Securing medical devices is not a new challenge. Former Vice President Cheney, for example, had the wireless capabilities of a defibrillator disabled when implanted near his heart in 2007, and hospital IT departments and health providers have for years secured medical devices to protect patient data and meet HIPAA requirements.
With the expansion of security perimeters, the surge in telehealth usage (particularly during COVID-19), and proliferation in the number and types of connected technologies, healthcare cybersecurity has evolved into a more complex and urgent effort.
Today, larger hospital systems have approximately 350,000+ medical devices running simultaneously. On top of this, millions of additional connected devices are maintained by the patients themselves. Over the next 10 years, it’s estimated the number of connected medical devices could increase to roughly 50 billion, driven by innovations such as 5G, edge computing, and more. This rise in connectivity has increased the threat of cyberattacks not just to patient data, but also patient safety. Vulnerabilities in healthcare technology (e.g., an MRI machine or pacemaker) can lead to patient harm if diagnoses are delayed or the right treatments don’t get to the right people.
What can the healthcare industry do to strengthen their defenses today? How can they lay the groundwork for more secure devices and networks tomorrow?
The challenges are interconnected. The solutions cannot be siloed, and collaboration between manufacturers, doctors, healthcare delivery organizations and regulators is more critical now than ever before.
Device manufacturers: Integrating security into product design
Many organizations view medical device cybersecurity as protecting technology while it is deployed as part of a local network. Yet medical devices also need to be designed and developed with mobile and cloud security in mind, with thoughtful consideration about the patient experience. It is especially important we take this step as medical technology moves beyond the four walls of the hospital and into the homes of patients. The connected device itself needs to be secure, as opposed to the network surrounding the device.
We also need greater visibility and transparency across the medical device supply chain—a “software bill of materials.” The multicomponent nature of many medical products, such as insulin pumps or pacemakers, make the final product feel like a black box: hospitals and users know what it’s intended to do, but they don’t have much understanding about the individual components that make everything work. That makes it difficult to solve cybersecurity problems as they arise.
According to the 2019 HIMSS Cybersecurity Survey, just over 15% of significant security issues were initially started through either medical device problems in hospitals or vendor medical devices. As a result, some of these issues led to ransomware attacks exposing vulnerabilities, as healthcare providers and device makers scrambled to figure out just which of the products were at risk, while their systems were under threat. A software bill of materials would have helped them respond quickly to security, license, and operational risks.
Healthcare delivery organizations: Prioritizing preparedness and patient education
Healthcare providers, for their part, need to strengthen their threat awareness and preparedness, thinking about security from device procurement all the way to the sunsetting of legacy devices, which can extend over years and decades.
It’s currently not uncommon for healthcare facilities to use legacy technology that is 15 to 20 years old. Many of these devices are no longer supported and their security doesn’t meet the baseline of today’s evolving threats. However, as there is no replacement technology that serves the same functions, we need to provide heightened monitoring of these devices.
Threat modeling can help hospitals and providers understand their risks and increase resilience. Training and preparedness exercises are imperative in another critical area of cybersecurity: the humans operating the devices. Such exercises can put doctors, for instance, in an emergency treatment scenario with a malfunctioning device, and the discussions that follow provide valuable opportunities to educate, build awareness of, and proactively prepare for cyber threats.
Providers might consider “cybersecurity informed consent” to educate patients. When a patient signs a form before a procedure that acknowledges potential risks like infection or side effects, cyber-informed consent could include risks related to data breaches, denial of service attacks, ransomware, and more. It’s an opportunity to both manage risk and engage patients in conversations about cybersecurity, increasing trust in the technology that is essential for their health.
Regulators: Connecting a complex marketplace
The healthcare industry in the US is tremendously complex, comprised of hundreds of large healthcare systems, thousands of groups of physician practices, public and private payers, medical device manufacturers, software companies, and so on.
This expanding healthcare ecosystem can make it difficult to coordinate. Groups like the Food & Drug Administration (FDA) and the Healthcare Sector Coordinating Council have been rising to the challenge.
They’ve assembled subgroups and task forces in areas like device development and the treatment of legacy technologies. They’ve been reaching out to hospitals, patients, medical device manufacturers, and others to strengthen information-sharing and preparedness, to move toward a more open, collaborative cybersecurity environment.
Last year, the FDA issued a safety communication to alert health care providers and patients about cybersecurity vulnerabilities identified in a wireless telemetry technology used for communication that impacted more than 20 types of implantable cardiac devices, programmers, and home monitors. Later in 2019, the same device maker recalled thousands of insulin pumps due to unpatchable cyber vulnerabilities.
These are but two examples of many that demonstrate not only the impact of cybersecurity to patient health but to device makers and the healthcare system at large. Connected health should give patients access to approved technologies that can save lives without introducing risks to patient safety.
As the world continues to realize the promise of connected technologies, we must monitor threats, manage risks, and increase our network resilience. Working together to incorporate cybersecurity into device design, industry regulations, provider resilience, and patient education are where we should start.
Contributing author: Shannon Lantzy, Chief Scientist, Booz Allen Hamilton.