The Label2Enable project addresses the growing use of health apps and the need for reliable assessment criteria. Leveraging the ISO 82304-2 Technical Specification, it aims to create an EU mHealth label. Key objectives include establishing an EU certification scheme for app assessments, offering detailed health app quality reports, and promoting label adoption through communication and social experimentation. The project focuses on aligning the label with European approval processes, ensuring cross-country recognition, and establishing a sustainable non-profit entity for ongoing promotion and accreditation. This multifaceted approach aims to enhance trust, encourage usage, and achieve widespread adoption of the label.
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.
European Health and Digital Executive Agency (HaDEA)
Horizon Europe (HE)