The healthcare industry continues to be bombarded with security attacks, and these cyber attacks are continuously evolving and become more sophisticated over time. At the same time, the healthcare ecosystem has become more connected with the increasing use of Internet of Things (IoT) medical devices, and these medical devices introduce vulnerabilities into healthcare organizations.
Unsecured and poorly secured medical devices put patients at risk of great harm if those devices are hacked, while also posing a threat to the security and privacy of patients’ protected health information (PHI). A recent medical device security report, the result of a collaborative effort between the College of Healthcare Information Management Executives (CHIME), the Association for Executives in Healthcare Information Security (AEHIS), and the Orem, Utah-based KLAS Research, sheds light on the current state of the medical device security industry. For the report, KLAS interviewed 148 CIOs, chief information security officers (CISOs), chief technology officers (CTOs) and other professionals at provider organizations to gauge their level of confidence in their medical device security strategies, the most common challenges they face, their perceptions of the security and transparency of major medical device manufacturers, and the best practices they leverage to overcome medical device security challenges.
The author of the report, Dan Czech, director, market analysis, cybersecurity at KLAS Research, will provide an in-depth overview of this report and medical device security trends during Healthcare Informatics’ Seattle Health IT Summit Oct. 22-23 at the Grand Hyatt Seattle.
The sheer number of connected medical devices that the average healthcare provider is trying to manage speaks to the tremendous challenge IT security leaders face, says Czech. “We spoke to organizations ranging from small to mid-sized clinics all the way to large multi-hospital IDNs (integrated delivery networks), and everyone in between, and the average number of connected medical devices was just under 10,000 medical devices. You think of the enormity of that problem, for an organization to wrap their arms around the problem of managing 10,000 devices,” he says.
What’s more, respondents reported that, among the thousands of connected medical devices that their organizations are managing, about one-third (33 percent) of those devices are “unpatchable.”
According to the research, 18 percent of provider organizations had medical devices impacted by malware or ransomware in the last 18 months, although few of these incidents resulted in compromised PHI or an audit by the Office for Civil Rights, U.S. Department of Health and Human Services (HHS OCR).
Czech notes that there have not been any patient safety events, to date, as a result of a medical device security issue; however, respondents cite patient safety as a top concern. “Let’s take an infusion pump,” he says. “The ability for a bad actor to gain access to that pump and change the dosage of the medication that’s being injected into a human, that is the kind of patient safety issue that we are concerned about.”
Czech continues, “Another way medical device security affects patient safety is if a device is on Windows XP, and WannaCry ransomware hits; if something like that happens, that device is taken out of production. You may have an oncology patient who needs consistent treatment with a medical device, and if you take that out of production, it disrupts patient care and impacts patient safety.”
The report found that most respondents are either neutral about or not confident in their current medical device security strategy, with CISOs and CIOs more likely to report concern. Only 39 percent of respondents said they were very confident or confident that their current strategy protects patient safety and prevents disruptions in care. Thirty-one percent said they were unconfident or very unconfident, and another 30 percent were neutral. About one-fifth of respondents feel that the inherent risks of medical devices—several of which are outside of their control—will prevent them from ever feeling confident.
Those healthcare leaders who expressed confidence most often point to their security processes and policies, including access limitations, network segmentation and regular device monitoring and risk assessment, as the source of their confidence, followed by strong technology. To support these processes and policies, many leverage security technologies, such as access controls, asset tracking, firewalls, and medical device monitoring. Strong executive support (financial and organizational) and cross-department collaboration also drive confidence, as evidenced by the fact that large IDNs, who more commonly have greater financial resources, are more likely to be confident in their strategies, according to the report.
“Respondents who report they are more confident also are those that have a clear line of ownership, not a shared responsibility,” Czech notes.
Those respondents that lacked confidence in their medical device security cited lack of manufacturer support as the top reason. Almost as common are internal issues related to basic—but hard-to-master—security tasks, such as understanding what assets exist in their organization, which have been patched, which are connected to their network, and what systems those devices are talking to. “Asset and inventory visibility is the basic blocking and tackling of medical device security strategy—you can’t protect what you don’t know. They are looking for tools and processes that they can put in place that will help them understand all the devices they have, what’s connected to their networks, and some cases, what software is on the devices” Czech says.
What’s more, 76 percent of provider organizations report that their resources are insufficient or too strained to adequately secure their medical devices.
More Manufacturer Support and Collaboration Needed
Taking a deep dive into the root causes of medical device security struggles, the report finds that interviewed organizations are almost unanimous in citing manufacturer-related factors as a cause of their medical device security issues. Most provider organization see this issue as one of shared responsibility. As one CISO explained in the report, “I think there needs to be a coordinated effort between the manufacturers, the provider sites, and the regulators. I wish there were some other way for us to address this issue, but without that three-way partnership, I just don’t see how things will work out.”
According to Czech, the research findings indicate there is a gap between how long organizations expect to be able to use a device and how long vendors feel they can keep a device up to date and secure. As a result, nearly all interviewed organizations (93 percent) have struggled with out-of-date operating systems or the inability to patch a device throughout its expected life cycle. Currently, many manufacturers do not allow customers to patch devices themselves, or void warranties if they do.
Insufficient security controls, insufficient encryption, and hardcoded passwords are each cited as manufacturer-caused issues by about half of respondents. Adding to provider organizations’ frustration, on average, almost one-third of medical device vendors decline to offer contract provisions favorable to security.
However, the industry is beginning to shift, Czech notes. "Many provider organizations have drawn a line in the sand to say all contracts now and going forward will include standardized security contract language," he says. "This trend has been led by forward-thinking provider organizations and it also has benefited smaller organizations that may not have the legal teams or the cybersecurity teams that bigger organizations have, but they can use that standardized language in their contracts as well."
What’s interesting, Czech notes, is that many respondents spontaneously brought up frustrations regarding the role of the U.S. Food and Drug Administration (FDA) in medical device security, though KLAS did not specifically ask respondents about it. “It gets back to shared responsibility,” he says. “Respondents feel that manufacturers have a stake in this, they have a stake in this, but so does the FDA. Predominantly, the concern that they shared was that their manufacturer would hide behind their perceptions of the FDA regulations."
Almost two-thirds of respondents said manufacturers blame FDA policies, claiming the policies prevent them from making devices more secure. About a third said FDA policies are unclear, giving manufacturers ways to skirt around responsibility and a third said that even when policies are clear, the FDA doesn’t hold manufacturers accountable, according to the report.
Cybersecurity Programs Advancing Forward
According to the research, organizations are increasingly adopting a number of best practices to strengthen medical device security. There are foundational best practices that organization should implement, such as performing risk assessments, ensuring the inclusion of security provisions in their contracts, and ensuring they receive a software bill of materials, Czech notes. Organizations also report using the most common and basic defense techniques such as network segmentation, antivirus software, and vulnerability scanning to ameliorate security risk.
With regards to organizations’ patching strategies, many provider organizations have begun requesting that vendors use contract language that clearly outlines patching responsibilities and timelines.
Providers also are leveraging third-party solutions to improve medical device security, with nearly 75 percent of respondents currently using or planning to use third-party software or services, according to the report. Network access control (NAC) is most often used to segment networks and approve/deny access. To reduce costs and clearly define ownership, other organizations outsource their clinical engineering as well.
Looking at overall cybersecurity trends, the report indicates that organizations are investing more resources, both operationally and financially, in their cybersecurity programs. Almost 70 percent of organizations (68 percent) report having a VP or C-level leader in charge of the security program, and that’s up from only 42 percent in 2017, representing a 26-percent increase.
“Large IDNs are definitely leading the way with CISO leadership, as about 80 percent of their organizations have a CISO in charge, whereas if you look at clinics and community hospitals, those would be hospitals under 200 beds, only less than 10 percent have a CISO in charge,” Czech says. “Many of those smaller organizations have a CIO that wears two hats—an IT hat and a security hat.”
Organizations also reported improvements to security programs compared to a year ago. Twenty-seven percent considered their security programs to be fully functional and 47 percent said they were developed or starting to function in 2018, compared to 16 percent and 41 percent, respectively, in 2017.
More than half of organizations (57 percent) report that security is an agenda item at board meetings monthly or quarterly. In addition, 83 percent of organizations have increased their security budget in the last two years, and, on average, budgets increased by 85 percent, according to the report.