CEN/ISO Gap Analysis a.k.a. cMHAFF - CEN/ISO Harmonization
Conformity Assessment Ad Hoc Group
mHealth Hub & HL7 Foundation
No new attendees
CEN/ISO Gap Analysis a.k.a. cMHAFF - CEN/ISO Harmonization & Conformity Assessment Ad Hoc Group
Final review of cMHAFF/ISO harmonization text for inclusion within ISO TS82304-2
Approved by subworkgroup
Need to get ballot NIB in order by to meet the January 2021 WGM deadline.
Need to get the workgroup vote on approval to ballot by early October so that it has time to be passed on to the steering division for approval afterwards
For projects other than investigative and reaffirmations, to submit a NIB, your PSS must have been approved by TSC a minimum of four weeks before the start of the WGM that precedes the NIB deadline.
Notes from 6/25 Meeting
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 since that where applicable cMHAFF has been incorporated in the TS. In cooperation 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 Conformity 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
New Business: mHealth Hub and HL7 Foundation involvement
Frank informed the team about HL7 foundation joining in with the mHealth Hub. By the initiative of Catherine Chronaki, Giorgio Cangioli, Gora Datta & Frank have been asked to join the initative (and have accepted ).
Gora Datta- Find out what approvals need to be made (e.g., TSC approval) before submitting NIB on