
Opinion of the German Social Insurance on European Health Data Space (EHDS)
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.