What are the most important cybersecurity practices for securing medical devices?

Inventorying devices is very important and so understanding and classifying the data that passes through them to prioritize and apply security controls.

While working with a renowned Australian hospital, I spotted an inconsistency in their device inventory system. While compliant with the ADHA standards, they missed aligning with the PSPF. Post gap analysis, we launched a comprehensive audit, finding devices containing PID lacking robust security. Subsequently, we redefined the architecture, introducing a broader device management system aligned with both the ADHA and the PSPF. It was quite simple but the result? Seamless, secure operations. Lesson: Balancing your functional and non-functional requirements is paramount in cybersecurity.

3 things first: 1. Have a complete understanding of data flows, which is imperative to evaluating medical devices and risk. 2. Understand the legal, regulatory, compliance and risk management contextual factors for your organization (e.g. HIPAA, HL7, x73, etc). 3. Establish a risk management framework and risk appetite to help assess risk and prioritize assets.

Implement defense in depth on the device itself. Protect the runtime environment from exploits and zero days. Something like RASP: for integrity verification. Don’t bank on design controls and patching.

It’s also crucially important to identify what type of data is being stored in and being handled by your systems and classify those systems based on the sensitivity level of that data as wells. In particular any patient records and other medical information may be considered PHI or protected health information and will have legal regulatory requirements such as meeting HIPAA standards.

Patches, IOS version and upgrades will reduce some level of risk of attacks / ransomware. Old legacy systems to be removed from network and all tightly build system with hardened configurations has to be deployed.

Firstly, you must be aware that just like any other change, there is a level of risk associated with any patch. You should have a clear change management and patch management policy that defines the process where you will gauge the possible positive and negative impacts of the patch and the planning, testing, and deployment process. Ultimately, patching is just one part of your broader plan for hardening medical devices. Hardening refers to reducing the attack surface as much as possible. Hardening includes patching for any security vulnerabilities, disabling any unnecessary applications, ports, services, ensure applications are configured securely, enabling any possible endpoint and network protection capabilities.

Firstly, per TGA, medical (or better say clinical) devices can't be actively patched. It's essential to distinguish between IT vs OT. While patches mitigate vulnerabilities, a comprehensive strategy is vital for operational and business consistency. In cybersecurity, balancing immediate solutions with a broader view is key. Consider this: you might diligently patch, but miss device interdependencies. The result? Devices might malfunction after updates due to overlooked compatibility issues. The mistake? Not testing patches in real-world-like environments. My suggestion: Beyond patching, create a test environment reflecting actual device interactions (at minimum). This not only ensures functionality but identifies potential weaknesses.

Applying regular security patches and updates make it less prone to any zero day vulnerabilities. Esoecially when there are lot of OEM devices used it is paramount to apply security patches.

Beside having a good vulnerability and patch management plan in place, it is important to stagger the patch process, starting with low patient impacting departments to determine if there are any operational issues with the new updates and patches. Thereafter, you may proceed with rolling out the updates and patches if no issue is observed. If you have good communication channel with other healthcare organisations using the same equipment, you could set up group networks to share the security updates and patches plans and progress. This will help reduce any risks, unexpected issues as well as a broader network of user community to share intel.

Securing clinical devices goes beyond mere encryption. While it's pivotal to encrypt and restrict device access, the depth of security needed is profound. Take, for instance, the involvement of PHI. Encryption is non-negotiable, but have we pondered data obfuscation or anonymisation? The implementation of a zero-trust model and RBAC is a game-changer. Furthermore, frequent access reviews become indispensable. As other members rightly pointed out, a holistic strategy is the key. Beyond physical access management with key cards, there's a world of authentication and authorisation methods waiting to be explored. Dive deep into MFA, at Rest and In-Transit device-specific encryption , and nuanced password rules...

Encryption is a must. Since PHI is involved, data masking, data anonymization also should be looked into. Role based access with zero trust model to be implemented. Regular reviews of access are must.

Implementing access control in the context of medical equipment is critical, needing a complete strategy. It includes not only the management of physical access via key cards, but also emphasizes the importance of authentication and authorization methods. These procedures must be closely monitored and scrutinized on a regular basis. Furthermore, when implementing aspects such as multi-factor authentication (MFA), data and device encryption, and password settings including criteria such as expiration periods, retry limits, and password reset rules, careful consideration is required.

If these devices are handling sensitive data PHI, in my perspective, authentication and encryption is the most important section to be concern. Not just because confidentiality itself but for the legal troubles that a leak might trigger.

Strong access control methods such as passwords, biometrics, or smart cards are undoubtedly must measures. For an added layer of access control, boot-level security can enforced through defining specific OS-booting rules because Protecting PHI is critical part. Definitely data or device encryption is again must requirements however obfuscation/ masking should also be given due thoughts or an added layer of security.

As medical devices are quite different in functionality from endpoint devices and servers (for example), it is important to understand what is "normal" activity on the device to be able to trap for anomalous behavior. It takes time for security teams to baseline the logs from the devices and identify the patterns but once we have that it become trivial to integrate the appropriate monitoring and alerting for the device set.

In the unyielding quest for medical device security, the crucial imperative step is the vigilant monitoring and auditing of device activity. This involves systematically collecting and analyzing device logs, alerts, and events to promptly detect and respond to any signs of suspicious or malicious behavior. Leveraging tools like intrusion detection systems, antivirus software, and firewalls enhances the ability to scrutinize device activity effectively. Regular reviews of device logs and reports are paramount, enabling the timely identification and reporting of any incidents or anomalies.

Intrusion detection systems, antivirus software, firewalls and analysing devices logs/ alerts/events has been into the practice from long. New technologies have now enabled us to analyse the logs much faster than earlier where security teams would take significant time to analyse logs. For timely identification and reporting of anomalies, a robust system is required to monitor device logs in real-time which should provide alerts for suspicious or unauthorized activities immediately. Therefore, such a system analyses the risky activity patterns to set up alerts for potential security threats. It's proven that regular reviews helps in identifying and addressing security breaches much promptly.

Educating and training staff and users is the linchpin in fortifying medical device security. By fostering awareness and imparting skills, we establish a crucial defence layer. Regular training sessions, workshops, and online courses, specifically addressing device security policies and best practices, are essential. Encouraging a proactive approach, we must motivate staff and users to promptly report any issues, fostering a culture of vigilance. This strategy not only mitigates risks but ensures a collective commitment to the safe and secure use of medical devices, ultimately safeguarding patient well-being and upholding the integrity of our healthcare systems.

Educating and training staff and users is crucial for enhancing cybersecurity in the context of medical devices. This involves imparting knowledge and skills to promote best practices for safeguarding these devices. It is essential to ensure that both employees and end-users are well-informed and proficient in cybersecurity measures to protect sensitive medical data and prevent potential threats.

Given the critical nature of healthcare, a small misstep or oversight can have significant repercussions on patient safety and data security. Educating and training staff and users not only cultivates a culture of awareness but also empowers them with the necessary skills to operate these devices securely and respond to potential issues proactively. Regular training sessions and open channels for reporting problems contribute to creating a vigilant and informed community, which is indispensable in navigating the complex and sensitive landscape of medical device security.

In the holistic approach to securing medical devices, the fifth pivotal step involves the education and training of staff and users. This proactive measure serves as a foundation for heightened awareness and the development of essential skills for the safe and secure use of devices. Regular training sessions, workshops, or online courses should be conducted, delving into topics like device security policies, procedures, and best practices. Empowering staff and users with the knowledge to identify and report problems or issues with the devices not only fosters a culture of vigilance but also ensures a collective effort in maintaining the security integrity of medical devices.

It is important that companies in the medical industry educate and train staff on how to use medical devices that are life and death scenarios. The investment in proper education and training for medical device use, not only will save lives, but it could save billions of dollars in cost from potential lawsuits that may arise if loss of life did occur from improper medical device usage.

Continuous improvement and monitoring is extremely critical especially in dynamic and rapidly evolving threat and attack surface.

Understanding the cybersecurity objectives of confidentiality, integrity, or availability for medical systems and data is crucial. Each requires a different control environment. Confidentiality safeguards patient privacy, integrity ensures data accuracy, and availability guarantees key medical equipment to be operational.

The challenge with traditional approaches to securing medical devices (barring a few expensive advanced ones) is that they are insecure by design. It is very difficult to fix a vulnerability or harden those devices because they do not use traditional operating systems. The ONLY way to introduce security is by introducing Zero Trust holistically by microsegmentation approaches. I have successfully used an approach I call Mission critical Assurance using Zero-trust Enforcement, that allows such medical devices to communicate only the relevant data to predefined destinations by defining a security criteria to define zones and conduits. I prefer the concepts and approaches in ISA62443, complemented with ISO27001 governance.

Medical devices bring a different level of complexity to the table for security practitioners. Many of them contain PHI which needs to be protected for the privacy and confidentiality of the patient. Some of these devices could mean life or death for a patient. This is why it is so critical to secure these devices. Many medical devices are also difficult to secure because they may be multi-million dollar devices built on legacy systems where patching is almost non-existent. These devices need to be secured using segmentation, baseline security configurations, zero-trust, proper provisioning, and additional monitoring and alerting.

Security-by-design and security-by-default should be put in place. Perform threat modelling and security & risk assessment of the device architecture. Perform VAPT of the medical device. If code eg firmware is developed internally, perform code review ie. SAST. Hardening checklist should be in place and implemented with good-to-have features disabled as a default.

Segment connected medical devices and apply Zero Trust least-privilege policies to prevent attacks and lateral movement of threats.

In my view, medical devices are particularly challenging. Isolation and segmentation combined with understanding the practical and also theoretical data flows to and from the individual device is key. Careful risk analysis should always be performed, as medical devices tend to have a direct impact on health and human life. Always have a plan B and plan C up your sleeve for critical assets.