EU-funded R&D project

Championing Standardisation for European Digital Health

Label2Enable is one of the projects the European Commission has launched to contribute to an innovative, sustainable and globally competitive health industry. European leadership in digital technologies like health apps creates jobs and economic growth, in particular with small- and medium-sized enterprises (SMEs). European standards are to ensure patient safety, quality of healthcare, effectiveness, interoperability and productivity. Citizens, health care providers and health systems benefit from a swift uptake of health apps that significantly improve health outcomes. Health app manufacturers benefit from more efficiency in co-creating health apps that satisfy the needs of patients, health care providers and health authorities and regulators and accelerated time-to-market.

The project consists of three pillars: Trust, Use and Adoption

Consortium partners i-HD,  ORCHAHIMSSEIT Health and  COCIR cooperate in the pillar Trust. They will co-create and test the CEN-ISO/TS 82304-2 handbook for accredited health app assessment organizations, in ISO terminology an ISO/IEC 17065 certification scheme. They will ensure that the handbook contains appropriate accepted assessment methodologies, aligns with EU legislation and values, produces the same consistent results regardless of the assessment organization involved, and works as well for app manufacturers. They will secure maintenance of the handbook after the project and enable accreditation of assessment organizations. They will also investigate if legislation for the label is sensible and who is to pay for the assessment.

Consortium partners  European Patients ForumKaunas ClinicsLUMCEuroHealthNet and the  University of Amsterdam cooperate in the pillar Use. They will investigate who consumers trust most to give them recommendations on health apps and what will also help people with low health literacy to use the quality label. They will find out what healthcare professionals need in the detailed health app quality report to be able to recommend health apps and how to display the label effectively in app stores, app libraries and trusted sources.

Consortium partners  empirica, i-HD,  LUMCISSTIC Salut Social Foundation and  Tatjana Prenda Trupec cooperate in the pillar Adoption to promote CEN-ISO/TS 82304-2. They will involve stakeholders through various channels. With ‘‘use stories’’ of pilots with CEN-ISO/TS 82304-2 in Italy, Catalonia, and the Netherlands and potentially more countries or regions, they will provide insights on how to implement the assessment framework effectively. Finally, they will explore with health insurers and health technology assessment bodies how the ISO assessment framework can help in decision-making on reimbursement of health apps.

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