AI systems in healthcare can help diagnose disease, prevent outbreaks, discover treatments, tailor interventions and enable Internet of Health Things devices. However, the use of AI raises questions about the proper interpretation, application and interplay of EU regulations in force (GDPR, MDR/IVDR) and new legislative initiatives (AIA, European Health Data Space). The panel will debate critical data protection and AI governance challenges regarding the development and use of AI systems in health innovation and research. The speakers will discuss regulatory and governance affairs for AI-supported medical and consumer health devices, with a particular focus on mental health applications. In addition, the discussion will address consent mechanisms, anonymisation and related risk mitigation measures concerning the use of AI in healthcare and explore the possible implications of regulating AI in light of the foreseen European Health Data Space.
• What are the possible implications of the AIA for the innovation of Internet of Health Things devices and interconnected AI systems?
• Is implementing privacy by design and fostering privacy-enhancing technologies the better way to enable health research on the basis of consent?
• What are the concerns of using data-driven technologies in medical & consumer health devices intended to be used for mental health purposes?
• What are the legal challenges and risks concerning the anonymisation of health data and how to mitigate the risks associated with re-identification?
• Is the interplay between the AIA and the European Health Data Space initiative enough to establish a clear set of rules applicable to AI in health research?