Commission proposes European Health Data Space to unlock research opportunities

Regulatory NewsRegulatory News | 04 May 2022 |  By 

The European Commission has proposed creating a European Health Data Space (EHDS) that will make it easier for developers and manufacturers of medicinal products to access data for research.
Currently, most health-related data held in the European Union is inaccessible to researchers and other stakeholders that could use it to inform the development of medicinal products. According to officials at the Commission, businesses “face important obstacles in accessing the data they need to develop new products,” notably because in many cases “consent is the only way to access data” for purposes other than its original use.
“It is very costly and cumbersome for researchers to get consent from every patient to use the patient’s data in their research. Even when the patient consents, data holders are sometimes reluctant to provide data for reasons other than data protection and prefer to keep the health data for their activities. The current regulatory fragmentation between Member States hampers research and innovation by small players, as well as cross-border research,” the Commission wrote in a communication to other EU bodies.
The Commission revealed a cross-stakeholder appetite for policies that make better use of health data when it ran a public consultation last year. In a survey that mostly attracted responses from EU citizens and non-governmental organizations, 89% of respondents said the European Health Data Space should support and accelerate research in health. The Commission is now acting on that feedback.
EHDS is a far-reaching proposal intended to empower EU citizens to control their health data and impose specific essential requirements on electronic health record systems to promote interoperability and data portability. For developers and manufacturers of medicinal products, the proposals related to secondary use of health data are among the highlights.
The Commission wants to “fully unleash the benefits of the secondary use of electronic health data” by getting data holders to make information available for research. In doing so, the Commission envisages EHDS helping the EU to meet the aims of the Pharmaceutical Strategy for Europe and the mandate of the European Health Emergency Preparedness and Response Authority.
Specifically, EHDS will create a legal and technical environment designed to support the development of medicinal products, vaccines, medical devices and in vitro diagnostics. The framework will draw on the creation of HealthData@EU, a decentralized EU infrastructure for secondary use of health data that will connect health data access bodies.
Researchers who want to re-use health data will apply for a permit from an access body, although it will be possible to directly request data from a single health data provider if the same safeguards for privacy and security are in place. The same access options will be available to researchers based inside the EU and overseas.
Each permit will set out how the data may be used. Processing of electronic health data for secondary use will happen in secure environments provided by the health data access bodies, which the EU will require to meet “very high standards of privacy and cybersecurity.” The permits will only allow extraction of anonymous data from the processing environment. If access to personal electronic health data is needed, pseudonymized records will be made available. The proposal prohibits attempts to re-identify the data subjects.
The Commission has high hopes for the initiative, talking up the potential for EHDS to improve the diagnosis and treatment of cancer and the prevention, detection and response to public health crises. Officials have quantified the benefits. By enabling more efficient secondary use of health data, the Commission thinks the EU can realize benefits of more than €3.4 billion ($3.6 billion) for “researchers and innovators in digital health, medical devices and medicinal products.” The Commission also expects EHDS to cut the cost of regulatory processes by making it cheaper for agencies to access health data.
The Council and the European Parliament will now discuss the proposal put forward by the Commission.
Press Release


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