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The EU-U.S. Data Privacy Framework introduces provisions for clinical trials, emphasizing patient consent and transparency, while U.S.-based organizations must self-certify their compliance to participate. Rising health data privacy regulations in the U.S. and innovations like MIT’s privacy-preserving AI techniques and synthetic data strategies aim to balance data protection and utility. Cybersecurity incidents, including the MOVEit attack affecting U.S. health institutions and HCA Healthcare’s data breach impacting 11 million individuals, highlight ongoing vulnerabilities. Enforcement actions, such as the FTC’s ban on BetterHelp for sharing sensitive health data, underline the need for strict compliance and ethical data practices in the evolving privacy landscape.

The Nevada Health Data Privacy Act and the EU Data Act highlight evolving efforts to regulate data access, sharing, and privacy, with specific focus areas like healthcare and industrial data. AI governance progresses with updates to the AI Act, addressing high-risk applications and impact assessments, while international cooperation, such as the Atlantic Declaration and the EU-WHO digital health partnership, fosters innovation and privacy-enhancing technologies. Meanwhile, enforcement actions like FTC’s case against genetic testing company 1Health and ransomware attacks on biotech firms like Enzo Biochem underline the critical need for robust data protection measures in both regulatory and operational practices.

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.