In the HaWa specs "de-verbosing" is the current topic. In that respect it has been suggested to minimize the reference to cMHAFF according to the following action:
- 20200622_actions: Frank to draft suggested text for HL7 cMHAFF (maybe in Annex A - (Informative) Rationale for scope - rather than as the whole annex)
- As of now, cMHAFF is described in Annex E (informative): Relationship to HL7 Consumer Mobile Health Application Functional Framework
// start text
The HL7 consumer Mobile Health Application Functional Framework (cMHAFF) is an HL7 Standard for Trial Use (STU). The primary goals of HL7 cMHAFF are to provide a standard against which a mobile app’s foundational characteristics -- including but not limited to security, privacy, data access, data export, and transparency/disclosure of conditions -- can be assessed.
The framework is based on the lifecycle of an app (https://cmhaff.healtheservice.com/Standard/Overview/TabId/1034/ArtMID/3808/ArticleID/21202/2-Overview.aspx), as experienced by an individual consumer, from first deciding to download an app, to determining what happens with consumer data after the app has been deleted from a smartphone. It is important to note that the Framework does not speak directly to the specific health or clinical functionality of an app but can be extended to do so through the use of profiles (with constraints and/or extensions) developed on top of HL7 cMHAFF.
The site https://cmhaff.healtheservice.com/ provides a visual overview of the HL7 CMHAFF STU and application for piloting cMHAFF use in testing and potential for certification of health apps.
Relationship with EN-ISO/IEC DTS 82304-2
The HL7 cMHAFF standard has a standard trial use (STU) status and is due to become a formal standard in 2021 (ANSI approval). Balloting for normative standard is targeted for May 2021.
During this same period the EN-ISO/IEC TS 82304-2 will run its course.
Alignment of cMHAFF to EN-ISO/IEC DTS 82304-2
During the development cycle of the CEN/ISO specification, HL7 cMHAFF will work to harmonize efforts to better align with:
- definitions: preferably taken from the Standards Knowledge Management Tool (SKTM) glossary;
- definitions: https://www.iso.org/obp/ui;
- (CEN/ISO specification??) conformance statement levels;
The formal relationship between HL7 cMHAFF and the EN-ISO/IEC DTS 82304-2
HL7 is formally aligned with the EN-ISO/IEC DTS 82304-2 through the participation of an HL7 cMHAFF author in the CEN/ISO project. Extensive effort has been put into aligning the QRCA section of EN-ISO/IEC DTS 82304-2 with relevant parts of HL7 cMHAFF . Where applicable it has so been noted (??). The parts where both HL7 cMHAFF and a CEN/ISO standard would apply, the CEN/ISO reference was inserted. Vice-versa alignment will be undertaken on HL7 cMHAFF's part, after the technical specification (82304-2) is published by ISO TC215 (targeted for December 2020).
// end text
- Seek approval by the CEN/ISO community;
- Seek approval by the HL7 community, a.k.a. HL7 HQ;
- execute alignment;
- setup plan for profiling.