Articles of the European Health Data Space (EHDS), Article 32, Registration of EHR systems and wellness applications



Article 32, Registration of EHR systems and wellness applications, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)

1. The Commission shall establish and maintain a publicly available database with information on EHR systems for which an EU declaration of conformity has been issued pursuant to Article 26 and wellness applications for which a label has been issued pursuant to Article 31.


2. Before placing on the market or putting into service an EHR system referred to in Article 14 or a wellness application referred to in Article 31, the manufacturer of such EHR system or wellness application or, where applicable, its authorised representative shall register the required data into the EU database referred to in paragraph 1.


3. Medical devices or high-risk AI systems referred to in paragraphs 3 and 4 of Article 14 of this Regulation shall be registered in the database established pursuant to Regulations (EU) 2017/745 or […] [AI Act COM/2021/206 final], as applicable.


4. The Commission is empowered to adopt delegated acts in accordance with Article 67 to determine the list of required data to be registered by the manufacturers of EHR systems and wellness applications pursuant to paragraph 2.