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    European Health Data Space Regulation

    Annex I

    Navigation log

    Table of Contents

    Chapter I – General provisions

    Chapter II – Primary use

    Chapter III – Ehr systems and wellness applications

    Chapter IV – Secondary use

    Chapter V – Additional actions

    Chapter VI – European governance and coordination

    Chapter VII – Delegation of powers and committee procedure

    Chapter VIII – Miscellaneous

    Chapter IX – Deferred application, transitional and final provisions

    Recitals (115)

    Annexes

    Annex I

    Main characteristics of priority categories of personal electronic health data for primary use

    Regulation (EU) 2025/327 · EN/DE/FR
    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.
    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.
    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.
    Annex 1