The Importance of Penetration Testing in Connected Medical Devices

In recent months, we've noticed a significant increase in requests for penetration testing on medical devices. This trend highlights the rising awareness of cybersecurity threats in the medical field and the need for robust security measures to protect patient safety and data integrity. Given how critical these devices are in healthcare, securing them goes beyond the normal commercial responsibility.

Why Penetration Testing?

Penetration testing, or "pen testing," involves simulating cyberattacks on software and systems to identify vulnerabilities before malicious actors can exploit them. For medical devices, this process is crucial because even a minor lapse of security could lead to significant risks, including unauthorized access to sensitive patient data, device malfunction, or worse, life-threatening scenarios.

Key Findings from Our Recent Tests

  1. Vulnerabilities in Bluetooth Communication: Many medical devices now use Bluetooth Low Energy (BLE) to communicate with a mobile device. Our tests revealed that many devices use “Just Works” communications instead of higher security models.  Loose protections could allow hackers to intercept the data in transit, leading to potentially harmful outcomes or data theft.
  2. Outdated Software Components: We found that several devices were using outdated software components, libraries and frameworks with known vulnerabilities. It can be painful when the project development goes over a long period of time, but it is critical to continually update to the latest.
  3. Weak User Authentication: Our testing uncovered instances of weak or fixed passwords being used, making it easier for unauthorized users to gain access to the device’s functionality. Paradoxically, this seems to be especially true of field service/technician access, who generally have elevated privileges.  Without a cloud or network server to manage passwords, it is more challenging to provide protected access, but there are solutions, and it is necessary. 
  4. Decompilation revelations.  Being able to read the source code is a great way for attackers to see vulnerabilities or to steal IP.  Most high level languages are not naturally protected from  decompilation and it is important to obfuscate the code to prevent reverse engineering.
  5. Mobile Applications.  Our tests revealed that many developers mistakenly rely solely on mobile operating systems for security. However, if an app runs on a jail-broken or rooted device, these protections are compromised. It is crucial to follow best practices, such as those outlined by OWASP MAS, to ensure mobile apps are secured against potential threats. Our penetration testers specifically look for these weaknesses.

Why This Matters

The consequences of a security breach in a medical device can be severe. Beyond the immediate risk to patient health, there are also potential legal and financial repercussions for manufacturers, not to mention the damage to their reputation. Pen testing helps identify and address these vulnerabilities before they can be exploited, ensuring that the devices are safe and secure for patient use.

Conclusion

As medical devices become increasingly connected and integrated with broader healthcare systems, the need for rigorous cybersecurity measures, including penetration testing, will only grow. By proactively addressing vulnerabilities through regular pen testing, medical device manufacturers can not only comply with regulatory standards but also contribute to a safer healthcare environment.

If you’re looking to enhance the security of your medical devices, don't hesitate to reach out to us directly. We’re here to help you safeguard your devices and ensure they meet the highest standards of cybersecurity.

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Roxana Greenman, PhD

Roxana is VP of Programs & Communication at Promenade Software, Inc. She has over 30 years of experience leading integrated teams from concept through delivery of complex projects, proactively anticipating roadblocks, and paving a path for client success. Having worked for NASA Ames Research Center, Lawrence Livermore National Laboratory, Hyundai AutoEver Telematics America, and small business organizations in the technology sector, she has gained an extensive knowledge in product development and technical and operational management. Roxana is passionate about helping customers in their quest for innovation and reaching their goals.

Roxana holds a Ph.D. in Aeronautical and Astronautical Engineering from Stanford University.

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PROMENADE SOFTWARE

Promenade Software, Inc. specializes in software development for medical devices and other safety-critical applications.
Promenade is ISO 13485, and CypherMed Cloud is SOC2 Type II certified.