In the past ten years, the rapid incorporation of digital health devices into healthcare systems has brought about a paradigm shift in patient care. More than ever, clinical operations depend on the data flow between an interconnected network of devices and software. And while this smarter, more connected way of working has generally led to safer, more efficient patient care, it has also made the healthcare sector an increasingly attractive target for cyber criminals who, if they can effectively disrupt that data flow, have the power to bring hospitals to a complete standstill.
“Cyber threats to the healthcare industry used to be about data being stolen and sold,” says Michelle Jump, who started working in the medical device sector in 2010 and is now CEO of MedSec, a firm that provides cybersecurity services for medical device manufacturers. But, in 2017, when the WannaCry ransomware attack severely disrupted healthcare organisations worldwide, including nearly 80 hospital trusts in the UK, it became clear that the threat to the healthcare industry from cyber criminals had become much more serious.
The more devices are interconnected, the larger the attack surface is for hackers and the more crippling it is for a hospital if those systems are unable to communicate with each other. “In a ransomware attack, the cyber attackers encrypt all your data until you pay them to get it released,” Jump explains. “Essentially, because hospitals are now so dependent on interconnectivity and data availability to operate safely, we went from data being stolen and sold to the shutdown of entire hospitals.”
And the consequences of that extend far beyond mere inconvenience, stresses Nimi Ocholi, VP, R&D, product security for BD. “Patient care can be interrupted and even compromised when medical devices cannot be used or trusted due to a cyberattack,” he says. “While BD views smart, connected care as a positive force driving the future of healthcare, it also means that healthcare providers and medical device manufacturers must be even more vigilant than in the past and implement robust cybersecurity measures that prioritise patient safety in the face of increasing cybersecurity threats.”
Understanding risks and vulnerabilities
As medical devices often serve as the point of entry for hackers trying to access a healthcare system’s network, manufacturers have had to start approaching device design in a new way, with a much greater focus on the post-market space and how they maintain devices’ digital security in the long run.
“It’s no longer about the product just breaking because of physics. Manufacturers now have to think about how malicious actors can actively seek to break devices,” Jump explains. “And once a device is designed and on the market, hackers don’t go to sleep – they are always trying to find new vulnerabilities in products. As they get better and better at it, we have to get better and better too.”
For this reason, cybersecurity risk management has now become a critical part of the medical device development process, something that may not sound like a huge shift for an industry that is by its very nature risk averse but, Jump says, is something she has seen some manufacturers struggle with.
“Manufacturers have a great track record of understanding and utilising risk management activities in everything they do, because they have to demonstrate they have safe and effective devices, and that centres around risk management,” she explains. “The problem is that security risk management is a parallel but distinctly different process. Manufacturers need to know how to identify and score all of their security risks. Every decision they make has to be documented and justified. This process is quite new to the industry and requires a certain level of understanding of how security attackers function.”
A key part of this process is threat modelling. “This is where you take a look at the design of the device and ask, ‘Where could someone attack this?’ Once you find those soft spots in the design, you feed that into risk management,” Jump explains.
But understanding cyber risks is not enough in itself. “Before they take a product to market, regulations also mandate that manufacturers must give it to somebody and have them try to break it,” Jump continues. “It’s not just a single risk that you’re looking at. An experienced hacker will start to leverage different kinds of vulnerabilities in order to get deeper into your device and to get to more things. It’s a collection of risks and vulnerabilities.”
“It’s no longer about the product just breaking because of physics. Manufacturers now have to think about how malicious actors can actively seek to break devices.”
Michelle Jump
Cybersecurity: a team sport
Due to the evolving nature of cybersecurity threats to the healthcare sector, the market for cybersecurity in medical devices is growing rapidly. According to GlobalData, it will increase at a CAGR of 12.2% between 2022 and 2027, reaching $1.1bn. Anecdotally, Jump has also seen enormous growth in the investment medical device manufacturers are making in both in-house cybersecurity expertise and collaboration with external experts, such as penetration testers.
As Ocholi explains, cybersecurity is a team sport. “Embracing a community of practice approach is part of helping the industry advance and mature its cybersecurity capabilities,” he explains. “Cybersecurity testing, including vulnerability scanning and penetration testing, is part of our total life cycle management approach to protecting BD products. We conduct robust cybersecurity testing on our products, and we also partner with external third parties for additional penetration testing, where suitable. We value collaboration with ethical hackers, as well, to identify opportunities to further strengthen our products and the environments in which they operate.”
It’s all part of the BD Cybersecurity Framework, a blueprint that is aligned to multiple industry standards, including those from the International Organization for Standardization (ISO) and the National Institute of Standards and Technology (NIST). “This framework incorporates design requirements, including cybersecurity risk assessment, penetration testing, vulnerability scanning, threat modelling, code analysis, system hardening and continuous vulnerability management,” Ocholi explains.
BD has also updated the framework to account for new cybersecurity requirements, such as providing a software bill of materials, which is now required for medical devices brought to market in the US.
Usability and security: how to strike the balance
One area that can be tricky for both medical device manufacturers and healthcare providers to navigate is striking the right balance between usability and cybersecurity. As Jump says, “They are usually at odds with each other. For example, a manufacturer might want to put in two-factor authentication to make a connected device more secure, but there’s a chance you’re going to tick off doctors, especially if it’s for emergency use.
“There’s always a risk versus usability trade-off. You have to put in the right kinds of controls but you also have to communicate with hospitals about why you’ve put those controls in. And sometimes hospitals will make decisions whereby they sacrifice a bit of security in order to enhance usability, or vice versa. But the manufacturer has a responsibility to explain those choices and what the risk trade off is.”
In the US, for example, FDA requirements for cybersecurity labelling require device manufacturers to provide users with information for managing security risks. According to Ocholi, achieving seamless interoperability without compromising security requires robust planning, testing and collaboration in the clinical environment.
Another challenge manufacturers often face is advancing cybersecurity while serving customers where they are, with the devices they have in use. “In reality, the usability of a medical device often extends beyond its intended useful life. This is why communicating a clear End of Support (EOS) strategy for legacy devices is critical, so healthcare providers can make informed and timely decisions about maintaining and upgrading devices without compromising patient care or security,” he says.
BD collaborates with customers to enable them to secure and maintain BD products throughout their intended life cycle. This includes everything from implementation guidance to communicating about potential vulnerabilities, patch management and options for updating systems to increase performance and security.
A continuous learning process
Jump and Ocholi have been encouraged to see the progress the medical device industry has made on both the legislative and cyber literacy fronts over recent years. As regulatory standards have risen around the world, says Jump, it has become mission critical for manufacturers to implement processes like cybersecurity risk management and ensure they have a comprehensive post-market plan for their products in order to get them to market. “When guidelines became law, we saw a real groundswell of change and we’ve now hit a point where we have a common set of rules that most regulators agree with, which set the bar pretty high,” she notes.
Ocholi has also seen cybersecurity awareness training become more common in hospitals, which is resulting in clinicians becoming more familiar with cybersecurity controls and risk management practices, another element that is crucial to securing healthcare environments. “Training employees to recognize and report potential threats can significantly reduce the impact of cyberattacks in the healthcare setting,” he notes. “This includes everything from recognising phishing and social engineering attacks, to following manufacturer guidelines for implementing and using medical devices in the care setting – from the hospital to the pharmacy, and even at home.”
Of course, cyber attacks are only going to continue to become more sophisticated, frequent and adaptive. From Ocholi’s perspective, this means medical device players must seek to continuously learn from and contribute to the broader community of cybersecurity working groups and advocacy organisations in healthcare, from customers to government agencies to cybersecurity working groups and security researchers. For example, BD engages with multiple organisations that enable two-way dialogue between regulatory bodies and medical device manufacturers, such as the Healthcare Sector Coordinating Council (HSCC) and the Medical Device Innovation Consortium (MDIC). Cyber criminals won’t let up – and neither can the medical device industry, on any front.
