Medical device makers should take new steps to protect their products from malware and cyberattacks or face the possibility that U.S. Food and Drug Administration won't approve their devices for use, the FDA said.
The FDA issued new cybersecurity recommendations for medical devices on Thursday, following reports that some devices have been compromise.
Recent vulnerabilities involving Philips fetal monitors and in Oracle software used in body fluid analysis machines are among the incidents that prompted the FDA to issue the recommendations, a spokeswoman for the agency said.
In one case reported in October, malware slowed down fetal monitors used on women with high-risk pregnancies at a Boston hospital, and in another case, the FDA in January issued a warning about Oracle software that could allow remote access to the databases of Roche Cobra analysis devices, she said.
Representatives of Philips and Oracle didn't immediately respond to requests for comment on the FDA recommendations.
"Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches," the FDA said in its recommendations. "As medical devices are increasingly interconnected, via the Internet, hospital networks, other medical device, and smartphones, there is an increased risk of cybersecurity breaches, which could affect how a medical device operates."
Under proposed rules issued by the FDA, the agency is recommending that device makers provide it with their plans for providing updates and patches, said Erica Jefferson, an FDA spokeswoman.
"Once the guidance is finalized, the agency might consider withholding marketing clearance or approval for medical devices that fail to appropriately address cybersecurity risks," she said.
The FDA is not aware of any patient injuries or deaths associated with cybersecurity incidents, the agency said. The agency doesn't have "any indication that any specific devices or systems in clinical use have been purposely targeted at this time," it said.
The FDA has seen medical devices infected or disabled by malware, and the presence of malware on hospital computers, smartphones and tablets, the agency said. The agency has also found health care providers with "uncontrolled distribution of passwords" and disabled passwords in software designed to have limited access, it said.
Other health care providers have failed to apply software updates and patches in a timely manner, the agency said.
The agency wants medical device makers to "take appropriate steps to limit the opportunities for unauthorized access to medical devices," the FDA said in its recommendations. Manufacturers should review their cybersecurity practices to assure that appropriate safeguards are in place to prevent unauthorized access, the agency said.
Health care providers should also take steps to limit access and to improve cybersecurity, the agency said.
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