The a16z Show Taking the Pulse on Medical Device Security
Jul 22, 2020
Beau Woods, a Cyber Safety Innovation Fellow with deep expertise in cybersecurity, and Andy Coravos, co-founder of Elektra Labs and former FDA EIR, delve into the often-overlooked world of medical device security. They discuss the ethical dilemmas and safety concerns of devices like pacemakers and insulin pumps, emphasizing the need for robust regulatory frameworks. The conversation covers the challenges of integrating security into medical software and the vital collaboration needed among stakeholders to protect patient safety in an increasingly digital healthcare landscape.
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Initial Resistance to Security
- Medical device makers initially resisted security concerns, citing safety and efficacy as priorities.
- Financial motives and FDA approval processes were also cited as obstacles.
FDA Guidelines on Security Patches
- Ship security patches for medical devices if they don't change critical functions or advertised features.
- Major changes require re-approval or re-clearance from the FDA.
Device Classification by Claims
- FDA device classification depends on the manufacturer's claims, not just hardware/software.
- A Fitbit claiming to diagnose AFib becomes a medical device, changing its regulatory status.