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Difference between revisions of "CMHAFF call, Tuesday June 6"
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(Created page with "Agenda: *Re-orientation to project timeline and goals for next ballot **STU vs Informative -- revisit last week's decision. Gora strongly feels it should be STU to have more ...") |
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**3.2, (1.2) Product Risk Assessment and Mitigation | **3.2, (1.2) Product Risk Assessment and Mitigation | ||
*Request for help reviewing European materials | *Request for help reviewing European materials | ||
| − | **French guidance | + | **[http://wiki.hl7.org/index.php?title=File:French_good_practice_guidelines_on_mHealth_apps.pdf French guidance] |
**Draft material from Netherlands | **Draft material from Netherlands | ||
**Finnish PHR presentation at Madrid (posted on HL7 webpage): are any draft certification criteria available? | **Finnish PHR presentation at Madrid (posted on HL7 webpage): are any draft certification criteria available? | ||
Revision as of 20:03, 3 June 2017
Agenda:
- Re-orientation to project timeline and goals for next ballot
- STU vs Informative -- revisit last week's decision. Gora strongly feels it should be STU to have more impact
- Timeline -- Still aim for September ballot, but assess impact on content if changing to STU
- Review highlighted changes in cMHAFF draft, uploaded HERE
- 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.
- 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.
- 2.3.4 Risk Factors
- 2.4 Environmental Scan
- 3.2, (1.2) Product Risk Assessment and Mitigation
- Request for help reviewing European materials
- French guidance
- Draft material from Netherlands
- Finnish PHR presentation at Madrid (posted on HL7 webpage): are any draft certification criteria available?
