European Health Data Space Regulation
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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
Recital 19
(19) 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 General Data Protection Regulation (GDPR), 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 General Data Protection Regulation (GDPR). 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 General Data Protection Regulation (GDPR), 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.