Electronics
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
Medical Device Developments /
www.nsmedicaldevices.com
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. ●
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With the increased threat of cyber attacks, healthcare settings have been ramping up their staff cybersecurity training programmes.
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