European Health Data Space enters into force

Contents

The entry into force of the Regulation on the European Health Data Space (EHDS) is seen by many as a milestone for healthcare in Europe. The EU member states now have two years, until March 26, 2027, to implement the requirements of the regulation.

From a political perspective, the coronavirus crisis has highlighted the urgency of a uniform European approach to healthcare data – Data should be more easily available, especially in times of crisis.

The EHDS is intended to make pseudonymized health data available from the electronic patient records of the legally insured, clinical studies, the 400 medical registers in the healthcare system, health insurance billing data, genetic data, etc. – also for AI training.

Aims of the EHDS

One of the main objectives of the EHDS is to improve cross-border healthcare. By introducing an EU-wide accessible digital patient record, citizens should be able to view their health data, including prescriptions, image data and laboratory tests, across borders. This should improve the treatment of patients in other EU countries –, for example when on vacation –.

The EHDS focuses in particular on promoting research. It is also intended to support evidence-based decisions in healthcare policy. The plan is to use the data to safeguard the public interest, inform political decision-makers and for statistical analyses.

The EHDS is intended to promote interoperability between the healthcare systems of the EU member states. To this end, the EU Commission intends to define the technical specifications "by means of implementing acts" by March 26, 2027, initially for the following categories and thus also an interoperable, European exchange format for electronic health records (EHR), which could pose a major challenge:

• patient summaries
• electronic prescriptions
• electronic dispensing of medicines
• Medical imaging and related imaging-based findings
• Medical test results, including laboratory and other diagnostic results and related reports
• discharge reports.

For example, prescriptions should be in a common format – One interoperability standard for this could be FHIR HL7.

Member States are obliged to connect service providers to the central data exchange platform MyHealth@EU to enable access to information such as prescriptions, allergies, vaccinations and current medications.

The HealthData@EU project, on the other hand, is intended to "accelerate secondary use while increasing legal certainty, respecting the privacy of natural persons and being interoperable" , according to the regulation. Due to the sensitivity of health data, principles such as 'data protection by design', 'data protection by default' and the concept of 'better bringing the questions to the data than transferring the data itself' should be adhered to wherever possible".

The task of the countries is to appoint national contact points for the use of secondary data and to connect them to HealthData@EU. In Germany, the Data Access and Coordination Office at the Federal Institute for Drugs and Medical Devices (BfArM) is responsible for this. The legal basis for this was created with the Health Data Utilization Act. The "Joint Action Towards the European Health Data Space 2" (TEHDAS 2) is developing the guidelines and technical specifications for the cross-border secondary use of health data.

Provision of data on request

Access to health data is to be strictly regulated. Data is only to be made available on request for approved purposes. However, there have always been considerable data protection concerns, especially with regard to the secondary use of data, due to the risk of commercialization of health data. Big tech, pharmaceutical and medical technology companies in particular have shown great interest in health data. Originally, no right of objection was envisaged, but adjustments were made following fierce criticism.

It is still unclear when the first research projects with data from Germany will start. It was only recently announced that the data from the electronic patient file will not be transferred to the Health Research Data Center, which is based at the Federal Institute for Drugs and Medical Devices, from the middle of the year as planned due to delays. Overall, a large part of the infrastructure for the EHDS is still under construction. It is unclear when scientific findings can be generated from the data, which will have to be curated at great expense in the future. In addition, legal questions about what is possible still need to be clarified.

Bitkom is pleased

"Whether for the development of new therapies or for the training of artificial intelligence in medicine: pseudonymized health data from Europe will make new diagnosis and treatment methods possible in Europe in the future," says Bitkom CEO Dr. Bernhard Rohleder.

It is important "that the implementation of the EHDS progresses at the same pace in all member states and that there are no special national approaches. In particular, the very different levels of digitization in the individual countries could hinder a smooth implementation".

(mack)