CMHAFF call, Thursday, August 17

Attendees: ____

AGENDA:

• Review specific comments in latest draft File:CMHAFF STU Ballot Draft.docx
  • DKT4 decision tree
  • DKT6 and DKT8 levels of criticality -- if used, need clear definitions so developers can easily classify their apps
  • DKT13 -- How do we find authoritative references for things like "secure coding" or do we just leave it open-ended?
  • DKT22 reorganization of "Informing Users" section. Does it make sense?
  • DKT29-30 granularity vs precision -- are both needed?
  • DKT38-39 "syncing" data and "pairing" of devices: should they be within the same section?
  • DKT41 decision on what to do with provenance discussion
  • DKT42-44 new "Interoperability" section
  • DKT50 revisit "Conditions and Agreements" and how it differs from "Informing Consumers/Users"
  • DKT57 Should Windows platform considerations be included or not
• Check status, set schedule for recommendations from additional European documents. Look for gaps (missing in cMHAFF, but within scope), or contradictions (recommendations that run counter to cMHAFF).
  • File:Charismha abr v.01.1e-20160606 (003) ENG SHORT VERSION.pdf -- GERMAN Chances and Risks of Mobile Health Apps" to compare to cMHAFF. (HARRY RHODES)
  • UNITED KINGDOM Guidance Guidance for medical device stand-alone software, including apps, from UK Medicines and Healthcare Products Regulatory Agency (MHRA) (ADAMU)
  • GERMAN Assessment Criteria for health-related apps These are mostly intended for developers to use in self-assessment, but the assessments also contain reviews by a third party. (DAVID reviewed, found nothing major to add to cMHAFF)
  • File:National authorisation criteria of Finnish PHR v2.2 Nokia Translation.xlsx -- FINNISH National Authorisation (Certification) Criteria for PHR (unofficial translation into English) Contains approximately 80 criteria in 6 categories. (NATHAN BOTTS)
  • File:Draft guidelines mhealth apps not for publication DTao Comments.docx -- Draft mHealth Guidelines from a project not completed in EU (unpublished, not for distribution), with a mandate "to develop guidelines for assessing the validity and reliability of the data that health apps collect and process." While the project was never completed, there was a report on the work (DAVID TAO -- done)
    • File:ReportofmHealthWorkingGroup-June2017cleanpdf.pdf of which page 6 summarizes 13 categories for assessment that were discussed, of which six had a higher degree of consensus than others.
    • File:Assessment Questionnaire.xlsx -- Assessment Questionnaire from a project not completed in EU (unpublished, not for distribution)