Regulatory and Legal Aspects of Disruptive Technology in Healthcare

Patients, medical professionals, industry, and researchers are all experiencing a change in how treatments are developed, delivered and experienced due to the use of digital technologies – especially artificial intelligence (AI) – in healthcare. The rapid advancement of AI has opened a world of possibilities, but it has also raised several ethical dilemmas and concerns about the current regulatory and legal systems.

Identifying and implementing practical and transparent solutions to these regulatory issues is essential for ensuring public confidence in healthcare quality and safety and efficacy of new digital products. This course is an introduction to the topic and focuses on how to navigate this highly complex and rapidly changing landscape effectively.

As digital technologies, especially AI, disrupt healthcare, new opportunities and risks arise for everyone involved. The development of these technologies relies heavily on data and algorithms for the prevention, diagnosis, treatment, and monitoring of diseases. For example, systems like these are designed to recognize disease patterns, diagnose illnesses accurately and deliver clinical decision support in real-time and some already marketed products.

This course introduces how this technological development raises several complex and significant questions: How will AI systems affect biomedical research, particularly data sharing, cross-border data transfers and data confidentiality? Which general ethical and legal principles should AI-based methods and solutions follow? In what ways will different legal and ethical frameworks affect these technological advancements in the MedTech industry? In this space, interdisciplinarity is vital to understanding and responding to many of the most pressing issues in regulation and law today.