Article 23, Common specifications, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)
1. The Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements set out in Annex II, including a time limit for implementing those common specifications. Where relevant, the common specifications shall take into account the specificities of medical devices and high risk AI systems referred to in paragraphs 3 and 4 of Article 14.
Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
2. The common specifications referred to in paragraph 1 shall include the following elements:
(a) scope;
(b) applicability to different categories of EHR systems or functions included in them;
(c) version;
(d) validity period;
(e) normative part;
(f) explanatory part, including any relevant implementation guidelines.
3. The common specifications may include elements related to the following:
(a) datasets containing electronic health data and defining structures, such as data fields and data groups for the representation of clinical content and other parts of the electronic health data;
(b) coding systems and values to be used in datasets containing electronic health data;
(c) other requirements related to data quality, such as the completeness and accuracy of electronic health data;
(d) technical specifications, standards and profiles for the exchange of electronic health data;
(e) requirements and principles related to security, confidentiality, integrity, patient safety and protection of electronic health data;
(f) specifications and requirements related to identification management and the use of electronic identification.
4. EHR systems, medical devices and high risk AI systems referred to in Article 14 that are in conformity with the common specifications referred to in paragraph 1 shall be considered to be in conformity with the essential requirements covered by those specifications or parts thereof, set out in Annex II covered by those common specifications or the relevant parts of those common specifications.
5. Where common specifications covering interoperability and security requirements of EHR systems affect medical devices or high-risk AI systems falling under other acts, such as Regulations (EU) 2017/745 or […] [AI Act COM/2021/206 final], the adoption of those common specifications may be preceded by a consultation with the Medical Devices Coordination Group (MDCG) referred to in Article 103 of Regulation (EU) 2017/745 or the European Artificial Intelligence Board referred to in Article 56 of Regulation […] [AI Act COM/2021/206 final], as applicable.
6. Where common specifications covering interoperability and security requirements of medical devices or high-risk AI systems falling under other acts such as Regulation (EU) 2017/745 or Regulation […] [AI Act COM/2021/206 final], impact EHR systems, the adoption of those common specifications shall be preceded by a consultation with the EHDS Board, especially its subgroup for Chapters II and III of this Regulation.