Health App Assessment in Europe

Health App Assessment in Europe Passed

Thursday May 7, 2026 09:30 - 10:00 A1

Track: Från fragmentering till gemensam kvalitet – så skapar vi jämlik tillgång till hälsoappar

The European project Label2Enable, conducted between 2022 and 2024, has tested how ISO/TS 82304-2 (Health and wellness apps - quality and reliability), an assignment from the European Commission, can be applied in practice to assess the quality and trustworthiness of health apps. A handbook app assessment for ISO/TS 82304-2 was developed and tested with 24 app manufacturers and 5 app assessment organizations from 5 countries. Several studies were performed, with a focus on addressing multi-stakeholder needs.

The results show that ISO/TS 82304-2 has the potential to function as the common European assessment framework. Several countries are mapping, piloting, considering to adopt or adopting ISO/TS 82304-2 as a basis for health app assessment. Joint action of the member states Xt-EHR recently positively evaluated ISO/TS 82304-2 and the Label2Enable deliverables to prove conformance with the European Health Data Space (EHDS) regulation Article 47 (Labelling wellness applications).

Language

English

Topic

Policy

Seminar type

Live + On site

Lecture type

Presentation

Objective of lecture

Inspiration

Level of knowledge

Intermediate

Target audience

Management/decision makers
Politicians
Organizational development
Researchers

Keyword

Welfare development
Management
Innovation/research
Test/validation
Apps

Conference

Vitalis

Lecturers

Petra Hoogendoorn Lecturer

Lead expert
CEN-ISO/TS 82304-2

Petra Hoogendoorn is an industrial engineer and change manager, and lead expert of CEN-ISO/TS 82304-2 (Health and wellness apps - quality and reliability), an initiative from the European Commission. She coordinated the Horizon Europe Label2Enable project, and supports health authorities on the digital transformation of health and care related to health apps. This includes assignments for the Dutch Ministry of Health, NHS England and the Xt-EHR joint action of the EU member states to create their deliverable on labelling wellness applications (European Health Data Space regulation Article 47), input for the related implementing legislation.

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