Project Name: Adopting CEN-ISO/TS 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.<br />


The project has three pillars: Trust, Use and Adoption

TRUST: Co-create the trusted CEN-ISO/TS 82304-2 EU certification scheme (handbook for accredited health app assessment):

  • Test scheme with 24 manufacturers and 5 app assessment organisations for consistency, efficiency and clarity
  • Align assessment methods and pass/fail with EU legislation, EU values and stakeholder trust
  • Analyse business models for app assessment and existing label legislations for applicability

USE: Co-create the communication citizens and health care professionals need:

  • Survey whose recommendations on health apps citizens trust and what health care professionals need to recommend health apps
  • Test how to introduce the label to people with limited health literacy
  • Propose level of detail health app quality report
  • Test label display in app stores, app libraries and trusted sources

ADOPTION: Co-create a single market (cross-country recognition of EU certification scheme):

  • Involve relevant stakeholders through various channels
  • Document 'use stories' of pilots with CEN-ISO/TS 82304-2 in Italy, Catalonia, the Netherlands, Norway, ..
  • Explore with health insurers and Health Technology Assessment bodies how the ISO assessment framework can help in decision-making on reimbursement of health apps

Main standardisation interest

This project largely covered towards the future it involves potentially scaling up to more use cases than health and wellness apps, further adoption in Europe and beyond, (funding of) revision/alignment processes, further infrastructure to support the certification and follow-up processes, the legislation: EHDS (labelling of wellness apps) and beyond, being part of the strategic agenda, accreditation, etc.


Open Call Topic(s): Health

Project Acronym: Label2Enable


Grant Agreement Id: 101057522

Start Date:

End Date:

Programme: HORIZON.2.1 - Health

Call for proposal: HORIZON-HLTH-2021-IND-07

Funding Scheme: CSA - Coordination and support action