UK: Managing Medical Device Security Risk

Last Updated: 15 August 2017
Article by Vanessa Lim, Russell Jones and Nick Sikorski

Most Read Contributor in UK, August 2017

This week's blog appeared as an article in Deloitte Insights in the CIO Journal from The Wall Street Journal last month and is written by our colleagues in the US: Veronica Lim, Principle; Russell Jones, partner; and Nick Sikorski, senior consultant. The article, linked to a Dbrief Webcast in May 2017 titled Medical devices and the Internet of Things: A three-layer defence against cyber threats, discusses the cyber security issues affecting new and legacy medical devices and the strategies companies can use to mitigate the risks associated with them.

Security Risk

Over the past 50 years, connected medical devices have evolved significantly mainly due to technological innovations. For example, the earliest insulin pump was essentially a backpack insulin delivery system with no connectivity, no local data storage, and limited mobility. Fast forward to present day, and insulin pumps are typically connected systems that allow for automated blood glucose motioning and insulin administration, and remote monitoring and interaction with physicians. Many have internet connectivity, local data storage and cloud usage, and, through smartphone apps, high mobility.

There is a growing generation of medical equipment that communicates via a private network, public internet or point-to-point connection (wired or wireless). They are some of the newest and most distributed endpoints in what we might call the Internet of Medicine—and they can make patients' lives easier, improve health outcomes and save lives.

The growth of connected medical devices may also render them susceptible to cybersecurity attacks, as evidenced by the number and severity of cyber incidents reported over the past year that has wreaked havoc on many health care systems across the globe.1

Defending connected medical devices from security threats has become a critical imperative for leaders of both device manufacturers and health care providers. Improperly secured medical devices can pose a risk to patient safety and also to hospital systems because cybercriminals can use them as entry points into hospital networks.

It's a new frontier of risk for Chief Information Officers (CIO) and cybersecurity professionals in life sciences and health care organizations. By working with product engineers, tech leaders can apply industry-leading medical device risk management practices, from bolstering product quality and safety to identifying, protecting, detecting, responding to, and recovering from medical device security threats.

Strengthening the Weakest Links

Connected medical devices are often the weakest links in health care networks because updating, patching, or replacing the thousands of devices in use can be a daunting task. According to a poll of attendees of a recent Deloitte webinar, the largest cybersecurity challenge for the industry is identifying and mitigating cybersecurity threats to legacy-connected medical devices already in the field.

Many countries are beginning to address this emergent risk with regulatory policy led by the FDA. The FDA has issued pre- and post-market guidance aimed at reducing uncontrolled risk to patient safety through guidelines to secure connected medical devices throughout their life cycle and across stakeholders. Additionally, industry groups such as the Association for the Advancement of Medical Instrumentation (AAMI) have released security risk management guidance for connected medical devices. Following several years of development, the European Commission (EC) has also produced new rules in 2017 to ensure the safety of medical devices in the future. The new Regulations aim to increase security and regulatory certainty and take into account the latest developments in the sector, including medical software, apps and cybersecurity practices.2

Device manufacturers and health care providers have also taken steps to bolster their security practices. Manufacturers are working to secure devices prior to deploying them, and are conducting technical security testing and security-risk assessment on devices while in development. They have also increased efforts to coordinate with the security community, customers, and others to disclose vulnerabilities and share information aimed at helping secure their devices. For health care providers, it is typical to scrutinize the security of medical devices prior to procuring them, meaning they are more apt to reject devices if they fail to meet certain security requirements.

Despite these efforts, deployed and legacy devices often continue to pose significant security risks. When it comes to identifying and mitigating those risks, the industry generally has much more work to do. Many product engineers and architects lack the training they need to design safe and secure medical devices. Additionally, many manufacturers and providers have relatively immature incident response processes, making it difficult to monitor, respond to, and contain breaches when they do occur. While manufacturers and providers have begun to increase headcount for medical device security, staffing often remains inadequate at addressing the full scope of device security needs.

Integrating Traditional IT and Medical Device Security

CIOs can play a significant role in helping the industry get its arms around the complex issue of securing connected medical devices. In the past, product developers and enterprise IT barely spoke, let alone collaborated to manage the risks of connected medical devices. The product side traditionally remained focused on manufacturing secure devices based on market demand, while IT's information security efforts were aimed at ensuring the confidentiality, integrity, and availability of corporate information assets.

Now the security of connected medical devices and the hospital IT environment are interdependent. In this environment, the most effective programs for mitigating cybersecurity risk involve collaboration between these organizations.

In fact, there are areas of overlap in medical device development and enterprise IT cyber risk mitigation practices, such as the management of security operations centers, adherence to secure development life cycles, and cybersecurity education and training. Rather than continue managing risk independently, the two groups can come together to provide more cohesive threat and vulnerability prevention, management, and remediation.

Building a Three-Layer Defence

IT and medical device security leaders can work proactively to secure connected medical devices by establishing a three-layer defence made up of documentation hierarchy, product security risk management, and security event and incident handling.Much of what has constituted medical device security practices

Much of what has constituted medical device security practices has been ad hoc and device-specific. The first step is establishing a medical device documentation hierarchy by turning institutional knowledge into formal policy to direct medical device security activities. IT and medical device security leaders can apply standard quality management approaches to cybersecurity, and build a platform of standards, procedures, and more detailed work instructions and templates to guide IT and medical device security professionals and engineers. Such an approach can be helpful—should a regulatory inquiry occur—and invaluable in times of crisis.

Secondly, IT and medical device security leaders can partner on product security risk management activities. The health care industry has decades of experience ensuring that medical devices are safe before they go to market—and they can take a similar approach to make them cyber resilient. Security risk management activities performed throughout the device life cycle can help identify, measure, and mitigate threats and also can inform the board and key stakeholders about the risk landscape.

Finally, IT and medical device security leaders can conduct thorough security event and incident handling activities, including forensic investigations to uncover breach sources, reducing exposure and reputational impact, and informing risk assessment and policy. Gathering intelligence about who attacked, what they did, and how they did it can help companies limit the damage, manage their response, and adapt for the future.

These three lines of defence can collectively address the risks presented by connected medical devices while protecting patients and corporate assets. IT and medical device security leaders, along with other key stakeholders, such as regulators, security researchers, academics, and government agencies, could benefit from focusing on these defence layers as potential threats to connected medical devices and the ecosystems in which they operate.

Footnotes

1. "Medical Devices Hit by Ransomware for the First Time in U.S. Hospitals," Forbes, May 17, 2017.

2. http://europa.eu/rapid/press-release_MEMO-17-848_en.htm

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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