How can we foster data-driven innovation in healthcare while upholding patient privacy? This module examines the legal and ethical frameworks – such as the European Health Data Space (EHDS) Regulation– that aim to reconcile these competing priorities, and it will consider recently proposed changes to health data privacy law, such as the Digital Omnibus Proposal.

As digital health systems become more interconnected, cyber threats pose significant risks to patient data and medical infrastructure. This module explores technical and regulatory strategies to build resilience and protect innovation from cyber vulnerabilities.

The rapid development of AI, including large language models, in healthcare raises complex questions about intellectual property, liability, and governance. This module addresses how to foster innovation while ensuring accountability and ethical deployment of AI technologies.

Digital tools like AI chatbots and well-being apps offer new avenues for mental health support, but they also introduce challenges such as algorithmic bias and data sensitivity. This module focuses on resolving these tensions through ethical design and robust regulation. It also addresses the challenges of regulating mass-market large language model chatbots that provide (sometimes unsafe) mental health support to users.

Bringing new medical technologies to market requires navigating regulatory pathways and ensuring safety and efficacy. This module provides insights into clinical trials, conformity assessments, and post-market surveillance, emphasizing how to align innovation with public health needs and discusses the increasing role of regulatory sandboxes and real-world performance monitoring of digital technologies.

Digital health solutions and data analytics play a crucial role in strengthening public health systems. This module explores how to build resilience against future crises, focusing on pandemic response, supply chain security, and cross-border collaboration.