Artificial intelligence (AI) has the potential to rapidly aid progress in the performance of medical devices. Yet, as the technology becomes ever more complex, questions of cybersecurity and trust arise. To ensure the safety of healthcare organizations, providers, and patients, it is more important than ever for manufacturers to implement advanced security controls into their medical devices.

AI holds enormous promise for streamlining medical diagnostics, managing patient and clinical data, and contributing to research and development of medical devices.

Recent developments have seen AI outperform expert radiologists at spotting breast cancer amongst other diagnostic successes. This has sparked an increase in investment in such technologies that is set to continue to grow significantly in the coming years.

While there is significant potential for AI in healthcare, there are also limitations. The primary challenge is how best to secure AI-powered connected medical devices from increasingly frequent and complex cybersecurity risks.

Cybersecurity and AI Medical Devices: What’s the risk?

Taking greater cybersecurity measures to protect medical devices is more important now than ever.

For more than a decade, healthcare has been the largest target for data breaches. Breaches of data in this context can have severe implications, as patients’ lives can be in danger from outdated and unprotected medical devices.

For example, a 2019 study from Ben-Gurion University demonstrated how hackers could manipulate CT and MRI results of lung cancer patients – gaining complete control over the number, size, and location of tumours. Both radiologists and AI algorithms were unable to differentiate between the altered and correct scans.

In the age of the Internet of Things (IoT), cybersecurity risks also stem from the fact that a multitude of medical devices – including ‘smart’ pacemakers and insulin pumps – are now increasingly connected to the Internet. This makes them extremely vulnerable to attacks.

This kind of ‘health hacking’ has the potential to impact patient lives, and can also result in insurance fraud, ransomware attacks and other issues for both patients and healthcare providers. However, there are steps medical device manufacturers can take to protect their devices.

Discover how our standards support medical device manufacturers bring compliant products to market efficiently and safely by visiting our ‘Medical Devices Topic Page’.

Take control of cybersecurity vulnerabilities with BS EN ISO/IEC 27002

The key to ensuring AI-enabled medical devices are secure lies in taking complete control.

Restricting and preventing access to a system is a critical step in protecting systems from cyber risks. A newly revised international cybersecurity standard can help manufacturers to determine and implement the latest security controls to manage the information security risk of their medical devices.

BS EN ISO/IEC 27002:2022 Information technology, cybersecurity and privacy protection—Information security controls gives you the latest comprehensive list of internationally recognized information security controls. It helps manufacturers identify the different areas of security risk for their products and implement the appropriate controls to mitigate that risk.

In the revision of this standard, the security control guidance was consolidated and modernized to reflect the evolvement of technologies and practices including threat intelligence, information security for use of cloud services, and data leakage prevention.

The implementation of the BS EN ISO/IEC 27002 security control guidance enables manufacturers to build effective barriers to entry - such as logins and passwords - to ensure that only those who are authorized to have access can see the data from the device areable to maintain continuous control over their information security, despite the nature of cyberattacks changing.

To learn more about the scope of BS EN ISO/IEC 27002, read our article ‘The 4 pillars of control: A modern approach to information security controls’.

Digital trust and the benefits of ISO/IEC 27002

As the application of AI medical devices is only set to increase, manufacturers can reap the benefits of demonstrating their commitment to information security.

BS EN ISO/IEC 27002 can help medical device manufacturers to:

• Identify and select controls that are appropriate and proportionate to the risks faced by their AI medical devices

• Increase the resilience of their medical device information security

• Show patients and healthcare providers that their information security management is world-class, improving digital trust and possibly the demand for their medical devices

• Strengthen their risk management and reduce the likelihood of information security breaches

By prioritizing digital trust and implementing effective information security controls, manufacturers can drive the future of the use of AI in medical devices and be the transformative force within the sector for the benefit of patients and healthcare providers alike.

Achieve digital trust in your AI medical devices by adding BS EN ISO/IEC 27002 to your collection today.