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FDA Publishes Cyber Guidance for Medical Devices

By Katy Linsky, Evan D. Wolff, David Bodenheimer & John Fuson on October 8, 2014
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The FDA recently passed down a set of guidelines governing the cybersecurity of medical devices. The guidelines, which are the first of its kind, were issued in response to the FDA’s recognition of the particular security concerns involved in the handling of sensitive medical information. The recommendations vary based on the specific vulnerabilities of each device, and the FDA puts the onus on manufacturers to identify such vulnerabilities and protect against them using increased security controls as necessary at the manufacturing stage. The FDA also incorporates the cybsecurity functions from the NIST Cybersecurity Framework to assist manufacturers in each stage of protection and recovery. Please read the full alert analyzing the guidelines here.

Photo of Evan D. Wolff Evan D. Wolff

Evan D. Wolff is a partner in Crowell & Moring’s Washington, D.C. office, where he is co-chair of the firm’s Chambers USA-ranked Privacy & Cybersecurity Group and a member of the Government Contracts Group. Evan has a national reputation for his deep technical…

Evan D. Wolff is a partner in Crowell & Moring’s Washington, D.C. office, where he is co-chair of the firm’s Chambers USA-ranked Privacy & Cybersecurity Group and a member of the Government Contracts Group. Evan has a national reputation for his deep technical background and understanding of complex cybersecurity legal and policy issues. Calling upon his experiences as a scientist, program manager, and lawyer, Evan takes an innovative approach to developing blended legal, technical, and governance mechanisms to prepare companies with rapid and comprehensive responses to rapidly evolving cybersecurity risks and threats. Evan has conducted training and incident simulations, developed response plans, led privileged investigations, and advised on hundreds of data breaches where he works closely with forensic investigators. Evan also counsels businesses on both domestic and international privacy compliance matters, including the EU General Data Protection Regulation (GDPR), and the California Consumer Privacy Act (CCPA). He is also a Registered Practitioner under the Cybersecurity Maturity Model Certification (CMMC) framework.

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Photo of John Fuson John Fuson

John Fuson is a partner in the firm’s Health Care, Product Risk Management (PRM), and White Collar and Regulatory Enforcement groups, focusing on U.S. Food and Drug Administration (FDA) enforcement and counseling matters.

Read more about John FusonEmail
  • Posted in:
    Privacy & Data Security
  • Blog:
    Data Law Insights
  • Organization:
    Crowell & Moring LLP
  • Article: View Original Source

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