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 4. Electronic health data access services for natural persons and their representatives
- 1.Member States shall ensure that one or more electronic health data access services at national, regional or local level are established, thereby enabling natural persons to access their personal electronic health data and exercise their rights provided for in Articles 3 and 5 to 10. Such electronic health data access services shall be free of charge for the natural persons and their representatives referred to in paragraph 2 of this Article.
- 2.Member States shall ensure that one or more proxy services are established as a functionality of electronic health data access services which enables:
- (a)natural persons to authorise other natural persons of their choice to access their personal electronic health data, or part thereof, on their behalf for a limited or unlimited period and, if needed, for a specific purpose only, and to manage those authorisations; and
- (b)legal representatives of natural persons to access personal electronic health data of those natural persons whose affairs they administer, in accordance with national law.
Member States shall establish rules regarding the authorisations referred to in point (a) of the first subparagraph and actions of guardians and other legal representatives.
- 3.The proxy services referred to in paragraph 2 shall provide authorisations in a transparent and easily understandable way, free of charge, and electronically or on paper. Natural persons and their representatives shall be informed about their authorisation rights, including about how to exercise those rights, and about the authorisation process. The proxy services shall provide an easy complaint mechanism for natural persons.
- 4.The proxy services referred to in paragraph 2 of this Article shall be interoperable among Member States. The Commission shall, by means of implementing acts, lay down the technical specifications for the interoperability of the proxy services of the Member States. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
- 5.The electronic health data access services and the proxy services shall be easily accessible for persons with disabilities, vulnerable groups and persons with low digital literacy.
Relevant Recitals for this Article
Natural persons should be able to provide an authorisation to other natural persons of their choice, such as their relatives or other close natural persons, enabling such persons of their choice to access or control the access to the personal electronic health data of the natural persons who provide the authorisation or to use digital health services on their behalf. Such authorisations could also be convenient for other usage by natural persons provided with such an authorisation. Proxy services for enabling and implementing such authorisations should be established by Member States, and be linked to personal electronic health data access services such as patient portals or patient-facing applications for mobile devices. Those proxy services should also enable guardians to act on behalf of their dependents, including minors; in such situations, authorisations could be automatic. In addition to those proxy services, Member States should also establish easily accessible support services to be provided by adequately trained staff dedicated to assisting natural persons when exercising their rights. In order to take into account cases in which the display of some personal electronic health data of dependent persons to their guardians could be contrary to the interests or the will of their dependents, including minors, Member States should be able to provide in national law for limitations and safeguards as well as for mechanisms for their technical implementation. Personal electronic health data access services, such as patient portals or patient-facing applications for mobile devices, should make use of such authorisations and thus enable authorised natural persons to access personal electronic health data falling within the scope of the authorisation. In order to provide a horizontal solution with increased user-friendliness, digital proxy solutions should be aligned with Regulation (EU) No 910/2014 of the European Parliament and of the Council and the technical specifications of the European Digital Identity Wallet. That alignment would contribute to reducing both the administrative and financial burden for Member States by lowering the risk of developing parallel systems that are not interoperable across the Union.