Interview with Prof. Rolf Schwartmann, Head of the Cologne Research Center for Media Law at the Technical University of Cologne, Chairman of the German Association for Data Protection and Data Security (GDD) and member of Germany’s Data Ethics Commission
European Union citizens have the right to free movement, settlement, and employment across the member states. In efforts to also digitize the health and care sector, another right is now being added:the EUplans to build a European Health Data Space to facilitate the secure cross-border exchange of health data.
Prof. Rolf Schwartmann
In this MEDICA-tradefair.com interview, data security lawyer Rolf Schwartmann talks about the status quo, describes the measures that are being taken and explains how a common European data space can support the healthcare sector – even in these pandemic times.
Prof. Schwartmann, are there plans to share health data across the EU? Is there a current framework for this, or will it be created in the near future?
Prof. Rolf Schwartmann: In the European Union, the primary responsibility for health protection and healthcare systems lies with the EU member states. The Treaty of Lisbon stipulates a high level of human health protection within the Union, but this role is limited to complementing the policies of EU member states and promoting and strengthening their collaboration. The EU aims to foster synergies to protect and improve the health of its citizens and prevent and combat diseases and health threats. It is a question of promoting close cooperation between the member states’ public health agencies while respecting the individual historical diversity and identities.
What specific measures are being taken in this context?
Schwartmann: The goal is to create a European Health Data Space that creates benefits for EU citizens including a personalized medicine boost, increased mobility, and a contribution to the European Green Deal. On November 11, 2020, the European Commission and the German Presidency of the Council of the EU announced their intention to work closely together on a secure and patient-oriented use of health data for Europe. They also announced efforts of EU-wide collaboration in this area, through a European Health Data Space for better healthcare, better research and better health policy making. This is a direct follow-up measure of the European Data strategy the Commission adopted in February this year, where the Commission had already stressed the importance of creating European data spaces, including on health matters. The set-up of the European Health Data Space will be an integral part of building a European Health Union. The Commission has launched a first set of proposals to reinforce preparedness and response during health crises.
What does the Commission propose?
Schwartmann: The first step is to create a "Regulation on serious-cross border threats to health” as part of the creation of a European Health Union. The goal is to strengthen EU crisis preparedness and response to health risks and pandemics. Another objective is the implementation of AI-powered monitoring and surveillance systems. This also includes improved data transmission, an obligation for member states to establish health-related statistics and powers to declare EU health emergencies. This is intended to increase EU coordination that would allow for the development, stockpiling, and procurement of products relevant to the crisis.
The European Health Data Space is designed to allow access to health data under a trusted governance and clear rules and support the free movement of digital health services. By 2025, patients from all member states should be able to share their data with healthcare professionals of their choice when traveling abroad.
The European Health Card has helped people to receive healthcare in the member states for years now. Soon, a Europen Health Union could support it by internationally providing access to patient data.
Does this include data-based response measures to COVID-19?
Schwartmann: Yes, pandemic research depends on the availability of data provided by research infrastructures, facilitating the reanalysis of raw data and the assessment of the social impact and effectiveness of protective measures to reduce pandemic transmission. The goal is to develop a European platform to share SARS-CoV-2 data, which is also connected to the European Open Science Cloud. This should enable the rapid collection and sharing of available research data to speed up research. The plan is to commit researchers to provide immediate and full open access to information and to share research outcomes (including data, models, workflows, results) in real time. Over 73,000 users are currently taking part in this open science project.
In other words, it is all about sharing health data.
Schwartmann: That's the motto. The transfer of health data mirrors the freedom of movement within the EU. The increasing personal mobility within the Union has prompted the European institutions to adopt a Directive in 2011 (2011/24/EU) on patients' rights in cross-border healthcare and guarantee the free provision of healthcare for its citizens. This facilitates a safe, efficient, and interoperable exchange of health data for member states.
How can political and social acceptance of the use of personal health data be increased and where do you see the biggest challenges in this setting?
Schwartmann: The Data Ethics Commission has studied this issue and presented its final report and recommendations in October 2019. A major challenge pertains to strict GDPR compliance relating to the processing of personal data, and the use of public and industry data without any personal reference. We must ensure maximum data and information security and make data accessible for everyone, be it public or private entities or SMEs. This will necessitate a comprehensive consultation of the European Commission as it relates to concrete measures.
What are the potential benefits for the healthcare sector?
Schwartmann: This strengthens and promotes the comprehensive use and re-use of health data, which is critical for an innovative healthcare sector. As care recipients, patients benefit thanks to more effective and efficient healthcare. This positive development also affects the physicians and other healthcare professionals as care providers. What is more, health insurance and long-term care insurance companies profit as service providers as they can achieve economic growth resulting from more effective treatments. It also supports public health authorities in evidence-based decision making, which promotes access to health services, and improves their efficiency, effectiveness, and sustainability. All this also strengthens the EU’s industry competitiveness. Better access to health data across borders can simplify the work of healthcare regulators and facilitate clinical trial management that focuses on the safety of drugs. EU citizens must also have the right to access their personal health records, to approve the processing and sharing of their data, and to demand the right to data portability.
Personalized medicine is another key issue that affects industry and society. Personalized medicine targets individual patient needs as it allows physicians to use data for robust decision-making. This will make it possible to tailor the right therapeutic strategy for the right person at the right time, or to determine the patient’s predisposition to disease and deliver timely and targeted prevention.
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