

Healthcare Data Privacy, Clinical Trials and AI Governance: Protecting Patient Data in a Changing Research Landscape with Shaun Hastings
DISCLAIMER - The views and opinions expressed about the real-world examples are those of the guest and host. They do not represent or reflect the official views of any company, organisation, or employer mentioned and are based on public information and personal interpretation. In this episode, Aakash Suri sits down with returning guest Shaun Hastings, an experienced quality and compliance leader, to explore the evolving intersection of data privacy, clinical research, and artificial intelligence. The conversation unpacks the privacy implications of decentralised clinical trials, wearables, and recent high-profile healthcare data breaches. KEY TAKEAWAYS The Insider Risk of Biobanks: The UK Biobank breach highlights the severe risks of insider threats, where pseudonymised genetic data was accessed via shared credentials and offered for sale online. Sub-processor Oversight is Crucial: A 5 million euro fine issued to IQVIA demonstrates that relying on data warehouses acting as subcontractors without strict privacy checks and sponsor oversight leads to massive compliance failures. Decentralised Trials and Cloud Risks: Shifting clinical trials to patients' homes and utilising wearables introduces new risks, as health data is transmitted to cloud-based apps managed by large tech corporations outside secure hospital environments. Updating Informed Consent for AI: Current informed consent forms generally cover future research but fail to explicitly address the use of patient data for training AI models, which must be updated to meet transparency obligations like Article 50 of the EU AI Act. BEST MOMENTS "Pseudonymisation removes the risk is a major healthcare privacy myth." "Data privacy is now a CEO topic. It's on the table of the CEO and the board of directors. It's not an afterthought." "As a sponsor, you're maybe two, three people away from that actual place... the responsibility lies with the controller, right, ultimately." TO CONNECT WITH SEAN HASTINGS linkedin.com/in/shaunhastings TO CONNECT WITH YOUR HOST LinkedIn - Aakash Suri LinkedIn - AS Privacy & AI Solutions LtdTik Tok Instagram www.letstalkprivacy.com HOST BIO PICCASO Nominated & Final Shortlisted for, Rising Star SME 2026 Aakash is a recognised Data Privacy leader who helps organisations navigate complex regulations with clarity, confidence, and common sense. Unlike the legalese-driven privacy pros who simply regurgitate the law, Aakash breaks down what the rules actually mean, translates them into plain English, and gives businesses three SMART, pragmatic steps to demonstrate real compliance.


















