Focus must be on added value for patients

CC – 12/2022

In May, the European Commission presented a Regulation Proposal to create a European Health Data Space (EHDS). Being the central digitisation project in the field of health policy, it is an ambitious major project. The European Representation of the German Social Insurance (DSV) has assumed an overarching position on the draft regulation in an opinion. In addition to detailed comments, the opinion also makes specific proposals for amendments.

Opportunities for patients and social security systems

The DSV welcomes, in principle, the establishment of the EHDS. It offers the opportunity for added value for patients and social security systems, not only through digital, cross-border access to health data for medical treatment, but also through their meaningful pooling for research and policy-making purposes. However, the draft regulation needs to be made more precise on 12 points, including the envisaged time and regulatory framework, the Member States' say on the matter, compliance with data protection standards and the meaningful harmonisation of infrastructure for primary and secondary data use.

Harmonisation of existing national structures

The Member States are responsible for the design of the social security systems. Therefore, the establishment of the EHDS should be carefully done with the aim of integrating existing and proven national structures. Only if viable and practical solutions are worked out together with the Member States and the institutions responsible for implementation at national level can a functional EHDS emerge. Member States should, for example, be given a sufficient degree of control and say in the adoption of implementing and delegated acts. The social insurance institutions in Germany are particularly affected by the regulatory content of the EHDS and they must be comprehensively involved.

Aligning data use with the common good

Health data use under the EHDS should always be in public interest and serve the common good. From the point of view of DSV, innovations that contribute to health or social security should be favoured. The use of health data for research and policy-making must primarily benefit patients and social and health systems. The DSV also suggested that the intended access rights of industry and the use of health data for commercial purposes should be critically reviewed. Combating malpractice in the health sector should also be included as an additional purpose in the regulation. In addition, the data provided by the solidarity community and used by third parties must lead to adequate quid pro quos, for example through financial compensation.

Ensuring high data quality in the EHR

DSV warns against including data from wellness applications in the electronic health record (EHR) as long as they do not meet adequate quality standards. The voluntary labelling of wellness applications envisaged by the European Commission aims exclusively at their interoperability, but without defining quality requirements. Few meaningful data from wellness applications could degrade the overall data quality in the EHR. Therefore, it should be possible to include only quality-assured data from applications certified as medical devices in the EHR.

The DSV opinion on the EHDS can be found here.