Testing of the EU certification scheme for health and wellness apps is underway. App manufacturers can still get involved.


October 11, 2022

Label2Enable has started working with European manufacturers of health and wellness apps who want to be one of the first to test and inform a trusted EU certification scheme building on the CEN-ISO/TS 82304-2 quality label for health and wellness apps. Interested app manufacturers are encouraged to get involved.

The activity, led by ORCHA, is part of Label2Enable’s overall goal of promoting the adoption of CEN-ISO/TS 82304-2 and its quality label for health and wellness apps. A trusted EU certification scheme is needed in order to provide and maintain interpretive guidance to those assessing compliance with the standard, thus ensuring consistent assessments of the evidence across multiple (accredited) app checkers.

24 health and wellness apps are planned to be assessed in three rounds in the period September 2022 – August 2023:

- Round 1 (September – October 2022) – targeting 8 app assessments

- Round 2 (exp. February – March 2023) – targeting further 8 app assessments

- Round 3 (exp. July – August 2023) – targeting further 8 app assessments

In its selection of apps for the different rounds, Label2Enable is looking to assess apps available in English, which are developed by manufacturers from all across Europe and which focus on specific health conditions or wellness needs.

The process is supported by five app checker organisations based in Canada, Catalonia, France, Italy and the United Kingdom. The selected app manufacturers and app checkers work collaboratively to develop a draft assessment of the app. The manufacturers provide information about their app based on 81 questions in the assessment framework, grouped into four health app quality aspects. The assessment is then carried out by two app checkers, who provide an agreed draft report of their findings. The report can serve as guidance for the app manufacturer on how to improve the app’s compliance with the CEN-ISO/TS 82304-2 and the certification scheme in its current draft.

Benefits for the app manufacturers include:

- The draft assessment is free of charge

- The report provides useful insights that can help inform the app’s further development

- The participating manufacturers help to shape the process and prepare it for the final certification scheme

- As early pioneers, a subsidised costs for the subsequent official certification of the app in 2024 is being considered

Are you a health and wellness app manufacturer? You should consider getting involved in the second or third assessment rounds. Contact us.

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