Article 36

1.
By ... [two years from the date of entry into force of this Regulation], the Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements laid down in Annex II, including a common template and a time limit for implementing those common specifications. Where relevant, those common specifications shall take into account the specificities of medical devices and high-risk AI systems referred to in Article 27(1) and (2), respectively, including the state-of-the-art standards for health informatics and the European electronic health record exchange format. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).

2.
The common specifications referred to in paragraph 1 shall include the following information and elements:

• (a) their scope;


• (b) their applicability to different categories of EHR systems or functions included in them;


• (c) their version;


• (d) their validity period;


• (e) a normative part;


• (f) an explanatory part, including any relevant implementation guidelines.

3.
The common specifications referred to in paragraph 1 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, taking due account of both potential future harmonisation of terminologies and their compatibility with existing national terminologies;


• (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 patient safety and the security, confidentiality, integrity 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, in vitro diagnostic medical devices and high-risk AI systems referred to in Articles 25 and 27 that are in conformity with the common specifications referred to in paragraph 1 of this Article shall be considered to be in conformity with the essential requirements covered by those common specifications or parts thereof, laid down in Annex II, and covered by those common specifications or the relevant parts thereof.

5.
Where common specifications covering interoperability and security requirements of EHR systems affect medical devices, in vitro diagnostic medical devices or high-risk AI systems falling under other legal acts, such as Regulation (EU) 2017/745, (EU) 2017/746 or (EU) 2024/1689, the adoption of those common specifications may be preceded by a consultation with the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745 or the European Artificial Intelligence Board established by Article 65 of Regulation (EU) 2024/1689 and the European Data Protection Board (EDPB), as applicable.

6.
Where common specifications covering interoperability and security requirements of medical devices, in vitro diagnostic medical devices or high-risk AI systems falling under other legal acts, such as Regulation (EU) 2017/745, (EU) 2017/746 or (EU) 2024/1689, affect EHR systems, the Commission shall ensure that the adoption of those common specifications is preceded by a consultation with the EHDS Board and the EDPB, as applicable.