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.

Informations projet

Label2Enable

N° de convention de subvention: 101057522

DOI

10.3030/101057522

Projet clôturé

Date de signature de la CE 29 Avril 2022

Date de début 1 Mai 2022

Date de fin 30 Juin 2024

Financé au titre de

• Health

Coût total

€ 1 999 957,50

Contribution de l’UE

€ 1 999 957,00

Coordonné par

ACADEMISCH ZIEKENHUIS LEIDEN
Netherlands

Periodic Reporting for period 2 - Label2Enable (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.)

Période du rapport: 2023-05-01 au 2024-06-30

Résumé du contexte et des objectifs généraux du projet

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 has leveraged the ISO 82304-2 Technical Specification and its health app quality label to create an EU assessment and EU mHealth label. It has pursued 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 has promoted the use of the label through mass communication and social experimentation.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

Key deliverables included an ISO 17000 series compliant certification scheme which includes an app assessor handbook for CEN ISO/TS 82304-2. The handbook was grounded in a pilot with 24 apps, guidance from subject matter experts, alignment with EU level legislation and international and EU standardization, a comparative analysis with European HTA frameworks, health care professionals’ needs to confidently recommend health apps and scientific evidence on quality in health apps. The Label2Enable health care professional advisory board created guidance for the CEN ISO/TS 82304-2 health app quality report, the detailed version of the health app quality label that aims to provide what health care professionals need to confidently recommend high-quality health apps. We gathered in several studies evidence for the multi-stakeholder effectiveness of the label, created 6 educational videos for citizens subtitled in 26 languages, and co-created recommendations for the reimbursement of health apps. Our research with health authorities and medical societies provides evidence of the compatibility of the CEN ISO/TS 82304-2 health app assessment framework and related products and services with their needs. A multi-stakeholder roadmap to the preferred future of labelling digital health and a sustainable entity guide next steps.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

CEN ISO/TS 82304-2 health app quality labels can now be issued. Recommendations going forward include:
- achieve a scalable secure user-friendly EU platform for the assessments, quality labels and quality reports
- explore automated assessments and onboarding trusted existing assessments
- endorse the health app assessment handbook
- consider expanding the framework beyond health and wellness apps
- learn from existing labelling efforts (energy, food, medication) in scaling to a digital single market
- enable use of the EU flag on the label and uptake in app stores
- support inclusive multi-stakeholder uptake of the label, report and health apps
- research national digital health strategies to finetune compatibility of the handbook and support member states in their decision-making on adoption and implementation of CEN ISO/TS 82304-2

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