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 Ms Saila Rinne, Head of the AI in Health and Life Sciences Unit, in the AI Office, European Commission. Prof. Dr Paul Quinn will provide the introductory remarks, and Ms Sara Roda will moderate the talk.Â