• Safi Bello

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.

For more information on the Food and Drug Administration issuing a final guidance on medical devices' cybersecurity click on the pictures below to read the articles.

Food and Drug Administration final guidance protects medical devices from hacks - Read More from Modern Healthcare
New Rules for Avoiding Cyber Bugs in Medical Devices - Read More from Scientifc American
FDA finalizes cybersecurity guidance for medical devices - Read More from Health Care IT News
US posts rules for addressing cyber bugs in medical devices - Read More from Fox News
Abbott gets US antitrust approval to buy St. Jude Medical - Read More from CNBC
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