Article 15, Placing on the market and putting into service, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)
1. EHR systems may be placed on the market or put into service only if they comply with the provisions laid down in this Chapter.
2. EHR systems that are manufactured and used within health institutions established in the Union and EHR systems offered as a service within the meaning of Article 1(1), point (b), of Directive (EU) 2015/1535 of the European Parliament and of the Council to a natural or legal person established in the Union shall be considered as having been put into service.