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European health data space

As part of the European data strategy, the EU Commission has released the first proposal for a European data space in a specific area, focusing on health data, in particular on electronic health data.

These are the main objectives of this proposal:

  • Enable more transparency, availability and control of data subjects over their electronic health data
  • Facilitate the health treatment of the data subject, through the use of electronic health data on a unique dedicated digital platform, even in another EU member state (primary use)
  • Legitimize the use of electronic health data, located on a unique electronic digital platform, also for health research and policy-making purposes (secondary use).

Relevant are the overlap profiles with the GDPR and the solutions proposed by the Commission to the two EU co-legislators (Parliament and Council) in identifying the fair balance between protecting special category of data, right to health and encouraging innovation.

The main health data initiatives

The European Health Data Space proposal is preceded by other initiatives from different sources, both EU and national, on the wider topic of health data. In this regard, the main ones are listed below:

Clinical trials

In the area of clinical trials, we recall:

  • Opinion 3/2019 concerning “the Questions and Answers on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection regulation (GDPR) (art. 70.1.b))”, adopted by the EDPB on January 23, 2019
  • The document “EDPB Document on response to the request from the European Commission for clarifications on the consistent application of the GDPR, focusing on health research”, adopted by the EDPB on February 2, 2021
  • The document “Question and Answers on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation” issued by the European Commission Directorate General for Health and Food Safety
  • The decree of the Italian Ministry of Health of November 30, 2021 on non-profit clinical trials of drugs
  • The preliminary version of the document “Guidance document on how to approach the 4 protection of personal data and commercially confidential 5 information in documents uploaded and published in the 6 Clinical Trial Information System (CTIS)” issued by the European Medicine Agency (EMA) on April 7, 2022.

Electronic health data

On electronic health data, in addition to the European Commission’s proposed regulation:

  • The document of the Superior Health Council of the Italian Ministry of Health “Proposal for the outline of the Reform of Health Information Systems” dated January 11, 2022.

Regulation of health data

On the wider topic of the regulation of health data:

  • The study “Assessment of the EU Member States’ rules on health data in the light of GDPR” published in 2021 by the Directorate General on Health and Food Safety of the European Commission.

Covid-19 context

Concerning the emergency context related to Covid-19:

  • The “Guidelines 03/2020 on the processing of data concerning health for the purpose of scientific research in the context of the COVID-19 outbreak” , adopted by the EDBP on April 21, 2020
  • The “Guidelines 04/2020 on the use of location data and contact tracing tools in the context of the COVID-19 outbreak”, adopted on April 21, 2020.

Proposal for a regulation on the European Health Data Space

On May 3, 2022, the EU Commission released its proposal for a Regulation on the European Health Data Space [COM(2022) 197 final]; it bears the title “European Health Data Space.” In fact, the subject of the proposal is the access and secure exchange of electronic health data, both nationally and cross-borders. There are many points of contact between this proposal and the GDPR.