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CMHAFF call, Thursday, August 3
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Attendees:
AGENDA
- Review of recommendations re French Good Practice Guidelines -- Frank, Adamu, Harry
- Consider comment points in latest draft of cMHAFF: File:CMHAFF STU Ballot Draft.docx
- Assign reviewers to each section
- Check status and/or assign reviewers to remaining European guidelines (see below)
- 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-along 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- File:Draft guidelines mhealth apps not for publication DTao Comments.docx -- Draft mHealth Guidelines from a project not completed in EU (unpublished, not for distribution), with a mandate "to develop guidelines for assessing the validity and reliability of the data that health apps collect and process."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- File:Assessment Questionnaire.xlsx -- Assessment Questionnaire from a project not completed in EU (unpublished, not for distribution)
- 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. (UNASSIGNED)
