Article 14, Interplay with legislation governing medical devices and AI systems, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)
1. EHR systems intended by their manufacturer for primary use of priority categories of electronic health data referred to in Article 5 shall be subject to the provisions laid down in this Chapter.
2. This Chapter shall not apply to general software used in a healthcare environment.
3. Manufacturers of medical devices as defined in Article 2(1) of Regulation (EU) 2017/745 that claim interoperability of those medical devices with EHR systems shall prove compliance with the essential requirements on interoperability laid down in Section 2 of Annex II of this Regulation. Article 23 of this Chapter shall be applicable to those medical devices.
4. Providers of high-risk AI systems as defined in Article 6 of Regulation […] [AI act COM/2021/206 final], which does not fall within the scope of Regulation (EU) 2017/745, that claim interoperability of those AI systems with EHR systems will need to prove compliance with the essential requirements on interoperability laid down in Section 2 of Annex II of this Regulation. Article 23 of this Chapter shall be applicable to those high-risk AI systems.
5. Member States may maintain or define specific rules for the procurement, reimbursement or financing of EHR systems in the context of the organisation, delivery or financing of healthcare services.