How to ensure the cybersecurity of medical devices?

The pandemic has led to a leap forward in medical technology. Connected medical devices have reformed healthcare in many ways, but they also come with a new set of challenges. Cybersecurity risks should already be managed in the design phase of product development. But how do medical manufacturers ensure their devices are resilient to potential attacks?

In 2020, the role of telehealth proved to be crucial, reducing disease exposure among both patients and healthcare workers. We have witnessed extraordinary developments in the fields of teleradiology and telepathology. The proliferation of digital point-of-care devices was equally remarkable, allowing for in-vitro diagnostics.

Other connectable devices are becoming widely usable in our homes, including glucose meters, insulin pumps, or smart insulin pens for diabetes. Even in fitness, internet-connected biometrics have emerged and are becoming an integral part of healthcare. Finally, it is worth mentioning biosensors, which can reduce the reliance on traditional laboratory techniques. They provide immediate, on-site diagnostics and do not require sample pre-treatment.

Such interconnectedness means more and more patients wish to share clinical information with hospitals, caregivers, and insurers. Access to data will be a critical part of the decentralization of diagnostics, and an IT segment is expected to emerge to deal with sensitive medical information.

Alarmingly, the proliferation of such tools also increases the threat of cybersecurity attacks. Hence, it is inevitable to include safety considerations in the design of medical devices. Currently, there are no laws that require cybersecurity tests to take place. However, most guidance standards indicate that such a scan should be considered. Manufacturers and health organizations that fail to guarantee the security of their medical devices can expect heavy repercussions, both financially and in terms of their reputation.

Protecting connected medical devices requires a continuous lifecycle approach whereby cybersecurity is an integral part of product development. Security now needs a seat at the design table: many weaknesses are due to poor design choices and the lack of clear-cut requirements. A review from a security expert can uncover security vulnerabilities, which can be mitigated during development long before the product goes into manufacturing.

Ideally, global security assessment takes place in the design and development phase, including risk management analysis and ensuring that the design features meet general requirements. Later, in the testing and verification phase, penetration tests and vulnerability scans must be taken to ensure the device is resilient to cyberattacks. Eventually, an IT security assessment takes place right before the product's approval.

While you can conduct these tests on your own if you have the appropriate competencies within your organization, it's typically an impartial third party who oversees the process. Depending on the provider you choose, you may also benefit from a broader knowledge of your industry.

Not sure where to test the cybersecurity of your medical device? Visit LabShare’s platform, register for free, and choose from a multitude of laboratories all over the world.