To strengthen the safety of medical devices, the FDA finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.
The final guidance, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” recommends that manufacturers consider cybersecurity risks as part of the design and development of a medical device, and submit documentation to the FDA about the risks identified and controls in place to mitigate those risks. The guidance also recommends that manufacturers submit their plans for providing patches and updates to operating systems and medical software.
As medical devices become more interconnected and interoperable, they can improve the care patients receive and create efficiencies in the healthcare system. Some medical devices, like computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. By carefully considering possible cybersecurity risks while designing medical devices, and having a plan to manage system or software updates, manufacturers can reduce the vulnerability in their medical devices.
“There is no such thing as a threat-proof medical device,” said Suzanne Schwartz, MD, MBA, director of emergency preparedness/operations and medical countermeasures at the FDA’s Center for Devices and Radiological Health. “It is important for medical device manufacturers to remain vigilant about cybersecurity and to appropriately protect patients from those risks.”
The FDA’s concerns about cybersecurity vulnerabilities include malware infections on network-connected medical devices or computers, smartphones, and tablets used to access patient data; unsecured or uncontrolled distribution of passwords; failure to provide timely security software updates and patches to medical devices and networks; and security vulnerabilities in off-the-shelf software designed to prevent unauthorized access to the device or network. The FDA has neither an indication that specific devices or systems have been purposely targeted, nor reports that any patients have been harmed as a result of cybersecurity breaches, but remains concerned about device-related cybersecurity vulnerabilities and their potential to adversely impact public health.
See the FDA Announcement
See also Medical Law Perspectives, April 2012 Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory