MedicalTPM: 物理芯片信任根、FDA 524B 网络安全合规与抗量子生命支持系统加固

MedicalTPM Architecture & Patient Safety Cryptographic Topology

Ultra-low-power lattice core, patient telemetry seal, and secure clinical attestation

Central System: Medical Crypto Core - IEC 62304 Class C Enclave

Cryptographic Nodes

• Low-Power Lattice ALU
• Telemetry Encryption Seal
• Firmware Verification Unit
• Emergency Access Bypass
• Battery Life Monitor

Architectural Layers & Protocols

• Ultra-Low-Power Silicon Plane (Sub-Threshold CMOS / 28nm FD-SOI): Executing post-quantum key exchange with minimal energy consumption for 10-year battery life.
• Medical Device Firmware Integrity (IEC 62304 Class C Verified Bootloader): Preventing unauthorized firmware modifications on life-critical devices (pacemakers, pumps).
• Patient Data Privacy Enclave (Hardware-Sealed AES-256 / ML-KEM Telemetry): Encrypting vital sign streams and diagnostic logs before BLE/Wi-Fi wireless transmission.
• Clinical Attestation & Identity (Device Unique Identifier (UDI) Hardware Binding): Providing cryptographic proof of genuine medical device provenance to hospital firewalls.

Key Metrics: < 3.8 mW (Active Handshake Power) | 10+ Years (Implantable Battery Life) | Class C (IEC 62304 Safety Standard) | FDA 524B (Cybersecurity Conformance)