We've blogged about medical device cybersecurity topics here and most recently here. The topic is in the news yet again with the FDA issuing a draft guidance outlining postmarket recommendations for medical device manufacturers to address cybersecurity risks. The draft guidance recommends that manufacturers should execute a structured, systematic, and comprehensive cybersecurity risk management program that includes several components, as well as voluntary participate in information sharing via an Information Sharing Analysis Organization ("ISAO") – a collaborative and transparent group in which public and private-sector members share confidential cybersecurity information.
For more information on the draft guidance and the essential components medical device manufacturers need to know about, read the blog post authored by Reed Smith Associate Vicki Morris on Health Industry Washington Watch.
Please note that comments to the draft guidance are due April 21, 2016 and can be submitted here.
This article is presented for informational purposes only and is not intended to constitute legal advice.