Workshop Description
A hospital trust operating a modern estate has several thousand connected devices. Infusion pumps, ventilators, pacemakers, insulin delivery systems, imaging equipment, wearable monitors. Every device that communicates over a network uses cryptography. Most of that cryptography is RSA or ECC, implemented in firmware that was written years ago and certified against a specific algorithm suite that cannot be changed without regulatory re-approval. That is not a future problem. It is a current liability, because adversaries are harvesting device communications traffic now with the intention of decrypting it once quantum capability arrives.
The FDA made cryptographic agility a premarket submission requirement in its June 2025 final guidance, the third iteration of its medical device cybersecurity framework. Under FD&C Act Section 524B, FDA now has authority to refuse device submissions lacking cryptographic resilience planning. For NHS trusts and private hospital groups managing existing device fleets, the question is sequencing: which devices present the highest quantum cryptographic risk, and how do you build a remediation programme that does not disrupt clinical operations? This workshop provides the risk triage framework, covers the regulatory requirements across US, UK, and EU jurisdictions (including the post-Brexit divergence between MHRA and EU MDR/IVDR), and works through the practical constraints of deploying lightweight PQC algorithms on resource-limited embedded systems.
What participants cover
- FDA June 2025 final guidance and FD&C Act Section 524B: premarket submission requirements for cryptographic agility
- Cryptographic exposure analysis by device class: infusion pumps, ventilators, DICOM/PACS imaging, wearable RPM
- Resource-constrained PQC: CRYSTALS-Kyber and SPHINCS+ on ARM Cortex-M embedded systems with limited flash
- IEC 62443-4-2 security capability requirements applied to medical device quantum risk classification
- MHRA and EU MDR/IVDR divergence: navigating post-Brexit regulatory expectations for cryptographic device updates
- Fleet triage framework: prioritising devices by cryptographic exposure, update capability, and remaining clinical life