Prioritizing Cybersecurity in the Med Device Industry

by | Feb 12, 2021 | Cybersecurity, Digital Health, FDA, Medical Devices, Quality, Quality Systems, Software

The FDA is in a constant state of working to optimize regulatory requirements for advancing technology. Digital health has been a hot topic for the agency over the past year due to increases in remote healthcare amidst the COVID-19 pandemic and advances in technology like AI/ML. Last week, the FDA named its first-ever acting director of medical device cybersecurity for the CDRH, Kevin Fu.1 The appointment of this position also correlates with the development of the FDA’s Digital Health Center of Excellence, which was launched last September to focus on the growing digital health industry.

Although we have barely just begun the 2nd month of 2021, the FDA has already made it clear that cybersecurity/digital health is one of its focuses in 2021. Between the update to the AI/ML Action Plan released last month, and now the appointment of a brand-new position aimed directly at cybersecurity, 2021 is shaping up to be a big year for software as a medical device (SaMD) products.

To many, this is a step in the right direction and shows the agency’s commitment to keeping up with technological trends. Additionally, the cybersecurity focus is likely a response to the vulnerabilities highlighted during the pandemic. There were several cases of reported cybersecurity vulnerabilities last year, such as IBM’s issue with insulin pumps that could be remotely controlled by hackers to alter medication dosages and manipulate readings from monitors.2 No matter the reason, this is undoubtedly a step in the right direction for the FDA and public health.

As the FDA diligently works to close the regulatory gap for digital health technology, the agency will likely look to collaborate with industry to ensure regulations adequately protect public health while simultaneously promoting technological advancement. I am willing to bet that 2021 will continue to be a year focused, among other things, on digital health and SaMD’s. Luckily, the technical team at EMMA International is on top of the changing regulatory landscape and can help make sure your team is up to speed! If you have a SaMD or other digital health product, we can help make sure it is compliant. Give us a call at 248-987-4497 or email info@emmainternational.com to get connected with us today!


1University of Michigan (Feb 2021) Kevin Fu fills new leadership position at FDA’s center for devices and radiological health retrieved on 02/08/2021 from: https://cse.engin.umich.edu/stories/kevin-fu-fills-new-leadership-position-at-fdas-center-for-devices-and-radiological-health-overseeing-medical-device-security

2Slabodkin (Aug 2020) Insulin pumps among millions of devices facing risk from newly disclosed cyber vulnerability retrieved on 02/08/21 from: https://www.medtechdive.com/news/insulin-pumps-among-millions-of-iot-devices-vulnerable-to-hacker-attacks/584043/

Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

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