Newsletters

The EU continues to advance its regulatory framework with the Clinical Trials Information System (CTIS) enhancing transparency in clinical trials and the AI Act establishing obligations for AI developers and users. Digital health technologies, like wearable sensors and decentralized trials, are rising in prominence, but challenges such as the digital divide and privacy concerns persist. Enforcement actions, including the French Supervisory Authority’s fines against Doctissimo for GDPR and cookie violations, and the EU court’s prudent stance on compensation for data breaches, highlight the increasing scrutiny and accountability surrounding data privacy and security in healthcare and beyond.

Synthetic data emerges as a potential solution to privacy concerns in healthcare, allowing the use of realistic but artificial datasets to ensure data security and compliance. Meanwhile, challenges persist in decentralized trials and AI applications in medicine, such as ensuring data protection, managing bias, and maintaining patient rights when AI influences clinical trial participation. Regulatory bodies like the FTC are enforcing stricter data handling practices for health apps, and new legislative initiatives, such as the UK’s “Data Protection and Digital Information Bill” and the EU’s forthcoming pharmaceutical reform, aim to address data protection and healthcare accessibility issues amid evolving technological and societal demands.