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.

Información del proyecto

Label2Enable

Identificador del acuerdo de subvención: 101057522

DOI

10.3030/101057522

Proyecto cerrado

Fecha de la firma de la CE 29 Abril 2022

Fecha de inicio 1 Mayo 2022

Fecha de finalización 30 Junio 2024

Financiado con arreglo a

• Health

Coste total

€ 1 999 957,50

Aportación de la UE

€ 1 999 957,00

Coordinado por

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.)

Período documentado: 2023-05-01 hasta 2024-06-30

Resumen del contexto y de los objetivos generales del proyecto

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.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

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.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

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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