HELT 2024 - Cloned

HEALTH(Y) AI & DATA: BRIDGING INNOVATION AND REGULATION

HEALTH, LAW, AND TECHNOLOGY (HELT) SYMPOSIUM 2024

April 25, 2024, Brussels, Belgium

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Health care is simultaneously both a response to a pressing human need and big business. It represents a major source of public spending; given demographic trends and the costs of new treatment methods, the costs are likely to increase in the future. One of the major sources of contemporary innovation in healthcare and related research is the rapid development of AI-based tools to assist in healthcare and related research. These technologies have allowed new methods of diagnosis, treatment, and research to be envisaged and developed. In addition, AI-based tools are allowing traditional administrative and management processes to be refined, saving resources and improving efficiency.

Whilst having immense potential, such changes do not come without concerns. The widespread use of AI has traditionally become associated with problems relating to robustness, fairness and bias. In the domain of healthcare and related research, the potential for harm related to such concerns is in many cases amplified. Furthermore, many are worried by the intrusion of questionable commercial practices or the potential for increased concentration of economic power. To build ‘healthy’ algorithms, reliable data and effective data governance practices play a crucial role, while the diverse data generated from AI applications in healthcare also pose significant challenges.

Following on from the success of HELT 2023, the VUB’s Health & Ageing Law Lab (HALL) will explore these themes in the HELT 2024 symposium. It will invite speakers and participants from a wide range of perspectives, allowing the multidisciplinary nature of these issues to be explored. The symposium will address these issues from computational, medical, research-based legal and ethical perspectives, as well as from a policy and regulatory background. Our aim will be to approach these complex issues in a holistic manner.

Panels

PANEL 1 AI & Healthcare

In 2020, the European Commission envisioned AI as a life-changing force  by improving healthcare. Nowadays, AI applications have become integral to the provision of healthcare and medical research. Qualified as medical devices, numerous medical AI applications have been approved by the regulatory authorities both in the EU and the US across various domains such as radiology, cardiology, ophthalmology, gastroenterology, and neurology. The panel will discuss the state-of-the-art advancements and utilisation of AI in healthcare. It will explore the existing regulatory landscape of AI applications, along with the remaining ethical and legal challenges, as well as the role of the AI Act in addressing them. Speakers representing patients, healthcare professionals and institutions, regulators, and policy-makers will share their experiences and perspectives, thus facilitating a cross-sectoral dialogue and fruitful exchange of ideas.

Panel 2 AI & Research using Health Data

AI has been employed across a spectrum of health research domains, including clinical, genetic, behavioural, and public health research in recent years. It is believed that AI will significantly enhance health research by enabling faster and more precise analysis and identification of patterns within expansive and complex datasets. Consequently, AI is expected to hold the potential to effectively address crucial health challenges, thereby advancing the provision of superior healthcare services. Nevertheless, integrating AI into health research faces limitations like concerns about data quality, AI's inability to display certain human traits, and ethical issues due to its black-box nature. This panel brings together experts at the forefront of AI and health research to delve into the transformative impact of AI on the prospective landscape of research using health data. It seeks to discuss prevailing challenges, and explore potential ways for optimizing the utilization of AI in the domain of health research.

Panel 3 How will the European Health Data Space (EHDS) shape AI governance in the health sector?

The development of AI is inevitably affected by data policies, as the effectiveness and accuracy of AI-based systems depend on the availability and accessibility of high-quality and diverse datasets, including a large amount of health data. As the first sector-specific regulation of the EU's data strategy, it is the objective of the European Health Data Space (EHDS) to make more health data available for innovation, research, and policymaking. As part of this, the EHDS proposal recognizes the training, testing, and evaluation of algorithms as one of the purposes for the secondary use of electronic health data. In the meantime, AI-powered applications and devices generate a vast amount of health data, which can also be fed back into the data-sharing ecosystem. This panel will explore the potential implications of the EHDS is a world where AI driven processes are available to bring about transformative changes using electronic health data.

Panel 4 AI as a Disruptive Force in the Regulation of Healthcare and Related Research

AI may be far more than an agent for change in the way health data is used, rather it is likely to be a force of immense disruption. This will be felt in several ways, including in the manner in which technologies that depend upon health data are both used and regulated. This disruption will call into question the way data is collected and shared and the very systems designed to regulate the use of health data and associated technologies. This includes the use of AI technologies (including foundation/generative models) in the development, quality assurance, oversight and delivery of the functionality of medical devices. This panel will discuss to what extent current regulatory and other structural paradigms will remain fit for purpose in the coming decades." It will also look at the socio-technological perspective of the future of AI, questioning how the regulation of health data and associated AI technologies should focus on both economic and social value creation, avoid information asymmetries, and strengthen our unique European right to access healthcare

HELT Networking Session

Join us for an engaging interlude during lunch at our side event in the Balcony Room on the first floor. This exclusive gathering offers a unique platform for attendees to immerse themselves in bite-sized presentations delivered by PhDs, recent post-docs, and industry professionals. These dynamic speakers will delve into the pragmatic facets of their innovative research and work, using this opportunity to spotlight their contributions, share key findings, and discuss potential challenges in the realms of health, research, and AI. Banners and/or roll-ups will also be featured to visually showcase the work of the presenters. Moreover, this side event will also provide an opportunity for networking and connecting with people within the academic and industrial spheres who share a passion for advancing these critical fields. Do not miss this chance to gain valuable insights, forge meaningful connections, and be part of a vibrant community at the forefront of groundbreaking developments.

If you are interested in presenting at the HELT 2024 side event for academia and industry, please contact Karen Cruyt at karen.cruyt@vub.be and let us know what the title of your presentation would be. Please also provide an abstract of your presentation of about 250 words. Feel free to contact us through this same e-mail should you have any questions.

HELT & European Health and Pharma Law Review (EHPL)

We are happy to share that this year, the HELT Symposium is supported by the European Health and Pharma Law Review (EHPL) – the journal of the Lexxion Publisher. The EHPL has been one of the most recognisable forums for the development and research in pharmaceutical and health law. The journal published cutting-edge research from across the health law space, including topics related to medical devices, artificial intelligence, digital health and big data.

We invite attendees of the HELT NETWORKING SESSION to publish their research in EHPL. Based on the expressed intent of participants, submitted abstract and presentations delivered during the event, the selected candidates will be supported in the publication process. While the articles are subject to the double peer-reviews, HALL and EHPL will ensure the smooth submission and review.

Keynote Speaker

Pēteris Zilgalvis

Pēteris Zilgalvis studied at the University of California, Los Angeles – UCLA (United States), where he graduated Cum laude in political science in 1986. He continued his studies at the University of Southern California (United States), where he was awarded a Juris Doctor in 1990. He was A Visiting Fellow at St. Antony’s College, University Oxford from 2013 to 2014, and was an Associate of the Political Economy of Financial Markets programme there from 2014 to 2017.
He began his career in 1990 as a Senior Adviser at the Environmental Protection Committee, Parliament, Latvia, a position he held until 1992. He then began working at the Latvian Ministry of Foreign Affairs as a desk officer for the European Parliament, the United Nations, the United Nations Environment Programme (UNEP) and the United Nations Educational, Scientific and Cultural Organization (UNESCO). In addition, he was admitted to the California Bar (United States) in 1991.
In 1993, Mr Zilgalvis held the position of Environmental Specialist for the Baltic Region at the World Bank and was appointed Senior Environmental Law Adviser for the project ‘Russian Federation – Environmental Management Project’ in 1996.
In 1996, he was appointed Deputy Head of the Bioethics Department at the Council of Europe, a position he held until 2005. He subsequently joined the European Commission as Head of the Governance and Ethics Unit and then, in 2010, as the Head of the Infectious Diseases and Public Health Unit. Between 2010 and 2016, he continued his career within the European Commission as Head of the Health and Well Being Unit. In 2016 he was appointed Head of the Digital Innovation and Blockchain Unit and held that position along with that of the Co-Chair of the FinTech Task Force until 2021. He is also the author of publications in legal journals, in connection with fields such as bioethics, digital technology, human rights and environmental law.
Mr Zilgavis was appointed as a Judge at the General Court on 27 September 2021.

Member of the AI Management Board of the Court of Justice
Member of the Editorial Board of the Baltic Yearbook of International Law
Member of the World Economic Forum Digital Currency Governance Consortium
Member of the Organisation for Economic Co-operation and Development Blockchain Expert Policy Advisory Board

Panel Speakers

Allison Gilbert

Allison Gilbert is a medical doctor specialised in Emergency Medicine (ULiège-CHU Liège). She obtained a PhD in Medical Sciences (ULiège) with specific research on the management of the Emergency Department patient flow (triage systems). She followed a training in AI in Healthcare at ULB-UMons (Interuniversity certification in AI in medicine and digital health) and also an online executive master in e-health (Institute for Smarthealth, France). Currently, she is working as a postdoctoral researcher exploring the potential of AI applications in Healthcare and specifically in emergency medicine, under the supervision of Professor Giovanni Briganti at UMons, Chair of AI and Digital Medicine.

Bart de Witte

Bart de Witte is a luminary in the dynamic realm of Artificial Intelligence (AI) within the healthcare sector. With a profound impact on the landscape, Bart serves as a guiding force in navigating the intricate balance between AI's potential benefits and the pitfalls it poses to healthcare accessibility. Having transitioned from a successful tenure at IBM, Bart is the visionary founder of the Hippo AI Foundation, a non-profit organization, based in Berlin committed to accelerating open collaboration and innovation pushing the open-source agenda for healthcare. His mission revolves around fostering data solidarity and promoting active patient participation, addressing the critical need to democratize AI in healthcare and mitigate the risk of data monopolies that could reshape the medical field. Bart's influence extends globally, as evidenced by his roles as a scientific board member and advisor, where he actively shapes policy decisions at the nexus of technology, innovation, and healthcare. His dedicated counsel to governments, including prominent positions with the World Health Organization (WHO) and the United Nations Office of the Secretary General, underscores his commitment to reshaping the global healthcare landscape. Recipient of the prestigious German AI Awards, Bart's groundbreaking projects, such as leveraging AI to address breast cancer, exemplify his dedication to tackling global challenges aligned with the United Nations Sustainable Development Goals (SDGs). Bart de Witte is a well-known speaker, author, lecturer and entrepreneur. In his enlightening talks, Bart not only explores a visionary perspective on regenerative AI but also poses a crucial question often overlooked by ethical frameworks: who owns the future of AI?

David Murphy

David Murphy is a Deputy Commissioner at the Data Protection Commission Ireland, responsible for supervision activities across the Public, Health, and Voluntary Sectors. Having joined the DPC in 2016, David has worked in the area of consultative engagement, providing best practice guidance and advice to organisations in both the public and private sectors on compliance with the data protection legislative frameworks. David participates in the work of the European Data Protection Board, on behalf of the DPC, on matters relating to public policy and health. He also frequently represents the DPC as a conference and event speaker on data protection topics.

Erika Ellyne

Erika Ellyne advises Belgian and international clients on a wide variety of matters. She practices in the area of ICT law, data protection, and more general commercial contracts law. She is focused on law and technology matters broadly speaking and the legal questions they entail. More specifically she is specialized in data (personal /non-personal) law and the new EU regulations (DSA, DGA, Data Act, AI Act…), cyber security, the EHDS, e-signatures, and related EU consumer protection and product safety issues.

Prior to joining ALTIUS, she worked both as a lawyer and gained in-house experience through multiple secondments/ and interim positions. She continues to be associated with the VUB, HALL (Health Aging and Law Lab) as a researcher participating in health law and technology projects, including AI as a medical device.

Jaisalmer de Frutos

Jaisalmer de Frutos is Policy Officer for the Digital Transformation Cluster at the European Public Health Alliance. In 2020, she obtained a PhD in Medical and Health Sciences, under a joint agreement between Universidad Autonoma de Madrid (Spain) and Edith Cowan University (Australia). In 2022, Jaisalmer was selected to take part in Unleash Social Innovation Lab, in India. She also has prior experience working for the European Institutions, providing feedback to policy at HaDEA and monitoring health projects at EISMEA.

Currently, Jaisalmer contributes to the development of people-centered digital policies that enhance population health. She works to ensure that equity, privacy, autonomy, and accountability are at the bases of the design and deployment of digital health tools, including artificial intelligence-based tools. Moreover, she advocates for ethical use of health data by healthcare workers, researchers, innovators, and policymakers, especially in the light of the creation of the European Health Data Space.

Milana Trucl

Milana Trucl is a Policy Officer at the European Patients’ Forum. She develops and guides the policy and advocacy work in the area of digital health. Her goal is to ensure that the patient perspective is integrated into EU policies, initiatives and projects on digital health and artificial intelligence in healthcare, and to shed light on the importance of patient engagement, health literacy and equitable access to digital services and solutions.

Nikolaus Forgó

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.

Ralf Bendrath

Ralf Bendrath is an adviser for civil liberties, justice and home affairs for Greens/EFA in the European Parliament. He hacked the Commodore C-64 in the eighties, studied political science with a focus on security policy and information warfare in the nineties, and researched internet privacy and data protection in the 2000s at universities in Germany, the Netherlands, and the U.S. Since 2009, he has been working in the European Parliament, including as adviser for the chief negotiator on the General Data Protection Regulation (GDPR). He was involved in the negotiations on both the Artificial Intelligence Act and the European Health Data Space, among other digital files.

Rudolf Wagner

Rudolf Wagner is a distinguished executive leader with over 15 years of experience in the Pharma and Medical Devices industry, including Software and AI in Digital Health. As the Global Director Head of Quality and Regulatory Affairs EVP, Wagner has a proven track record of success in overseeing all aspects of quality and regulatory affairs, compliance management, team leadership, and P&L responsibility. He has led the QARA team to significant achievements, such as securing EU MDR Class IIb and US FDA 510(k) certification for innovative medical solutions within record time. Wagner's expertise spans strategic planning, business growth, team development, and cross-functional collaboration, having led teams across all five continents and registered medical devices in over 132 countries. He is multilingual, with proficiency in English and German, and is recognized for his ability to drive business expansion and navigate complex regulatory landscapes globally.

Sofie De Broe

Sofie De Broe is the leading official (ad interim) of the Health (Care) Data Agency for Belgium, delegated from Sciensano. She holds a PhD in statistics/reproductive health from the University of Southampton and was head of methodology and scientific director of the Center for Big Data Statistics (CBDS) at Statistics Netherlands.

Stephen Gilbert

Stephen Gilbert is Professor of Medical Device Regulatory Science at the Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden where he teaches and conducts research on regulatory science with a team of colleagues. He worked in senior MedTech and Digital Heath roles in the industry for 5 years, before returning to academia in 2022. His 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 the market. My 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.

Thierry Geerts

From 2011 to 2024, Thierry Geerts has been heading Google in Belgium and Luxembourg, the company that has become much more than just a search engine. He graduated from the VUB as a Solvay Business Engineer and soon became general manager of an industrial laundry company. With the advent of the internet in the mid-1990s, he reoriented himself towards the media industry and held various management positions at VUM (now Mediahuis), publisher of newspapers such as De Standaard and Het Nieuwsblad.
His book Digitalis (2018), in which he describes the possibilities of the digital world, has meanwhile sold more than 25,000 copies. In 2021 he published his new book, Homo Digitalis, about the impact of the digital revolution on people and society.

Thomas Lampert

Dr Thomas Lampert holds the Chair of Data Science and Artificial Intelligence at Télécom Physique Strasbourg and the ICube research laboratory, University of Strasbourg. His research focuses on theoretical aspects of AI and its application to real-world problems, particularly (but not limited to) deep learning, unsupervised approaches, domain adaptation, representation learning, and clustering. He completed his PhD at the University of York, UK, which was conducted in collaboration with QinetiQ Ltd. and DSTL, an executive agency of the UK Ministry of Defence. He has held positions in industry and academia in the UK and France, has acted as a consultant to several companies and start-ups, and is an alumnus of the prestigious US Department of State’s International Visitor Leadership Program. He acts as an expert on AI for the Council of Europe and has developed a training course on AI for their Human Rights Education for Legal Professionals (HELP) program.

More information about panel speakers will be updated soon.