With the support of TEHDAS and SITRA
The European Health Data Space will be a health-specific ecosystem. Practically speaking, the space covers a wide range of actions, including:
- Rules.
- Common standards and practices.
- Infrastructures.
- Governance
The European Commission’s proposal for European Health Data Space has three main aims. The space aims to:
- Support individuals to take control of their own health data.
- Support the use of health data in four ways (for better healthcare delivery, better research, better innovation, and better policy making).
- Enable the European Union to make full use of the potential offered by the safe and secure exchange, use and re-use of health data.
The space’s two chief foci are on the primary use of data and the secondary use of data. Here, the goals are to:
- Empower individuals through increased digital access to and control of their electronic personal health data, nationally and cross-borders, as well as support to their free movement, [while] fostering a genuine single market for electronic health record systems, relevant medical devices, and high risk artificial intelligence (AI) systems. To read more about these uses of data, examine “primary use of data” and read about the underpinning infrastructure, MyHealth@EU.
- Provide a set-up for the use of health data for research, innovation, policy making and regulatory activities that is consistent, trustworthy and efficient (this type of use of data is referred to as “secondary use of data”).
Overall, the proposed Regulation on the space has five main objectives. These objectives benefit a wide range of stakeholders. These objectives benefit a wide range of stakeholders, including citizens/patients, policy-makers, industrial players including manufacturers and small and medium-sized enterprises, and researchers.
Acknowledgement: COM(2022) 196/2: “A European Health Data Space:harnessing the power of health data for people, patients and innovation”
Of course, ultimately, all these kinds of stakeholders should be brought together so that they all gain benefits from the space.
Among EHTEL’s multi-stakeholder members are several of these kinds of stakeholders. Examples of two groups to which these objectives may particularly apply are:
- People working with digital health services/products.
- Policy makers/regulators – whether they function at regional, national or international (European) levels.
Policy makers and regulators, for example, are keenly interested by the practical application of the data collected by the space.
Savings facilited by the space
Overall, the solution proposed in the space, for secondary use(s) of health data, is anticipated to bring about significant economic savings of at least EUR 5.4 billion over the next decade in Europe.
To take just a single example of the potential savings that could result from the space, it is possible to focus on regulators and policy makers at the national level.
Regulators and policy makers will have easier access to health data for the benefit of public health and the overall functioning of healthcare systems.
In terms of savings, it has been calculated – for example – that, in a medium-sized European Union country, the negotiation of a reduction of up to 5% on the price(s) of medicinal products (based on better knowledge about the actual effects of the medicines) could equate to EUR 50 million a year in money saved.
Financing of the space
At European Union level, financing of EUR 810 million is available to support the European Health Data Space. Over EUR 330 million have been earmarked for European Health Data Space activities and infrastructures: with EUR 280 million under the EU4Health Programme, and an additional EUR 50 million under the Digital Europe Programme. Grants will be available to European Member States. Other forms of financing will be available through the Connecting Europe Facility for cloud and Horizon Europe on research and innovation. Especially – under the Recovery and Resilience Facility for investments in health, including digital health and the secondary use of health data – the Member States themselves have earmarked EUR 12 billion.
Governance of the space
Governance of the space will be handled by a new European Health Data Space Board. The Board will reinforce current governance mechanisms that exist currently at national and European levels. It will be composed of representatives from European Member States’ digital health authorities and health data access bodies, as well as nominated observers.
The intention is to leverage the current cooperation on the primary use(s) of health data achieved through the two European infrastructures that were built in record time over the past two years, particularly the EU Digital COVID Certificate and contact tracing/warning apps.
More details on the use and governance of these certificates and apps will surely be forthcoming.
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Other items of especial interest included in the data space Regulations involve matters such as fees and charges related to the various aspects of the space; data altruism; labelling and certification; and interoperability – including semantic interoperability – and security. These are all subjects likely to be explored by EHTEL in autumn 2022. Look out therefore for EHTEL’s next steps in this direction.
To find out more about the European Health Data Space, visit the official European Commission website.
