Securing the Internet of Healthcare

50 Pages Posted: 24 Feb 2018 Last revised: 4 Jun 2018

See all articles by Scott Shackelford

Scott Shackelford

Indiana University - Kelley School of Business - Department of Business Law; Harvard Kennedy School Belfer Center for Science & International Affairs; Center for Applied Cybersecurity Research; Stanford Center for Internet and Society; Stanford Law School

Michael Mattioli

Indiana University Maurer School of Law

Steven Myers

Indiana University; Indiana University Bloomington - Center for Applied Cybersecurity Research

Austin E. Brady

Indiana University Maurer School of Law; Indiana University-Bloomington, Cybersecurity Program

Yvette Wang

Indiana University Maurer School of Law

Stephanie Wong

Indiana University Bloomington, Maruer School of Law, Students

Date Written: February 22, 2018

Abstract

Cybersecurity, including the security of information technology (IT), is a critical requirement in ensuring society trusts, and therefore can benefit from, modern technology. Problematically, though, rarely a day goes by without a news story related to how critical data has been exposed, exfiltrated, or otherwise inappropriately used or accessed as a result of supply chain vulnerabilities. From the Russian government's campaign to influence the 2016 U.S. presidential election to the September 2017 Equifax breach of more than 140-million Americans' credit reports, mitigating cyber risk has become a topic of conversation in boardrooms and the White House, on Wall Street and Main Street. But oftentimes these discussions miss the problems replete in the often-expansive supply chains on which many of these products and services we depend on are built; this is particularly true in the medical device context. The problem recently made national news with the FDA-mandated recall of more than 400,000 pacemakers that were found to be vulnerable to hackers necessitating a firmware update. This Article explores the myriad vulnerabilities in the supply chain for medical devices, investigates existing FDA cybersecurity and privacy regulations to identify any potential governance gaps, and suggests a path forward to boost cybersecurity due diligence for manufacturers by making use of new approaches and technologies, including blockchain.

Keywords: medical device, cybersecurity, supply chain, blockchain, FDA

Suggested Citation

Shackelford, Scott J. and Mattioli, Michael and Myers, Steven and Brady, Austin E. and Wang, Ruihan and Wong, Stephanie, Securing the Internet of Healthcare (February 22, 2018). Minnesota Journal of Law, Science & Technology, 2018; Kelley School of Business Research Paper No. 18-16. Available at SSRN: https://ssrn.com/abstract=3128683

Scott J. Shackelford (Contact Author)

Indiana University - Kelley School of Business - Department of Business Law ( email )

Bloomington, IN 47405
United States

Harvard Kennedy School Belfer Center for Science & International Affairs ( email )

79 JFK Street
Cambridge, MA 02138
United States

Center for Applied Cybersecurity Research ( email )

Wylie Hall 105
100 South Woodlawn
Bloomington, IN 47405
United States

Stanford Center for Internet and Society ( email )

Palo Alto, CA
United States

Stanford Law School ( email )

Stanford, CA 94305
United States

Michael Mattioli

Indiana University Maurer School of Law ( email )

211 S. Indiana Avenue
Bloomington, IN 47405
United States

HOME PAGE: http://www.michaelmattioli.org

Steven Myers

Indiana University ( email )

107 S Indiana Ave
100 South Woodlawn
Bloomington, IN 47405
United States

Indiana University Bloomington - Center for Applied Cybersecurity Research ( email )

Wylie Hall 105
100 South Woodlawn
Bloomington, IN 47405
United States

Austin E. Brady

Indiana University Maurer School of Law ( email )

Bloomington, IN
United States

Indiana University-Bloomington, Cybersecurity Program ( email )

Bloomington, IN
United States

Ruihan Wang

Indiana University Maurer School of Law ( email )

211 S Indiana Ave
Bloomington, IN 47405
United States

Stephanie Wong

Indiana University Bloomington, Maruer School of Law, Students ( email )

Bloomington, IN
United States

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