Session 2: Regulatory on Medical Devices, AI Act, Privacy-Preserving and Ethical Considerations

Speakers: Nathan Lea, Rudolf Mayer, Sofia Tsekeridou​

Nathan Lea PhD, MBCS is an independent consultant who is working with i~HD as their data protection officer and on the development of adaptive codes of practice and standard operating procedures to govern and secure the use of health and genetic data for research purposes and digital health innovation. He has focused his work on operational security and design implementation and he has an interest in understanding the legal, ethical and societal impacts and concerns around novel health data uses, particularly in the area of Artificial Intelligence for health management and genomics research.

Nathan also works part time for Cancer Research UK as their Trusted Research Environment Lead. He was the Information Governance Lead for the University College London Hospitals NHS Foundation Trust NIHR Biomedical Research Centre Clinical Research Informatics Unit and a Senior Research Fellow at UCL where his research and teaching focused on understanding legal, ethical and security requirements for Big Data driven clinical research. He has a history as a software engineer in the clinical care systems development and deployment in practice. Nathan has worked with the UCL European Institute to examine the implications of No Deal Brexit on EU Data Flows and reviewing transatlantic data flows in the light of Privacy Shield and the Schrems II Case.

Dr. Sofia Tsekeridou is a Senior Research and Innovation Manager - Expert at the Research and Innovation Development Dept. of Netcompany BELUX. She holds an ECE Diploma and a PhD in Computer Science, both from Aristotle University of Thessaloniki, Greece. She has more than 25 years' experience in project/technical management and research, development and innovation activities, primarily in the fields of software engineering, multimodal data management, AI and security/cybersecurity. She has published many papers at international scientific journals and conferences and has contributed to TV Anytime, W3C, IEEE and ETSI standardization bodies. Dr. Tsekeridou is a senior member of IEEE, co-lead of the BDVA Healthcare Task Force and an expert member of the FCT-INFRA sub-group of EC DG HOME CERIS expert group. She holds a personnel security clearance at EU SECRET and NATO SECRET level.

Rudolph Mayer, SBA research