When you think about cybersecurity, your mind might jump to firewalls, antivirus software, or penetration testing. But there’s another unsung hero: the protocols that quietly secure our communications behind the scenes. One of the most important of these is Transport Layer Security (TLS)—the foundation of secure internet traffic.
The latest version, TLS 1.3, became an official standard in 2018 and remains the most up-to-date version today. For most people, TLS 1.3 simply means a faster, safer internet. But for medical devices, it carries much more weight. The FDA’s 2025 Cybersecurity in Medical Devices Guidance identifies cryptography, confidentiality, and authenticity as core requirements for ensuring device safety. TLS 1.3 directly addresses those needs, helping manufacturers protect both patient safety and regulatory compliance.
What Exactly Is TLS 1.3?
TLS is the successor to SSL and works like a lock on data in motion. Whenever a connected medical device transmits information—whether that’s patient data, firmware updates, or diagnostic results—TLS ensures the communication is private and tamper-proof.
TLS 1.3 improves on earlier versions by eliminating outdated algorithms, introducing faster handshakes that reduce latency, and enforcing forward secrecy so that even if long-term keys are compromised, past communications remain safe. The protocol is also streamlined, which reduces the overall attack surface.
For medical devices, these improvements aren’t just conveniences. They directly align with FDA’s requirements to ensure authenticity, confidentiality, and integrity of communications.
Why TLS 1.3 Matters for Medical Devices
A connected medical device isn’t just sending harmless data—it may be transmitting patient records, therapy settings, or device logs needed for critical care. If this information is intercepted or altered, the consequences can range from data breaches to patient harm.
Consider three common risks. Without strong encryption, attackers could launch man-in-the-middle attacks to intercept sensitive information in transit. Insecure update channels could allow them to tamper with firmware, compromising device functionality or safety. And even absent a direct attack, using outdated encryption can create regulatory setbacks, since the FDA now expects validated and documented cryptographic protections in premarket submissions.
TLS 1.3 helps mitigate all of these risks, providing both stronger security and a clearer path to compliance.
FDA Expectations and TLS 1.3
The FDA guidance highlights several security objectives manufacturers must meet: authenticity, confidentiality, integrity, and resilience. TLS 1.3 directly supports these goals. It prevents impersonation by ensuring that devices only communicate with trusted systems, protects patient and device data from being exposed, and detects tampering if it occurs. Because it is built with modern cryptography, it also helps devices remain secure as new threats emerge.
Including TLS 1.3 in a device’s security architecture strengthens its Secure Product Development Framework (SPDF)—something the FDA views as an essential approach to designing secure, trustworthy devices.
Real-World Use Cases
The value of TLS 1.3 is clear when applied to actual medical device scenarios. Remote cardiac monitors depend on encrypted communications to transmit telemetry to cloud dashboards. Imaging systems must transfer large scan files across hospital networks without exposing protected health information. Infusion pumps and therapy devices need authenticated, secure channels for receiving software updates.
In each case, TLS 1.3 ensures that sensitive communications remain secure, even if attackers attempt interception or manipulation.
How Blue Goat Cyber Supports Manufacturers
At Blue Goat Cyber, we don’t just recommend security features—we help manufacturers align them with FDA regulatory expectations. Our team provides hands-on support to:
- Implement secure communication protocols like TLS 1.3 during design and development.
- Conduct penetration testing to validate that device communications withstand modern attacks.
- Map TLS adoption to FDA cybersecurity submission requirements.
- Integrate secure communication into the broader SPDF lifecycle.
This approach results in devices that are both resilient in the field and ready for regulatory review.
Conclusion
TLS 1.3 is the latest and most secure version of the TLS protocol. It delivers stronger encryption, faster performance, and forward secrecy that protects past communications from future compromises. For medical devices, these improvements directly support FDA’s cybersecurity requirements for authenticity, confidentiality, and integrity.
Adopting TLS 1.3 isn’t just about staying current—it’s about building devices that protect patients, safeguard data, and meet regulatory expectations.
If your device still relies on TLS 1.2 or earlier, now is the time to act. Contact Blue Goat Cyber to validate your device security architecture and prepare for FDA compliance.