Article 38, Obligations of health data access bodies towards natural persons, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)
1. Health data access bodies shall make publicly available and easily searchable the conditions under which electronic health data is made available for secondary use, with information concerning:
(a) the legal basis under which access is granted;
(b) the technical and organisational measures taken to protect the rights of natural persons;
(c) the applicable rights of natural persons in relation to secondary use of electronic health data;
(d) the arrangements for natural persons to exercise their rights in accordance with Chapter III of Regulation (EU) 2016/679;
(e) the results or outcomes of the projects for which the electronic health data were used.
2. Health data access bodies shall not be obliged to provide the specific information under Article 14 of Regulation (EU) 2016/679 to each natural person concerning the use of their data for projects subject to a data permit and shall provide general public information on all the data permits issued pursuant to Article 46.
3. Where a health data access body is informed by a data user of a finding that may impact on the health of a natural person, the health data access body may inform the natural person and his or her treating health professional about that finding.
4. Member States shall regularly inform the public at large about the role and benefits of health data access bodies.