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Difference between revisions of "CMHAFF call, Thursday, August 17"
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**'''[[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) | **'''[[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) | ||
**'''[https://www.gov.uk/government/publications/medical-devices-software-applications-apps UNITED KINGDOM Guidance]''' Guidance for medical device stand-alone software, including apps, from UK Medicines and Healthcare Products Regulatory Agency (MHRA) (ADAMU) | **'''[https://www.gov.uk/government/publications/medical-devices-software-applications-apps UNITED KINGDOM Guidance]''' Guidance for medical device stand-alone software, including apps, from UK Medicines and Healthcare Products Regulatory Agency (MHRA) (ADAMU) | ||
| − | **'''[https://appcheck.de/kriterienkatalog 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. ( | + | **'''[https://appcheck.de/kriterienkatalog 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: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apps_not for publication_DTao_Comments.docx]]''' -- Draft mHealth Guidelines from a project not completed in EU (unpublished, not for distribution), with a mandate "to develop guidelines for assessing the validity and reliability of the data that health apps collect and process."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: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: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:Assessment Questionnaire.xlsx]]''' -- Assessment Questionnaire from a project not completed in EU (unpublished, not for distribution) | ||
Revision as of 19:08, 14 August 2017
Attendees: ____
AGENDA:
- TO BE ADDED
- Review specific comments in latest draft File:CMHAFF STU Ballot Draft.docx
- DKT4 decision tree
- DKT6 levels of criticality -- if used, need clear definitions so developers can easily classify their apps
- 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)
