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Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (Text with EEA relevance) article annex_I CELEX: 32025R0327 Main characteristics of priority categories of personal electronic health data for primary use
Electronic health data category Main characteristics of electronic health data included under the category 1. Patient summaries Electronic health data that include significant clinical facts related to an identified natural person and that are essential for the provision of safe and efficient healthcare to that person. The following information is part of a patient summary: 1. Personal details
2. Contact information
3. Information on insurance
4. Allergies
5. Medical alerts
6. Vaccination/prophylaxis information, possibly in the form of a vaccination card
7. Current, resolved, closed or inactive problems, including in an international classification coding
8. Textual information related to medical history
9. Medical devices and implants
10. Medical or care procedures
11. Functional status
12. Current and relevant past medicines
13. Social history observations related to health
14. Pregnancy history
15. Patient-provided data
16. Observation results pertaining to the health condition
17. Plan of care |
Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (Text with EEA relevance) article annex_I CELEX: 32025R0327 18. Information on a rare disease, such as details about the impact or characteristics of the disease
2. Electronic prescriptions Electronic health data constituting a prescription for a medicinal product as defined in Article 3, point (k), of Directive 2011/24/EU
3. Electronic dispensations Information on the supply of a medicinal product to a natural person by a pharmacy based on an electronic prescription
4. Medical imaging studies and related imaging reports Electronic health data related to the use of or produced by technologies that are used to view the human body in order to prevent, diagnose, monitor or treat medical conditions
5. Medical test results, including laboratory and other diagnostic results and related reports Electronic health data representing results of studies performed in particular through in vitro diagnostics such as clinical biochemistry, haematology, transfusion medicine, microbiology, immunology and others, and including, where relevant, reports supporting the interpretation of the results |
Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (Text with EEA relevance) article annex_I CELEX: 32025R0327 6. Discharge reports Electronic health data related to a healthcare encounter or episode of care and including essential information about admission, treatment and discharge of a natural person. |