EHDS
Data & Privacy
- Data Act
- Data Governance Act
- EHDS
- ePrivacy Directive
- GDPR
AI & Trust
- Artificial Intelligence Act
- Product Liability Directive
Cybersecurity
- Cyber Resilience Act
- Cybersecurity Act
- DORA
- NIS2
Digital Services & Media
- Digital Markets Act
- Digital Services Act
- European Media Freedom Act
European Health Data Space Regulation
- Recitals
CHAPTER I
GENERAL PROVISIONSArticles 1 — 2
CHAPTER II
PRIMARY USEArticles 3 — 24
CHAPTER III
EHR SYSTEMS AND WELLNESS APPLICATIONSArticles 25 — 49
CHAPTER IV
SECONDARY USEArticles 50 — 81
CHAPTER V
ADDITIONAL ACTIONSArticles 82 — 91
CHAPTER VI
EUROPEAN GOVERNANCE AND COORDINATIONArticles 92 — 96
CHAPTER VII
DELEGATION OF POWERS AND COMMITTEE PROCEDUREArticles 97 — 98
CHAPTER VIII
MISCELLANEOUSArticles 99 — 104
CHAPTER IX
DEFERRED APPLICATION, TRANSITIONAL AND FINAL PROVISIONSArticles 105 — 105
ANNEXES
EHDS
Annex I. 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. | |
| 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 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. |