Challenge

The healthcare industry is experiencing a substantial growth in the number of available health apps, estimated to surpass 350,000. This abundance presents significant challenges for patients, healthcare professionals, and health systems in identifying and choosing apps that are effective, reliable, and safe. The lack of standardized criteria for evaluating the quality and efficacy of these apps intensifies the problem, leading to potential risks associated with the adoption of applications that are not effective or secure.

Solutions

Label2Enable has facilitated the creation of a standardized, EU-wide health app quality label, promoting trust and transparency in digital health solutions. The project is structured around three pillars: Trust, Use, and Adoption. The project developed an ISO 17065-aligned certification scheme for the CEN-ISO/TS 82304-2 health app quality label, ensuring compliance with EU legislation and values. This scheme was tested with 24 health app manufacturers and six assessment organizations across six countries. Additionally, the project conducted surveys involving over 1,200 citizens from 33 countries and healthcare professionals to understand trust dynamics and app recommendation behaviors. The label was also tested with individuals possessing low health literacy in four European countries to ensure accessibility and effectiveness. personas surveys workshops roundtables

Results

The project’s efforts have led to the development of a certification scheme that supports the integration of high-quality health apps into healthcare systems, aiding in prevention, care, and self-care. By aligning with EU regulations and involving diverse stakeholders, Label2Enable contributes to the advancement of the European Health Data Space and the digital transformation of healthcare services.