Yujan Shrestha and J. David Giese discuss challenges in medical device cybersecurity, including balancing FDA guidelines with practical hospital and manufacturer needs. They highlight risks like network vulnerabilities and outdated dependencies, recommending best practices such as code reviews, automated testing, and prioritizing tool validation for critical security areas.
*Participants*
1. Yujan Shrestha - CEO, Partner
2. J. David Giese - President, Partner
*Key Takeaways*
1. Complexity of Cybersecurity for Medical Devices: Medical devices face unique cybersecurity threats, particularly when connected to hospital networks. Ensuring device security requires balancing FDA guidelines with the needs of hospitals and patient safety.
2. FDA's Role and Limitations: The FDA requires certain cybersecurity measures but cannot mandate everything needed for optimal device security. This creates a gap between what the FDA requires and what hospitals or manufacturers might consider essential.
3. Hospital IT and Device Manufacturer Dynamics: Hospitals often demand compliance with standards like SOC 2 and ISO 27001 for security. This adds another layer of requirements for device manufacturers aiming to integrate their devices seamlessly within hospital networks.
4. Best Practices in Cybersecurity Assurance: Effective practices include code reviews, using automated testing tools like Snyk, and periodically checking the Software Bill of Materials (SBOM) for vulnerabilities.
5. Tool Validation Challenges: Validating tools can be time-consuming and may not significantly enhance device security. Focus on essential validations, especially for tools critical to safety, while minimizing efforts on well-established tools where risks are low.
#medicaldevices #medicalsoftware #innolitics #cybersecurity #fda #threat
