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Article 4

Electronic health data access services for natural persons and their representatives

In short: Member States shall provide health data access services to natural persons.

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 [Article 4(4)] 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.

Discussion

On paragraph 4: i.e. from the patients perspective all Member States must offer one and the same functionality to provide access to health data.


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About Ringholm bv

Ringholm bv is a group of European experts in the field of messaging standards and systems integration in healthcare IT. We provide the industry's most advanced training courses and consulting on healthcare information exchange standards.