+SECTION 1 Scope and general provisions for EHR systems
---+Article 25 Harmonised software components of EHR systems
------+Article 25 1
------+Article 25 2
---+Article 26 Placing on the market and putting into service
------+Article 26 1
------+Article 26 2
------+Article 26 3
---+Article 27 Relation to Union law governing medical devices, in vitro diagnostic medical devices and AI systems
------+Article 27 1
------+Article 27 2
---+Article 28 Claims
------+Article 28 (a)
------+Article 28 (b)
------+Article 28 (c)
---+Article 29 Procurement, reimbursement and financing

SECTION 1 Scope and general provisions for EHR systems

SECTION 1 Scope and general provisions for EHR systems

1. Panoramica

,
Article 25 Harmonised software components of EHR systems
Article 26 Placing on the market and putting into service
Article 27 Relation to Union law governing medical devices, in vitro diagnostic medical devices and AI systems
Article 28 Claims

In the information sheet, instructions for use or other information accompanying EHR systems, and in the advertising of EHR systems, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the professional user as defined in Article 3, point (8), of Regulation (EU) 2018/1807 of the European Parliament and of the Council (34) with regard to their intended purpose, interoperability and security by:
Article 29 Procurement, reimbursement and financing

Article 29

Procurement, reimbursement and financing

Member States may maintain or define specific rules for the procurement or financing of, or reimbursement for, EHR systems in the context of the organisation, delivery or financing of healthcare services, provided that such rules are compliant with Union law and do not affect the functioning or compliance of the harmonised software components of EHR systems.

1.1 Riferimenti

1.2 Requisiti identificati

1.3 Standard correlati

2. Requisiti identificati

Requisiti

3. Standard correlati

Standard