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CMHAFF call, Tuesday July 11
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Attendees: David Tao, Nathan Botts, Gora Datta, Frank Pfloeg
AGENDA:
- New meeting time(s) -- decision was to make it THURSDAY AT 3PM Eastern Time (USA). The next meeting will be on July 20th.
- Review of recommendations regarding French Good Practice Guidelines being considered to fill cMHAFF gaps:
- Adamu -- Security/Reliability: Reliability.
- Adamu sent the following in an email to last meeting's attendees: "I think most of the requirements /criteria could be part of the product risk assessment in cMHAFF. Some could be due to device or platform/system environment in which the application runs. In general cMHAFF product risk assessment & mitigation mentions security & privacy ( and rightly so ) as there is direct impact/dependency there but not much on indirect risk/dependency such as device , platform /system or network reliability. These are out of the developers control but any app that has critical indirect/ dependency on these indirect factors could mention them ( as part of CnA or requirements on vendors of these products). No new section in cMHAFF but some of the HAS Reliability criteria can be included in already existing cMHAFF sections."
- Decide which specific Reliability criteria should be in cMHAFF, and which cMHAFF sections they should go into
- Frank -- Usability/Use: Acceptability; Usability/Use: Integration/Import; Health Content: Standardisation; Health Content: Interpreted Content
- Harry -- Technical Content: Data Flow
- Adamu -- Security/Reliability: Reliability.
- Review of changes in cMHAFF not previously reviewed
- 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