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Adopting ISO 82304-2 and a trusted EU mHealth label for a single market that enables patients, citizens, health professionals, systems and authorities to benefit from a healthy supply of useful apps.

Project description

Improving the quality of health apps

The increase in health apps in recent years has brought about many benefits and helped people to take control of their health and wellbeing. However, there are many apps to choose from, and it can be difficult to determine which ones are reliable and trustworthy. In this context, the EU-funded Label2Enable project will leverage the ISO 82304-2 Technical Specification and its health app quality label to create an EU assessment and EU mHealth label. It will pursue a certification scheme for consistent app assessments, a detailed health app quality report for health professionals, and targeted multi-stakeholder engagement for adoption. The project will promote the use of the label through mass communication and social experimentation.


There is a growing recognition that health and wellness apps need to play a much stronger role in health care systems, self-care and health prevention than they do today. However, health care systems, health professionals, patients and citizens lack means to adequately assess the quality and reliability of the many apps to choose from, for every purpose, in each app store. Suppliers experience the varying national approval processes as confusing and unclear as to what is expected and the depth of evidence that is required by each approval body. We intend to break through the impasse by leveraging the golden opportunity of the publication in July 2021 of the ISO 82304?2 Technical Specification (TS) and its health app quality label. Work is now needed to turn this globally endorsed quality assessment and health app quality label into the EU assessment and EU mHealth label, embed it within the approval and reimbursement processes of European countries and foster cross-country alignment of these approval processes. The objective of Label2Enable is threefold: achieve trust, use and adoption. We will pursue: 1. trust with an EU certification scheme that results in consistent compliant inclusive app assessments 2. use with: - a more detailed health app quality report that enables health professionals to recommend apps and insurers to speed up decisions on reimbursements - supporting communication that enables all patients, citizens and carers to use the label in considering health apps - social experimentation to promote app stores, app libraries and other routinely used trusted sources that (seek to) offer health apps to effectively publish the label alongside them 3. adoption of the TS and cross-country recognition with pilots, use stories, advocacy, mass communication and targeted multi-stakeholder engagement, affordable app assessments and a sustainable non-profit entity that will maintain the scheme, accredit app assessors and promote the TS after the project.


Net EU contribution
€ 710 957,00
Albinusdreef 2
2333 ZA Leiden

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West-Nederland Zuid-Holland Agglomeratie Leiden en Bollenstreek
Activity type
Higher or Secondary Education Establishments
Other funding
€ 0,50

Participants (13)