EHDS, Article 36, EU

1. By 26 March 2027, 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.

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