIM
element is before explaining what                                                             concepts are already
else it can be.                                                                               defined. We should not
                                                                                              repeat that info.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                                    39                                    March 2003
                                                       V3 Ballot Submission/Resolution Form

This sentence indicates that there    Yes            Persuasive                               Remove the reference to
may be different purposes of the                                                              IIHI, use default CDA
custodian, but does not explain how                                                           header.
one would determine which
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.


We should not override the           Yes             Not persuasive                           The meaning is not
meaning of this element.                                                                      overriden, this usage note
I am unclear on what this is trying                                                           provider information to
to say. I can imaging that we are                                                             implementers on
trying to identify a party to whom                                                            instantiating these
we are sending IIHI that is ruled by                                                          documents.
this consent. This meaning does not
come through in this paragraph. I
also don't understand how this
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.
Our meaning is not that different     Yes            Persuasive with mod                      Add the suggested
than the CDA meaning of this                                                                  wording remove redunant
element. We should only explain                                                               statements.
that the legal authenticator in the
case of a privacy consent directive
is often times the client or their
legal guardian.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                         40                                              March 2003
                                                       V3 Ballot Submission/Resolution Form

The @code value is the policy id as Yes              Pending input from submitter             What changes are required?
found in the access control decision
database. This is the key value that
is used to identify the policy rule
(language) that this consent
document is acknowledging.

The @code/System value is the         Yes            Pending input from submitter             What changes are required?
identifier of the assigning authority
of the policy identified in @code

The @code/SystemName value is           Yes          Pending input from submitter             What changes are required?
the descriptive name of the policy
identified in @code.
Digital Signatures would                Yes          Pending input from submitter             What changes are required?
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.

                                                     Considered - Question Answered           "Patient" is a role played
                                                                                              in the context of a specific
Some part of document uses term                                                               encounter.
“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
It is not clear if person information                Considered - Question Answered           That information is part of
is optional under                                                                             the CDA R2 specification.
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.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                                    41                                     March 2003
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There should be way to explicitly                    Considered - Question Answered           The status of the consent
revoke previously defined consent.                                                            "active", "obsolete" may
It may be possible to submti RPLC                                                             be used to specify that a
document with revised                                                                         consent directive is in
documentationOf->serviceEvent-                                                                effect (active), has expired
>EffectiveTime-high value.                                                                    (completed), or was
                                                                                              revoked (aborted).

This consent directive can also be                   Considered - Question Answered           These use cases are
extended to support the following                                                             supported without the need
business cases ((may be it can                                                                for extensions.
already support but I may have
missed):
a) Patient is at provider B and signs
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.
b) Patient gives bi-directional (2-
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.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                                    42                                     March 2003
                                                            V3 Ballot Submission/Resolution Form

                                                          Persuasive                               Accept proposed wording




                                              To be       Persuasive                               To be discussed
Consider adding the five categories           discussed
of consent described in ONC’s
Consent Directives Document
released March 31, 2010
                                                          Persuasive                               Accept proposed wording




Missing completion of statement?                          Persuasive with mod                      Duplicate, the statement
Need to add clarification to this                                                                  will be removed, no longer
statement                                                                                          applicable.

Need to clarify what it is referred to                    Persuasive with mod                      Duplicate, the statement
by ‘Code System Names’                                                                             will be removed, no longer
                                                                                                   applicable.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                              43                                              March 2003
                                                       V3 Ballot Submission/Resolution Form

I believe a statement like this would                Persuasive                               Accept proposed wording
be helpful to clarify the scope of
applicability of this specification




                                                     Persuasive                               Accept proposed wording




By establishing the definition of
‘Client’ as is noted here, and
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?




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                      44                                              March 2003
                                                       V3 Ballot Submission/Resolution Form

                                                     Persuasive                               Accept proposed wording




What is an ‘electronic’ signature? Is                Considered - Question Answered           Any type of signature
it the pasting of a wet signature in a                                                        (scanned wet, digital) is
document? Or is it a digital                                                                  included.
signature encoding?




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                                    45                                  March 2003
                                                     V3 Ballot Submission/Resolution Form




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    46                    March 2003
                                                     V3 Ballot Submission/Resolution Form




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    47                    March 2003
                                                     V3 Ballot Submission/Resolution Form




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    48                    March 2003
                                                                    V3 Ballot Submission/Resolution Form

    Against
                                                                                                          Ballot Comment Tracking

              Abstain
                        Change    Substantive                                                       On Behalf of    Submitter
                        Applied   Change        Submitted By      Organization       On behalf of   Email           Tracking ID Referred To   Received From



                                                Liora Alschuler




                                                Liora Alschuler



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

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


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




                                                Keith W. Boone




                                                                  GE Healthcare



185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                                             49                                                             March 2003
                                                              V3 Ballot Submission/Resolution Form




                                           Keith W. Boone




                                                            GE Healthcare



                                           Keith W. Boone


                                                            GE Healthcare

                                           Keith W. Boone
                                                            GE Healthcare




                                           Keith W. Boone




                                                            GE Healthcare




                                           Keith W. Boone



                                                            GE Healthcare




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                             50                    March 2003
                                                              V3 Ballot Submission/Resolution Form



                                           Keith W. Boone
                                                            GE Healthcare




                                           Keith W. Boone



                                                            GE Healthcare




                                           Keith W. Boone



                                                            GE Healthcare



                                           Keith W. Boone


                                                            GE Healthcare




                                           Keith W. Boone



                                                            GE Healthcare




                                           Keith W. Boone




                                                            GE Healthcare




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                             51                    March 2003
                                                              V3 Ballot Submission/Resolution Form



                                           Keith W. Boone

                                                            GE Healthcare




                                           Keith W. Boone




                                                            GE Healthcare


                                           Keith W. Boone

                                                            GE Healthcare


                                           Keith W. Boone
                                                            GE Healthcare




                                           Keith W. Boone



                                                            GE Healthcare


                                           Keith W. Boone

                                                            GE Healthcare


                                           Keith W. Boone
                                                            GE Healthcare

                                           Keith W. Boone
                                                            GE Healthcare




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                             52                    March 2003
                                                              V3 Ballot Submission/Resolution Form




                                           Keith W. Boone


                                                            GE Healthcare




                                           Keith W. Boone




                                                            GE Healthcare


                                           Keith W. Boone

                                                            GE Healthcare



                                           Keith W. Boone


                                                            GE Healthcare




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                             53                    March 2003
                                                              V3 Ballot Submission/Resolution Form




                                           Keith W. Boone




                                                            GE Healthcare




                                           Keith W. Boone



                                                            GE Healthcare


                                           Keith W. Boone

                                                            GE Healthcare
                                           Keith W. Boone
                                                            GE Healthcare

                                           Keith W. Boone
                                                            GE Healthcare


                                           Keith W. Boone

                                                            GE Healthcare



                                           Keith W. Boone


                                                            GE Healthcare




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                             54                    March 2003
                                                              V3 Ballot Submission/Resolution Form




                                           Keith W. Boone




                                                            GE Healthcare




                                           Keith W. Boone



                                                            GE Healthcare


                                           Keith W. Boone
                                                            GE Healthcare


                                           Keith W. Boone

                                                            GE Healthcare




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                             55                    March 2003
                                                              V3 Ballot Submission/Resolution Form




                                           Keith W. Boone




                                                            GE Healthcare




                                           Keith W. Boone




                                                            GE Healthcare




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                             56                    March 2003
                                                              V3 Ballot Submission/Resolution Form



                                           Keith W. Boone

                                                            GE Healthcare




                                           Keith W. Boone




                                                            GE Healthcare



                                           Keith W. Boone


                                                            GE Healthcare




                                           Keith W. Boone




                                                            GE Healthcare



                                           Keith W. Boone


                                                            GE Healthcare




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                             57                    March 2003
                                                              V3 Ballot Submission/Resolution Form




                                           Keith W. Boone


                                                            GE Healthcare




                                           Keith W. Boone




                                                            GE Healthcare


                                           Keith W. Boone

                                                            GE Healthcare




                                           Doug Pratt



                                                            Siemens




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                             58                    March 2003
                                                            V3 Ballot Submission/Resolution Form




                                           Doug Pratt




                                                          Siemens


                                           Doug Pratt
                                                          Siemens




                                           John Moehrke




                                                          GE Healthcare




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                           59                    March 2003
                                                            V3 Ballot Submission/Resolution Form




                                           John Moehrke




                                                          GE Healthcare



                                           John Moehrke


                                                          GE Healthcare




                                           John Moehrke




                                                          GE Healthcare


                                           John Moehrke

                                                          GE Healthcare




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                           60                    March 2003
                                                            V3 Ballot Submission/Resolution Form




                                           John Moehrke




                                                          GE Healthcare




                                           John Moehrke




                                                          GE Healthcare



                                           John Moehrke


                                                          GE Healthcare




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                           61                    March 2003
                                                            V3 Ballot Submission/Resolution Form




                                           John Moehrke




                                                          GE Healthcare


                                           John Moehrke

                                                          GE Healthcare


                                           John Moehrke

                                                          GE Healthcare



                                           John Moehrke


                                                          GE Healthcare




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                           62                    March 2003
                                                            V3 Ballot Submission/Resolution Form




                                           John Moehrke




                                                          GE Healthcare




                                           John Moehrke




                                                          GE Healthcare




                                           John Moehrke




                                                          GE Healthcare



185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                           63                    March 2003
                                                            V3 Ballot Submission/Resolution Form




                                           John Moehrke


                                                          GE Healthcare


                                           John Moehrke
                                                          GE Healthcare

                                           John Moehrke
                                                          GE Healthcare




                                           John Moehrke



                                                          GE Healthcare




                                           Chirag Bhatt



                                                          FEI




                                           Chirag Bhatt



                                                          FEI




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                           64                    March 2003
                                                            V3 Ballot Submission/Resolution Form




                                           Chirag Bhatt



                                                          FEI




                                           Chirag Bhatt




                                                          FEI




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                           65                    March 2003
                                                             V3 Ballot Submission/Resolution Form




                                           Walter Suarez   Kaiser Permanente




                                           Walter Suarez   Kaiser Permanente




                                           Walter Suarez   Kaiser Permanente




                                           Walter Suarez   Kaiser Permanente



                                           Walter Suarez   Kaiser Permanente




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                             66                   March 2003
                                                             V3 Ballot Submission/Resolution Form




                                           Walter Suarez   Kaiser Permanente




                                           Walter Suarez   Kaiser Permanente




                                           Walter Suarez   Kaiser Permanente




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                             67                   March 2003
                                                             V3 Ballot Submission/Resolution Form




                                           Walter Suarez   Kaiser Permanente




                                           Walter Suarez   Kaiser Permanente




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                             68                   March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    69                    March 2003
                                                     V3 Ballot Submission/Resolution Form




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    70                    March 2003
                                                     V3 Ballot Submission/Resolution Form




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    71                    March 2003
                                                     V3 Ballot Submission/Resolution Form




Notes




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    72                    March 2003
                                                     V3 Ballot Submission/Resolution Form




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    73                    March 2003
                                                     V3 Ballot Submission/Resolution Form




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    74                    March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    75                    March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    76                    March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    77                    March 2003
                                                     V3 Ballot Submission/Resolution Form




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    78                    March 2003
                                                     V3 Ballot Submission/Resolution Form




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    79                    March 2003
                                                     V3 Ballot Submission/Resolution Form




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    80                    March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    81                    March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    82                    March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    83                    March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    84                    March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    85                    March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    86                    March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    87                    March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    88                    March 2003
                                                     V3 Ballot Submission/Resolution Form




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    89                    March 2003
                                                     V3 Ballot Submission/Resolution Form




185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    90                    March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    91                    March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    92                    March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    93                    March 2003
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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Ballot]                    94                    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.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.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".


185d9aae-0de7-4fb9-8948-ed11a64f0b48.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.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.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.."




185d9aae-0de7-4fb9-8948-ed11a64f0b48.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.




185d9aae-0de7-4fb9-8948-ed11a64f0b48.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
 On Behalf Of Email     pool 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.



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                                          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.




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                                          Ballot Submission/Resolution Instructions




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                                          Ballot Submission/Resolution Instructions




185d9aae-0de7-4fb9-8948-ed11a64f0b48.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;


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                                            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.




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                                                          Ballot Submission/Resolution Instructions




     int the

econciliation




 Comments.




           of

st indicate a




                185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Instructions Cont..]                       August, 2002
                                                         Ballot Submission/Resolution Instructions




en submitted


more input




t no change




 some WG's




               185d9aae-0de7-4fb9-8948-ed11a64f0b48.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).
  ------------------------------------------------------------------




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 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


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                                                              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.


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                                                               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?

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 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.




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, 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


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 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




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 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




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



he ballot (as it currently seems to state in the




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185d9aae-0de7-4fb9-8948-ed11a64f0b48.xlsx [Co-Chair Guidelines]              119                    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    dered         Pendi Pendi
                                                                              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
??



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                                                         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




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                                                                           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




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                                                    V3 Ballot Submission/Resolution Form




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omment can be scheduled for discussion.




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