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Guidance on Securing Wireless Infusion Pumps Issued by NIST

The National Institute of Standards and Technology (NIST), in collaboration with the National Cybersecurity Center of Excellence (NCCoE), has released new guidance for healthcare delivery organizations on securing wireless infusion pumps to prevent unauthorized access.

Infusion pumps, and many other medical devices, used to interact only with the patient and healthcare provider; however, advances in technology have improved functionality and now the devices can interact with a much wider range of healthcare systems and networks.  The additional functionality of the devices has allowed vulnerabilities to be introduced that could be easily exploited to cause patients to come to harm.

Wireless infusion pumps are of particular concern. Vulnerabilities could be exploited by malicious actors allowing drug doses to be altered, the functioning of the infusion pumps to be changed or patients’ protected health information to be accessed.  Typically, the devices have poor cybersecurity protections in place to prevent unauthorized access.

The risks introduced by the devices have been widely reported in recent years. While no cyberattacks are known to have resulted in patients coming to harm, there is considerable potential for malicious actors to hack the devices unless action is taken to improve device security.

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The 246-page guidance on securing wireless infusion pumps was written following collaboration with a wide range of security companies following a January 2016 request submitted in the federal register.

NIST and NCCoE conducted questionnaire-based risk assessments to analyze risk factors and signed a Cooperative Research and Development Agreement with B. Braun Medical Inc, Baxter Healthcare Corporation, Becton, Dickinson and Company, Cisco, Clearwater Compliance, DigiCert, Hospira Inc., Intercede, MDISS, PFP Cybersecurity, Ramparts, Smiths Medical, Symantec Corporation, TDi Technologies, Inc., and The MITRE Corporation, all of which helped to develop an example solution.

The guidance offers best practices that can be adopted to improve the security of wireless infusion pumps, mitigate vulnerabilities and protect against threats. The document includes a list of potential vulnerabilities and a questionnaire-based risk assessment that can be used by healthcare organizations to identify risks. The risk assessment maps security characteristics to HIPAA Security Rule requirements and available cybersecurity standards.

“Based on our risk assessment findings, we apply security controls to the pump’s ecosystem to create a ‘defense-in-depth’ solution for protecting infusion pumps and their surrounding systems against various risk factors,” explained NIST in the guidance.

Several commercially available technologies and tools are available to healthcare organizations that allow them to plug vulnerabilities and make it harder for unauthorized individuals to gain access to the devices, some of which have been detailed in the report along with product installation guides and suggested configurations.

NIST says, “Ultimately, we show how biomedical, networking, and cybersecurity engineers and IT professionals can securely configure and deploy wireless infusion pumps to reduce cybersecurity risk.”

The guidance on securing wireless infusion pumps (NIST Special Publication 1800-8) can be downloaded on this link.

Image Source: J. Stoughton/NIST

Author: Steve Alder is the editor-in-chief of HIPAA Journal. Steve is responsible for editorial policy regarding the topics covered on HIPAA Journal. He is a specialist on healthcare industry legal and regulatory affairs, and has several years of experience writing about HIPAA and other related legal topics. Steve has developed a deep understanding of regulatory issues surrounding the use of information technology in the healthcare industry and has written hundreds of articles on HIPAA-related topics.