The U.S. Food and Drug Administration (FDA) named University of Michigan Associate Professor Kevin Fu Acting Director of Medical Device Security in its Center for Devices and Radiological Health. This is a newly created 12-month post in which Fu will “work to bridge the gap between medicine and computer science and help manufacturers protect medical devices from digital security threats.” Fu stated that his primary activities will include

  • Envisioning a strategic roadmap for the future state of medical device cybersecurity.
  • Assessing opportunities to fully integrate cybersecurity principles through the lens of the center’s total product life cycle model.
  • Training and mentoring CDRH staff for premarket and postmarket technical review of medical device cybersecurity.
  • Engaging multiple stakeholders across the medical device and cybersecurity ecosystems.
  • Fostering medtech cybersecurity collaborations across the federal government, including the National Institute of Standards and Technology, National Science Foundation, National Security Agency, Department of Health and Human Services, National Telecommunications and Information Administration, Cybersecurity and Infrastructure Security Agency, Department of Veterans Affairs, Department of Defense, Federal Trade Commission and others.

Fu also noted that “the FDA is working closely with federal partners — HHS and CISA — on sector incident and emergency response. The FDA’s 2021 efforts for the cybersecurity focal point program will further increase the review consistency of premarket submissions.”

The creation of this new post is the latest in the FDA’s ongoing efforts to promote cybersecurity in medical devices. As we previously reported, the FDA has published draft guidance for medical device manufacturers outlining steps that can be taken in the premarket process to better protect medical devices from cybersecurity threats. We expect this focus to continue especially as we see a rise in ransomware attacks and other hacking activity.

The FDA’s increasing focus on cybersecurity is yet another reason relevant employers and medical device manufacturers should continue to assess and address potential data security risks.

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Photo of Michael R. Bertoncini Michael R. Bertoncini

Michael R. Bertoncini is a Principal in the Boston, Massachusetts, office of Jackson Lewis P.C. He practices labor and employment law, with a particular emphasis on labor relations, employment law counseling and litigation, and data privacy and security law.

In labor relations matters…

Michael R. Bertoncini is a Principal in the Boston, Massachusetts, office of Jackson Lewis P.C. He practices labor and employment law, with a particular emphasis on labor relations, employment law counseling and litigation, and data privacy and security law.

In labor relations matters, he regularly counsels clients on the practice of positive employee relations, negotiates collective bargaining agreements on behalf of organized clients, represents clients in labor arbitrations and National Labor Relations Board proceedings, and counsels clients with respect to rights and obligations under collective bargaining agreements and applicable labor and employment laws. He also has extensive experience in advising organizations responding to corporate campaigns and negotiating neutrality agreements.

Mr. Bertoncini’s privacy and data security practice focuses on advising clients on complying with HIPAA and other state and federal privacy and data security laws. He regularly reviews and develops policies and procedures, written information security plans and integrated compliance programs to assist clients in meeting their obligations under privacy and data security laws. Mr. Bertoncini has represented clients in investigations of alleged data breaches and advises them on their reporting obligations in the event of a data breach. He also conducts workplace training programs on HIPAA compliance and related privacy and data security topics.

Before joining Jackson Lewis, Mr. Bertoncini was Deputy General Counsel for a hospital system that is the largest fully integrated community care organization in New England. He was responsible for all of the system’s labor and employment law matters, and was involved in its acquisition by a private equity firm as well as its growth from six to ten hospitals in a twelve-month period. His three years as in-house counsel for this large health care system give Mr. Bertoncini a keen understanding of the impact of labor and employment law issues on clients’ business operations.

In addition to his labor relations and privacy experience, Mr. Bertoncini has extensive experience in conducting internal investigations and counseling clients on whistleblower and retaliation matters, as well as negotiating executive agreements, both employment and separation agreements. Mr. Bertoncini also represents clients in the litigation of employment matters. His litigation experience includes matters before federal and state courts and administrative agencies. He has appeared before United States Courts of Appeals and District Courts, Massachusetts and New York state courts, the Equal Employment Opportunity Commission, and the Massachusetts Commission Against Discrimination.

Mr. Bertoncini is a frequent speaker and trainer on labor and employment law topics for various organizations including Massachusetts Continuing Legal Education, Council on Education in Management, Lorman Education Services, the Boston Bar Association, and several chambers of commerce.

While attending Boston College, he received the John A. McCarthy, SJ Award for the most distinguished Scholar of the College thesis.