November 29, 2021

Volume XI, Number 333

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November 29, 2021

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OIG FY 2016 Work Plan Includes Review of FDA’s Oversight of Networked Devices

On November 2, 2015, the HHS Office of Inspector General (OIG) published its FY 2016 Work Plan, which summarizes new and ongoing activities that OIG plans to pursue with respect to HHS programs and operations during the fiscal year.

The FY 2016 Work Plan includes a new review initiative to examine “whether FDA’s oversight of hospitals’ networked medical devices is sufficient to effectively protect associated electronic protected health information (ePHI) and ensure beneficiary safety.”  The Work Plan notes that networked medical devices, such as radiology systems and medication dispensing systems that are integrated with electronic medical records and the larger health network, “pose a growing threat to the security and privacy of personal health information.”  OIG’s Work Plans for FY 2014 and FY 2015 both included a similar review focused on oversight by CMS of hospitals’ security controls over networked medical devices.  This review activity has been removed in the FY 2016 Work Plan.

Medical device cybersecurity is an area of increasing focus for FDA.  For example, last month FDA issued a final guidance on addressing cybersecurity issues for medical devices.  Also last month, FDA’s Center for Devices and Radiological Health released its NY 2016 Regulatory Science Priorities, which included researching ways to enhance performance of digital health and medical device cybersecurity.

© 2021 Covington & Burling LLPNational Law Review, Volume V, Number 317
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About this Author

Christina Kuhn, Covington, Food and drug lawyer
Associate

Christina Kuhn advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products.

Ms. Kuhn frequently helps multinational device manufacturers as well as start-up device companies navigate the premarket regulatory process, advising companies on regulatory classification, clinical development strategy...

202-662-5653
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