HL7 Governance and Operations Manual
Table of Contents
Adopted January 26, 2009
Last Update: May 16, 2011
Introduction ................................................................................................................................................ I
Notice of Current Edition ........................................................................................................................... I
Additions and/or Revisions Subsequently Adopted .................................................................................. I
01 The Corporation .................................................................................................................................. 1
01.01 Primary Office ............................................................................................................................. 1
01.02 Business Office ........................................................................................................................... 1
01.03 Registered Trademark ................................................................................................................ 1
01.04 Letterhead ................................................................................................................................... 1
01.05 Media Relations .......................................................................................................................... 1
02 Purpose, Objectives, and Approach.................................................................................................... 1
02.01 Comprehensive Framework ....................................................................................................... 1
02.02 Protocol Specifications ............................................................................................................... 1
02.03 Mission Statement ...................................................................................................................... 2
02.04 Contract Work Process ............................................................................................................... 2
03 Membership ......................................................................................................................................... 3
03.01 Establishing Membership ........................................................................................................... 3
03.01.01 Current Member ................................................................................................................. 3
03.02 Clarifying Individual Membership................................................................................................ 3
03.02.01 Association with an Organizational Member ..................................................................... 3
03.02.02 Software Application or Systems Development ................................................................. 3
03.02.03 Implementation Services.................................................................................................... 3
03.02.04 Supporting In-house Operations ........................................................................................ 4
03.03 Classification of Organizational Members .................................................................................. 4
03.03.01 Classes of Organizational Membership ............................................................................. 4
03.03.01.01 Vendor/Manufacturer................................................................................................. 4
03.03.01.02 Consultant ................................................................................................................. 4
03.03.01.03 Healthcare Provider/User .......................................................................................... 4
03.03.01.04 Associations/Government Agencies/Universities ...................................................... 4
03.03.01.05 Payer/Third Party Administrator ................................................................................ 4
03.03.01.06 Pharmaceutical .......................................................................................................... 4
03.04 Termination of Membership ........................................................................................................ 4
03.04.01 Resignation ........................................................................................................................ 4
03.04.02 Failure to Renew ................................................................................................................ 5
03.04.03 Cause ................................................................................................................................. 5
03.05 Change of Membership Status due to Change of Employment ................................................. 5
03.06 Designated Voting Representative Proxy ................................................................................... 5
03.07 Membership Declaration ............................................................................................................. 5
04 Dues, Fees, and Donations ................................................................................................................. 5
04.01 Dues ........................................................................................................................................... 5
04.01.01 Student ............................................................................................................................... 5
04.01.02 Individual ............................................................................................................................ 6
04.01.03 Organizational .................................................................................................................... 6
04.01.03.01 Supporter ................................................................................................................... 6
04.01.03.02 Benefactor ................................................................................................................. 6
04.02 Fees ............................................................................................................................................ 6
04.02.01 Hardship Waiver ................................................................................................................ 6
04.02.02 Student Waiver .................................................................................................................. 6
04.02.03 Professional Courtesy ........................................................................................................ 7
04.03 Donations .................................................................................................................................... 7
05 Participation ......................................................................................................................................... 7
05.01 HL7 Protocol Specification Development and Maintenance ...................................................... 7
05.02 Work Group Co-chair Nomination and Election ......................................................................... 7
05.02.01 Co-chair Nomination .......................................................................................................... 7
05.02.02 Co-chair Ballots .................................................................................................................. 7
05.02.03 Absentee Voting ................................................................................................................. 8
05.02.04 Voting at the Working Group Meeting ................................................................................ 8
05.02.04.01 Variance to Voting Process ....................................................................................... 8
HL7 Governance and Operations Manual
Table of Contents
Adopted January 26, 2009
Last Update: May 16, 2011
05.02.05 Tally and Announcement ................................................................................................... 8
05.03 Administrative Ballots ................................................................................................................. 8
05.04 Majority Rule ............................................................................................................................... 9
06 Governance ......................................................................................................................................... 9
06.01 Board of Directors ....................................................................................................................... 9
06.01.01 Limits to Organizational Representation ............................................................................ 9
06.01.02 Nomination and Election of Officers and HL7 Directors .................................................... 9
06.01.02.01 Nomination and Election Schedule ........................................................................... 9
06.01.02.02 Officer Nomination Criteria and Voting Pool ............................................................. 9
06.01.02.03 HL7 Director Nomination Criteria and Voting Pool .................................................... 9
06.01.02.04 Nomination and Election Process ............................................................................. 9
06.01.02.05 Appointment of an Interim HL7 Director to Fill a Vacancy ...................................... 10
06.01.03 Nomination and Election of Affiliate Directors ................................................................. 11
06.01.03.01 Appointment of an Interim Affiliate Director to Fill a Vacancy ................................. 11
06.01.04 Director Term of Office..................................................................................................... 12
06.01.05 Directors Nominated by the Chief Executive Officer ....................................................... 12
06.01.06 Travel for HL7 Board Functions ....................................................................................... 12
06.01.06.01 Attendance at Working Group Meetings ................................................................. 12
06.01.06.02 Attending the Annual Board Retreat ....................................................................... 12
06.02 Duties and Powers of the Board of Directors ........................................................................... 13
06.02.01 Managing the HL7 Roadmap ........................................................................................... 13
06.02.01.01 Strategic Initiatives .................................................................................................. 13
06.02.01.02 Roadmap Tasks ...................................................................................................... 13
06.02.01.03 Impact on the Annual Budget .................................................................................. 13
06.02.01.04 Execution ................................................................................................................. 13
06.03 Board of Directors Meetings ..................................................................................................... 14
06.03.01 Observers ........................................................................................................................ 14
06.03.02 Board Appointed Committee Chairs ................................................................................ 14
06.04 Conflict of Interest ..................................................................................................................... 15
06.04.01 Definitions ........................................................................................................................ 15
06.04.02 Procedures ....................................................................................................................... 15
06.04.02.01 Duty to Disclose ...................................................................................................... 15
06.04.02.02 Determining Whether a Conflict of Interest Exists .................................................. 15
06.04.02.03 Addressing the Conflict of Interest .......................................................................... 15
06.04.02.04 Violations of the Conflict of Interest Policy .............................................................. 16
06.04.03 Records of Proceedings................................................................................................... 16
06.04.04 Compensation Decisions ................................................................................................. 16
06.04.05 Annual Statements ........................................................................................................... 16
06.04.06 Periodic Review ............................................................................................................... 16
06.04.07 Use of Outside Experts .................................................................................................... 17
06.05 Code of Ethics .......................................................................................................................... 17
06.06 Submitting and Resolving Motions via Email ........................................................................... 17
06.07 Liability Insurance ..................................................................................................................... 18
06.08 Fiscal Policy .............................................................................................................................. 18
06.08.01 Expenditure Limits ........................................................................................................... 18
06.08.02 Annual Budget ................................................................................................................. 18
06.08.03 Investment Strategy ......................................................................................................... 18
06.08.04 Travel for HL7 Related Business ..................................................................................... 18
06.08.05 Reimbursement of Reasonable Expenses ...................................................................... 19
06.09 Whistleblower Policy ................................................................................................................. 19
06.09.01 Reporting Encouraged ..................................................................................................... 19
06.09.02 Protection from Retaliation .............................................................................................. 19
06.09.03 Reporting Process ........................................................................................................... 20
07 Officers .............................................................................................................................................. 20
07.01 The Executive Committee ........................................................................................................ 20
07.02 Chair ......................................................................................................................................... 20
07.02.01 Term of Office .................................................................................................................. 20
HL7 Governance and Operations Manual
Table of Contents
Adopted January 26, 2009
Last Update: May 16, 2011
07.02.02 Representing HL7 ............................................................................................................ 20
07.02.03 Reimbursing Expenses of the HL7 Chair and Vice Chair ................................................ 21
07.03 Chair-Elect ................................................................................................................................ 21
07.03.01 Term of Office .................................................................................................................. 21
07.04 Immediate Past Chair ............................................................................................................... 21
07.04.01 Term of Office .................................................................................................................. 21
07.05 Secretary .................................................................................................................................. 21
07.05.01 Term of Office .................................................................................................................. 22
07.06 Treasurer .................................................................................................................................. 22
07.06.01 Term of Office .................................................................................................................. 22
08 Appointed Positions .......................................................................................................................... 22
08.01 HL7 Liaisons ............................................................................................................................. 22
09 The Working Group ........................................................................................................................... 22
09.01 The Technical Steering Committee (TSC) ............................................................................... 22
09.01.01 TSC Elections .................................................................................................................. 23
09.01.01.01 TSC Chair ................................................................................................................ 23
09.01.01.02 Steering Division Co-chairs ..................................................................................... 23
09.01.01.03 Affiliate Representatives ......................................................................................... 23
09.01.02 Term of Office .................................................................................................................. 24
09.01.02.01 TSC Chair ................................................................................................................ 24
09.01.02.02 Elected Members .................................................................................................... 24
09.01.02.03 Ad Hoc Member ...................................................................................................... 24
09.01.03 Vacancies ........................................................................................................................ 24
09.01.03.01 TSC Chair ................................................................................................................ 24
09.01.03.02 SD Co-chairs ........................................................................................................... 24
09.01.03.03 Affiliate Representative ........................................................................................... 24
09.01.04 Meetings .......................................................................................................................... 24
09.01.05 Observers ........................................................................................................................ 24
09.01.06 Interpretation of the HL7 Protocol Specifications ............................................................ 25
09.01.07 Endorsing Tools for Standards Development .................................................................. 25
09.02 Work Groups............................................................................................................................. 25
09.02.01 Establishing a Work Group .............................................................................................. 25
09.02.01.01 Criteria ..................................................................................................................... 25
09.02.01.02 Process ................................................................................................................... 25
09.02.02 Changing a Work Group Name or Mission/Charter ......................................................... 26
09.02.03 Dissolution of a Work Group ............................................................................................ 26
09.02.04 Work Group Co-Chairs .................................................................................................... 27
09.02.04.01 Responsibilities ....................................................................................................... 27
09.02.04.02 Term of Office .......................................................................................................... 27
09.02.04.03 Removal from Office................................................................................................ 27
09.02.04.04 Stepping Down due to Change in Membership Status ........................................... 27
09.02.04.05 Technical and Support Services Steering Division (T3SD) Work Groups .............. 28
09.02.05 Decision Making Practices ............................................................................................... 28
09.03 Architecture Board (ArB) .......................................................................................................... 28
09.03.01 Composition ..................................................................................................................... 28
09.03.02 Criteria for Membership ................................................................................................... 29
09.03.02.01 Qualifications ........................................................................................................... 29
09.03.02.02 Commitment ............................................................................................................ 29
09.03.02.03 Trial Participation..................................................................................................... 29
09.03.03 Term of Membership ........................................................................................................ 29
09.03.03.01 ArB Chair and Vice Chair ........................................................................................ 29
09.03.03.02 Other Members ....................................................................................................... 29
09.03.03.03 Notification of Renewal............................................................................................ 29
09.03.04 Change of Member Employment Status .......................................................................... 30
09.03.05 Removal of Member ......................................................................................................... 30
09.03.06 Conduct of Meetings ........................................................................................................ 30
10 Committees and Councils ................................................................................................................. 30
HL7 Governance and Operations Manual
Table of Contents
Adopted January 26, 2009
Last Update: May 16, 2011
10.01 Advisory Council ....................................................................................................................... 30
10.02 International Council ................................................................................................................. 30
10.02.01 United States Representation .......................................................................................... 30
10.03 Finance Committee .................................................................................................................. 30
10.04 Governance and Operations Committee .................................................................................. 31
10.05 Marketing Council ..................................................................................................................... 31
10.06 Nomination Committee ............................................................................................................. 31
10.06.01 Composition ..................................................................................................................... 31
10.06.01.01 Elected Representatives ......................................................................................... 32
10.06.01.02 Advisory Council and Board Representatives ......................................................... 32
10.06.01.03 TSC Representative ................................................................................................ 32
10.06.02 Announcement ................................................................................................................. 32
10.06.03 Selecting a Chair .............................................................................................................. 32
10.07 Organizational Relations Committee ........................................................................................ 32
10.08 Policy Advisory Committee ....................................................................................................... 32
10.09 Process Improvement Committee ............................................................................................ 33
10.10 Recognition and Awards Committee ........................................................................................ 33
10.11 Strategic Initiatives Committee ................................................................................................. 33
10.11.01 Strategic Initiatives Process Timeline .............................................................................. 34
11 Conferences, Meetings, and Educational Programs ......................................................................... 34
11.01 Meeting Notice .......................................................................................................................... 34
11.02 Meetings in Conjunction with HL7 ............................................................................................ 34
11.03 Tutorials .................................................................................................................................... 34
11.04 Special Meetings ...................................................................................................................... 35
12 Electronic Ballots ............................................................................................................................... 35
12.01 Alternative to Electronic Ballot Format ..................................................................................... 36
12.02 Consideration of Recommended Actions ................................................................................. 36
12.03 Naming Convention .................................................................................................................. 36
12.03.01 Constructing V2.x Ballot Protocol Specification Names .................................................. 36
12.03.02 Constructing Other HL7 Ballot and Protocol Specification Names .................................. 36
12.03.03 Approving HL7 Ballot and Protocol Specification Names ................................................ 37
13 Review Ballots ................................................................................................................................... 37
13.01 Informative Documents ............................................................................................................. 37
13.01.01 Initiation ............................................................................................................................ 38
13.01.02 Forming the Review Group .............................................................................................. 38
13.01.02.01 US Realm-specific Review Group ........................................................................... 38
13.01.03 Ballot Package ................................................................................................................. 38
13.01.04 Handling Comments ........................................................................................................ 38
13.01.05 Approval ........................................................................................................................... 39
13.01.06 Registration as an ANSI Technical Report ...................................................................... 39
13.01.06.01 Criteria for Registration ........................................................................................... 39
13.01.06.02 Required Foreword.................................................................................................. 39
13.01.06.03 Procedures for Approval and ANSI Registration ..................................................... 40
13.01.06.04 Designation and Publication .................................................................................... 40
13.01.06.05 Challenging the Registration of a Technical Report ................................................ 40
13.01.07 Withdrawal of an Informative Document .......................................................................... 41
13.02 Draft Standards......................................................................................................................... 41
13.02.01 Initiation ............................................................................................................................ 41
13.02.02 Forming the Review Group .............................................................................................. 41
13.02.03 Ballot Package ................................................................................................................. 42
13.02.04 Handling Comments ........................................................................................................ 42
13.02.05 Approval ........................................................................................................................... 42
13.02.06 Trial Use ........................................................................................................................... 42
13.02.06.01 Draft Standard for Trial Use (DSTU) Front Matter .................................................. 43
13.02.06.02 Extending the Trial Use Period ............................................................................... 43
13.02.07 Results of the Trial Use Period ........................................................................................ 43
13.02.08 Backwards Compatibility to Base American National Standard ...................................... 43
HL7 Governance and Operations Manual
Table of Contents
Adopted January 26, 2009
Last Update: May 16, 2011
13.03 Comment-only Ballot ................................................................................................................ 43
13.03.01 Initiation ............................................................................................................................ 44
13.03.02 Forming the Review Group .............................................................................................. 44
13.03.03 Ballot Package ................................................................................................................. 44
13.03.04 Results of the Review ...................................................................................................... 44
14 Normative Ballot ................................................................................................................................ 44
14.01 Normative Ballot Content .......................................................................................................... 44
14.01.01 Proposed Normative Content .......................................................................................... 44
14.01.02 Moving an Informative Document to Normative Ballot .................................................... 45
14.01.03 Moving a Draft Standard to Normative Ballot .................................................................. 45
14.01.04 Normative Ballot Resulting from External Requirements ................................................ 45
14.01.05 Components Labeled “For Comment Only” ..................................................................... 45
14.01.06 Confirmation of Previous Ballot Reconciliation ................................................................ 45
14.02 Notice of Normative Ballot ........................................................................................................ 46
14.03 Forming the Ballot Pool and Establishing the Consensus Group ............................................ 46
14.03.01 Member Participation in the Ballot Pool ........................................................................... 46
14.03.02 Nonmember Participation in the Ballot Pool .................................................................... 46
14.03.03 Seeking Balance in the Ballot Pool .................................................................................. 47
14.03.04 Establishing the Consensus Group ................................................................................. 47
14.03.05 Opening a Ballot Pool for Subsequent Normative Ballots of the Same Content ............. 47
14.03.06 Ballot Pool or Consensus Group Variance Process ........................................................ 47
14.04 Issuing a Normative Ballot ........................................................................................................ 48
14.04.01 Authority ........................................................................................................................... 48
14.04.02 Return Date ...................................................................................................................... 48
14.04.03 Reason ............................................................................................................................. 48
14.04.04 Instructions ....................................................................................................................... 48
14.04.05 Cooperating ANSI ASD.................................................................................................... 48
14.05 Approval .................................................................................................................................... 48
14.05.01 Achieving the Necessary Ballot Response Level ............................................................ 48
14.05.02 Unresolved Negatives ...................................................................................................... 48
14.05.03 Approved Components .................................................................................................... 49
14.05.04 Reporting Concerns in the Voting Process ...................................................................... 49
14.06 Accompanying Statements ....................................................................................................... 49
14.06.01 Retraction ......................................................................................................................... 49
14.06.02 Affirmative Ballots ............................................................................................................ 49
14.06.03 Negative Ballots ............................................................................................................... 49
14.06.03.01 Submission of Comments ....................................................................................... 49
14.06.03.02 Without Comments .................................................................................................. 49
14.07 Notification of Discussion of Responses .................................................................................. 49
14.08 Negative Ballots Not Previously Considered ............................................................................ 49
14.08.01 Motions for Handling Negative Ballots ............................................................................. 49
14.08.01.01 Not Related ............................................................................................................. 50
14.08.01.02 Not Persuasive ........................................................................................................ 50
14.08.01.03 Persuasive ............................................................................................................... 50
14.08.02 Confirmation of Withdrawn Negative Ballot ..................................................................... 50
14.08.03 Effect of Withdrawn Negative .......................................................................................... 50
14.08.04 Substantive Change ......................................................................................................... 50
14.09 Negative Ballots Previously Considered .................................................................................. 51
14.10 Notification of Disposition of Negative Ballots .......................................................................... 51
14.10.01 Fulfilling Notification of Disposition Requirements ........................................................... 51
14.10.02 Execution of Organizational or Affiliate Representative Proxy ........................................ 51
14.11 Re-circulation of Unresolved Negative Comments................................................................... 51
14.12 Appeal ....................................................................................................................................... 51
14.13 Posting the Reconciliation Package ......................................................................................... 52
14.14 Discontinuance of a Standards Project .................................................................................... 52
15 Submission of American National Standards .................................................................................... 52
15.01 Prerequisites for Submission .................................................................................................... 52
HL7 Governance and Operations Manual
Table of Contents
Adopted January 26, 2009
Last Update: May 16, 2011
15.01.01 PINS Form ....................................................................................................................... 52
15.01.02 BSR-8 Form ..................................................................................................................... 52
15.01.03 Adherence to ANSI Patent Policy .................................................................................... 52
15.01.04 Adherence to ANSI Metric Policy ..................................................................................... 53
15.01.05 Exclusion of Commercial Terms and Conditions ............................................................. 53
15.01.06 Records Retention as Evidence of Compliance .............................................................. 53
15.02 Required Information ................................................................................................................ 53
15.02.01 BSR-9 Form ..................................................................................................................... 53
15.03 Submission of HL7 American National Standards for ISO Approval........................................ 53
15.04 Maintenance of HL7 American National Standards ................................................................. 54
15.04.01 Reaffirmation of an HL7 American National Standard ..................................................... 54
15.04.02 Withdrawal of an HL7 American National Standard ........................................................ 54
15.04.03 Use of Continuous Maintenance ...................................................................................... 54
15.04.03.01 Schedule ................................................................................................................. 54
15.04.03.02 Language Applicable to all Standards under Continuous Maintenance ................. 54
15.05 Maintenance of ANSI Membership ........................................................................................... 55
16 Intellectual Property........................................................................................................................... 55
16.01 Copyright .................................................................................................................................. 55
16.01.01 Copyright Protection ........................................................................................................ 55
16.01.02 Commitment ..................................................................................................................... 55
16.01.03 Previously Copyrighted Material ...................................................................................... 56
16.01.04 Independently Developed Specifications ......................................................................... 56
16.01.05 Negotiated Use of HL7 Copyrighted Material .................................................................. 56
16.01.06 Academic Access to HL7 Copyrighted Materials ............................................................. 56
16.01.07 Use of HL7 Copyrighted Materials in Other Educational Scenarios ................................ 56
16.01.08 Public Access to HL7 Copyrighted Vocabulary Tables ................................................... 57
16.02 Trademarks ............................................................................................................................... 57
16.03 Patents ...................................................................................................................................... 57
16.03.01 Commitment ..................................................................................................................... 57
16.03.02 Essential Patent Claims ................................................................................................... 57
16.03.03 Withdrawal and Survival of Commitments for Essential Patent Claims .......................... 58
16.03.04 Disclaimer ........................................................................................................................ 58
16.04 Material in the Public Domain ................................................................................................... 58
17 Maintenance ...................................................................................................................................... 58
17.01 Membership Participation ......................................................................................................... 58
17.02 During the Working Group Meeting .......................................................................................... 58
17.03 Concurrent Processes Interim to Working Group Meetings ..................................................... 59
17.03.01 Developing the GOM Revisions ....................................................................................... 59
17.03.02 Exceptional Work Item Requests ..................................................................................... 59
17.03.03 Developing the Work Item List for the Next Cycle ........................................................... 59
17.04 Executive Committee Action ..................................................................................................... 59
17.05 Effective Date of Revision or Addition ...................................................................................... 59
17.06 Periodic Adoption in its Entirety ................................................................................................ 60
17.07 ANSI Review and Accreditation................................................................................................ 60
17.08 Process Flow Chart .................................................................................................................. 61
18 Externally Developed Implementation Guides .................................................................................. 62
18.01 Endorsement ............................................................................................................................ 62
18.02 Adoption .................................................................................................................................... 62
18.03 Process ..................................................................................................................................... 62
18.04 Associated Fees ....................................................................................................................... 62
18.05 Distribution ................................................................................................................................ 63
18.05.01 Dependence on a Base Specification .............................................................................. 63
Addendum A – HL7 Vocabulary Copyright and License ........................................................................ 64
HL7 Governance and Operations Manual
Adopted January 26, 2009 Page I
Last Update: May 16, 2011
Introduction
The Governance and Operations Manual (GOM) defines standard operating procedures and various
policies created to clarify, support, and/or implement the tenets of the Bylaws. The GOM is
established to assure the uniformity, equity, quality, efficiency, and compliance of administrative and
organizational activities through standard methods and guidelines. GOM maintenance shall be
proactive, iterative, and broadly engage the membership as defined in §17.
With the adoption of additions or revisions to the GOM, the HL7 Secretary shall add them to the
manual with annotation in the following table reflecting the date adopted or revised. Additions and
revisions will be posted within ten working days of the date on which they were adopted. Periodically
the HL7 Secretary, using his or her best judgment, may call for ratification of the GOM in its entirety by
the Executive Committee. Upon ratification of the GOM in its entirety it shall be posted with a new
adoption date and all internal notations of addition or revision removed.
The GOM will be maintained and distributed electronically via the HL7 Web site. A hard copy of the
manual is available upon request to those without electronic access. A processing fee, established by
the Executive Committee, will be assessed to cover printing, postage, and handling.
Notice of Current Edition
This edition of the Governance and Operations Manual, adopted in its entirety January 26, 2009, is the
current edition, which supersedes and rescinds all previous editions of the GOM.
Additions and/or Revisions Subsequently Adopted |
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