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HL7 International

Proposed Technical Process Deviation Policy

Draft 8-March-2019

 

HL7 International’s Mission is to provide standards that empower global health data interoperability.   A critical pre-requisite to achieving this mission is to conform to documented practices to ensure HL7 upholds it core values and meets basic requirements as a voluntary consensus standards body [1] and ANSI-accredited Standards Development Organization (SDO). 

 

Recognizing that defining standards for representing health information is a dynamic and evolving process, and often must adjust to changing regulatory, business, medical and scientific imperatives, a standardized process for requesting and approving deviations from documented procedures may be necessary from time to time. 

 

Proposed Procedure for Process Deviations

 

1.  A valid need is identified by an authorized member with a leadership role in the HL7 Working Group (e.g., TSC or Governance Committee member, Co-Chair or Project Facilitator)

 

2.  A request to approve a deviation from a documented procedure is submitted to the CTO and TSC Chair.  The request must specify the context for the request (i.e., the project or product affected), list all documented procedures that cannot be met, propose the alternative process that will be used instead and the time period when the deviation will be in effect, and be accompanied with a rationale for the change and a statement indicating approval by the appropriate committees with a link to the appropriate committee minutes documenting such approvals

 

3.  If the request is deemed valid by the CTO and TSC Chair (after the requestor addresses any outstanding questions and performs any requested updates), it will be forwarded for review and approval to the TSC

 

4.  If the TSC approves the request (after the requestor addresses any outstanding questions and performs any requested updates) the deviation approval will be documented as a formal motion in TSC minutes; records will be registered with HL7 HQ

 

5.  The work group or project leads will maintain any necessary documentation to verify that the alternative procedure was followed and will notify HQ and the TSC after it has completed all necessary activities covered under the approved deviation. 

 

6.  The TSC will retain the right to review such documentation after completion of the designated time period.  If the requester believes the alternative procedure(s) may offer value to HL7, they may request that the TSC consider modifying existing procedures under existing processes for modifying the GOM, precepts, forms or other process instruments to accommodate this deviation for future uses.


[1] As defined in t he US National Technology Transfer and Advancement Act of 1995 (Public Law 104-113), this includes openness, balance of interest, due process and an appeals process https://www.nist.gov/standardsgov/omba119

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