Article 36
Conformity of the harmonised software components of EHR systems - Common specifications
In short: Common specifications will be adopted by the commission by means of an implementing act latest March 2027.
- By 26 March 2027, the Commission shall, by means of an [Article 36(1)] Implementation Act , 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).
- 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.
- 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.
- EHR systems, medical devices, in vitro diagnostic medical devices and high-risk AI systems referred to in
Article 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.
- 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 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.
- 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.
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