The U.S. Food and Drug Administration (FDA) is not sufficiently protecting medical devices such as pacemakers and insulin pumps from being hacked, according to a U.S. Department of Health and Human Services (HHS) report.
The report says FDA policies fail to address medical device cybersecurity problems, the organization has not sufficiently tested its ability to respond to emergencies, and the agency lacks written standard operating procedures.
In addition, the study says the FDA has failed to adequately assess the risk that violations of cybersecurity in medical devices can pose.
Said FDA commissioner Dr. Scott Gottlieb, "We want to assure patients and providers that the FDA is working hard to be prepared and responsive when medical device cyber vulnerabilities are identified."
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