European Health Data Space Regulation, High-Risk AI Systems Claiming Interoperability with EHR Systems (Article 27(2))

Article 27(2) requires providers of AI systems considered high-risk under Article 6 of Regulation (EU) 2024/1689, that do not fall within the scope of Regulation (EU) 2017/745 or (EU) 2017/746 and that claim interoperability with the harmonised software components of EHR systems, to prove compliance with the essential requirements on the European interoperability software component and the European logging software component laid down in Section 2 of Annex II.

Article 27(2) applies Article 36 of the Regulation to those high-risk AI systems. Under Article 36(4), high-risk AI systems referred to in Article 27 that are in conformity with the common specifications adopted under Article 36(1) are considered to be in conformity with the essential requirements in Annex II that those specifications cover.

Article 105 applies Article 27, with Articles 3 to 15, 23(2) to (6), 25, 26, 47, 48 and 49, from 26 March 2029 to the priority categories of personal electronic health data in Article 14(1), points (a), (b) and (c), and to EHR systems intended by the manufacturer to process them, and from 26 March 2031 to the categories in points (d), (e) and (f).