POSITION | HEALTH POLICY | EHDS
The need for a common European Health Data Space Key messages from European business associations.
February 2021 A connected and interoperable European Health Data Space (EHDS) is essential to unlock the potential of health data in Europe. The initiative will first and foremost benefit societies in Europe – including patients and healthcare providers – as it can play a crucial role in developing innovative technologies and treatments. Standard protocols can be replaced by personalised, data-driven insights and interventions. A joint European approach pools resources and evidence, e.g. on rare diseases. On the economic level, linking the health data regimes of the 27 Member States will scale up the amount of aggregated data available for research and development. Such an innovation-friendly environment is key to a competitive healthcare industry and data-driven business models. The ultimate benefits are better and smarter healthcare for everyone in Europe and enhanced welfare outcomes, as well as an effective pandemic preparedness. Digitisation and the EHDS are also levers to more preventive healthcare. They create a new B2C-market of health-related services (e.g. apps, wearables). While the General Data Protection Regulation (GDPR) has aimed at creating a level playing field for the use of personal health data, fragmentation concerning its implementation remains within and between Member States. In addition to diverse governance models regarding access and use of health data across Europe, health data is collected in multiple registers and other sources 1 with a wide spread of data quality within individual Member States. Business associations representing, among other, the pharmaceutical industry, medical technology, the biotechnology industry, information & communications technology and healthcare suppliers across Europe therefore expressly welcome the establishment of the EHDS.
Sources include – amongst others – electronic health records, healthcare data, genomics, registries, behavioural data and social data. 1
The need for a common European Health Data Space
Building a strong European Health Data Space European policy efforts should address the fragmented health data landscape to allow cross-border application of health data in research and development, as well as innovative applications and solutions. The legislative initiative for the EHDS should foster the creation of data-driven business models, create a level playing field and allow companies to compete globally. All measures should ensure legal certainty and stability. The EHDS framework must address multiple issues: 1. Interoperability and standardisation: Encouraging the (technical and semantical) interoperability of systems and data portability are objectives the EU should pursue. Notably by promoting the use and, if needed, facilitating the development of international industry-led standards. 2. Health data: Future regulations on the EHDS must promote both primary and secondary use of aggregated health data. We must make health data available for research and development purposes across all sectors of the healthcare system – including equal access for private and public research activities. Moreover, it could be explored whether additional European initiatives on the secondary use of health data for research and businesses are needed. 2 3. Trust: User-friendliness, a high level of security and the adoption of best practices are key elements to build trust among the various user groups of the EHDS. The EU needs to take decisive action to harmonise the application of regulations and guidance for health data processing for primary and secondary use across Europe. Moreover, it is crucial to develop capacities in regulators, industry and patients to enable further trust and data innovation in digital health. 4. Public-private partnership: A successful data governance should be based on a meaningful publicprivate partnership. The health industry is one of the main pillars of medical research and is acknowledged to be a relevant part of the provision of healthcare. A boost to innovation can only be achieved by a strong dialogue and an inclusive industry participation. 5. Future policy must enable data-driven innovation: A well-functioning, innovation- and businessfriendly legal framework for the EHDS – including the use of open standards – should deliver legal certainty, fair competition and allocation of rights and duties. 6. Coherence with proposed Data Governance Act (DGA): The EHDS legislation should complement the proposed DGA. Moreover, providing more legal certainty to companies for anonymising personal data could contribute to a more coherent interpretation and application of the GDPR for both the primary and secondary use of health data.
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See for example https://stm.fi/en/secondary-use-of-health-and-social-data
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The need for a common European Health Data Space
Governance model The EHDS requires a clear governance framework – especially due to the current fragmentation of health data regimes and a lack of coordination across Europe. The precise structure should be defined in a dialogue with – public and private – stakeholders and rely on markets for the best available technologies. The public-private governance model could explore the following aspects: ▪ Implementation of a central health data entity at EU level as a reference centre in a public private partnership. This entity could connect national or regional (depending on the respective healthcare system) health data trust centres through a secure network. ▪ The national or regional health data trust centres should anonymise their respective health data and make it available on an aggregated level for research, development and innovation purposes. ▪ The EU level health data entity serves as a clearing house between researchers, industry and national or regional health data trust centres. It is the central repository of information on the amount and type of data available, while the data itself resides in the respective trust centres according to a federated approach. ▪ Further responsibilities of the health data entity could include ensuring interoperability and standardisation, as well as promoting secure and easy identification. ▪ Technologies that permit research performed within data spaces such as the EHDS by means of algorithms should be explored further. These methods allow researchers to query the database without any actual data transfer – only aggregated results depending on the respective research questions would be transferred. ▪ To link national data spaces the EHDS should promote a European approach for citizens to safely store and manage their health data; for healthcare providers to store, administer, assess and exchange health data as well as to foster precision medicine; and to support scientific research. ▪ A Code of Conduct (CoC) for secondary use of health data should complement the legislative framework and the governance structure for the EHDS. Such a measure enhances legal certainty and transparency. The industry and other users of health data should be key players in this process.
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The need for a common European Health Data Space
Contact ARIIS – Alliance pour la Recherche et l'Innovation des Industries de Santé Marco Fiorini General Secretary T: +33 1 79 35 69 10 marco.fiorini@ariis.fr BDI – Federation of German Industries Christoph Mönnigmann Senior Project Manager T: +49 30 2028 1570 c.moennigmann@ifg.bdi.eu DI – Confederation of Danish Industry Ema Radmilovic European Affairs Adviser T: +32 471 58 03 56 emra@di.dk FEFIS – Fédération Française des Industries de Santé Sophie de La Motte de Broöns Secretary General T: +33 1 79 35 69 10 slmb@fefis.fr FIEEC – Fédération des Industries Électriques, Électroniques et de Communication Guillaume Adam Director of European and Digital Affairs T: +33 1 45 05 71 85 gadam@fieec.fr Ibec – Irish Business and Employers Confederation Austin Dowling European Affairs Executive T: +32 2 740 14 34 austin.dowling@ibec.ie VNO-NCW & MKB-Nederland – Confederation of Netherlands Industry and Employers Anthony Stigter Deputy Director Social Affairs and Health Care T: +31 6 11 35 17 39 stigter@vnoncw-mkb.nl
BDI document number: D 1332
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