Food And Drug Administration Issues Final Guidance On Medical Devices' Cybersecurity

The U.S. Food and Drug Administration has issued a final guidance detailing how medical device makers can protect users by boosting the security and monitoring of their products. The regulations apply to all medical devices, including those already out on the market such as pacemakers and insulin pumps. According to Dr. Suzanne Schwartz, Associate Director for Science and Strategic Partnerships at the FDA's Center for Devices and Radiological Health -- Device makers should develop "a structured and comprehensive program to manage cybersecurity risks" even after their products are sold. The FDA is currently investigating claims that St. Jude Medical's heart devices are vulnerable to hacks that could be life-threatening to patients. The allegations, made by short-selling investment firm Muddy Waters and cybersecurity company MedSec Holdings, claim St. Jude's devices "lack even the most basic forms of security". According to the Federal Trade Commission on Tuesday Healthcare company Abbott Laboratories won the U.S. Antitrust approval for its proposed $25 billion acquisition of medical device maker St. Jude Medical.

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