US FDA to Convene Workshop to Discuss Medical Device Cybersecurity

Published By : 04 Dec 2015 | Published By : QYRESEARCH

The United States Food and Drug Administration will be holding a two day workshop next month to talk about how the agency can tackle the cyber security of medical devices – a threat that is now becoming more imminent than ever. 

The public workshop comes five months after the FDA issued a safety communication regarding the cyber security of medical devices. This notice brought to the fore concerns regarding the vulnerabilities of a computerized infusion pump system Symbiq by Hospira.

Coordinating cyber security initiatives for the Center for Devices and Radiological Health at the US FDA, Suzanne Schwartz told Bloomberg in November that the notice had set a precedent.

Along with that first warning notice, the FDA released a final guidance last October asking manufacturers of medical devices to consider the risks of cyber security while designing and developing a medical device. The FDA called on the manufacturers to submit to the agency the documentation regarding the risks devices could face and how to control them in order to mitigate the impact. 

The US FDA – together with the Department of Health and Human Services, the National Health Information Sharing Analysis Center, and the Department of Homeland Security – will be convening the workshop called “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity”, aimed at bringing stakeholders together to discuss the challenges of device cyber security. 

The FDA has previously even gone to the extent of asking hackers to submit their security bugs to the agency. It said that the workshop will more specifically talk about past collaborative measures, the unresolved challenges and gaps that have in the past hampered progress, and current frameworks that are being used to track a company’s progress in securing medical devices from cyber attacks or threats. 

The announcement of the upcoming workshop comes after the National Electrical Manufacturers Association and the Medical Imaging and Technology Alliance released a white paper focusing on communications security and device security.

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