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In light of recent high-profile cybersecurity breaches in the healthcare industry, post-market medical device cybersecurity is becoming increasingly important to all entities in the medical device ecosystem. Leading FDA and cybersecurity lawyers at Debevoise & Plimpton LLP will present an overview of legal, regulatory, and commercial issues associated with medical device cybersecurity, including recommendations for implementing coordinated vulnerability disclosure (CVD) policies and interacting with regulators, security researchers, and healthcare delivery organizations. The presentation will address the comprehensive medical device cybersecurity report issued by Debevoise & Plimpton, in conjunction with Alvarez & Marsal, on behalf of the Medical Device Innovation Consortium (MDIC): http://mdic.org/wp-content/uploads/2018/10/MDIC-CybersecurityReport.pdf. The report was issued after extensive consultation with FDA officials, leading security researchers, a medical device trade association, and a number of medical device companies.
This Briefing, led by Debevoise authors Luke Dembosky, Jeremy Feigelson , Paul D. Rubin, and Melissa B. Runsten, will address the following:
• Current cybersecurity issues within the medical device ecosystem and the associated legal risks confronted by medical device manufacturers (MDMs)
• Legal and commercial considerations for effective cybersecurity practices and risk mitigation
• Recommendations for interacting with the wide range of stakeholders in the medical device ecosystem
• Key findings regarding the development and implementation of CVD policies
• How the adoption and effective implementation of strong CVD policies by MDMs supports public health and safety, and may provide MDMs with a number of legal benefits