Debevoise Collaborates with Industry and FDA to Prepare Medical Device Cybersecurity Report

1 October 2018

Debevoise & Plimpton has partnered with the Medical Device Innovation Consortium, the first non-profit public-private partnership with the sole objective of advancing medical device regulatory science, and Alvarez & Marsal to prepare the just-released “Medical Device Cybersecurity Report: Advancing Coordinated Vulnerability Disclosure.”

As medical devices and healthcare environments become more sophisticated and interconnected through networks and information systems, the risk of medical device cybersecurity vulnerabilities impacting patient safety and privacy has increased significantly. This report is intended to advance the adoption of coordinated vulnerability disclosures by the medical device industry and to promote and inform cybersecurity discussions across the health sector. Additionally, the report provides extensive best practices and describes the legal and non-legal issues associated with cybersecurity vulnerability assessments.

The report addresses the importance of CVD policies for medical device manufacturers and stakeholders across the medical device industry, including the creation of publicly available online portals to solicit vulnerability information. The report is based on the feedback obtained during interviews with large and small medical device companies, leading security researchers, representatives of medical device trade associations, and FDA officials. It also includes an assessment of publicly available information issued by FDA and other stakeholders.

Research for this report was compiled by a cross-disciplinary team of lawyers from Debevoise’s Healthcare and Cybersecurity & Data Privacy Practice Groups. The Debevoise team was led by partners Luke Dembosky and Paul D. Rubin and also included partners Jeremy Feigelson, Mark P. Goodman, Maura K. Monaghan, counsel Jacob W. Stahl and associates Mason Fitch and Melissa Runsten.

Click here to read the full report.

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