Intuitionlab-AI-Medical-Device-Cybersecurity-Regulations-and-Risks-2026.md

This report surveys the cybersecurity landscape for AI-enabled medical devices, documenting high prevalence of software and connectivity vulnerabilities, AI-specific risks (adversarial attacks, data poisoning, model theft), historical incidents (pacemaker and insulin pump recalls, ransomware impacts on hospitals), and regulatory/standards expectations (FDA §524B, EU MDR, NIS2, AI Act, ISO/IEC/UL standards). It recommends lifecycle-based secure development, SBOMs, threat modeling, secure update/patching, coordinated disclosure, and post-market vulnerability management to protect patient safety and ensure compliance.