As we navigate through 2025, the landscape of medical device cybersecurity continues to evolve, presenting both challenges and opportunities. With the increasing sophistication of medical devices and the growing threat of cyberattacks, it is crucial for health care organizations and manufacturers to adopt robust cybersecurity measures. Financial impact of a medical device cybersecurity event is difficult to quantify but it can include direct costs (e.g., remediation, fines), indirect costs (e.g., reputational damage, operational disruption) and long-term costs (e.g., increased insurance premiums). Here’s a consolidated approach to start securing medical devices in 2025.
- Conduct Comprehensive Risk Assessments
Regular risk assessments are essential for identifying potential security threats and vulnerabilities. These assessments should be thorough and include all aspects of the device’s operation, from hardware to software and network connectivity. Ensure medical device assets and related security documentation are included in ongoing risk assessment and asset management processes with vendors that maintain support agreements for their devices.
- Regular Software Updates and Patching
Keeping medical device software up-to-date is vital for mitigating vulnerabilities. Manufacturers and health care providers must establish processes for regular software updates and patch management to address security flaws promptly. Consider escalating replacement if legacy devices no longer provide updates and patches.
- Enhance Vendor Management
Health care organizations must ensure that their vendor agreements have appropriate terms to obligate vendors to comply with stringent cybersecurity standards, including all embedded operating systems and 3rd party software. This includes conducting regular audits, requiring detailed security documentation and establishing clear communication channels for reporting and addressing security issues[1].
- Educate and Train Staff
Human error remains a significant risk factor in cybersecurity. Providing regular training and education to staff on best practices, recognizing phishing attempts and responding to security incidents can significantly reduce the likelihood of breaches.
- Develop a Robust Incident Response Plan
A well-defined incident response plan is crucial for effectively managing cybersecurity incidents. This plan should outline the steps to detect, respond to and recover from cyberattacks, ensuring minimal disruption to health care services.
- Implement Robust Encryption or Mitigate
Encryption is a critical component of medical device security. Ensuring that data transmitted between devices and health care systems is encrypted can protect sensitive information from interception and unauthorized access. This includes both data at rest and data in transit. For legacy devices that may not have encryption capabilities, then establish policies/procedures to mitigate.
- Embrace Zero-Trust Security
Zero-trust security is becoming a cornerstone of medical device cybersecurity. This approach operates on the principle of “never trust, always verify,” ensuring that every device, user and network segment is continuously authenticated and authorized. Implementing microsegmentation can help isolate devices and limit the potential impact of a breach[1].
- Secure by Design
Manufacturers are increasingly adopting a “secure by design” philosophy, integrating security measures from the initial stages of device development. This proactive approach ensures that security is not an afterthought but a fundamental aspect of the device’s lifecycle[1]. Procurement preference to emphasize secure by design during contracting process is recommended.
- Leverage Artificial Intelligence (“AI”)
AI and machine learning are playing a significant role in enhancing medical device security. These technologies can help identify vulnerabilities, detect anomalies and respond to threats in real-time. However, it is essential to secure AI algorithms and data pipelines to prevent manipulation by cybercriminals[1][2].
- Collaborate with Regulatory Bodies
Staying informed about regulatory requirements and collaborating with bodies like the FDA can help ensure compliance with the latest cybersecurity standards. This collaboration can also provide valuable insights into emerging threats and best practices[2].
Practical Takeaways
In 2025, securing medical devices requires a multifaceted approach that combines advanced technologies, proactive strategies and continuous vigilance. By embracing zero-trust security, leveraging AI, ensuring regular updates and fostering collaboration, health care organizations can protect their devices and patient data from evolving cyber threats. Staying ahead of these challenges is essential for maintaining trust and delivering high-quality care in an increasingly digital world. Hall Render Advisory Services has extensive experience establishing practical, real-world approaches to health care cybersecurity.
If you have any questions or need further insights on medical device cybersecurity, feel free to reach out to:
- Mark Branstetter at mbranstetter@HallRenderAS.com or (615) 423-6651; or
- Your primary Hall Render Advisory Services contact.
Hall Render and Hall Render Advisory Services blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
References
[1] 2025 Medical Device Cybersecurity Trends: What Will Shape The Industry? – Forbes
[2] OCT Medical Devices 2025: AI innovation expected to increase cybersecurity risks in 2025
