CMHAFF call, Thursday, August 10

Attendees: ____

AGENDA

• Review of recommendations re French Good Practice Guidelines: Reliability (Adamu)
• Review latest draft of cMHAFF: File:CMHAFF STU Ballot Draft.docx
  • Section 3.3.1.1, Informing Consumers/Users section, review conformance statements. Logically group them, decide upon conformance strength and whether there are too many (currently 24). When trying to add ideas from many sources, cMHAFF grows larger and larger.
  • Specific comment numbers to discuss:
    • to be added...

• Check status and/or assign reviewers to remaining European guidelines (see below). The goal is to review these over the next month, to identify 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. (UNASSIGNED)
  • 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  • File:Draft guidelines mhealth apps not for publication DTao Comments.docx -- Draft mHealth Guidelines from a project not completed in EU (unpublished, not for distribution), with a mandate "to develop guidelines for assessing the validity and reliability of the data that health apps collect and process."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 (UNASSIGNED)
    • 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    • File:Assessment Questionnaire.xlsx -- Assessment Questionnaire from a project not completed in EU (unpublished, not for distribution)