Risk Assessment Framework for Evaluation of Cybersecurity Threats and Vulnerabilities in Medical Devices
Date of Award
Jeffrey T. McDonald, Ph.D
Dr. Harold Pardue, Dr. Brad Glisson, Dr. Mike Jacobs, Dr. Todd Andel
Medical devices are vulnerable to cybersecurity exploitation and, while they can provide improvements to clinical care, they can put healthcare organizations and their patients at risk of adverse impacts. Evidence has shown that the proliferation of devices on medical networks present cybersecurity challenges for healthcare organizations due to their lack of built-in cybersecurity controls and the inability for organizations to implement security controls on them. The negative impacts of cybersecurity exploitation in healthcare can include the loss of patient confidentiality, risk to patient safety, negative financial consequences for the organization, and loss of business reputation. Assessing the risk of vulnerabilities and threats to medical devices can inform healthcare organizations toward prioritization of resources to reduce risk most effectively. In this research, we build upon a database-driven approach to risk assessment that is based on the elements of threat, vulnerability, asset, and control (TVA-C). We contribute a novel framework for the cybersecurity risk assessment of medical devices. Using a series of papers, we answer questions related to the risk assessment of networked medical devices. We first conducted a case study empirical analysis that determined the scope of security vulnerabilities in a typical computerized medical environment. We then created a cybersecurity risk framework to identify threats and vulnerabilities to medical devices and produce a quantified risk assessment. These results supported actionable decision making at managerial and operational levels of a typical healthcare organization. Finally, we applied the framework using a data set of medical devices received from a partnering healthcare organization. We compare the assessment results of our framework to a commercial risk assessment vulnerability management system used to analyze the same assets. The study also compares our framework results to the NIST Common Vulnerability Scoring System (CVSS) scores related to identified vulnerabilities reported through the Common Vulnerability and Exposure (CVE) program. As a result of these studies, we recognize several contributions to the area of healthcare cybersecurity. To begin with, we provide the first comprehensive vulnerability assessment of a robotic surgical environment, using a da Vinci surgical robot along with its supporting computing assets. This assessment supports the assertion that networked computer environments are at risk of being compromised in healthcare facilities. Next, our framework, known as MedDevRisk, provides a novel method for risk quantification. In addition, our assessment approach uniquely considers the assets that are of value to a medical organization, going beyond the medical device itself. Finally, our incorporation of risk scenarios into the framework represents a novel approach to medical device risk assessment, which was synthesized from other well-known standards. To our knowledge, our research is the first to apply a quantified assessment framework to the problem area of healthcare cybersecurity and medical networked devices. We would conclude that a reduction in the uncertainty about the riskiness of the cybersecurity status of medical devices can be achieved using this framework.
Van Devender, Maureen S., "Risk Assessment Framework for Evaluation of Cybersecurity Threats and Vulnerabilities in Medical Devices" (2023). Theses and Dissertations. 147.