Mayuri Jangale / Nandini Kumavat / Swapnil Mirajgave
AI-driven healthcare is transforming diagnostics, robotics, and telemedicine, but regulatory challenges pose significant hurdles. Compliance with evolving medical device regulations, data privacy laws, and ethical standards is crucial for safe and effective implementation. AI-powered diagnostics must ensure accuracy and patient safety while meeting FDA and EU MDR requirements. Robotics in surgery and patient care require adherence to safety protocols and liability frameworks. Telemedicine faces legal complexities, including cross-border regulations and patient data security under HIPAA and GDPR. To navigate these challenges, healthcare organizations must implement robust risk management strategies, ensure transparency in AI decision-making, and establish continuous monitoring and validation processes. Collaboration with regulatory bodies, adherence to ethical AI principles, and proactive policy adaptation are essential for long-term success. This book explores strategies to align AI innovations with legal requirements, helping stakeholders integrate AI responsibly while ensuring patient trust and regulatory compliance.
