|50 min||CEN/ISO Gap Analysis a.k.a. cMHAFF - CEN/ISO Harmonization & Conformity Assessment Ad Hoc Group|
- CEN/ISO and CMHAFF Inclusion Discussion
- Discussion on certification need and impact in relation to global software as a medical device
- First step in integration between ISO and HL7 - How to collaborate?
- As the two efforts evolve within standardization cycles each will benefit from each others formal progress
- Notes from 6/11 Meeting
- Focused this meeting primarily on how to harmonize cMHAFF and CEN/ISO and what our views should be on how the CEN/ISO Technical Specification will co-exist with the cMHAFF Framework.
- As of now cMHAFF is reverenced in the TS in Annex E (Informative) "relationship to HL7 Consumer Mobile Health Application Functional Framework"
- The idea was to have the CEN/ISO specs as a overall TS and cMHAFF as the profiled version - as in realm specific, health topic specific - of the TS
- This requires mapping of the TS to cMHAFF and vv
- This mapping process is almost finished in the sence that where applicable cMHAFF has been incorperated in the TS. Incorperation and adjustment form the TS point of view in cMHAFF has not been undertaken yet.
- Basically the main question in the meet was how do we envisage the co-existence of cMHAFF to the CEN/ISO specs. This led to an invitation to Gora to help us define this co-existence, also in relation to the Conformatiy Assessment Ad Hoc Group which is founded by the initiative of Gora (which is the understanding by Frank). Ther invite to Gora reads as follows:
Hi Gora, From the CEN/ISO perspective (as relayed by Frank) it sounds as though there are some questions on the ongoing “relationship” between HaWa and CMHAFF and how formal that continues to be moving forward. Members of the conformance assessment adhoc group (that you helped to intiate as we understand it) seem to be having questions about this and the benefits or not. We are not completely sure we understand all of the implications/politics involved between CEN/ISO and HL7 CMHAFF and think we could benefit from some of your background/guidance on this. Would you be available to join the CMHAFF meeting next week (6/18) to discuss this and formulate a position of sorts that can be communicated to that team. Thanks, -Nathan