Medical Vocabulary Worksheet

Document Sample
Medical Vocabulary Worksheet Powered By Docstoc
					                                                              V3 Ballot Submission/Resolution Form

                              BALLOT TITLE:       HL7 Implementation Guide for Clinical Document Architecture, Release 2: Consent Directives, Release 1
                                                  (CDAR2_IG_CONSENTDIR_R1_D1_2010JAN) - 1st DSTU Ballot


                          BALLOT CYCLE:           January 2010
                 SUBMITTED BY IDENTIFIER:
                   OVERALL BALLOT VOTE:           Negative




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Submitter]                                   1                                                                  March 2003
                                                       V3 Ballot Submission/Resolution Form

                              BALLOT TITLE:



                          BALLOT CYCLE:
                 SUBMITTED BY IDENTIFIER:
                   OVERALL BALLOT VOTE:




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Submitter]                    2                     March 2003
                                                                V3 Ballot Submission/Resolution Form



                                                                           Vote
Ballot                                   Chap                              and
Committee       Artifact   Artifact ID   ter  Section      Ballot   Pubs   Type    Existing Wording                        Proposed Wording
CBCC                                     1    1.3                   No       A-S   Health Information Technology           Health Information Technology
                                                                                   Standards Panel (HITSP)                 Standards Panel (HITSP)
                                                                                   Constructs,Transaction Package          Constructs, Transaction Package
                                                                                   (TP30)                                  (TP30) Manage Consent Directives

CBCC                                     2      2                   No      A-Q    Page 16: Error! Reference source
                                                                                   not found.

CBCC                                     3      3.1.4               No      A-Q    CONF-CD-15:                             CONF-CD-15:
                                                                                   ClinicalDocument/custodian/assigne      ClinicalDocument/custodian/assigne
                                                                                   dCustodian/representedCustodianOr       dCustodian/representedCustodianOr
                                                                                   ganization/telecom element MAY be       ganization/telecom element MAY be
                                                                                   present to specify the address of the   present to specify the telephone
                                                                                   custodian.                              number of the custodian.

CBCC                                                                No      A-S


CBCC                                     4      4.1                 No      A-S    CONF-CD-30: LOINC codes
                                                                                   SHALL be used with the sections in
                                                                                   a Consent Directive. See Table 1:
                                                                                   LOINC Codes for Sections.

CBCC                                     4      4.1                 No      A-S    CONF-CD-31, Table 1: LOINC
                                                                                   Codes for Sections, Code: TBD

CBCC                                     4      4.2                 No      A-Q    CONF-CD-32: A Consent Directive
                                                                                   SHALL contain the sections
                                                                                   described hereunder.
CBCC                                     4      4.3                 No      A-Q    CONF-CD-51: A Consent Directive
                                                                                   MAY contain the sections described
                                                                                   hereunder.
CBCC                                     4      4.3.1               No      A-Q    This section provides a narrative
                                                                                   block to reference and a entry to
                                                                                   enumerate all the signatures that
                                                                                   could not be included in the
                                                                                   document header.
CBCC                                            Appendix            Yes     A-S    SDWG: Structured Documents         SDWG: Structured Documents
                                                A                                  Working Committee                  Working Group




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                                          3                                                                    March 2003
                                                           V3 Ballot Submission/Resolution Form

CBCC                                            Appendix     No    A-S
                                                A


CBCC                                     3      1                  A-T    patientIdRole


CCBC                                     3      Figure 8           A-T    Devise used for scanning


CCBC                                     3      1.4                A-C


CBCC                                     Ackno               No    A-T    with modeling support was provided with modeling support provided
                                         wledg
                                         ement
                                         s
CCBC                                     Ackno               No    A-C    the IHE BPPC specification as its     the IHE BPPC specification as the
                                         wledg                            precursor                             precursor pf this specification
                                         ement
                                         s
CCBC                                     Table               No    A-T
                                         of
                                         Figure
                                         s
CCBC                                     1      1.3          No    A-C   This guide is organized
                                                                         into the following major sections:
                                                                         • Header Constraints Specific to the
                                                                         Consent Directive
                                                                         • Structured Section
                                                                         The Structured Section …
CCBC                                     1      1.6          No   Neg-Mi CONF-ex1: Conformance                  CONF-ex1: Conformance
                                                                         requirements original to this DSTU     requirements original to this DSTU
                                                                         are numbered CONF DS 1, CONF           are numbered CONF-CD-1, CONF-
                                                                         DS 2, etc.                             CD-2, etc.
CCBC                                     1      1.7          No    A-T releatedCondition                        relatedCondition




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                                 4                                                                  March 2003
                                                        V3 Ballot Submission/Resolution Form

CCBC                                     1      1.7       No   Neg-Mi




CCBC                                     1      1.7       No    A-T     Consents Directive Implementation     Consent Directive Implementation
                                                                        Guide                                 Guide

CCBC                                     1      1.7       No    A-T     the "client's                         the client's


CCBC                                     1      1.7.1     No    A-T     Their use is optional                 Their use is optional.


CCBC                                     1      1.7.2     No    A-T     several instance                      several instances


CCBC                                     1      1.7.2     No   Neg-Mj During the effort of the project team
                                                                      to map the CPCD DAM to the CDA
                                                                      R2 document, the project team
                                                                      identified several instance when the
                                                                      Consent Directive concepts could
                                                                      not be mapped to a corresponding
                                                                      class or attribute in a CDA R2
                                                                      document structure.
CCBC                                     2                No    A-T Error! Reference source not found


CCBC                                     3      3.1.6     No    A-T     substitute decisions maker            substitute decision maker


CCBC                                     3      3.1.8     No    A-T     When the effective duration of a      When the effective duration of a
                                                                        Consent Directive expire,             Consent Directive expires,




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                                5                                                               March 2003
                                                           V3 Ballot Submission/Resolution Form

CCBC                                     4       4.1         No    A-T    The scope of the this project             The scope of this project


CCBC                                     4       4.2.1       No    A-Q    <code code="57016-8"
                                                                          codeSystem="2.16.840.1.113883.6.1
                                                                          " codeSystemName="LOINC"
                                                                          displayName="Privacy Policy
                                                                          Acknowledgement Document"/>




CCBC                                     4       4.2.1.1     No    A-T    an composite entry                        a composite entry


CCBC                                     4       4.2.1.1     No    A-T    This section ... include the a            This section ... include the a


CCBC                                     4       4.2.1.1     No   Neg-Mi <code code="371422002"
                                                                         codeSystemName="VA/KP Problem
                                                                         Value Set"
                                                                         codeSystem="2.16.840.1.113883.3.8
                                                                         8.12.3221.7.4"
                                                                         displayName="History of substance
                                                                         abuse (situation)"/>
CCBC                                     4       4.2.1.1     No    A-T with to specify                     to specify


CCBC                                     4       4.3.1       No    A-T    This section is a workaround this         This section is a workaround for
                                                                          issued and it will become obsolete if     this issue and it will become
                                                                          CDA R3 add the ability to specify         obsolete if CDA R3 adds the ability
                                                                          not only that signature was collected     to specify not only that a signature
                                                                          but to add the signature inline with      was collected but to include the
                                                                          the rest of the authenticator‟s details   signature inline with the rest of the
                                                                                                                    authenticator‟s details.

CCBC                                     Appen               No    A-T    Electronic health record                  Electronic Health Record
                                         dix A

CCBC                                     Appen               No    A-T    Electronic medical record                 Electronic Medical Record
                                         dix A




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                                 6                                                                         March 2003
                                                          V3 Ballot Submission/Resolution Form

CBCC            DM         CDAR2_IG_C             3.1.2          Neg-Mi <patientRole>                             The use of the word <patientRole>
                           ONSENTDIR                                                                              is confusing and overloaded security
                           _R1_D1_2010                                                                            use of the word "role". Amore
                           JAN                                                                                    descriptive term might be
                                                                                                                  <patientInfo> or
                                                                                                                  <patientDemographics>.
CBCC                                              3.1.8          Neg-Mi When the effective duration of a          Replace with: "the effective duration
                                                                        Consent Directive expire, the             of a Consent Directive establishes
                                                                        consent or authorization is               the validity period directed by…."
                                                                        automatically revoked…                    Justification: as worded this embeds
                                                                                                                  a policy statement into the definition
                                                                                                                  of an element The use of an element
                                                                                                                  in a policy is at the discretion of
                                                                                                                  policy enforcement entities and
                                                                                                                  should not be specified here. All
                                                                                                                  that should be required is a
                                                                                                                  description of the attribute.




CBCC                                     4        1)              A-C    Care should be taken so as not to        It is recommended that the authors
                                                                         give the impression that this            conclude clarification of the
                                                                         document is creating a policy            meaning of "computable
                                                                         language. It is understood that the      representation".
                                                                         intent here is to express a consent
                                                                         directive as a series of computable
                                                                         attributes that can represent multiple
                                                                         forms of consent directives
                                                                         including"authorizations" or
                                                                         "restriction requests " or other types
                                                                         of consent directives that may be
                                                                         defined within a jurisdiction. this
                                                                         document by referencing such
                                                                         policies, provides the required
                                                                         attribute values.

                                                                         If this is not the intent of the
                                                                         document, then the vote type than
                                                                         the vote type should be recorded as
                                                                         negative major.

CBCC                                     4.2.1.                  Neg-Mi CONF-CD-36: This section                  CONF-CD-36: This section MAY
                                         1                              SHOULD…




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                                7                                                                         March 2003
                                                               V3 Ballot Submission/Resolution Form

CBCC                                     4.2.1.                       Neg-Mj CONF-CD-38: This section MAY
                                         1                                   specify…

CBCC                                     4.2.1.                       Neg-Mi CONF-CD-39: This section MAY
                                         1                                   include a
                                                                             /entry/organizer/component with a
                                                                             templateID of <TBD>…
CBCC                                     4.2.1.                       Neg-Mi CONF-CD-43: This section MAY
                                         1                                   include a
                                                                             /entry/organizer/component with a
                                                                             templateId of <TBD> to…
CBCC                                     4.2.1.                       Neg-Mi CONF-CD-45: This section MAY
                                         1                                   include a
                                                                             /entry/organizer/component
CBCC                                     4.2.1.                       Neg-Mj Many entries in this section
                                         1                                   contatain <TBD>

CBCC                                     Gener                        Neg-Mj This document has not been
                                         al                                  adequately reviewed by the relevant
                                                                             committees prior to submitting for
                                                                             ballot. This was hurriedly put
                                                                             together after the Sept 2008 approval
                                                                             for work without input or
                                                                             consideration from anyone other
                                                                             than the authors.

CBCC                                              1.1                  A-C    "…issued by a patient regarding        …issued by a patient regarding
                                                                              his/her individually…"                 their individually…


CBCC                                              1.2                  A-C    last sentence: This specification is
                                                                              inteded to capture the Consent
                                                                              Directive signed by a patient

CBCC                                              Figure 1             A-C    CPCP DAM                               Composite Privacy Consent
                                                                                                                     Directive Domain Analysis Model
                                                                                                                     (CPCD DAM)

CBCC                                              1.5 (under           A-C    <TBD>
                                                  Note)


CBCC                                              Figure 3             A-C




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                                     8                                                                March 2003
                                                        V3 Ballot Submission/Resolution Form

CBCC                                            1.7             A-T   This DSTU implementation guide         This DSTU implementation guide
                                                                      for Consent Directive is the second    for Consent Directive is the second
                                                                      such implemntation guide intended      such implemntation guide intended
                                                                      to This DSTU implementation guide      to exchange privacy preferences for
                                                                      for Consent Directive is the second    consumers as consent
                                                                      such implemntation guide intended      authorizations.
                                                                      to exchange privacy preferences for
                                                                      consumer asconsent authorizations.


CBCC                                            1.7             A-T   The Consents Directive                 The Consent Directive
                                                                      Implementation Guide…                  Implementation Guide...


CBCC                                            1.7             A-T   …custodians of the "clients's health
                                                                      records….


CBCC                                            1.7.1           A-T   the project team identified several    the project team identified several
                                                                      instance when…                         instances when...


CBCC                                            2               A-C   3.1 ClinicalDocument constraints



CBCC                                            3.1.7           A-Q   This may occur if the legal            This may occure if the
                                                                      authenticator/consenter makes a        legalAuthenticator makes a mark
                                                                      marke instead of a signature           instead of a signature




CBCC                                            3.1.7           A-T   …may identify and record the           …may identify and record the
                                                                      signature a person who...              signature of a person who...




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                             9                                                                    March 2003
                                                           V3 Ballot Submission/Resolution Form

CBCC                                            3.1.9              A-Q   A Consent Directiv may replace an
                                                                         exisiing or expired Consent
                                                                         Directive. This element refrences a
                                                                         previous Consent Directive that is
                                                                         intended to be replaced by the
                                                                         current document. The following
                                                                         asserts conformance to the Consent
                                                                         Directive DSTU




CBCC                                            3.2                A-Q   re: Good practice bullets



CBCC                                            4.1                A-T   The scope of the this project           The scope of this project…



CBCC                                            4.1                A-C   The scope of this project is to
                                                                         specify the consent Directive in a
                                                                         format that may be used to sign a
                                                                         consent directive as well as allowing
                                                                         information systems and specific
                                                                         rule engines to decode the assertions
                                                                         contained therein.

                                                                         This implentation guide defines
                                                                         required and optional sections.

CBCC                                            4.2.1.1            A-S   * Related Condition/Diagnosis
                                                                         allowed by the Consent Directive


CBCC                                            4.2.1.1            A-Q   <TBD>
                                                4.2.1.2
                                                4.3.1
                                                Appendix
                                                B




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                               10                                                            March 2003
                                                           V3 Ballot Submission/Resolution Form

CBCC                                            4.3.1              A-T     This section is a workaround this         This section is a workaround this
                                                                           issued and it will become osolete if      issued and it will become osolete if
                                                                           CDA R3 add the ability to specify         CDA R3 adds the ability to specify
                                                                           not only that signature was ollected      not only that signature was collected
                                                                           but to add the signature inine with       but to add the signature inline with
                                                                           the rest of the authenticator's details   the rest of the authenticator's details.


CBCC                                            Appendix           A-S
                                                A


CBCC                                                              Neg-Mj p 14, para 1. Therefore this
                                                                         specification includes the
                                                                         requirements specified in the CPCD
                                                                         DAM as seen in the following
                                                                         figures.




                                                                  Neg-Mi CONF-CD-5:                                  CONF-CD-5:
                                                                         ClinicalDocument/recordTarget               ClinicalDocument/recordTarget
                                                                         element MUST be present.                    element MAY be present.
                                                                  Neg-Mi CONF-CD-11:                                 CONF-CD-11:
                                                                         ClinicalDocument/custodian element          ClinicalDocument/custodian
                                                                         SHALL be present.                           element MAY be present.
                                                                   A-T CONF-CD-17: indented                          intended
                                                                  Neg-Mi




                                                                  Neg-Mj CONF-CD-35: This section SHALL              CONF-CD-35: This section MAY
                                                                         include the a entry/organizer/code          include the a entry/organizer/code
                                                                         element to specify the purpose of use       element to specify the purpose of
                                                                         for which the data consent is               use for which the data consent is
                                                                         applicable.                                 applicable.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                                  11                                                                           March 2003
                                                        V3 Ballot Submission/Resolution Form

CBCC                                     1      1.7.1          Neg-Mj Level 2 and Level 3 defintions           delete




CBCC                                     1      1.7.2          Neg-Mi                                          delete section



CCBC                                     4                     Neg-Mj All text regarding Strucured Body        delete




CBCC                       CONF-CD-12           3.1.4          Neg-Mj ClinicalDocument/custodian/assigne
                                                                      dCustodian/representedCustodianOr
                                                                      ganization element SHALL be
                                                                      present to specify the organization
                                                                      that has custody of the client‟s IIHI.




CBCC                       CONF-CD-17           3.1.5          Neg-Mj The value of                             MAY be present
                                                                      ClinicalDocument/informationRecip
                                                                      ient SHALL be present to specify the
                                                                      indented recipient of a Consent
                                                                      Directive
CBCC                       CONF-CD-17           3.1.5           A-T The value of                               The value of
                                                                      ClinicalDocument/informationRecip        ClinicalDocument/informationRecip
                                                                      ient SHALL be present to specify the     ient SHALL be present to specify
                                                                      indented recipient of a Consent          the intended recipient of a Consent
                                                                      Directive                                Directive




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                              12                                                                    March 2003
                                                        V3 Ballot Submission/Resolution Form

CBCC                       CONF-CD-24           3.1.7          Neg-Mi ClinicalDocument/legalAuthenticato      ClinicalDocument/authenticator
                                                                      r
CBCC                       CONF-CD-25           3.1.7          Neg-Mi ClinicalDocument/legalAuthenticato      ClinicalDocument/authenticator
                                                                      r
CBCC                                     1      1.2            Neg-Mi This specification is intended to       This specification is intended to
                                                                      capture the Consent Directive signed    capture the Consent Directive in a
                                                                      by a patient.                           CDA document.



CCBC                                     1      1.3            Neg-Mi




CCBC                                     1      1.7             A-S     The current specification is BPPC     The current specification is BPPC
                                                                        and it allows only for scanned signed which allows only for binary
                                                                        consent directives.                   acknowledgement of an externally
                                                                                                              identified and defined policy of no
                                                                                                              specific format.
CCBC                                     1                      A-S     consents




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                              13                                                                   March 2003
                                                      V3 Ballot Submission/Resolution Form

CCBC                                     1                    A-S   consents




CCBC                                     1      1.7           A-S   client




CCBC                                     1                    A-S   Where no constraints are stated in
                                                                    this guide, the Consent Directive
                                                                    document instances are subject to
                                                                    and are to be created in accordance
                                                                    with the base CDA R2, XDS-SD,
                                                                    and BPPC specifications.

CCBC                                     1      1.7           A-S   This specification defines additional   This specification defines additional
                                                                    constraints on CDA header and body      constraints on CDA header and
                                                                    elements used in a Discharge            body elements used in a BPPC
                                                                    Summary document in the U.S.            Document.
                                                                    realm.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                            14                                                                     March 2003
                                                          V3 Ballot Submission/Resolution Form

CCBC                                     1      1.7.1             A-S     The only Level 3 entries defined in
                                                                          this implementation guide are those
                                                                          for Hospital Discharge Diagnosis
                                                                          and Hospital Discharge Medications
                                                                          (which reuse CCD Templates).

CCBC                                     1      1.7.2            Neg-Mi




CCBC                                     1                        A-S




CCBC                                     3      3.1.1.3           A-S




CCBC                                     3      3.1.3             A-S     Similarly, the document header may
                                                                          identify the device used to scan the
                                                                          signed hardcopy document that
                                                                          contains the consent directive of the
                                                                          patient.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                                15                               March 2003
                                                        V3 Ballot Submission/Resolution Form

CCBC                                     3      3.1.4          Neg-Mi CONF-CD-11:
                                                                      ClinicalDocument/custodian element
                                                                      SHALL be present.




CCBC                                     3      3.1.5          Neg-Mi ClinicalDocument/informationRecip (remove section)
                                                                      ient




CCBC                                     3      3.1.6          Neg-Mi Each Consent Directive shall               Each Consent Directive may
                                                                      identify and record the signature of       identify and record the signature of
                                                                      the consenter.                             the consenter.

CCBC                                     3      3.1.8           A-S     Each Consent Directive may have a        Each Consent Directive may have
                                                                        an explicit duration by specifying the   an explicit duration by specifying
                                                                        related service                          the related service
                                                                        associated with issuing a consent        associated with issuing a consent
                                                                        directive.                               directive.

CCBC                                     3      3.1.8          Neg-Mi                                            CONF-CD-**:
                                                                                                                 ClinicalDocument/documentationOf
                                                                                                                 /serviceEvent/id element MAY be
                                                                                                                 present.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                              16                                                                       March 2003
                                                          V3 Ballot Submission/Resolution Form

CCBC                                     4                       Neg-Mi 1) A computable representation of
                                                                        the consent directive assertion using
                                                                        HL7-based
                                                                        sections and entries that enables the
                                                                        exchange of consent directives
                                                                        between
                                                                        organizations using very dissimilar
                                                                        security frameworks to enforce the
                                                                        assertions
                                                                        made by the consenter in the
                                                                        Consent Directive.
CCBC                                     4      4.2.1.1          Neg-Mj




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                                17                             March 2003
                                                          V3 Ballot Submission/Resolution Form

CCBC                                     4      4.2.1.1          Neg-Mj




CCBC                                     4      4.3.1            Neg-Mi Signatures




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                              18                March 2003
                                                           V3 Ballot Submission/Resolution Form

CBCC                                     Figure 1.7               Neg-Mi This figure is unreadable in the
                                         3                               document except at the highest
                                                                         resolutions. It should be redone to
                                                                         avoid use of interfering colors and
                                                                         lines.
                                         CONF-                    Neg-Mi This constraint is already present in   Remove the constraint, or note that
                                         CD-3                            CDA R2                                  it is already a requirement of R2

                                                 3.1.1.3          Neg-Mj This is already present as a            Clarify wording, and or remove the
                                                                         constraint in CDA R2, AND the           section.
                                                                         wording is confusing at it conflates
                                                                         the effective time of the document
                                                                         with the effective time of the
                                                                         Consent.




                                         CONF- 3.1.2              Neg-Mj These are already constraints of R2
                                         CD-5
                                         &6
                                               3.1.3              Neg-Mj The AUTHOR of the document need Remove this section.
                                                                         not be the author of the policy, and
                                                                         is in fact often NOT the author of the
                                                                         policy.
                                         CONF- 3.1.3              Neg-Mj In CDA R2, Author SHALL be
                                         CD-8                            present. The IG cannot relax this
                                                                         constaint.
                                         CONF-                    Neg-Mj These are already constraints of R2
                                         CD-
                                         11 to
                                         13
                                         CONF-                    Neg-Mj These are already constraints of R2
                                         CD-
                                         12 to
                                         16
                                         CONF-                    Neg-Mi Duplicate of CONF-CD-13
                                         CD-
                                         16
                                                 3.1.6            Neg-Mi signatureCode/@code element             signatureCode/@code attribute shall
                                                                                                                 be present with a value of S to
                                                                                                                 record…




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                                 19                                                                   March 2003
                                                           V3 Ballot Submission/Resolution Form

                                                  3.1.7           Neg-Mi signatureCode/@code element                signatureCode/@code attribute shall
                                                                                                                    be present with a value of S to
                                                                                                                    record…
                                         Figure                            The example shows both nullFlavor
                                         13                                and <low> and <high>

                                         4                        Neg-Mi


                                                                  Neg-Mi CONF-CD-41: This section
                                                                         SHOULD include a
                                                                         /entry/organizer/component/observat
                                                                         ion/@negationId attribute
                                                                         with default of “false” indicating
                                                                         that the action specified is enable
                                                                         and a default of “true” if the action is
                                                                         not allowed by the Consent
                                                                         Directive. By default the value is
                                                                         “false” for negationInd.
                                         4.2.1.                   Neg-Mj
                                         1



                                         CONF-                    Neg-Mj
                                         CD-
                                         42
                                         Page                     Neg-Mi
                                         29


                                         CONF-
                                         CD-
                                         47
                                         4.3.1                    Neg-Mi




CBCC                                              sample          Neg-Mi author appears to be an HP scannign suggest a more explicit author
                                                                         devicw




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                                 20                                                                      March 2003
                                                             V3 Ballot Submission/Resolution Form

CCBC                                            sample              Neg-Mi sample body is structured however put the scanned document here
                                                                           there is no narrative block, only
                                                                           <text mediaType="text/x-hl7-
                                                                           text+xml">
                                                                             <content />
                                                                             </text>
CCBC                                            sample              Neg-Mi observation that I believe contains supply as separate file
                                                                           the scanned file appears to be in-line,
                                                                           can't render it in IE



CCBC                                            1.7.1                A-Q   This specification defines additional
                                                                           constraints on CDA header and body
                                                                           elements used in a Discharge
                                                                           Summary document in the U.S.
                                                                           realm
CCBC                                            2                   Neg-Mj The section states: "The CDA             review template
                                                                           General Header Constraints template      2.16.840.1.113883.10.20.3 and
                                                                           is reused here." and "CONF-CD-8:         either conform to it or delete the
                                                                           ClinicalDocument/author element          reference to "General Header
                                                                           MAY be present"                          Constraints" which states: CONF-
                                                                                                                    HP-38: The assignedAuthor/id
                                                                                                                    element SHALL be present.
CBCC            ??         CDAR2_IG_C 1.6.3     Keywords             A-S
                           ONSENTDIR
                           _R1_D1_2010
                           JAN



CCBC            ??         CDAR2_IG_C 3.1.2     Clinical             A-S    CONF-CD-5:                              CONF-CD-5:
                           ONSENTDIR            Document/                   ClinicalDocument/recordTarget           ClinicalDocument/recordTarget
                           _R1_D1_2010          recordTarg                  element MUST be present.                element SHALL be present.
                           JAN                  et
CCBC            ??         CDAR2_IG_C 3.1.2     Clinical             A-S    CONF-CD-6:                              CONF-CD-6:
                           ONSENTDIR            Document/                   ClinicalDocument/patientIdRole/@i       ClinicalDocument/patientIdRole/@i
                           _R1_D1_2010          recordTarg                  d element MUST be                       d element SHALL be
                           JAN                  et                          present to specify the target record.   present to specify the target record.

CCBC            ??         CDAR2_IG_C 3.1.2     Clinical             A-S    CONF-CD-7:                              CONF-CD-7:
                           ONSENTDIR            Document/                   ClinicalDocument/patientIdRole/pati     ClinicalDocument/patientIdRole/pat
                           _R1_D1_2010          recordTarg                  ent element MUST be                     ient element SHALL be
                           JAN                  et                          present.                                present.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                                  21                                                                       March 2003
                                                             V3 Ballot Submission/Resolution Form

CCBC            ??         CDAR2_IG_C 3.1.4     ClinicalDo           A-S   Each Consent Directive shall           Each Consent Directive shall
                           ONSENTDIR            cument/cus                 identify the organization that is      identify the entity that is custodian
                           _R1_D1_2010          todian                     custodian of the IIHI                  of the IIHI
                           JAN                                             referenced by the Consent Directive.   referenced by the Consent Directive.

CCBC            ??         CDAR2_IG_C 3.1.4     ClinicalDo           A-S   CONF-CD-16:                            CONF-CD-16:
                           ONSENTDIR            cument/cus                 ClinicalDocument/custodian/assigne     ClinicalDocument/custodian/assigne
                           _R1_D1_2010          todian                     dCustodian/represe                     dCustodian/represe
                           JAN                                             ntedCustodianOrganization/id           ntedCustodianOrganization/id
                                                                           element SHALL be present to            element SHALL be present to
                                                                           specify the                            specify the
                                                                           custodian organization‟s unique        custodian entity's unique national
                                                                           national identifier.                   identifier.
CCBC            ??         CDAR2_IG_C 3.1.4     ClinicalDo           A-S   CONF-CD-16:
                           ONSENTDIR            cument/cus                 ClinicalDocument/custodian/assigne
                           _R1_D1_2010          todian                     dCustodian/represe
                           JAN                                             ntedCustodianOrganization/id
                                                                           element SHALL be present to
                                                                           specify the
                                                                           custodian organization‟s unique
                                                                           national identifier.




CCBC            ??         CDAR2_IG_C 3.1.4     ClinicalDo           A-S   <country>US</country>
                           ONSENTDIR            cument/cus
                           _R1_D1_2010          todian
                           JAN                  Figure 9:
                                                ClinicalDo
                                                cument/do
                                                cumentatio
                                                nOf/custod
                                                ian
                                                example
CCBC            ??         CDAR2_IG_C 3.1.5     ClinicalDo           A-S   CONF-CD-19: The value of               CONF-CD-19: The value of
                           ONSENTDIR            cument/inf                 ClinicalDocument/informationRecip      ClinicalDocument/informationRecip
                           _R1_D1_2010          ormationR                  ient/intendedRecipient/receiv          ient/intendedRecipient/receiv
                           JAN                  ecipient                   edOrganization/id MAY be present       edOrganization/id MAY be present
                                                                           to specify the provider                to specify the recipient entity‟s
                                                                           organization‟s unique national         unique national identifier.
                                                                           identifier.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                                 22                                                                      March 2003
                                                               V3 Ballot Submission/Resolution Form

CCBC            ??         CDAR2_IG_C 3.1.5       ClinicalDo           A-S    CONF-CD-19: The value of               CONF-CD-19: The value of
                           ONSENTDIR              cument/inf                  ClinicalDocument/informationRecip      ClinicalDocument/informationRecip
                           _R1_D1_2010            ormationR                   ient/intendedRecipient/receiv          ient/intendedRecipient/receiv
                           JAN                    ecipient                    edOrganization/id MAY be present       edOrganization/id MAY be present
                                                                              to specify the provider                to specify the recipient entity‟s
                                                                              organization‟s unique national         unique national identifier.
                                                                              identifier.
CCBC            ??         CDAR2_IG_C    Throu                         A-S
                           ONSENTDIR     ghout
                           _R1_D1_2010   and in
                           JAN           multip
                                         le
                                         chapte
                                         rs



CBCC                                              3.1.1.1             Neg-Mi ClinicalDocument/templateId       ClinicalDocument/templateId
                                                                             element SHALL be present with the element SHALL be present with the
                                                                             value 2.16.840.1.113883.10.20     value TBD

                                                  3.1.2               Neg-Mi ClinicalDocument/recordTarget           ClinicalDocument/recordTarget
                                                                             element MUST be present.                element SHALL be present.

                                                  4                    A-S    Figure 16: nonXMLBody containing
                                                                              a scanned consent directive (IHE
                                                                              BPPC Example)
                                                  4.1                  A-S    LOINC codes SHALL be used with
                                                                              the sections in a Consent Directive.
                                                                              See Table 1: LOINC Codes for
                                                                              Sections.
                                                  4.2.1.1              A-S




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                                    23                                                                  March 2003
                                                    V3 Ballot Submission/Resolution Form

CBCC                                     all               Neg-Mj




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    24                    March 2003
                                                             V3 Ballot Submission/Resolution Form

StructDocs      ??                       2      2.3                 Neg-Mi Vocabulary domains represent value   From Core Principles:
                                                                           sets for coded CDA components.
                                                                           These domains can include HL7-       An HL7 Concept Domain is a
                                                                           defined concepts or can be drawn     named category of like concepts (a
                                                                           from HL7-recognized coding           semantic type) that will be bound to
                                                                           systems such as LOINC or             one or more attributes in a static
                                                                           SNOMED.                              model whose data types are coded.
                                                                                                                Concept Domains exist to constrain
                                                                                                                the intent of the coded element
                                                                                                                while deferring the association of
                                                                                                                the element to a specific coded
                                                                                                                terminology until later in the model
                                                                                                                development process. Thus, Concept
                                                                                                                Domains are independent of any
                                                                                                                specific vocabulary or Code System.

                                                                                                                Concept domains are universal in
                                                                                                                nature (independent of any Binding
                                                                                                                Realm), so the name for a Concept
                                                                                                                Domain should never contain any
                                                                                                                reference to a specific Binding
                                                                                                                Realm. Concept domains are and
                                                                                                                registered with HL7: they are
                                                                                                                proposed as part of the HL7
                                                                                                                standards development process and
                                                                                                                are approved by the RIM
                                                                                                                harmonization process. Both
                                                                                                                processes are described in the HL7
                                                                                                                Development Framework (HDF).

                                                                                                                A Concept Domain is documented
CBCC            ??         CDAR2_IG_C           Cover page           A-Q    Realm is not specified              by specifying a name and a narrative
                                                                                                                Specify realm
                           ONSENTDIR
                           _R1_D1_2010
                           JAN




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                                  25                                                                  March 2003
                                                      V3 Ballot Submission/Resolution Form

                ??         CDAR2_IG_C           4            Neg-Mj
                           ONSENTDIR
                           _R1_D1_2010
                           JAN




CBCC                                            1.7           A-S

CBCC                                            1.7           A-S




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                      26                    March 2003
                                                          V3 Ballot Submission/Resolution Form

CBCC                                             3..1.2           A-S     MUST                                  SHALL




                                                                 Neg-Mi This negative might reflect
                                                                        misunderstanding, and am willing to
                                                                        re-consider. But the specification
                                                                        doesn‟t make it clear how this is
                                                                        really to be used. An example and
                                                                        some narrative would help a lot. At
                                                                        present it seems like a shell that is
                                                                        waiting for important finishing
                                                                        touches. Reading the document does
                                                                        not give me a sense of how it works.
                                                                        I take it that this is intended for
                                                                        scanned consent documents, with the
                                                                        implication that you need a hand
                                                                        written signature. Are there going
                                                                        to be different named documents for
                                                                        different kinds of consent. If so
                                                                        where are they? Some concrete
                                                                        examples could help a lot here.
                                                                        One more thing- the other CDA‟s
                                                                        included the code system name with
                                                                        the code. That eased the reading and
                                                                        facilitated the understanding. Think
                                                                        this version did not do that.



CBCC                                     Gener                   Neg-Mi
                                         al




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                                27                                     March 2003
                                                    V3 Ballot Submission/Resolution Form




Comments
Add name of TP for people not familiar
with it.



Does this need to be fixed?


Shouldn't this be telephone number instead
of address? Address is captured in CONF-
CD-14.




Fix typos throughout document.


Why? Please explain why LOINC codes
have been selected for section names.
Some readers may not be familiar with
LOINC or how they can be used for section
titles.
Suggest using an example of a section
name that has an actual LOINC code
instead of TBD.
Is this an acceptable conformance
statement? How can conformance to this
be demonstrated?
Is this an acceptable conformance
statement? How can conformance to this
be demonstrated?
Could not?




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    28                    March 2003
                                                    V3 Ballot Submission/Resolution Form

Add the following acronyms: IG, HITSP,
TP, SNOMED CT, LOINC, XDS, XDS-
SD, CPCD, DAM, R2, XrML, XACML,
CCD, CONF, R3, TBD, ODRL.
used patientRole in example


used the wrong comment


CONF-CD-13 and CONF-CD-16 use the
same attribute

ungrammatical



unclear reference



Page numbers for Figures 3 and 4
incorrectly listed as "1"


References to sections should match actual
section names




Stated convention disagrees with actual
practice throughout the document


Typo in Figure 3 and subsequent figures




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    29                    March 2003
                                                    V3 Ballot Submission/Resolution Form

Figure 3 in this document fails to match the
model presented in the September 2009
DSTU version of Composite Privacy
Consent Directive Domain Analysis
document (that version is cited in Appendix
C as the source for this specification, and
it's the version in the current ballot
package). Descrepancies should be
explained/justified (or corrected).
Examples include different class names
(InformationObjectReference vs.
ObjectReference) and different
relationships such as the target of the
subjectOfConsent relationship emanating
from the ConsentDirectiveClass (Client vs.
PersonalHaelthRecord).




mismatched quotation mark


missing period


number agreement


This statement undermines confidence in
the specification, leaving the reader to
wonder which instances weren't mapped
and whether they're important. This could
be addressed by pointing out the instances
and describing their (un)importance.




number agreement




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    30                    March 2003
                                                    V3 Ballot Submission/Resolution Form

extraneous word


I didn't find this code using Internet
RELMA. Is it currently in LOINC? (Also
appears in Section 3.1.1.1)




extraneous word; same typo occurs several
times

The VA/KP Problem List is not a code
system, it's a subset of SNOMED CT (aka a
value set, as. The given code belongs to the
SNOMED CT code system, whose OID is
2.16.840.1.113883.6.96 .


extraneous word


ungrammatical




Should use initial capitals, consistent with
the other acronyms

Should use initial capitals, consistent with
the other acronyms




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    31                    March 2003
                                                    V3 Ballot Submission/Resolution Form




POU should anticipate ISO standards in
this area.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    32                    March 2003
                                                    V3 Ballot Submission/Resolution Form

Should allow for any role code specifiable
by OID not just the one indentified.

Establish what TBD is to be.



Establish what TBD is to be.



Establish what TBD is to be.


Establish what TBD is to be.


Obtain formal CBCC and Security
concurrence with this content and elements
presented.




make last sentence a new paragraph for
emphasis


for clarity



Are references for templateID fields to be
added here?


Is this the latest diagram?




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    33                    March 2003
                                                    V3 Ballot Submission/Resolution Form




Consent or Consents?



no end quote




When printing document, indicates
Reference source not found


I do not believe that both the terms legal
authenticator and consenter are needed
here. The reference is to the
legalAuthenicator as described in 3.1.6




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    34                    March 2003
                                                    V3 Ballot Submission/Resolution Form

Clarification needed: If a Consent
Directive is replaced, wouldn't the existing
Consent Directive be expired (or 'deleted')
and thus the new Consent Directive is put
in its place. I'm not sure the way
relatedDocument is considered a
Constraint. Does relatedDocument mean
that the new Consent Directive will
reference an expired/deleted Consent
Directive? If so, does this mean a file will
be maintained to access an expired Consent
Directive?
Have we received any recommendations
from other work groups?




Shouldn't this be included of Section 1.7
"Scope"




Recommend changing 'allowed' to
'identifed' 'specified' or 'indicated' [a
consent directive may allow, restrict….
Etc…)
Are the "templateID <TBD>" to be added
to this document or is this for the enterprise
to complete?




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    35                    March 2003
                                                    V3 Ballot Submission/Resolution Form




Add CPCD



Rather than reference only the CPCD DAM
Information Model, the Implementation
Guide should provide for the exchange of
any consent directive instances that
reference an appropriately constrained
schema. The Implementation Guide should
be loosely coupled to the Information
Models which would be separately
maintained.




Where signatures may or must be provided,
the specification should provide further
constraints to support signature
interoperability when the signatures are
intended to be computable.

Changing this makes the entire Section
content optional, allowing the exchange of
only alternate representations if required.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    36                    March 2003
                                                    V3 Ballot Submission/Resolution Form

Level 2 and Level 3 presume that patient
privacy can be defined within the HL7 v3
RIM. This presents a restricted view of
privacy that is not necessarily reflected in
the real world. We need a way to validly
incorporate concepts not included in the
RIM.
Speculation of future state does not belong
in a DSTU.


Use of structured data presume that patient
privacy can be defined within the HL7 v3
RIM in a computable manner. This
presents a restricted view of privacy that is
not necessarily reflected in the real world. I
recommend HL7 initiate work toward
consensus with cross-domain SDOs that
have devoloped computable syntax for
privacy preferences. HL7 should not
develop its own syntax, but should
contribute sematics to a cross-domain
consensus.

The custodian of the Consent Directive is
not necessarily the custodian of the IIHI.
For instance, the patient may sign a
Consent in a Health Information Exchange
(which is the custodian of that document)
which authorizes the release of information
from all providers participating in that HIE;
but the various providers are the custodians
of the IIHI.



The recipient may not be known at the time
of Consent, so this should at most be MAY
be present




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    37                    March 2003
                                                    V3 Ballot Submission/Resolution Form




First, "signed by a patient" is a policy
decision. The specification can not assume
that all consents will be signed by the
patient. Second, the intent of the
specification is to encode the consent
directive in a "CDA document".
Figure 1 is not referenced or explained. I
am unclear what the diagram is trying to
say. I am happy that this is showing that
this is logically related to BPPC, but I am
not sure the representation is accurate. The
BPPC profile allows for encpsulation of a
PDF, yet this figure seems to show it the
other way around.




Simple suggestion. BPPC main failing is
that it can't encode the policy in
computable form, but it can indicate
positive acknolwedgement of a uniquely
identified policy (of indeterminte form).
The use of 'consent' is often not
accompanied with 'privacy', there are many
forms of consent (consent to treat) that are
not the subject of this document.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    38                    March 2003
                                                    V3 Ballot Submission/Resolution Form

The use of 'consent' is considered restrictive
in some regions (e.g., USA) where it has a
legal definition that is constrained smaller
than consent directive. I believe we want to
be able to represent any for of patient
agreed to (consent) privacy policy. This
would be inclusive of the USA HIPAA
'authorization' term, where a patient agrees
that their data can be used for reasons
outside treatment, payment, or normal
operations. Further this specification could
be used by a patient (consumer) to declare
their privacy preferences. I would therefore
recommend against the use of consent. In
IHE-BPPC we decided to use the term
"Patient Privacy Policy" and "Patient
Privacy Policy Acknowledgement
Document" is an instance of a document
that includes a patient privacy policy.




The term 'client' starts here and is not
explained. I really don't think the word
'client' is a good word to describe the
'consumer' or 'patient' or 'subject of the
privacy policy'. The document should pick
a term and stick with it. This will mean that
the glossary and/or lead material needs to
explain the scope of the term so that the
reader is clear.
Is it appropriate for an HL7 document to
call upon IHE specifications for
constraints?




Better to start with a document with no
clinical content to remove. I suggest the
base is BPPC which is consistent with the
next paragraph. We may not need to say
"used in a xyz document" text at all. Note
section 2 indicates that the base is "CDA
General Header template".




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    39                    March 2003
                                                    V3 Ballot Submission/Resolution Form

remove the text from the third bullet




This section is nicely informative of the
problems encoding the CPCD DAM in
CDA document form, but it does not
indicate what problems existed. I do not
support HL7 invention of a policy language
for encoding the consent-directive in CDA
statements or RIM. I support the use of
external languages with healthcare specific
vocabulary. I recommend this section
indicate that this is the approach taken.

There appears to be a simple paragraph
explaining what a consent directive
document is. This is a document that
captures a patient/consumer agreement
with a specific set of privacy policy (i.e.
rules). Where these rules indicates
appropriate access/use of information about
that patient/consumer. (surely we have a
good paragraph somewhere).
What does the effectiveTime mean? I think
we mean that this is the time range where
the enclosed privacy-policy is effective.
Right? Meaning if the current date/time is
not in the range specified by effectiveTime
then the policy is not effective. This is what
BPPC used to support consents that were of
a defined duration, such as the state of MN
where consents are only good for the
duration of a treatment episode.




I think we will confuse our audience if we
bring in the scanning device in this
specification. The combination of the
privacy-policy template with a scanned-
document template should be logical for
people to follow.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    40                    March 2003
                                                    V3 Ballot Submission/Resolution Form

This section should be optional. There are
cases where the patient will use this
document format to express their
preferences for privacy rules associated
with all their data regardless of where it is
maintained. Further the location of the data
is not always obvious. I do think it is fine to
leave the section with the interpreation you
give, just make it optional.

It is not clear to me how this specificaiton
is utalizing the informationRecipient
differently than is defined in CDA. That
being simply indicating to whom the CDA
document that contains the privacy-policy
is initially intended to go. There seems to
be text in this section that indicates that
this is also related to other IIHI, which I
think is not clear and inappropriate. Stick
with the original definition found in CDA,
and if so then there is no need to put
constraints on this section here.

It is a policy choice to declare that the
consenter must be sign. There are good
reasons for 'implied' consent, or 'signature
on file'. This should be MAY.
First simple typo: additiona "a" found in
the sentence.
Second, what is the relationship to the
effectiveTime documented in 3.1.1.3?
Which wins?

Could include the BPPC mechanism to
have the service event hold an 'id' value
which is the unique idenfier of the policy
being acknowledged. This allows for
simple agreement of pre-staged policies.
This would not mean that the policy is not
encoded inside the CDA document, but it
does allow for quicker processing when a
boiler-plate policy has been agreed to
without modifications. This is what your
example shows: A bppc service event
agreeing to policy unique id
2.16.840.1.113883.3.72.4.2.5.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    41                    March 2003
                                                    V3 Ballot Submission/Resolution Form

HL7 does not today have a policy language
and should not invent one where there are
plenty to choose from. I recommend that
we stick with (2) and have bindings
between a set of externally defined policy
languages and our healthcare specific
vocabulary and concepts.




Remove section: The proposed section
would simply list the elements and not have
any way to show the relationships between
them. A policy language would need to be
developed to show policy grouping, targets,
subjects, subjectmatching rules, resources,
resource matching rules, actions, action
matching rules, environment, environment
matching rules, policy set referencing
methods, combining parameters, super-sets
of combiniing rules, expressions,
conditions, etc... There is far more to a
policy language than a flat list of attributes
used by the language.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    42                    March 2003
                                                    V3 Ballot Submission/Resolution Form

The use of HL7 RIM for encoding policy is
unnecessary given that there are plenty of
policy language schemas available that
have addressed the special needs of policy
language encoding. I recommend the use of
guidelines on how to apply HL7 specific
vocabulary to more than one existing policy
language standard schema with the use of
the Privacy and/or Security DAM as
guidance. This is sufficient to assure that
the external used policy languages can
consistently encode the Privacy and/or
Security DAM given the HL7 identified
healthcare specific vocabulary. The
addition of yet-another policy language that
is specific to HL7 domain would not be
helpful toward advancing healthcare or
privacy. I assert that there are plenty of
mature policy languages including
XACML and ORDL. I assert that HL7
showing how to use HL7 specific
vocabulary using two or more mature
policy languages is sufficient I assert that
policy language schema is significantly
different than an Information Model (e.g.
HL7 RIM, or HL7 statements) I assert that
inventing a new policy language schema is
not a useful exercise, nor does HL7 have
the skills inshould be of activity. with the
Signatures this type harmoized
signature work item owned by the Security
workgroup. The Security group has
recommended the use of encapsulating
XML-Digital Signatures rather than any
HL7 specific method, thus allowing for the
broadest use of exisiting digital signature
functionality.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    43                    March 2003
                                                    V3 Ballot Submission/Resolution Form




A value of X would indicated a singature
was intended but not collected!




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    44                    March 2003
                                                    V3 Ballot Submission/Resolution Form

A value of X would indicated a singature
was intended but not collected!




Item 1) in the list seems to indicate that
Level 3 is required when earlier material
indicates that it is optional.
Change "default" to "value"




As I understand it, this is a collection of
organizers denoting ACTS that are allowed
or not allowed by the consent directive. As
such, these are not observations.

The classCode of Criterion is EVN.CRT


Last conformance critieria is missing a
label of the form CONF-CD-XX


The classCode of Criterion is EVN.CRT


CDA-R2 supports external digital
signatures, and signatures can be included
using RIM-based extensions. This should
be considered for the DSTU since
signatures are expected to be supported in
R3 and it would be better to use the
appropriate RIM modeling




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    45                    March 2003
                                                    V3 Ballot Submission/Resolution Form

it would still be a bit of a kludge because
CDA R2 doesn't really accommodate
entries w/a blob of a body, however, I
believe it would be a sort of okay kludge;
as is, does not meet that criteria

could be operator error here, however, hard
to tell since I would expect the body to be
in <text>



is this a cut & paste issue?




It is very difficult to evaluate the intent of
the IG with these contradictory statements.
If I assume that the reference to the General
Header Constraints should not be taken
literally, then, I would have to ask why you
do not require an Author.

"Must" is not provided as an assertion
keyword, but "Must" is used in some
conformance statements within this IG
(e.g., paragraph 3.1.2 Clinical
Document/recordTarget). Please contact
danny.sawyer.ctr@tma.osd.mil for
resolution of any suggestions.
"Must" is not provided as an assertion
keyword, but "Must" is used in some
conformance statements within this IG.

"Must" is not provided as an assertion
keyword, but "Must" is used in some
conformance statements within this IG.


"Must" is not provided as an assertion
keyword, but "Must" is used in some
conformance statements within this IG.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    46                    March 2003
                                                    V3 Ballot Submission/Resolution Form

Seems that custodians of IIHI can be other
than an organization, as in the case of a
sole proprietorship physician. Suggest
changing the word "organization" to
"entity".
Seems that custodians of IIHI can be other
than an organization, as in the case of a
sole proprietorship physician. Suggest
changing the word "organization" to
"entity" and allowing for both a Type-1 or
Type-2 NPI.


Question: Can a custodian be a non-NPI
entity, such as Google for PHR? If so, then
rules that restrict certain entities from
obtaining NPI's would have to change and
non-HIPAA entities may have to be
directed to obtain an NPI (or some other
national identifier).




Comment: Note that the country code used
in the example is a two-character code.
However, the country code example in
chapter 3.1.2 is a three-character country
code ("USA"). Question: Are both two
and three-character country codes allowed?
What is the code source (ISO 3166)?



Question: Can a recipient ever be a non-
HIPAA organization or person entity (e.g.,
Google for PHR)? If so, then suggest
replacing "provider organization" with
"recipient entity".




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    47                    March 2003
                                                    V3 Ballot Submission/Resolution Form

Seems that recipient of the information can
be other than an organization, as in the case
of a sole proprietorship physician. Suggest
changing the word "organization" to
"entity" and allowing for both a Type-1 or
Type-2 NPI.

Comment: There is mixed use of both
"patient" and "client" throughout the IG
document. Sometimes, the mixed usage is
within the same chapter. It appears that
these terms are being used interchangably.
Suggest that either we pick one term to use
and standardize, or explain that these two
terms are interchangable, or define when
each of the terms should be used.

2.16.840.1.113883.10.20 is the root
template id for SDWG templates. It should
not be used directly, rather, child OIDs
need to be created underneith it.
Replace MUST with SHALL throughout
this section (and anywhere else it is used as
a conformance verb).
Maybe also include an example showing a
reference to the filename vs. B64 embedded
content.
Suggest moving the LOINC codes into the
appropriate section descriptions themselves
so they are associated with the section
template IDs.
Suggest adding a templateId to either the
entry or organizer (would prefer the
organizer) so that it can be easily validated
and also used in other IGs.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    48                    March 2003
                                                    V3 Ballot Submission/Resolution Form

I am concerned that this approach will just
add to the babel of consent and policy
languages. To be sure, CDA can
encapsulate anything, but there are many
efforts underway trying to make progress
with the capturing of policy. If you look at
the W3C wiki on policy languages
http://www.w3.org/Policy/pling/wiki/Policy
LangReview you can see how long the list
is.

My experience with P3P v1.1 was that this
is a very difficult area. P3P had to keep
trimming scope and constraining the policy
domain in order to make progress. In the
end, we developed a good description of
web site privacy policies, but it foundered
on the public value proposition. It did not
get integrated into browsers and web sites
did not find the public using it. When we
started it, there was thought that it might be
able to encompass healthcare needs, but
those were scoped out as the magnitude of
the problem became apparent.

I would rather work with several of these
organizations instead of developing
something new. I am not sure whether it is
reasonable to pick just one at this point or
not. It may make more sense to get real
clarity on the technical details of the use
requirements first, and then find the right
I would rather work with some of these
organizations instead of developing
something completely new. I am not sure
whether it is reasonable to pick just one at
this point or not. It may make more sense
to get real clarity on the technical details of
the use requirements first, and then find the
right group or groups to work with. Groups
that are dealing with other domains are
gaining very useful experience with what is
needed to capture many of the common
aspects of describing a privacy policy.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    49                    March 2003
                                                    V3 Ballot Submission/Resolution Form

Concept Domains (updated term) do not
contain or include any concepts. A
Concept Domain is a named category of
like concepts (a semantic type) that will be
bound to one or more attributes in a static
model whose data types are coded.

Concept Domains exist to constrain the
intent of the coded element while deferring
the association of the element to a specific
coded terminology until later in the model
development process.

Thus, Concept Domains are independent of
any specific vocabulary or Code System.

Update the description of Concept Domain
to more accurately reflect their intended
purpose and aline definition with the HL7
Core Principles ballot.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    50                    March 2003
                                                    V3 Ballot Submission/Resolution Form

The guide provides either too much
specification or too little specification,
depending on how you view it. Either way,
it does not appear to be implementable. On
the one hand, there is some mention of
existion representations that could be used,
but there is insufficient guidance in how to
precisely do so. On the other hand, ti
appears that a stab has been taken at
putting together an HL7-based
representation, but it is incomplete.
Following this guidance could not result in
the creation of documents that could meet
the use cases.

For example, various conformance criteria
call for the representation of key elements
such as "action allowed," "type of IIHI,"
and "level of sensitivity." However the
criteria are only "MAYs." How can a
consent document not include such
elements? At the same time, no guidance is
offered as to exactly how such fundamental
concepts are to be represented, or which
value sets are to be used.

Recommend taking a single approach and
following through completely.



Page 13 - Figure 3 does not have any text
associated with it.
Page 14 – Last sentence first paragraph
references “…this specification includes
the requirements specified in the CPCD
DAM as seen in the following figures”.
There are NO following figures in this
section.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    51                    March 2003
                                                    V3 Ballot Submission/Resolution Form

Several items use the term MUST instead
of the term SHALL (which is the one noted
at the beginning of the document – see
page 12). For example, the document
states: "CONF-CD-5:
ClinicalDocument/recordTarget: element
MUST be present." Word MUST should
be changed to SHALL




Several intances of "TBD", missing
diagrams and associated text, and
MUST/SHALL (see other comments).
These all need to be corrected before this
document can be endorsed, and suggest
that additional review by the SME
committee may be needed.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Ballot]                    52                    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.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [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 Committee        Select the committee 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 committee. This can include MnM (Modeling and Methodology) & CQ (Control Query). Enter
                          these committees if you feel the ballot can best be resolved by these groups. In some situations, chapter
                          specific committees such as OO (Observation and Orders) and FM (Financial Management) will refer
                          ballot comments to these committees if they are unable to resolve the ballot comment. An explanation of
                          the 'codes' used to represent the Ballot Committees 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 Committees 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".


5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [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 committee 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 Committee 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.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Instructions]                                                                                   August, 2002
                                            Ballot Submission/Resolution Instructions

                                          Committee Resolution (sections in turquoise)
  Comment Grouping        This is a free text field that committees can use to track similar or identical ballot comments. For example,
                          if a committee receives 10 identical or similar ballot comments the committee can place a code (e.g. C1) in
                          this column beside each of the 10 ballot comments. The committee 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.."




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [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 Inc. Bylaws and Policies and Procedures. 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 TC has agreed to make the requested change, 2) the TC has agreed to make the
                            requested change, but with modification; 3) the TC 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 TC 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 TC 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 TC 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 TC 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 committee 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 committee update the disposition as appropriate when the line item is resolved.
  Disposition Committee If the Disposition is "Refer", then select the committee that is ultimately responsible for resolving the ballot
                        comment. Otherwise, leave the column blank. If the Disposition is "Pending" for action by another
                        committee, select the appropriate committee.




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [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 committee 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 committee (or disposition committee) that will ensure that any accepted
                           changes are applied to subsequent materials published by the committee (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 committee 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 committee chairs to indicate if the line item is a substantive change.
  Substantive Change       NOTE: This is a placeholder in V3 pending definition of substantive change by the ARB.
                           This column is auto filled from the Submitter Worksheet. It is used to refer back to the submitter for a
                           given line item when all the ballot line items are combined into a single spreadsheet or database. For
                           Organization and Benefactor members, the designated contact must be one of your registered voters to
  Submitted By             conform with ANSI guidelines.
                           This column is auto filled from the Submitter Worksheet. Submitter's should enter the name of the
                           organization that they represent with respect to voting if different from the organization that they are
                           employed by. It is used to link the submitter's name with the organization they are voting on behalf of for a
  Organization             given line item when all the ballot line items are combined into a single spreadsheet or database.
                         This column is autofilled from the Submitter Worksheet. It is used to track the original submitter of the line
                         item. Many International Affiliates, Organizational, and Benefactor balloters pool comments from a variety
  On Behalf Of           of reviewers, which can be tracked using this column.
                         This column is autofilled from the Submitter Worksheet. It is used to track the email address of the original
                         submitter of the line item. Many International Affiliates, Organizational, and Benefactor balloters pool
  On Behalf Of Email     comments from a variety of reviewers, which can be tracked using this column.
  Submitter Tracking ID #Internal identifier (internal to the organization submitting the ballot). This should be a meaningful number
                         to the organization that allows them to track comments. This can be something as simple as the
                         reviewer‟s initials followed by a number for each comment, i.e. JD-1, or even more complex such as
                         „001XXhsJul03‟ where „001‟ is the unique item number, „XX‟ is the reviewer's initials, „hs‟ is the company


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



5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Instructions]                                                                                    August, 2002
                                           Ballot Submission/Resolution Instructions

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




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [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 committee 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
14.06.03.04 of the HL7 Bylaws states that if a ballot comment is to be withdrawn that there must be “…agreement without objection that the negative
vote is persuasive” and therefore TCs must take a vote to accept the comment as persuasive.

2. Persuasive with Mod. The committee 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 TC has accepted the intent of the ballot comment, but has changed the proposed solution
-The TC has accepted part of the ballot comment, and will make a change to the standard; the other part is not persuasive
-The TC 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 14.06.03.04 of the HL7 Bylaws states that if a ballot comment is to be withdrawn that there must be “…agreement without objection that the
negative vote is persuasive” and therefore TCs must take a vote to accept the comment as persuasive.

3. Not Persuasive. The committee does not believe the ballot comment has merit or is unclear. Section 14.06.03.03 of the HL7 Bylaws states that “A
motion or ballot to declare a negative response „not persuasive,‟ requires an affirmative vote of at least two-thirds of the combined affirmative and
negative votes cast by the Technical Committee members on the action for approval.” A change will not be made to the standard or proposed standard.
The committee 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 15.10 of the HL7 Bylaws.
Example scenarios include, but are not limited to;
- the submitter has provided a recommendation or comment that the committee 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 Related. The TC has determined that the ballot comment is not relevant to the domain at this point in the ballot cycle. Section 14.06.03.02 of
the HL7 Bylaws states that “A motion or ballot to declare a negative response „not related‟ to the item being balloted requires an affirmative vote of at
least two-thirds of the combined affirmative and negative votes cast by the Technical Committee members on the action for approval.” 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



5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Instructions Cont..]                                                                                  August, 2002
                                            Ballot Submission/Resolution Instructions

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

6. Pending Input from Submitter. This should be used when the TC 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 TC can track and sort their dispositions more accurately.

7. Pending Input from other Committee. The TC has determined that they cannot give the comment a disposition with out further input or a final
decision from another Committee. This should be used for comments that do belong to your TC but you require a decision from another Committee
such as ARB or MnM.

Applicable only to Affirmative Ballot Comments
8. Considered for future use. The TC, or a representative of the TC (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 committee using the
agreed upon procedures.

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

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




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Instructions Cont..]                                                                              August, 2002
                                                          Ballot Submission/Resolution Instructions




Comments.




d standard.




              5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Instructions Cont..]                          August, 2002
                                                           Ballot Submission/Resolution Instructions

n submitted




the question
quirements.

some TC's
up the good




               5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [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).
  ------------------------------------------------------------------




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Format Guidelines]                          64                                                March 2003
                                                               V3 Ballot Submission/Resolution Form




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Format Guidelines]                    65                    March 2003
                                                                 V3 Ballot Submission/Resolution Form


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

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

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


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


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

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

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


5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Co-Chair Guidelines]                         66                                                                               March 2003
                                                                 V3 Ballot Submission/Resolution Form

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


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


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

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

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

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

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

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


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


5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Co-Chair Guidelines]                           67                                                                               March 2003
                                                                 V3 Ballot Submission/Resolution Form

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

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


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

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


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


 Divided opinion on what requires a vote
 Issue
 Response · Do all negative line items require inspection/vote of the TC? – Yes, but you can group· Do all substantive line items require inspection/vote of the TC? Yes· How should non
 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 impe
 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 negative i
 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, while pr
 standard.
 Comment

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

5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Co-Chair Guidelines]                           68                                                                                March 2003
                                                                 V3 Ballot Submission/Resolution Form


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

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




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Co-Chair Guidelines]                           69                                                                                March 2003
                                                                 V3 Ballot Submission/Resolution Form




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Co-Chair Guidelines]                    70                    March 2003
                                                                                V3 Ballot Submission/Resolution Form


, or replaced by use cases)


lots returned on unmarked items will be found

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

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



       persuasive.· In all cases, the voter must

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




o 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


               5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Co-Chair Guidelines]                    71                    March 2003
                                                                                 V3 Ballot Submission/Resolution Form

 of the affirmative comment and whether or not




 ust notify the ballotter of this disposition.




whether or not the respondent has withdrawn



nion as to whether or not Technical

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




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

nt to HL7 HQ by email or fax.

otes with the negative balloters. The negative




                5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Co-Chair Guidelines]                    72                    March 2003
                                                                                V3 Ballot Submission/Resolution Form




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




 ? Yes· How should non-substantive changes be




owances for “Guideline Not Found”.




m purposes, but does not impede the ballot, e.g.
 does not count as a negative in the 90% rule.·
get the ballot to pass, while producing a quality




               5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Co-Chair Guidelines]                    73                    March 2003
                                                                                 V3 Ballot Submission/Resolution Form



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



he ballot (as it currently seems to state in the




                5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Co-Chair Guidelines]                    74                    March 2003
                                                                 V3 Ballot Submission/Resolution Form




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Co-Chair Guidelines]                    75                    March 2003
Ballot Committee Code   Ballot Committee Name Ballot Code Name

CQ                      Control/Query            CT
                                                 XML-ITS DataTypes

                                                 XML-ITS Structures

                                                 Datatypes Abstract
                                                 MT
                                                 TRANSPORT
                                                 UML-ITS DataTypes

                                                 CI, AI, QI
                                                 MI

FM                      Financial Management     AB
                                                 CR

M and M                 Modelling and Methodology
                                                RIM
                                                 Refinement

MedRec                  Medical Records          MR

OO                      Orders and Observations LB
                                                 OO
                                                 RX
                                                 BB
                                                 ME

PA                      Patient Administration   PA

PC                      Patient Care             PC

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

RCRIM                   Regulated Clinical Research Information Management
                                                 RR
                                                 RT

Sched                   Scheduling               SC

Vocab                   Vocabulary               Vocabulary (ref)
                                                 Glossary (ref)

ARB                     Architectural Review Board
CCOW                    Clinical Context Object Workgroup
CDS                     Clinical Decision Support
StructDocs   Structured Documents
PM           Personnel Management   PM
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: Accounting and Billing, Release 1
Version 3: Claims and Reimbursement, Release 1, 2, 3

Version 3: Reference Information Model
Version 3: Refinement, Extensibility and Conformance, Release 1, 2

Version 3: Medical Records, Release 1

Version 3: Laboratory, Release 1
Version 3: Orders and Observations, Release 1
Version 3: Pharmacy, Release 1
Version 3: Blood Bank, Release 1
Version 3: Medication, Release 1

Version 3: Patient Administration, Release 1, 2

Version 3: Patient Care, Release 1

Version 3: Guide
Version 3: Backbone

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

Version 3: Scheduling, Release 1, 2

Version 3: Vocabulary
Version 3: Glossary
Type of Document

Domain

Foundation

Foundation
Foundation
Domain
Foundations

Foundation
Domains
Domain

Domain
Domain

Foundation
Foundation

Domain

Domain
Domain
Domain
Domain
Domain

Domain

Domain

Reference
Reference

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


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

HD
AR
RM
IN
TE
MT
DM
ST



5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Setup]                                     82                                                                            March 2003
                                                   V3 Ballot Submission/Resolution Form

??
                                                        ARB,Att
                                                        ach,Car
                                                        dio,CBC
                                                        C,CCO
                                                        W,CDS,
                                                        CG,Clini
                                                        cal
                                                        Stateme
                                                        nt,Confo
                                                        rm,Ed,E
                                                        HR,FM,II
                                                        ,Implem
                                                        entation,
                                                        InM,ITS,
                                                        Lab,M
                                                        and M,M
                                                        and M/
                                                        CMETs,
                                                        M and
                                                        M/
                                                        Templat
                                                        es,M
                                                        and M/
                                                        Tooling,
                                                        MedRec,
                                                        OO,PA,
                                                        PC,PHE
                                                        R,PM,P
                                                        S,PSC,P
                                                        ublishing
                                                        ,RCRIM,
                                                        RX,Sche
                                                        d,Securit




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Setup]                    83                    March 2003
                                                                           V3 Ballot Submission/Resolution Form




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




              5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Setup]                                       84                                                                             March 2003
                                                   V3 Ballot Submission/Resolution Form




5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Setup]                    85                    March 2003
                                                                V3 Ballot Submission/Resolution Form




omment can be scheduled for discussion.




             5facedbd-11f3-473f-8f33-14fbd4a18c46.xls [Setup]                    86                    March 2003

				
DOCUMENT INFO
Description: Medical Vocabulary Worksheet document sample