AI-Enabled Medical Devices: New FDA Draft Guidance and Cybersecurity Insights

The Food and Drug Administration (FDA) has issued draft guidance to establish a comprehensive regulatory framework for artificial intelligence and machine learning (AI/ML) in medical devices. As AI becomes embedded in connected health technologies, the cybersecurity risks associated with such devices are growing exponentially. This webinar explores how the FDA's lifecycle-based approach to AI regulation intersects with cybersecurity for connected medical devices. Principals Barry Mathis and John Cross provided an overview of the FDA's draft guidance on AI/ML-enabled medical devices and discussed how cybersecurity risks in the Internet of Medical Things (IoMT) can be addressed. Attendees gained knowledge through these learning objectives: Learn about AI and its use cases, including use in embedded medical devices Understand the FDA's Total Product Lifecycle approach to regulating AI/ML-enabled medical devices Identify cybersecurity risks unique to IoMT devices Analyze a real-world case study of an AI-enabled insulin pump and its cybersecurity implications Apply compliance strategies, including Secure Product Development Frameworks and Software Bill of Materials, to meet FDA expectations This webinar is part of PYA's twice-monthly Healthcare Regulatory Roundup, a popular series during which PYA experts provide practical insights on the latest industry regulatory developments. PYA is dedicated to helping healthcare organizations understand regulatory requirements and prepare for and respond to cybersecurity threats.