Electronics
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
Medical Device Developments /
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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,
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