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.

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