HELT TALKS _2025-26-03

What are the 'HELT Talks' ?

HELT stands for Health, Ethics, Law, and Technology – four broad subject areas that intersect each other in discourses around improving quality and access to health care, or advancing medical research beyond the state-of-the-art. Following on the success of the HELT Symposium, our annual flagship event which brings together representatives from the academia, industry, research organisations, healthcare professionals and policymakers, the HELT Talks was conceived as a year-round (monthly) event, providing a dynamic platform for thought-provoking discussions and stimulating debates on the future of digital health and care, through the prism of regulatory responses and relevant policy initiatives.

What is the typical format of a session at HELT Talks?

HELT Talks sessions are typically divided into two parts. In the first part, each speaker gives a presentation on a specific topic, touching upon particular challenges and open issues around the integration of technology in the realm of health care that require delving into legal and regulatory frameworks. The second part of the session aims at encouraging a deeper level of reflection on the topic under discussion, through organic conversations between the speakers and the audience.

What kind of topics are covered at HELT Talks?

HELT Talks cover a breadth of topics on law, ethics, health and technology, ranging from legal challenges for the use of health data and regulatory issues concerning advanced medical technology, to the use of artificial intelligence in clinical settings and the application of ethical principles in health care.

TALK of the Month

30 January 2026 | 13:00-15:00

AI and Medical Ethics: Declaration of Helsinki, AI Act and EU policy developments

Since its adoption in 1964, the Declaration of Helsinki (DoH) continues to be a reference for conducting medical research involving human beings. This Declaration outlined the first international ethical benchmarks, protecting patients’ rights, autonomy and human dignity, while reinforcing fundamental ethical concepts such as informed consent, risk-benefit assessment, and the prioritisation of patient welfare.

The digitalisation in medicine and the deployment of AI in healthcare introduced complex ethical, organisational and legal challenges. Innovations, such as agentic AI, personalised and precision medicine, clinical decision-making systems, surgical robots, virtual health assistants or AI streamlined administrative processes, have a significant transformative potential. When properly regulated, effectively governed and ethically implemented, these emerging technologies may contribute to address the rising healthcare demand, mitigate administrative burdens, accelerate diagnosis and treatments, and alleviate the strain of an exhausted healthcare workforce.

The Artificial Intelligent Act (AIA), which entered into force in August 2024, and the new EU policy developments, such as the Apply AI Strategy or the AI Continent Action Plan, are initiatives which intend to drive innovation, accelerate the AI uptake, while ensuring a high-level of protection for health, safety and fundamental rights.

· The DoH was updated in October 2024, celebrating its 60th anniversary. What are the main changes of this latest revision?

· How is the WMA addressing the use of AI? Is the DoH prepared to deal with the emerging technologies in healthcare? What key recommendations is the WMA providing in this area?

· How is the European Commission supporting the implementation of the AI Act for deployers in healthcare? Can the new EU policy initiatives deliver to improve medical research, AI competences for the workforce, working conditions, access to health, and trustworthy datasets for healthcare?

· Is the healthcare sector ready to become dependant of AI, Large Language Models (LLMs) and big data analytics? How to ensure that AI is a positive disruptive innovation? How to mitigate the risks of dehumanising the healthcare profession, deskilling and critical thinking, and ensure patient safety?

This talk intends to brief participants on the relevant updates of the 2024 DoH revision, and translate principles and policies into actions. We will have the opportunity to hear from Dr Otmar Kloiber, Secretary General of the World Medical Association, and Dr Lucilla Sioli, Director of the EU AI Office, European Commission. Prof. Dr Paul Quinn will provide the introductory remarks, and Ms Sara Roda will moderate the talk.

Speakers

Dr. Otmar Kloiber

Secretary General of the World Medical Association

Dr Otmar Kloiber has served as Secretary General of the World Medical Association since 2005, following his departure from the German Medical Association as Deputy Secretary General. He holds an MD (1984) and a PhD (1986) from the University of Cologne, was a postdoctoral fellow in the Department of Biochemistry at the University of Minnesota, Duluth, and a scientific research fellow at the Max Planck Institute for Neurological Research. He holds an honorary doctorate from the Victor Babes University, Timisoara, Romania and was appointed Clinical Professor in Health Administration at the Brooks College of Health, University of North Florida, from 2009 to 2013. He is interested in the development of deontology under the influence of health system organisation and its relation to the provision of medical care. He provided advice to numerous governments on medical ethics and socio-medical issues. His advocacy focus is on ensuring equitable access to quality healthcare for all people.

Dr. Lucilla Sioli

Director of AI Office

Dr Lucilla Sioli is the Director of the "EU AI Office" within Directorate-General CONNECT at the European Commission. She is responsible for the coordination of the European AI strategy and its governance, including the AI Continent Action Plan, the Apply AI strategy, the implementation of the AI Act and international collaboration in AI and AI for good. She is also responsible for the coordination of the R&D&I activities in the field of AI and for the implementation of innovation activities in key strategic sectors such as healthcare, robotics and advanced manufacturing. Lucilla holds a PhD in economics from the University of Southampton (UK) and one from the Catholic University of Milan (Italy) and has been a civil servant with the European Commission since 1997.