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.