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 Article 11. Access by health professionals to personal electronic health data
- 1.Where health professionals process data in an electronic format, they shall have access to the relevant and necessary personal electronic health data of natural persons under their treatment through the health professional access services referred to in Article 12, irrespective of the Member State of affiliation and the Member State of treatment.
- 2.Where the Member State of affiliation of the natural person under treatment and the Member State of treatment of such natural person differ, cross-border access to the personal electronic health data of the natural person under treatment shall be provided through the cross-border infrastructure referred to in Article 23.
- 3.The access referred to in paragraphs 1 and 2 of this Article shall include at least the priority categories of personal electronic health data referred to in Article 14. In line with the principles provided for in Article 5 of Regulation (EU) 2016/679, Member States shall establish rules providing for the categories of personal electronic health data accessible by different categories of health professionals or for different healthcare tasks. Such rules shall take into account the possibility of restrictions imposed under Article 8 of this Regulation.
- 4.In the case of treatment in a Member State other than the Member State of affiliation, the rules referred to in paragraph 3 shall be those of the Member State of treatment.
- 5.Where access to personal electronic health data has been restricted by a natural person pursuant to Article 8, the healthcare provider or health professional shall not be informed of the restricted content of those data. By way of derogation from the first paragraph of Article 8, where necessary in order to protect the vital interests of the data subject, the healthcare provider or health professional may be granted access to the restricted electronic health data. Such cases shall be logged in a clear and understandable format and shall be easily accessible for the data subject. Member States may provide for additional safeguards.
Relevant Recitals for this Article
Access to electronic health records by healthcare providers or other individuals should be transparent to the natural persons concerned. Electronic health data access services should provide detailed information on access to data, such as when and which entity or natural person accessed data and which data were accessed. Natural persons should also be able to enable or disable automatic notifications regarding access to personal electronic health data relating to them through the health professional access services.
Timely and full access by health professionals to the medical records of patients is fundamental for ensuring continuity of care, avoiding duplications and errors, and reducing costs. However, due to a lack of interoperability, in many cases health professionals cannot access the complete medical records of their patients and cannot make optimal medical decisions for their diagnosis and treatment, which adds considerable costs both for health systems and for natural persons and can lead to worse health outcomes for natural persons. Electronic health data made available in an interoperable format and which can be transmitted between healthcare providers can also reduce the administrative burden on health professionals of manually entering or copying health data between electronic systems. Therefore, health professionals should be provided with appropriate electronic means, such as electronic devices and health professional portals or other health professional access services, to use personal electronic health data for the exercise of their duties. As it is difficult to exhaustively determine in advance which data from the existing data in priority categories are medically relevant in a specific episode of care, health professionals should have a wide access to data. When accessing data relating to their patients, health professionals should comply with the applicable law, codes of conduct, deontological guidelines or other provisions governing ethical conduct with respect to sharing or accessing information, particularly in life-threatening or extreme situations. In accordance with Regulation (EU) 2016/679, in order to limit their access to what is relevant in a specific episode of care, healthcare providers should follow the data minimisation principle when accessing personal electronic health data, limiting the data accessed to data that are strictly necessary and justified for a given service. Providing health professional access services is a task assigned in the public interest by this Regulation and the performance of such task requires the processing of personal data as referred to in Article 6(1), point (e), of Regulation (EU) 2016/679. This Regulation provides for conditions and safeguards for the processing of electronic health data by the health professional access service in accordance with Article 9(2), point (h), of Regulation (EU) 2016/679, for instance detailed provisions regarding logging of access to personal electronic health data and that aim to provide transparency towards data subjects. However, this Regulation should be without prejudice to national law concerning the processing of health data for the delivery of healthcare, including national law establishing categories of health professionals that can process different categories of electronic health data.
In some Member States, healthcare is provided by primary care management teams, which are groups of health professionals focused on primary care, such as general practitioners, that carry out their primary care activities based on a healthcare plan that they draw up. Other types of healthcare teams also exist in several Member States for other care purposes. In the context of primary use in the EHDS, access should be provided to the health professionals belonging to such teams.