In today’s healthcare environment, connected medical devices often interface with hospital networks, cloud services, and mobile applications. With this connectivity comes risk—specifically from unauthorized access, injection attacks, and misconfigured APIs.
That’s where Web Application Firewalls (WAFs) and reverse proxies come in. While both offer protective benefits, their roles and implementations differ—especially when applied to medical device cybersecurity.
This guide will help medical device manufacturers understand the difference, use cases, and best practices for choosing the right approach to secure their devices and comply with FDA expectations.
What is a WAF in Medical Device Security?
A Web Application Firewall (WAF) is a security tool that filters and monitors HTTP/HTTPS traffic between a web application and the Internet. It helps block known attack patterns, such as:
- SQL injection
- Cross-site scripting (XSS)
- Directory traversal
For medical device manufacturers, WAFs are essential when:
- Devices connect to cloud portals or management dashboards
- Web APIs handle sensitive patient or diagnostic data
- Remote configuration or monitoring is enabled over a web interface
Example: A WAF placed in front of a hospital’s infusion pump management portal blocks attempted injection attacks targeting known vulnerabilities in the device’s web stack.
What is a Reverse Proxy for Connected Devices?
A reverse proxy acts as an intermediary between a client (e.g., a mobile app or remote sensor) and backend servers. It handles:
- Authentication and access control
- SSL termination
- Caching and load balancing
- IP masking
In medical device ecosystems, reverse proxies are valuable when:
- Securing telemetry from wearable or implantable devices
- Managing mobile app authentication flows
- Routing requests across distributed health systems
Example: A reverse proxy inspects incoming data from cardiac monitors, checks access tokens, and routes valid requests to a HIPAA-compliant backend.
WAF vs. Reverse Proxy: Which to Use for Medical Device Infrastructure?
Most secure deployments use both:
- Reverse proxies for front-end security and routing
- WAFs behind them to block attacks at the application layer
This approach aligns with defense-in-depth principles and helps manufacturers address cybersecurity requirements in their SPDF and threat modeling documentation.
Implementation Tips for Medical Device Manufacturers
When deploying WAFs or reverse proxies:
- Use FIPS-validated or IEC 62304-compatible solutions
- Include architecture in your threat modeling process
- Document controls in your SPDF and eSTAR submission
- Validate configurations via penetration testing
- Enable robust logging for postmarket monitoring
Regulatory Relevance: SPDF & FDA Cybersecurity Guidance
The FDA’s latest guidance emphasizes secure communications, authentication, and logging. WAFs and proxies directly support:
- Documented cybersecurity risk controls
- Demonstrated SPDF implementation
- Postmarket CVE response and monitoring
- Third-party software validation through SBOM awareness
FAQ: WAFs, Proxies, and Device Security
Q: Which is better for connected medical devices—WAF or reverse proxy?
Both serve distinct purposes. Use reverse proxies for secure routing and access control, and WAFs for detecting and blocking malicious web traffic.
Q: Will the FDA expect documentation of WAFs or proxies?
Yes. If your device uses network-facing services or cloud components, the FDA expects these elements to be modeled, tested, and documented within your cybersecurity submission.
Final Thoughts
For medical device manufacturers, securing a device means more than writing secure code—it also requires building resilient infrastructure. WAFs and reverse proxies are proven tools to support compliance, defend against evolving threats, and protect patient data.
Let Blue Goat Cyber Secure Your Ecosystem
We help medical device manufacturers design and document FDA-compliant infrastructure—including WAF and reverse proxy strategies—aligned with AAMI TIR57, ISO 14971, and FDA SPDF requirements.
👉 Schedule your free cybersecurity consultation and fortify your infrastructure now.