CEN ISO TS 82304-2 ‘Health software – Quality and reliability of health and wellness apps’ has been approved. Publication is expected in August 2021

14 July 2021

The CEN and ISO committees on Health informatics as well as IEC/TC 62A have approved CEN ISO 82304-2 in ballot. 95% of the participating countries voted positive. The project team has resolved the editorial comments and decided to submit the document to ISO for publication.

The ballot also proposed technical comments. The project team decided not to resolve these comments as this would have resulted in an additional ballot and subsequent delay. The technical comments will be resolved in a future revision of EN  ISO 82304-2.

The Horizon Europe solicits a Coordination and Support Action to support the implementation of CEN ISO 82304-2. Contact zw@nen.nl for access to the (draft).

PREVIEW_content_page_ISO_82304-2

Other articles

IHE publishes the Sharing of IPS (sIPS) Profile

27 November 2023

CEN/TC 251 has been the initiator of and regular contributor to the International Patient Summary (IPS) set of standards and specifications. We are happy to announce that a new IHE profile has been added to the IPS family of standards and specifications. This sIPS Profile supports both publication and on-demand access to an IPS in HL7 … Continued

A short and clear introduction to the International Patient Summary (IPS)

11 September 2023

The International Patient Summary is a minimal and non-exhaustive set of basic clinical data of a patient, specialty-agnostic, condition-independent, but readily usable by all clinicians for the (un)scheduled patient care away from the patient’s home health system. Created originally by a CEN/TC 251 Project Team, in close collaboration with HL7 and IHE, the International Patient … Continued

CEN publishes a good practice guide for obtaining consent

21 July 2023

CEN has just published CWA 17933: Digital health innovations — Good practice guide for obtaining consent for the use of personal health information for research and innovations. Scope Since digital health innovations are still under development, or within the evaluation process, formal consent is usually needed for all stages of the development cycle. This CEN … Continued