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Difference between revisions of "CMHAFF call, Thursday, August 10"

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(Created page with "Attendees: ____ AGENDA *Review of recommendations re French Good Practice Guidelines: Reliability (Adamu) *Review latest draft of cMHAFF: '''File:cMHAFF_STU_Ballot_Draft.do...")
 
Line 6: Line 6:
 
**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.
 
**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:
 
**Specific comment numbers to discuss:
−
***to be added...
+
***DKT4 decision tree
−
 
+
***DKT6 levels of criticality -- if used, need clear definitions so developers can easily classify their apps
−
*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).  
+
***DKT10  narrative introductions for each category?
 +
***DKT14  reference for "secure coding practices?"
 +
***DKT20  style/wording decision throughout -- refer to "app," "product," or...?
 +
***DKT30  granularity vs precision -- are both needed?
 +
***DKT39 and DKT40  "syncing" data and "pairing" of devices?
 +
***DKT42  decision on what to do with provenance discussion
 +
***DKT43  new "Interoperability" section
 +
***DKT51  revisit "Conditions and Agreements" and how it differs from "Informing Consumers/Users"
 +
***DKT56  Glossary: build it, or refer to external glossary?
 +
***DKT46  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)
 
**'''[[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)

Revision as of 20:01, 9 August 2017

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:
      • DKT4 decision tree
      • DKT6 levels of criticality -- if used, need clear definitions so developers can easily classify their apps
      • DKT10 narrative introductions for each category?
      • DKT14 reference for "secure coding practices?"
      • DKT20 style/wording decision throughout -- refer to "app," "product," or...?
      • DKT30 granularity vs precision -- are both needed?
      • DKT39 and DKT40 "syncing" data and "pairing" of devices?
      • DKT42 decision on what to do with provenance discussion
      • DKT43 new "Interoperability" section
      • DKT51 revisit "Conditions and Agreements" and how it differs from "Informing Consumers/Users"
      • DKT56 Glossary: build it, or refer to external glossary?
      • DKT46 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).
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