CEN-ISO/TS 82304-2 was an initiative from the European Commission in search of harmonisation - also referred to as the Digital Single market. Aim of the Commission is to use digital tools and data for citizen empowerment and person-centred healthcare, while facilitating supply of innovative digital health solutions - also by Small and Medium-sizes Enterprises - with common principles and certification. Main content of this collabaration of the European Standardization Organizations CEN-CENELEC and the International Standard Development Organizations ISO and IEC is a health app quality assessment framework and a health app quality label. The presentation will provide the audience with knowledge about the rigor and evidence base of the framework, the health app quality label and the certification scheme the Label2Enable project co-creates and tests with 24 health apps from all over Europe and 6 app assessment organizations from 6 countries, including 2 Notified Bodies. It will also address the communication that the project co-creates to make considering and recommending health apps easier for citizens, patients and healthcare professionals, which national and regional authorities already investigate, pilot and use 82304-2, ongoing collaborations, and the draft European Health Data Space Regulation which includes labelling of wellness apps.