The 9 April RWE4Decisions Webinar “From Policy to Practice: EHDS Implementation to Support Better Real-World Evidence for HTA/Payers” brought together a vibrant community of over 200 participants to discuss how the European Health Data Space (EHDS) could generate robust real-world evidence (RWE) to support better informed, more timely HTA/Payers decisions. The discussion focused on practical steps toward EHDS implementation, offering multi-stakeholder perspectives that included policymakers, HTA/Payers, health technology developers, patients, and clinicians. Speakers shared insights into the opportunities of secondary use of health data under the EHDS, and national and pan-European initiatives showcasing how Member States are preparing for implementation and the evolving role of RWE in shaping patient-centred decisions.
Background
The Regulation for a European Health Data Space, adopted in April 2024, establishes a transformative framework for the use and sharing of health data across the EU. It aims to foster secure and efficient access to health data to improve healthcare delivery, drive research and innovation and support policy decisions, including HTA. By creating a harmonised EU digital ecosystem for health data, the EHDS will be key to unlock the potential of RWE to enable patient access to innovative therapies.
To meet the objectives of the EHDS, Member States will need to establish interoperabele digital infrastructures and robust governance mechanisms for health data. With varying levels of maturity in digitalisation of health data, setting a common baseline for capabilities – such as data formats, secure data-sharing protocols and alignment with data protection laws – will be essential. To ensure effective implementation, healthcare stakeholders including HTA/Payers need to be consulted when setting up the system. National and EU-level initiatives play a pivotal role in bridging these gaps.
The EHDS implementation faces several roadblocks ahead, including technical challenges, legal and ethical concerns, and organisational issues. This webinar identified actionable solutions and best practices in overcoming these obstacles for the secondary use of RWD, exploring how Member States are developing implementation models and drawing insights from these initiatives.
Co-moderated by:
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Eric SutherlandSenior Health Economist, Organisation for Economic Co-operation and Development (OECD)Eric is a Senior Health Economist leading the OECD’s work in Digital Health, bringing together policy guidance for digital tools, integrated data, and responsible analytics including artificial intelligence. In that role, he is accountable for measuring and evolving the OECD’s Recommendation on Health Data Governance (2017) and supporting digital health policy that provides data protection (e.g. security and privacy) and timely access to quality data to optimize the use of data for information, insights, and impact among individuals, health workers, policy makers, researchers, and innovators.
Prior to joining the OECD, Eric led the Secretariat for a pan-Canadian Health Data Strategy, bringing together experts and governmental leaders from across Canada to establish an integrated health data ecosystem that makes better use of data for health systems, public health, population health, research, and care. Eric authored the Pan-Canadian Heath Data and Information Governance Framework and Toolkit and has taught courses in data science, health data governance, and privacy. -
Karen FaceySenior Advisor HTA, FIPRA / RWE4Decisions Facilitator BioKaren Facey worked as a statistician in the pharmaceutical sector and UK medicines regulation, before becoming founding Chief Executive of the first national HTA agency in Scotland. Since 2003, Karen has been an independent consultant on health policy, HTA and patient involvement. She is passionate about holistic HTA to determine value and use of health service data to improve patient care. Karen is lead co-author of the paper on ‘RWE to Support Payer/HTA Decisions about Highly Innovative Technologies in the EU – Actions for Stakeholders’. She has just completed EC-funded research in the IMPACT HTA project developing tools to support OBMEA.
Keynote Speaker:
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David AsturiolPolicy Officer “Digital Health” Unit, DG SANTE, European CommissionDavid Asturiol is a policy officer at the European Commission’s Directorate-General for Health and Food Safety (DG SANTE), where he focuses on the implementation of the European Health Data Space (EHDS), particularly on the secondary uses of health data. He has also worked on the coordination of the European Reference Networks for Rare Diseases and contributed to the implementation of the European Union Digital COVID-19 Certificate.
With over 15 years of research experience in chemical toxicity, molecular modelling, and data science, Mr. Asturiol has authored more than 30 peer-reviewed publications. His expertise includes developing computational models to promote and advance predictive toxicology.
Panellists:
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Dr Jørgen Schøler KristensenChairman, Health Outcomes Observatory (H2O) Project; Former Chairman of the Danish Medicines CouncilJørgen Schøler Kristensen is a Danish physician and healthcare leader specialized in internal medicine and hematology. Earning his MD in 1983, he pursued a distinguished career in hematology, with a doctoral thesis on diagnosing acute leukemia. He has held key leadership roles, including Head of the Department of Hematology and Medical Director at Horsens Regional Hospital and later at Aarhus University Hospital.
A pioneer in hospital digitization since 1999, Jørgen Schøler Kristensen played a crucial role in developing Business Intelligence at the regional level, establishing national quality databases, and creating a national database of all prescribed hospital drugs. From 2013 to 2017, he led the national prioritization institute and subsequently served as Chairman of the Danish Medicines Council until 2025.
Jørgen Schøler Kristensen is deeply involved in healthcare digitalization and data-driven decision-making, with a focus on value-based healthcare and real-world evidence (RWE) in medicine evaluation. -
Maari ParkkinenProject Coordinator, FinHITS and Development Manager, FindataDevelopment Manager for the Finnish Social and Health Data Permit Authority (Findata) since 2021, Maari Parkkinen manages the FinHITS project launched in November 2023 to prepare the Finnish health data infrastructure of secondary use for the implementation of the European Health Data Space.
Prior to joining Findata as a senior specialist in 2020, she worked as a researcher and project manager for the Rehabilitation Foundation (Kuntoutussäätiö) from 2016 to 2020, and as researcher of the think tank Demos Helsinki. -
Ingrid MaesManaging Director and Founder, InovigateIngrid Maes is the Founder and Managing Director of Inovigate, an independent consulting company specialised in supporting actors from the life sciences and healthcare industries in navigating the complexities of the health ecosystem. Ingrid has over 30 years of experience in the sector, having assumed leading roles at Siemens and PwC in the 15 years leading to the launch of Inovigate. She has deep expertise in business strategy formulation and implementation, product development, market access strategies, and regulatory compliance. Ingrid holds a Master in Engineering Sciences – Chemistry & Biotechnology, Medicinal chemistry from Vrije Universiteit Brussel. -
Alexander NatzSecretary General, EUCOPEAlexander Natz is the Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) in Brussels and advises innovative pharmaceutical and biotech companies, including start-ups, in regulatory and pricing & reimbursement matters from the EU law and German law perspective. From 2008 to 2013, he was Head of the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he has been a lawyer at Sträter Law Firm in Germany with a special focus on managed entry agreements and licensing of pharmaceuticals. Dr. Natz has also worked in the field of competition law with the European Commission and in the pharmaceutical industry. As a research assistant at Duke University (USA) he has dealt with international pharmaceutical law. His doctorate was supervised by the former judge at the European Court of Justice, Prof. Dr. Ulrich Everling