Articles of the European Health Data Space (EHDS), Article 33, Minimum categories of electronic data for secondary use

Article 33, Minimum categories of electronic data for secondary use, Articles of the European Health Data Space (EHDS), (Proposal_3.5.2022)

1. Data holders shall make the following categories of electronic data available for secondary use in accordance with the provisions of this Chapter:

(a) EHRs;

(b) data impacting on health, including social, environmental behavioural determinants of health;

(c) relevant pathogen genomic data, impacting on human health;

(d) health-related administrative data, including claims and reimbursement data;

(e) human genetic, genomic and proteomic data;

(f) person generated electronic health data, including medical devices, wellness applications or other digital health applications;

(g) identification data related to health professionals involved in the treatment of a natural person;

(h) population wide health data registries (public health registries);

(i) electronic health data from medical registries for specific diseases;

(j) electronic health data from clinical trials;

(k) electronic health data from medical devices and from registries for medicinal products and medical devices;

(l) research cohorts, questionnaires and surveys related to health;

(m) electronic health data from biobanks and dedicated databases;

(n) electronic data related to insurance status, professional status, education, lifestyle, wellness and behaviour data relevant to health;

(o) electronic health data containing various improvements such as correction, annotation, enrichment received by the data holder following a processing based on a data permit.

2. The requirement in the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC.

3. The electronic health data referred to in paragraph 1 shall cover data processed for the provision of health or care or for public health, research, innovation, policy making, official statistics, patient safety or regulatory purposes, collected by entities and bodies in the health or care sectors, including public and private providers of health or care, entities or bodies performing research in relation to these sectors, and Union institutions, bodies, offices and agencies.

4. Electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use. Where such data is made available for secondary use, all measures necessary to preserve the confidentiality of IP rights and trade secrets shall be taken.

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.

6. Where a public sector body obtains data in emergency situations as defined in Article 15, point (a) or (b) of the Regulation […] [Data Act COM/2022/68 final], in accordance with the rules laid down in that Regulation, it may be supported by a health data access body to provide technical support to process the data or combing it with other data for joint analysis.

7. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the list in paragraph 1 to adapt it to the evolution of available electronic health data.

8. Health data access bodies may provide access to additional categories of electronic health data that they have been entrusted with pursuant to national law or based on voluntary cooperation with the relevant data holders at national level, in particular to electronic health data held by private entities in the health sector.