Health Data Sharing in an Interconnected Society
HEalth, Law, and Technology (HELT) Symposium 2023
April 26, 2023, Brussels, Belgium
Our increasingly digitised and connected society is driving the transformation of the health sector and the individual experiences and perceptions of healthcare. Increases in the ability to share data, in computing power and the ability to apply ever more complex forms of processing to health data are changing our very understanding of what health data is and how it should be used. Trends that wereconsidered aspirational or futuristic such as remote healthcare, personalised medicine, AI-based medical devices and big data health research are becoming entrenched.Technological change means that everyday more health data is being generated and stored. Demand for health data for scientific research is also rapidly increasing.
Health data governance is becoming a special case in the landscape of EU data policy and data protection legal framework. The General Data Protection Regulation (GDPR) already sets out extra constraints on the processing of healthdata as ‘special categories of personal data’ and importantly many Member States have availed themselves of the discretion to granted by the GDPR to introduce further conditions for processing health data. This has led to a continued fragmentation in terms of the regulatory picture.
Efforts can be seen from the European Union to remove the barriers to the free flow of health data and thus unleash its potential. This includes a proposal of the European Health Data Space (EHDS) in May 2022 as the first sectorial legislation for data governance, aiming to enhance individual control of their health data and build an effective mechanism for accessing health data for innovation, research and policymaking.
The first HELT (HEalth, Law, and Technology) symposium in 2023 will centre around the notion of ‘health data sharing in an interconnected society’. The symposium will be organised under the auspices of Health & Ageing Law Lab (HALL). HALL is located at the Vrije Universiteit Brussel in Belgium. Our goal is to generate conversations between different stakeholders, including policy makers, academics, regulators, healthcare professionals, scientific researchers and data subjects on the challenges of sharing of health data and the potential impact initiatives such as the proposed European Health Data Space will create.
Panel 1: The European Health Data Space: one step closer to the EU Single Market for Data?
The EHDS proposal is the first legislative framework to create one of the domain-specific data spaces suggested in the EU Data Strategy. The proposed act introduces a rather innovative approach to deal with different types of data for different purposes. In the health area, it aims to strengthen and harmonize the protection of personal data and at the same time to unleash the power of non-personal data. The pioneering role and ambitious goals, as well as accompanying legal, technical and organisational issues, places the proposal in a rather challenging environment. The panel will discuss the role of the EHDS proposal in the creation of the EU single market for data, its position in the existing and upcoming legal landscapes, and the relevant benefits and challenges.
Panel 2: EHDS and Interoperability of Health Data
Limited and disparate interoperability standards create potential barriers to both the exercise of individual control over their health data and the sharing health data for secondary use purposes, particularly in cross-border scenarios. The proposed EHDS envisages a range of measures to promote interoperability, including the introduction of the European electronic health record exchange format, the establishment of an EU data architecture for health data exchange and the imposition of interoperability obligations on EHR manufacturers. This panel will focus on a key issue, the role of interoperability in health data sharing, with various stakeholders to share their insights regarding the needs and challenges in developing a uniform and practical interoperability solution.
Panel 3: How to Manage IP in the Context of Health Data Sharing
The legal framework applicable to data sharing schemes(EHDS included) has competing interest to manage. On the one hand, the EU data strategy has clearly stated that it is important to make data available (through EHDS notably and other regulations), but at the same time Europe has to ensure sufficient incentives for innovators and respect for fundamental rights. This requires balancing rights granted under data sharing schemes and intellectual property rights. This panel will examine and discuss this clash of fundamental rights, the various interests at stake, and potential avenues for striking that balance.
Panel 4: EHDS and the secondary use of health data for scientific research
The increasingly interconnected world and availability of high levels of computing power mean that health data is constantly in demand for a range of secondary use purposes. One of the raison d'être behind of the European Health Data Space Proposal is to make electronic health data increasingly available for secondary use. This panel will discuss the challenges and opportunities presented by the demand for the secondary use both today and in the future.
Welcome speech by Prof. Paul Quinn
Keynote speech by Tomislav Sokol MEP
Panel 1 The European Health Data Space: One Step closer to the EU single market for data?
Panel 2 EHDS AND INTEROPerability of health data
Panel 3 EHDS AND INTELLECTUAL PROPERTY CHALLENGES IN THE DIGITAL SINGLE MARKET
Panel 4 EHDS AND THE SECONDARY USE OF HEALTH DATA FOR SCIENTIFIC RESEARCH
Tomislav Sokol MEP
Tomislav Sokol MEP was an Assistant Minister in the Ministry of Science and Education in 2017, after which he became a Member of the Croatian Parliament. He was a Member of the Croatian Parliament until July 2019, when he became a Member of the European Parliament. He is a Member of the Committee on the Internal Market and Consumer Protection (IMCO), Special Committee on the COVID-19 pandemic: lessons learned and recommendations for the future (COVI) and also EPP Vice Coordinator in COVI Committee, and a Substitute Member of the Committee on the Environment, Public Health and Food Safety (ENVI) and Committee on Regional Development (REGI) in the European Parliament.
Previously, he worked in a legal practice and is currently a Senior Lecturer at the Zagreb School of Economics and Management where he has taught Introduction to European Union and Principles of Law courses since the academic year 2010/2011. He is also an assistant professor at the Catholic University of Croatia where he has taught since the academic year 2016/2017. His areas of professional interest include the law of the European common market, EU health law, competition law, International and European social law and International and European trade law.
Alain Strowel is professor at the University Saint-Louis, Brussels and at the UCLouvain where he teaches courses in intellectual property, IT and media law. He also gives a course in the advanced master in intellectual property and IT law at the Munich IP Law Center. In 2020-2021, he was a fellow at the Weizenbaum Institute for the Networked Society (Berlin).
Alain is avocat at the Brussels bar since 1988, now partner with the firm Pierstone, specialised in digital and data law. Since the 1990s, he is an arbiter for the WIPO and “.be” domain names dispute resolution systems. He has been appointed as a trustee of the European Law Academy (ERA, Trier, 2012-2019) and was elected to the Academia Europaea in 2012. Since 2019, he chairs the Intellectual Property working group of All European Academies (ALLEA) and is a member of the Open Science working group. Today his research focuses on data governance, Artificial Intelligence and the regulation of online platforms.
He has been preparing several studies for WIPO and the European Commission (together with Technopolis, he prepared in 2021 a study for DG Connect (Copyright Unit) on the copyright policy options linked to the use of AI tools in the creative sectors)
Alessandra Cincotti joined SANOFI in 2022, supporting Sanofi Global Digital Health Business Development and Transaction Team. She provides partnering and strategic legal advice to the Digital Partnering & Strategy Team, supporting transactions leveraging data analytics and AI to advance healthcare.
Alessandra is a legal business partner to the Global Digital & Data Teams, accompanying the build of the Digital Real-World evidence and data foundations. She also takes an active role in internal and external cross-functional initiatives leveraging digital initiatives and focusing on enabling data-driven decision making (including EU key initiatives around Digital & Data, e.g., EU Strategy for Data; Data Governance Act, Data Act and EHDS’ proposals). She has more than 10-year experience in the life sciences sector, holding in-house counsel positions in retail pharma at the Walgreens Boots Alliance and more recently as a Senior Legal R&D and transactions lawyer at Servier. She also has experience in the public sphere having worked as a Senior Legal Counsel at the Tech Transfer Office of the French public research institute Inserm (Inserm Tranfert).
Annabel Seebohm is the COCIR Secretary General and DITTA Vice Chair since June 2022. She joined COCIR from the Standing Committee of European Doctors (CPME), where she held the position of Secretary General. Prior to CPME, Annabel was head of the Brussels office of the German Medical Association (GMA) and legal advisor in the joint legal department of the GMA and the National Association of Statutory Health Insurance Physicians (NASHIP). From 2007 to 2016 she was also general counsel of the World Medical Association (WMA). Annabel studied law at the University of Bonn, undertook her judicial service training in Hamburg and obtained a Masters’ degree from the University of Auckland, New Zealand. She is admitted to the Cologne Bar and a Fellow of SCIANA, the Health Leaders Network.
Anne-Catherine Lorrain is a lawyer and academic researcher in Intellectual Property and Digital Law. She has been working in the European Parliament since 2014. She is currently Policy Advisor in the EP’s Committee for Legal Affairs (JURI), representing the Greens-EFA political group; she is taking active part in the political negotiations on various EU regulatory dossiers (Data Act, AI Act, Directive on Copyright in the Digital Single Market, …). She used to work as a legal advisor in the music industry at the French division of the International Federation of the Phonographic Industry (IFPI) in Paris (2000-2003), and then started her carrier in EU affairs as Coordinator of the IP Policy Committee at the Trans-Atlantic Consumer Dialogue (TACD) in Brussels and Washington D.C. (2008-2009).
She is co-founder and former Executive Director of the COMMUNIA Association, an international non-for-profit organisation promoting the digital public domain. Besides, she is a member of Planet Positive 2030, an initiative supported by the IEEE Standards Association that brings together a global, open community of experts to chart a path for a human-centered and ethically designed technology via forward-looking green and digital transitions. Furthermore, she is Associate Fellow at the Research Centre Internet & Société (CNRS, Paris).
Catherine Chronaki is a computer engineer by training. She is Secretary General of HL7 Europe, active in Digital Health Policy and Standards. She led the Trillium Bridge and Trillium II projects on International Patient Summary standards under the EU-US MoU on eHealth and the eStandards roadmap for large scale eHealth deployment. She serves as interoperability lead in the IMI2 Gravitate Health project and coleads the ePI/eLabeling project in the Vulcan accelerator. Also sit on the HL7 International Board of Directors (2023), in the eHealth Stakeholders group of the European Commission (2020-2024) and serve as IMIA vice president of the European Federation for Medical Informatics (2022-24).
Griet Verhenneman is a legal expert on privacy, data protection, and e-health. Dr. Verhenneman combines expert theoretical knowledge built through years of academic work with DPO’s hands-on experience implementing data protection and privacy regulations in a challenging environment. In her position as Data Protection Officer at the University Hospitals KU Leuven (UZ Leuven), Griet helps translate the theoretical principles of data protection to the domains of care, scientific research, and the daily routine of running a university hospital. Griet acts as an external expert in the knowledge centre of the Belgian Data Protection Authority and is a member of the editorial board of the journal Tijdschrift Privacy & Persoonsgegevens. Dr. Verhenneman is also an Affiliated Senior Researcher and Lecturer in the Advanced Master program IP & ICT Law at KU Leuven for European Privacy and Data Protection Law.
Iñigo de Miguel Beriain
Iñigo de Miguel Beriain holds a degree in Economics and Business Administration, a degree and European PhD in Law, a PhD in Philosophy, and a PhD in Biomedical Research. He is an Ikerbasque Research Professor and Researcher at the Euskal Herriko Unibertsitatea (University of the Basque Country). He has participated in a lot of national and international research projects, such as PANELFIT (panelfit.eu), in which he served as deputy coordinator. He has published seven books and more than 150 articles and book chapters. He has given more than 100 papers and lectures at conferences and seminars.
Jan Clinck is a lawyer in Altius Law Firm in Belgium. Jan specialises in various aspects related to data protection and new technologies in different sectors such as health, media and retail. He also has a profound knowledge of ICT, e-commerce and intellectual property. Jan has built up solid experience in litigation related to these matters both before the courts and the data protection supervisory authority. He is also a scientific collaborator at the Universiteit Antwerpen. In this capacity he gives guest lectures on e-commerce and data protection law. Jan regularly speaks at conferences and also gives webinars on the latest evolutions in the field of data protection.
Johanna MC Blom
Johanna MC Blom is Associate Professor in Psychobiology and Pediatric and Behavioral Neuroscience, University of Modena. She is the Chair of the Ethical Committee for Research of the University of Modena and. Currently she is heading the initiative to develop guidelines for a common legal and ethical framework for receiving consent from minors in the face of the particular vulnerable condition in which they find themselves as consent of minors cannot be constructed following the parameters that ensure the participation of adult subjects in therapeutic and research activities.
Johanna is an expert in multidisciplinary behavioral toxicity studies linked to child abuse and severe and chronic diseases in childhood. She is working on innovative data driven network analysis as tool to detect and predict the driving forces of disability using digital data. Her current interests lie in (digital) assessment tools to detect early signs of cognitive and behavioral problems and designing decision tree algorithms by using network analysis and dynamic mapping to understand the driving factors of the trajectory that moves a patient from being at risk to full blown pathology especially during adolescence and test the effectiveness of treatment by linking them to outcome values dynamically recorded in an ecologically valid way.
Mahsa Shabani is Associate Professor in Health Law and Citizenship at University of Amsterdam in the Netherlands. She is also Assistant Professor in Health Privacy Law at the Faculty of Law and Criminology, Ghent University in Belgium. Her research focus is on personal data protection, health privacy, data sharing, and data-driven biomedical research ethics, law and policy. She has extensively published her work in scientific journals with a broad readership in the fields of data protection, medical law, bioethics, genomics and bioinformatics. Previously, she was a visiting scholar at the Center of Genomics and Policy at McGill University, the Center for Health, Law and Emerging Technologies (HeLEX) at University of Oxford, and the Columbia CEER at Columbia University Medical Center. In the recent years, she has been collaborating with various international and European projects such as the Regulatory and Ethics Working Group of Global Alliance for Genomics and Health initiative, EUCelLEX and euCanSHare projects. Currently, she is a member of the Ethics advisory broad of various European Commission (EC) and IMI funded projects and acts as an external expert for the EC. She is also a selected member of the Scientific Committee of the International Rare Diseases Research Consortium, European Society of Human Genetics (member of the SPC) and The Joint Action for the European Health Data Space.
Marlies Desomer is an administrator for the Committee on Civil Liberties, Justice and Home Affairs of the European Parliament, focusing inter alia on the European Health Data Space. She works at the European Parliament since 2009, previously for the Committee on the Internal Market and Consumer Protection and the Committee on Employment and Social Affairs. Marlies holds bachelor degrees in Law and in Philosophy, a master degree in Law, an advanced master in European Social Security, an EUI LL.M. degree in international, European and comparative law and a PhD in Law.
Nikolaus Forgó is a professor of IT- and IP Law at the University of Vienna, Department of Innovation and Digitalisation in Law. Since July 2018, Nikolaus has become an expert member of the Data Protection Council of the Republic of Austria. Nikolaus devotes himself to extensive dogmatic and third-party funded research for European, German and Austrian clients regarding questions of IT law, in particular data protection and data security law. He also has abundant experience in evaluation and consulting activities i.a. for the European Commission, the German Research Foundation, the German Ethics Council as well as various German and Austrian ministries.
Nicholas Vretos obtained the degree of BSc in Computer Science from the University Pierre et Marie Currie (Paris VI) in 2002 and his Ph.D. from the Aristotle University of Thessaloniki in 2012. During elaboration of his thesis, he taught as assistant and worked as a research assistant in Artificial Intelligence and Information Analysis Laboratory. He has worked in 15 European projects as Technical Manager/ WP Leader/researcher. He has published more than 70 articles in scientific journals and conference proceedings and several book chapters. He is a member of the IEEE and has committed as a reviewer for several journals and conferences in the field of image and video processing. He regularly serves as a reviewer for the EC and other national or international funding organisations. His main interests are in image and video processing, semantic analysis, neural networks and 3-D data processing in relation to Health, Social Science and Security.
Owe Langfeldt is a policy officer in the Digital Health unit of the European Commission’s Directorate-General for Health and Food Safety, focussing on the European Health Data Space. Earlier, he worked in the Directorate-General for Justice and Consumers, in the Data Protection unit, particularly on digital single market files, health, and home affairs. Before joining the Commission, Owe was a legal officer in the Supervision and Enforcement unit of the European Data Protection Supervisor.
Richard Rak is DIGITALEUROPE’s Digital Health Policy Officer. His work revolves around the establishment of the European Health Data Space (EHDS). Previously, Dr Richard Rak worked as a Marie Skłodowska-Curie Action researcher at the University of Vienna, the University of Bologna and the University of Turin, in collaboration with DocPlanner Group, where he completed the Law, Science and Technology Joint Doctorate – Rights of Internet of Everything program. He is a research fellow at the University of Milan. His research interest concerns privacy, data protection and data governance challenges in the Internet of Healthcare. Richard holds a master’s (Dr. jur.) degree in Law, an LL.M. degree in European Law, and bachelor’s degrees in Finance and Accounting, and Human Resource Management.
Sebastiaan Van Sandijk
Sebastiaan Van Sandijk is a Clinical Informatician at Odysseus Data Services where he works on data harmonisation, federated analysis and collaborative network studies, leveraging the OMOP common data model and OHDSI tools like Atlas and Arachne. With his health informatics background, he has broad experience with interoperability and multidisciplinary collaboration in bigger and smaller healthcare settings. In particular, with Odysseus, Sebastiaan is involved in the EHDEN and Darwin EU projects, the latter being an EHDS pathfinder project that has adopted the OMOP Common Data Model.
Shada Alsalamah is a contributor to the healthcare sector modernization movement, digital health transformation, and policymaking for better disease detection, prevention, and treatment. Currently, Dr. Alsalamah is an Associate Professor of Global Digital Health, Information Systems Department, College of Computer and Information Sciences, King Saud University, Riyadh, Saudi Arabia; a Technical Officer (Digital Health and AI), Strategy and Governance, Department of Digital Health and Innovation, World Health Organization, Geneva, Switzerland; and a Principle Investigator, Artificial Intelligence Center, Alfaisal University, Riyadh, Saudi Arabia. In addition, Dr. Alsalamah serves on a number of national and international boards and working groups including, but not limited to, The Organisation for Economic Co-operation and Development (OECD) Blockchain Expert Policy Advisory Board, Paris, France; The International Association for Trusted Blockchain Applications, Brussels, Belgium; ITU/WHO FG-Artificial Intelligence for Health (AI4H) Regulatory Considerations Working Group (WG-RC), Geneva, Switzerland; ITU/WHO FG-AI4H Dental Diagnostics and Digital Dentistry Topic Group (TG-Dental), Geneva, Switzerland; IEEE Computer Society Technical Committee on Security and Privacy; The Saudi Association for Information Security, Riyadh, Saudi Arabia; and The International Network for Forensic Odontology.
Stephen Gilbert's research goal is to advance the regulatory science of software as a medical device and AI enabled medical devices. Innovative digital approaches to healthcare must be accompanied by innovative approaches in regulation to ensure speed to market, to maximum access of patients to life saving treatments whilst ensuring safety on market. His main research interests are in: (i) data sharing and the European Health Data Space; (ii) approaches to market approval of adaptive AI enabled medical devices; (iii) drug<->digital/AI-enabled medical device product realisation; (iv) digital/virtual twins: as an organising concept of the future of healthcare.
Tugce Schmitt is a researcher at Maastricht University, where she pursues her PhD as an external candidate within the research line Value-Based Health Care (VBHC). Her PhD topic is the governance of health data for integrated care in Germany with a focus on the primary and secondary use of electronic health records data, and her broader research interest is data-driven innovation in health systems to achieve person-centred care.
The European projects that she has worked on in the past nine years are concerned with patients’ rights in cross-border healthcare (Directive 2011/24/EU), the Digital Single Market and the Europe’s Beating Cancer Plan. Before joining academia, she was a policy officer in one of the public law corporate bodies of the Federal Joint Committee in Germany, contributing to federal-level directives on quality assurance of health services.
Veronique Cimina is a Legal Officer in the Policy & Consultation Unit at the European Data Protection Supervisor (EDPS) since 2018. She contributes to the work of the EDPS on providing advice to the European Commission and other EU Institutions and Bodies on legislative and policy proposals regarding data protection. Before that, she was a legal intern in the Supervision and Enforcement Unit at the EDPS and a legal assistant in private practice in Rome. Veronique holds a Master's degree in European Law from Leiden University (Netherlands) and a Bachelor's degree in Political Science and International Relations from Università degli Studi Roma Tre in Rome.