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Difference between revisions of "CMHAFF call, Tuesday June 13"

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(Created page with "Attendees: Agenda *Revisiting of STU vs Informative. What changes in work, staffing, or dates would be needed for one vs. the other? Have participants in the call been able...")
 
 
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Attendees:  
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Attendees: David Tao, Gora Datta, Harry Rhodes, Paul Petronelli
  
Agenda
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Most of the meeting was spent reviewing the [http://wiki.hl7.org/index.php?title=File:French_good_practice_guidelines_on_mHealth_apps.pdf '''French mHealth Good Practice Guidelines''']) and impact on cMHAFF. We agreed that the French guidelines are an impressive document. They are more comprehensive than cMHAFF, and they are more of a "checklist" rather than standards-like "conformance statements" but could be translated into language suitable for a standard. This would be a lot of work, and would require considerable review and vetting, since many topics would not have been discussed before. However, the French guidelines have the benefit of extensive review by many stakeholders, plus an extensive bibliography.
  
*Revisiting of STU vs Informative. What changes in work, staffing, or dates would be needed for one vs. the other? Have participants in the call been able to review cMHAFF's current draft (available on Wiki [http://wiki.hl7.org/index.php?title=File:HL7_cMHAFF_Informative_Ballot_Draft.docx '''Latest Draft''']), as requested last week. Is it close enough that it can be brought to ballot with reasonable time and staffing? Many of the conformance criteria are "attestation" or "inspection" types of criteria, rather than "testable."
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The question was raised as to why France or other organizations would be interested in cMHAFF, if they already have their own guidelines? Gora said that EU countries have a high interest in being aligned with standards, and would have strong interest in seeing that their work is factored into HL7. He also said that the afternoon (US) time is tough for Europe to participate, and that morning times should be considered.
*Debrief on review of European materials (particularly the [http://wiki.hl7.org/index.php?title=File:French_good_practice_guidelines_on_mHealth_apps.pdf French guidance]) and impact on cMHAFF
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*Review the following specific recently changed sections of cMHAFF.
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Two options for moving cMHAFF forward were discussed:
**2.3 Lifecycle -- revised based on suggestions from 5/22: publishing on app store, meeting the app store requirements; app enhancements and maintenance after initial release; frequency of updates; keeping current with OS, etc.
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* Second Comment-Only ballot, for September cycle. This would not lock us in to either STU or Informative, and would not take as much work as getting an STU prepared (which is not feasible, given limited time and resources, to do by early August, which would be necessary to make a September ballot).  
**2.3.2 Use Case B -- say "regulated" vs "unregulated" and the criteria for what's regulated varies by realm (e.g.,FDA.) European example is in materials Matt sent me. Clarify if examples are realm-specific.
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* STU Ballot, target for January.  
**2.3.4 Risk Factors
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**2.4 Environmental Scan
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'''UPDATE:''' On the MH Friday call on June 16th, we agreed to proceed directly to STU for January, rather than an interim ballot in September.  
**3.2, (1.2) Product Risk Assessment and Mitigation
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To do the extensive amount of review of the French material and incorporate appropriate parts into cMHAFF, we'll need more lengthy working sessions. Gora said he could recruit additional attendees, especially from Europe. If we have these sessions and they involve persons in Europe, we'll schedule them much earlier in the day.
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POST MEETING ADDENDUM:
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*PRIOR TO JUNE 20th, PLEASE REVIEW THE FRENCH GOOD PRACTICE GUIDELINES AND CONSIDER WHAT IT WOULD TAKE TO INCORPORATE A LARGE AMOUNT OF IT INTO CMHAFF.  
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*David will send a special email, asking for European involvement and asking whether folks would be interested in participating in a special set of morning (US time) meetings to incorporate European work into cMHAFF.

Latest revision as of 15:18, 16 June 2017

Attendees: David Tao, Gora Datta, Harry Rhodes, Paul Petronelli

Most of the meeting was spent reviewing the French mHealth Good Practice Guidelines) and impact on cMHAFF. We agreed that the French guidelines are an impressive document. They are more comprehensive than cMHAFF, and they are more of a "checklist" rather than standards-like "conformance statements" but could be translated into language suitable for a standard. This would be a lot of work, and would require considerable review and vetting, since many topics would not have been discussed before. However, the French guidelines have the benefit of extensive review by many stakeholders, plus an extensive bibliography.

The question was raised as to why France or other organizations would be interested in cMHAFF, if they already have their own guidelines? Gora said that EU countries have a high interest in being aligned with standards, and would have strong interest in seeing that their work is factored into HL7. He also said that the afternoon (US) time is tough for Europe to participate, and that morning times should be considered.

Two options for moving cMHAFF forward were discussed:

  • Second Comment-Only ballot, for September cycle. This would not lock us in to either STU or Informative, and would not take as much work as getting an STU prepared (which is not feasible, given limited time and resources, to do by early August, which would be necessary to make a September ballot).
  • STU Ballot, target for January.

UPDATE: On the MH Friday call on June 16th, we agreed to proceed directly to STU for January, rather than an interim ballot in September.

To do the extensive amount of review of the French material and incorporate appropriate parts into cMHAFF, we'll need more lengthy working sessions. Gora said he could recruit additional attendees, especially from Europe. If we have these sessions and they involve persons in Europe, we'll schedule them much earlier in the day.

POST MEETING ADDENDUM:

  • PRIOR TO JUNE 20th, PLEASE REVIEW THE FRENCH GOOD PRACTICE GUIDELINES AND CONSIDER WHAT IT WOULD TAKE TO INCORPORATE A LARGE AMOUNT OF IT INTO CMHAFF.
  • David will send a special email, asking for European involvement and asking whether folks would be interested in participating in a special set of morning (US time) meetings to incorporate European work into cMHAFF.