Healthcare IT News December 28, 2023
The watchdog agency said that it found the existing coordination agreement does not reflect “organizational and procedural changes,” including the FDA’s authority to find that medical devices in use violate federal law.
The Government Accountability Office has completed its review of cybersecurity in medical devices under the Consolidated Appropriations Act of 2023 and recommended the commissioner of food and drugs at the U.S. Food and Drug Administration and the director of the Cybersecurity and Infrastructure Security Agency update their agencies’ medical device cybersecurity coordination agreement.
WHY IT MATTERS
GAO said in a summary released along with the December 21 report that it interviewed 25 non-federal entities representing healthcare providers, patients and medical device manufacturers to learn how they are challenged...
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