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.

Informazioni relative al progetto

Label2Enable

ID dell’accordo di sovvenzione: 101057522

DOI

10.3030/101057522

Progetto chiuso

Data della firma CE 29 Aprile 2022

Data di avvio 1 Maggio 2022

Data di completamento 30 Giugno 2024

Finanziato da

• Health

Costo totale

€ 1 999 957,50

Contributo UE

€ 1 999 957,00

Coordinato da

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.)

Periodo di rendicontazione: 2023-05-01 al 2024-06-30

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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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