AI in healthcare isn’t starting from a regulatory vacuum. It’s starting from an environment that already treats digital tools as safety‑critical: medical device rules, clinical trial regulations, GxP controls, HIPAA and GDPR, and payer oversight all assume that failing systems can directly harm patients or distort evidence. That makes healthcare one of the few sectors where AI is being plugged into dense, pre‑existing regulatory schemas rather than waiting for AI‑specific laws to catch up.
In the rapidly evolving landscape of healthcare, AI promises to revolutionize patient care, but it also brings significant risks. From algorithmic bias to data privacy breaches, the stakes are high. Effective AI governance is essential to harness the benefits of these technologies while safeguarding patient safety and ensuring compliance with regulations. This article delves into the critical challenges healthcare systems and pharmaceutical companies face, offering practical solutions and best practices for implementing trustworthy AI. Discover how to navigate the complexities of AI in healthcare and protect your organization from potential pitfalls.
