Update on CEN ISO/TS 82304-2

14 June 2022

The world is looking at the CEN ISO technical specification for Quality and Reliability of Health and Wellness Apps, (CEN ISO/TS 82304-2), which was published in 2021. It provides quality requirements for health apps and defines a health app quality label in order to visualize the quality and reliability of health apps. The technical specification is intended for use by app manufacturers as well as app assessment organizations in order to communicate the quality and reliability of a health app. Consumers, patients, carers, health care professionals and their organizations, health authorities, health insurers and the wider public can use the health app quality label and report when recommending or selecting a health app for use, or for adoption in care guidelines, care pathways and care contracts.

 

In a recent publication in Nature, an overview is provided of the health app policy in several nations. One conclusion is that “The sheer number of apps on the market in most countries represents a challenge for clinicians and patients. Our analyses of the relevant policies identified challenges in areas such as reimbursement, safety, and privacy and suggest that more regulatory work is needed in the areas of operationalization, implementation and international transferability of approvals.” The latter is exactly where the CEN ISO technical specification can help. When countries use approvals based upon the same international technical specification, it is much easier to transfer the approval from one country to another. Not only does this speed up the approval process for new health apps, it also saves the national regulatory authorities a lot of work.

 

In addition, the recently published draft regulation on the European Health Data Space, the European Commission is committed to ensure that natural persons have control over their own electronic health data, that they can benefit from a range of health-related products and services and that researchers, innovators, policy-makers and regulators can make the most of available electronic health data. To this end they advocate the use of “a voluntary label for wellness application and a cascading effect in medical devices that aim to be interoperable with EHR systems.”

 

Finally, we are happy to announce the start of the Label2Enable project, which will promote the CEN ISO/TS 82304-2 health app assessment framework and label in Europe. You can find out more about Label2Enable in this article.

Other articles

XpanDH kicks off to help enable individuals and organisations to adopt the European Electronic Health Records Exchange format

30 May 2023

You may already have seen mention of a new project on Expanding Digital Health across Europe – the XpanDH project. CEN/TC 251 is proud to be involved in the XpanDH project, which kicked off early in 2023. This project aims to expand the use of the European Electronic Health Record Exchange Format (EEHRxF) for use … Continued

Europe adopts ISO 13131 for telehealth services

28 November 2022

Recently, the 2021 revision of ISO 13131 Health informatics – Telehealth services – Quality planning guidelines has been published and adopted as a European standard. This standard will support the projected and much needed growth of telehealth services worldwide. Risk assessment needed more than ever The COVID-19 pandemic has highlighted and emphasised the importance of … Continued

Next JIC Open Forum on 30 November 2022

4 November 2022

Quality Labelling of Digital Tools Transcending national boundaries and organisations, the Joint Initiative Council’s standards development organisations work collaboratively to provide global, coordinated—not competitive—standards that address real-world healthcare issues. In its recently released white paper, the JIC explores the desired future of a digital health ecosystem where high-quality data is available to the right people, … Continued