+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
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SECTION 1 Scope and general provisions for EHR systems
SECTION 1 Scope and general provisions for EHR systems
1. Overview
| Summary |
Regulation |
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Article 25 Harmonised software components of EHR systems
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Article 26 Placing on the market and putting into service
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Article 27 Relation to Union law governing medical devices, in vitro diagnostic medical devices and AI systems
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Article 28 Claims
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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:
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Article 29 Procurement, reimbursement and financing
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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.
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,
1.1 References
1.2 Identified Requirements
1.3 Related Standards
2. Identified Requirements
Requirements
| Source |
Requirement |
3. Related Standards
Standards
| Source |
Requirement |
- Builddate: 05.03.2025 00:00:00 -Doknr: CELEX:32025R0327
- EULAW -
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