FDA plans workshop to address cybersecurity in medical devices

“There is no such thing as a threat-proof medical device.”

Suzanne Schwartz, M.D., MBA, director of emergency preparedness and medical countermeasures at the FDA’s Center for Devices and Radiological Health.

Two months after finalizing its first guidance on cybersecurity, the FDA has announced a public workshop entitled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity” to continue to address a growing safety consideration.

Since 2013, the FDA and other organizations have taken increased steps to address cybersecurity in the medical device industry.  In summer 2015, the FDA issued its first cybersecurity alert for a network enabled computerized pump designed for general infusion therapy.  Both the manufacturer and an independent research confirmed that the pump was vulnerable to access by an unauthorized remote user through the networked hospital information system.  The unauthorized user could then modify the dosage the pump delivers to a patient.  While no actual incidents were reported, both the manufacturer and the FDA recommended all hospitals immediately transition to other devices or at least disconnect the pump from the network and run offline as a temporary solution. For the full article click here 

 

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