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Medical Device Cybersecurity Gaps Discussed at FDA Workshop

This week, the U.S. Food and Drug Administration (FDA) is hosting a two-day workshop to identify current cybersecurity gaps that could be exploited by cybercriminals to gain access to medical devices. Best practices and cybersecurity tools that can be adopted to improve defenses against cyberattacks are under discussion.

This is the third time the FDA has held such a workshop on medical device security and it comes at an appropriate time. The recent WannaCry ransomware attacks resulted in Siemens, Bayer and other manufacturers’ devices having data encrypted.

Cyberattacks on medical devices have potential to cause considerable harm to patients. Cybercriminals could also target medical devices to obtain sensitive information on patients or use the devices to launch attacks on healthcare networks.

This week, the attacks only resulted in data being encrypted. Bayer reported that both of the healthcare organizations that were affected were able to recover data and restore the functionality of their medical devices within 24 hours. The medical devices were not specifically targeted and the aim of the attacks was to encrypt data rather than steal information or cause patients to be harmed. That may not always be the case.

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Studies have been conducted that demonstrated a theoretical risk of medical devices being hacked, and while the risk of cyberattacks on medical devices is likely to be low, this week’s incidents have clearly demonstrated that attacks are not only theoretical.

Medical devices now have the functionality to connect to healthcare networks and pass data directly to EHR systems, making them an attractive target for cybercriminals, even more so given the relative lack of security controls in place.

While there have been no reports of cyberattacks on medical devices being conducted that resulted in patients coming to harm, action does need to be taken now to ensure attacks cannot easily occur in the future. As the functionality of medical devices improves and new Smart devices come to market, the risk of cyberattacks is only ever likely to increase.

Progress is being made to improve medical device cybersecurity. Last week, the National Institute of Standards and Technology (NIST) issued new guidance for healthcare providers on securing wireless infusion pumps to prevent unauthorized access. However more needs to be done by manufacturers of the devices to improve security, something that the FDA is attempting to tackle.

At the workshop, the FDA, researchers and industry representatives discussed the challenges of securing medical devices and the possible tools and best practices that can be adopted to improve resilience against cyberattacks to prevent unauthorized access.

Many of the issues that were highlighted by the recent WannaCry attacks were raised at the meeting, including how to secure devices for their entire lifecycle, when the support for software on which the devices run often stops during the product lifecycle.

The workshop is continuing today with the discussions ongoing. A report on the outcome of the workshop will be published later this year.

Author: Steve Alder is the editor-in-chief of HIPAA Journal. Steve is responsible for editorial policy regarding the topics covered on HIPAA Journal. He is a specialist on healthcare industry legal and regulatory affairs, and has several years of experience writing about HIPAA and other related legal topics. Steve has developed a deep understanding of regulatory issues surrounding the use of information technology in the healthcare industry and has written hundreds of articles on HIPAA-related topics.