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Fireside Chat

Mo AliAmy Abernethy

FDA Principal Deputy Commissioner Amy Abernethy discusses medical device cybersecurity, big data, and regulatory collaboration.

Summary

Big Data and Patient Rights in Modern Healthcare

The discussion explores how real-world data collection can be balanced with patient rights, data privacy, and clinical research requirements in the digital era.

Cybersecurity Risks in Connected Medical Devices

As medical devices become increasingly networked, addressing software vulnerabilities and enforcing robust security baselines is essential to safeguard patient safety.

FDA Collaboration with Security Researchers

The conversation highlights regulatory initiatives, including the FDA-led Evidence Accelerator, designed to foster productive collaboration between federal regulators and independent security researchers.

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