Cybersecurity for Global Medical Device Supply Chain: The U.S. FDA's Role

5 Pages Posted: 26 Sep 2019

See all articles by Keman Huang

Keman Huang

Massachusetts Institute of Technology (MIT) - Sloan School of Management

Sophie Herscovici

Massachusetts Institute of Technology (MIT)

Stuart Madnick

Massachusetts Institute of Technology (MIT) - Sloan School of Management

Date Written: May 1, 2019

Abstract

Cybersecurity of medical devices is not only an issue of privacy, but a matter of life and death. The U.S. Food and Drug Administration (FDA) should increase its leadership role in managing emerging cybersecurity risks within the global medical device supply chain.

As a result of the growing use of information and communication technology (ICT) within medical devices, cybersecurity within medical devices is becoming a serious global issue that can no longer be ignored. Cybersecurity risks leave patients’ lives vulnerable to cyber attack. Connection vulnerabilities could allow hackers to change the settings on a patient’s St. Jude pacemaker remotely. Malware in MRI machines and CT scans could add or remove cancerous nodules, causing a patient to be misdiagnosed and wrongly treated. Ransomware attacks on hospitals could leave doctors and staff without the critical data they need to save patients’ lives. Since medical devices rely on global supply chains and because cyber threats exist on an international level, it is crucial that the United States work with other countries to address medical device cybersecurity concerns.

Keywords: cybersecurity, supply chain

Suggested Citation

Huang, Keman and Herscovici, Sophie and Madnick, Stuart E., Cybersecurity for Global Medical Device Supply Chain: The U.S. FDA's Role (May 1, 2019). Available at SSRN: https://ssrn.com/abstract=3455498 or http://dx.doi.org/10.2139/ssrn.3455498

Keman Huang

Massachusetts Institute of Technology (MIT) - Sloan School of Management ( email )

77 Massachusetts Ave. E62-663
Cambridge, MA 02142
United States

Sophie Herscovici

Massachusetts Institute of Technology (MIT) ( email )

77 Massachusetts Avenue
50 Memorial Drive
Cambridge, MA 02139-4307
United States

Stuart E. Madnick (Contact Author)

Massachusetts Institute of Technology (MIT) - Sloan School of Management ( email )

E53-321
Cambridge, MA 02142
United States
617-253-6671 (Phone)
617-253-3321 (Fax)

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