Rebecca HeroldNews of medical device security flaws are increasingly in the news. Consider the announcement from the U.S. Food & Drug Administration last year about a flaw in one model of a St. Jude Medical implantable pacemaker. This was subsequently covered in more than 14,000 published reports to date. Thirty-four different individuals sent me a message soon after the news broke, asking if I had heard about the approximately 750,000 pacemakers of this specific model that had significant security vulnerabilities. Many reports about other types of wirelessly connected medical device flaws occurred prior to that, and more have been reported in the few months since.

Medical devices are integral parts of hospital networks
According to various estimates from research organizations – and healthcare CISOs I chatted with at the Detroit SecureWorld event last fall, where I delivered a keynote about medical devices – anywhere from 30-70% of medical devices within hospitals and clinics are smart”… digitally connected to smartphones, the internet, clinic networks, directly to other devices, etc. These large numbers of medical devices attached to healthcare networks increase the possibilities for a wide range of security and privacy incidents to occur through exploiting their vulnerabilities – especially from and through the medical devices that have no legitimate security controls engineered within them.

Security and privacy incidents can occur due to various factors, such as:

  • Malicious outsider intent – hackers who use such things as ransomware, DDoS bots and other malware to shut down and disrupt network availability, exfiltrate and/or modify data, delete data, etc.
  • Malicious insider intent – inappropriately accessing patient data, using patient data for identity fraud and other crimes, selling patient data to criminals, etc.
  • Mistakes – input errors, programming errors, accidentally opening access to unauthorized individuals, etc.
  • Unintended consequences resulting from lack of planning – attaching smart medical devices to the network that the anti-malware software views as malicious, and subsequently shuts off, creating a denial of service as a result of data volume going beyond bandwidth capabilities, etc.
  • Lack of personnel information security and privacy awareness, which can lead to all the previous examples, in addition to knowingly taking actions that result in privacy breaches, data modification, patient harm, etc.

Security complexity requires multiple layers of controls
Some changes to medical devices can be done remotely. Some need to be done in proximity using near field communication (NFC) protocols. However, I’ve communicated with too many in the medical device industry who have expressed belief, or claimed, that using NFC is a 100% solution for security. When I asked upon three different occasions in 2017 about the security of their newly announced medical devices, representatives (IT security VPs/management) from each of three different large medical device manufacturers told me, “We use NFC, so security is not an issue.” When I explained that if medical devices attach via NFC to computers that are part of a network, then basically any other node on that network may be able to get to the medical device through that network connection, such as through control settings necessary for network functions, or through the use of discovery tools such as Shodan, each of the medical device representatives stopped communicating with me. Avoiding a security risk discussion does not solve the associated security risk.

Lack of planning and integrating with networks and systems can shut down medical devices, sometimes during operations. There have already been medical devices used for performing operations, such as heart procedures, that shut down as a result of an anti-virus scan. Or, the time a nurse tried charging her cellphone using the USB port in an anesthesia machine; it shut down the machine. I could provide a hundred additional examples. If medical device manufacturers do not improve the security engineering of their medical devices, security incidents will increase, along with privacy breaches and patient harm.

Medical device security concerns are justified
Healthcare providers (doctors, nurses and surgeons) are concerned. Rightly so. Flawed devices negatively impact their ability to assure patients they are providing them with safe devices that will help, and not potentially harm, them.

Healthcare information security practitioners (CISOs, CIOs, VPs, managers, etc.) are concerned. And for good reason. Security flaws within medical devices create vulnerabilities to data and functioning not only within the devices themselves, but also to the networks to which they are attached, and other devices on the networks.

Healthcare IT auditors are concerned. And they should be. Insufficient medical device security controls are compliance violations for growing numbers of regulations, laws and contractual requirements, in addition to facilities’ own posted privacy and security notices, which contain promises to which they are legally bound.

Healthcare regulators are increasingly concerned. Justifiably so. They are accountable for ensuring information security and privacy regulations are followed. When regulators see more reports of medical device security flaws and vulnerabilities, they are going to become more proactive to pressure medical device-makers to improve security controls, and to pressure device users to ensure devices are implemented with appropriate security.

Patients are concerned. Of course. Their lives could be at stake.

Dedicate 2018 to improving medical device security
As Data Privacy Day approaches this Sunday, here’s a recommendation for those in the medical device space (manufacturers, engineers, and vendors). Make it a goal in 2018 to successfully establish effective and practical information security controls within your devices. Stop telling hospitals and clinics that it is not practical for you to do this. It is actually more practical, and will significantly improve security protections for those using medical devices, to build the security controls into the devices from the start. This idea is supported by not only those in the information security profession, but also by the FDA and other regulators.

This will not let healthcare data security practitioners off the hook. Even if medical device creators improve the security of their devices, healthcare IT and security practitioners will still need to remain diligent to ensure the security of those devices in how they are connected to their networks, the control settings to access them, and the management of the data that comes from them. But improved device security will support these efforts.

Establish your baseline for current levels of medical device security now. Then, in December of this year, determine if and where there have been improvements, or if data security, privacy and patient protections have actually degraded. It all depends upon where medical device companies decide to place their priorities.

Rebecca Herold, President, SIMBUS, LLC and CEO, The Privacy Professor®

[ISACA Now Blog]

By Philip Hung Cao

Philip Hung Cao (aka #tekfarmer), MSCS, ZTX-I, CCISO, CISM, CCSP, CCSK, CASP, GICSP, PCNSE is a Strategist, Advisor, Contributor, Educator and Motivator. He has 20 years' experience in IT/Cybersecurity industry in various sectors & positions.

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