Europe's health data will be based on the Data Governance Act

The new proposal to create a “European Health Data Space” (EHDS) has been put forward by the European Commission.This is the first sector-specific legislation based on the Data Governance Act. The text must be approved by the Council and the European Parliament before it becomes final.

With what goal in mind?

This text aims to improve exchanges and access to various types of health data (electronic health records, genomic data, data from patient registries, etc.) in order to support healthcare provision (primary use of data) as well as health research and policy development (secondary use of data).

The project provides for European citizens to have free access to "a minimum set of primary health data (information specifically collected to study a particular issue, such as data on vaccines, electronic prescriptions, laboratory test results, and hospital discharge reports).

This access should strengthen “patients' right to control” their medical information. They will also have the right to restrict access to their data or share it with third parties free of charge.

Better regulate the reuse of medical data.

Through this text, the European Commission also wishes, above all, to regulate the so-called “secondary” reuse of data other than for the purposes for which it was originally collected. This reuse covers medical records, social, administrative, biomedical, genetic, and genomic data, public registers, clinical studies, and research questionnaires.

• The transmission of such data to third parties for harmful commercial or legal purposes, such as insurance premiums, advertising, or the sale of data to third parties, will be prohibited.

• Data will be authorized for use in supporting public authorities in the performance of their duties, education, scientific research, the development of innovative solutions for public interest purposes, and the development of algorithms for medical applications.

This text aims to create a framework for sharing health data by establishing “clear rules, common standards and practices, infrastructure, and a governance framework. Stella Kyriakides, Commissioner for Health and Food Safety.

To supervise these new exchanges, the European Commission plans to create a specialized entity: the European Digital and Health Data Board, which will be responsible for managing access requests for so-called secondary data.

How does this interface with current private/public healthcare spaces?

Through the EHDS, citizens will have immediate and free access to their health data in electronic form (prescriptions, lab results, hospital discharge letters, medical imaging reports, etc.) and will be able to share it with healthcare professionals.

The real question is how this European system will interact with French public shared medical record system. The question is also how european medical appointment platform, such as Doctolib, will comply with it?

It should be noted that Doctolib has already shared prescriptions, imaging reports, and laboratory results online between patients and healthcare professionals for some time now, using a US based public cloud infrastructure, with no prior oversight by the Digital Governance Act.

Trust and IT security must flow through this future health data space.

The answer has already been provided by the European Commission, which maintains that, given the particularly sensitive nature of the data, the provisions of the General Data Protection Regulation (GDPR) will apply de facto.

It specifies that “data processing may only take place in secure processing environments that must comply with very high standards of confidentiality.”

It should be noted that the economic stakes of the EHDS are considerable. The European Commission plans to inject more than €810 million into this project (€280 million under the EU4Health program and the rest through the Digital Europe program).