New version: Verordnung (EU) 2025/327 über den europäischen Gesundheitsdatenraum (CELEX:32025R0327) – 35 new, 0 changed, 0 removed

• Document: Verordnung (EU) 2025/327 über den europäischen Gesundheitsdatenraum (https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32025R0327)
• Version: CELEX:32025R0327
• Project: EULAW
• Import: #28044, 31.10.2026 12:34, eulaw

The new version was compared with the existing issues. Changes are only applied once approved in the administration (Importer › Proposed changes).

Review: 0 open, 35 applied, 0 rejected.

New sections (35)

• ANNEX I Main characteristics of priority categories of personal electronic health data for primary use [applied]
  CELEX:32025R0327#anx_I
• ANNEX II Essential requirements for the harmonised software components of EHR systems and for products for which interoperability with EHR systems ha… [applied]
  CELEX:32025R0327#anx_II
• 1. General requirements [applied]
  CELEX:32025R0327#anx_II_1
• 1.1. The harmonised software components of an EHR system shall achieve the performance intended by … [applied]
  CELEX:32025R0327#anx_II_1.1
• 1.2. The harmonised software components of the EHR system shall be designed and developed in such a … [applied]
  CELEX:32025R0327#anx_II_1.2
• 1.3. An EHR system shall be designed and developed in such a way that its interoperability, safety … [applied]
  CELEX:32025R0327#anx_II_1.3
• 1.4. The harmonised software components of an EHR system that is intended to be operated together … [applied]
  CELEX:32025R0327#anx_II_1.4
• 2. Requirements for interoperability [applied]
  CELEX:32025R0327#anx_II_2
• 2.1. Where an EHR system is designed to store or intermediate personal electronic health data, it … [applied]
  CELEX:32025R0327#anx_II_2.1
• 2.2. Where an EHR system is designed to store or intermediate personal electronic health data, it … [applied]
  CELEX:32025R0327#anx_II_2.2
• 2.3. Where an EHR system is designed to provide access to personal electronic health data, it shall … [applied]
  CELEX:32025R0327#anx_II_2.3
• 2.4. An EHR system that includes a functionality for entering structured personal electronic health … [applied]
  CELEX:32025R0327#anx_II_2.4
• 2.5. The harmonised software components of an EHR system shall not include features that prohibit … [applied]
  CELEX:32025R0327#anx_II_2.5
• 2.6. The harmonised software components of an EHR system shall not include features that prohibit … [applied]
  CELEX:32025R0327#anx_II_2.6
• 3. Requirements for security and logging. [applied]
  CELEX:32025R0327#anx_II_3
• 3.1. An EHR system designed to be used by health professionals shall provide reliable mechanisms … [applied]
  CELEX:32025R0327#anx_II_3.1
• 3.2. The European logging software component of an EHR system designed to enable access by … [applied]
  CELEX:32025R0327#anx_II_3.2
• 3.3. The harmonised software components of an EHR system shall include tools or mechanisms to … [applied]
  CELEX:32025R0327#anx_II_3.3
• 3.4. The harmonised software components of an EHR system that store personal electronic health data … [applied]
  CELEX:32025R0327#anx_II_3.4
• ANNEX III Technical documentation [applied]
  CELEX:32025R0327#anx_III
• 1. A detailed description of the EHR system including: (a) its intended purpose, and the date and … [applied]
  CELEX:32025R0327#anx_III_1
• 2. A detailed description of the system in place to evaluate the EHR system performance, where … [applied]
  CELEX:32025R0327#anx_III_2
• 3. The references to any common specification used in accordance with Article 36 and in relation to … [applied]
  CELEX:32025R0327#anx_III_3
• 4. The results and critical analyses of all verifications and validation tests undertaken to … [applied]
  CELEX:32025R0327#anx_III_4
• 5. A copy of the information sheet referred to in Article 38. [applied]
  CELEX:32025R0327#anx_III_5
• 6. A copy of the EU declaration of conformity. [applied]
  CELEX:32025R0327#anx_III_6
• ANNEX IV EU declaration of conformity [applied]
  CELEX:32025R0327#anx_IV
• 1. The name of the EHR system, version and any additional unambiguous reference allowing … [applied]
  CELEX:32025R0327#anx_IV_1
• 2. Name and address of the manufacturer or, where applicable, its authorised representative. [applied]
  CELEX:32025R0327#anx_IV_2
• 3. A statement that the EU declaration of conformity is issued under the sole responsibility of the … [applied]
  CELEX:32025R0327#anx_IV_3
• 4. A statement that the EHR system in question is in conformity with the provisions laid down in … [applied]
  CELEX:32025R0327#anx_IV_4
• 5. References to any relevant harmonised standards used and in relation to which conformity is … [applied]
  CELEX:32025R0327#anx_IV_5
• 6. References to any common specifications used and in relation to which conformity is declared. [applied]
  CELEX:32025R0327#anx_IV_6
• 7. Place and date of issue of the declaration, signature plus name and function of the person who … [applied]
  CELEX:32025R0327#anx_IV_7
• 8. Where applicable, additional information. [applied]
  CELEX:32025R0327#anx_IV_8

Pedidos ligados

• EULAW -

  European Regulation published on http://eur-lex.europa.eu/