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Article 8

Right of natural persons to restrict access

In short: Natural persons shall have the right to restrict access of health professionals and healthcare providers.

Natural persons shall have the right to restrict the access of health professionals and healthcare providers to all or parts of their personal electronic health data as referred to in Article 3.

When exercising the right referred to in the first paragraph, natural persons shall be made aware that restricting access might impact the provision of healthcare to them.

The fact that a natural person has restricted access under the first paragraph shall not be visible to healthcare providers.

Member States shall establish the rules and specific safeguards regarding such restriction mechanisms.

From a DG SANTE presentation:

  • Right to restrict access
    • Can set access restrictions on all or parts of data (e.g. data deemed by the person as more sensitive). Such data will not be accessible through health professional access services.
    • Restrictions are not visible to healthcare providers - not even the fact of their existence.
    • Healthcare providers can use 'breaking the glass' function if necessary to protect vital interests.
  • How to place restrictions on parts of health data?
    • This may depend on digital health infrastructure in every MS. Could be based on the selection of documents, episodes of care, specific datasets, etc.
    • The mechanisms should allow for sufficient granularity to restricts parts of datasets, such as components of the patient summaries.

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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.