A Quick Look at Medical Devices and Cybersecurity as Outlined by the FDA

The Food and Drug Administration (FDA) heavily regulates every aspect of medical devices. But cybersecurity is one area that more companies need to familiarize themselves with. Whether you’re developing devices with digital capabilities or looking to improve existing products, cybersecurity is something that the FDA takes seriously.

Medical devices today are increasingly connected to the Internet, internal networks, and rely on this connectivity to function. This enhanced connectivity improves the quality of care a medical professional can provide, but it also comes with inherent security risks.

Healthcare is a complex industry, and some of the strictest regulations govern it. Medical device manufacturers (MDMs) should be aware of cybersecurity risks and how to reduce the likelihood of data breaches or critical device failures.

How the FDA Recommends You Mitigate Cybersecurity Risks

MDMs must take the time to familiarize themselves with cybersecurity risks and how they can impact their devices.

The FDA recommends that MDMs:

• Stay aware of current risks that could impact their medical devices
• Work to identify potential risks and develop viable solutions
• Ensure that their devices have proper safeguards in place to maintain patient safety, reduce risk, and guarantee device performance.

Why Does Cybersecurity Awareness Matter?

While the FDA hasn’t reported any direct patient injuries or deaths as a result of cybersecurity problems, that doesn’t mean that this won’t become a problem in the future.

Hackers could easily target any device that relies on Internet connectivity or has the ability for remote control. Either of these scenarios could allow a hacker to interfere with critical device functions and cause serious patient harm.

The FDA recently recalled MiniMed insulin pumps after it was revealed that there was a serious cybersecurity vulnerability. According to the FDA, hackers could change the pump’s settings to alter how much insulin was delivered to a patient.

Stay Aware of the Risks – Keep Your Medical Device Training Up to Date

The Center for Professional Innovation and Education (CfPIE) provides pharmaceutical, biotech, and medical device companies with training and certifications that will keep your company compliant and in the good graces of the FDA.

How is your company approaching medical device cybersecurity? CfPIE offers a variety of medical device certifications and training programs that you can take to ensure that you’re up to date on the latest regulations.

Please contact our team at 1-610-648-7550 if you have any questions at all about our medical device training programs.

Useful Resources About How FDA Approaches Medical Device Cybersecurity

• Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
• Postmarket Management of Cybersecurity in Medical Devices
• Certain Medtronic MiniMed Insulin Pumps Have Potential Cybersecurity Risks: FDA Safety Communication
• Medical Device Reporting (MDR)
• MOU 225-18-028