医疗器械硬件安全模块与 IEC 62304 软件隔离信任金库

部署专用的硬件密码学隔离金库，保护重症生命维持设备、智能微量输液泵、植入式神经刺激器以及医院内网零信任临床遥测免遭任何恶意篡改与侧信道攻击。

MedicalHSM Clinical Silicon Architecture

Cryptographic Enclave: Medical Security Core — IEC 62304 Class C / FDA Enclave

Hardware Security Nodes & Co-Processors

  • Prescription Order Authenticator
  • Clinical Telemetry Encryptor
  • Life-Critical Actuator Interlock
  • Secure Medical Firmware Loader
  • Silicon Physical Tamper Mesh

Architectural Layers & Silicon Defenses

  • Layer 1: Medical-Grade Low-Power Silicon (ISO 13485 Certified Fab / Low-Leakage CMOS): Operating reliably inside battery-powered pacemakers and portable infusion pumps with sub-milliamp power consumption.
  • Layer 2: Fast Cryptographic Coprocessor (Hardware AES-GCM / SHA-256 / ECDSA P-256): Encrypting patient physiological telemetry and validating doctor prescription signatures in under 10 milliseconds.
  • Layer 3: Therapy Actuator Safety Interlock (Fail-Safe Hardware Bounds Checker): Enforcing hard upper dosage limits in silicon that cannot be overridden by compromised application microcontrollers.
  • Layer 4: Hospital IoMT & EHR Gateway Interface (HL7 FHIR / IEEE 11073 SDC / mTLS): Connecting medical devices to hospital Electronic Health Record (EHR) networks via authenticated, encrypted sessions.

Cryptographic Telemetry & Compliance: < 12 µA (Standby Quiescent Current) | Class C (IEC 62304 Highest Risk Tier) | 100% (Dosage Command Authentication) | FDA 510(k) (Premarket Cybersecurity Ready)

面向生命支持医疗设备的硬件信任根

Connected medical devices deliver life-saving therapies but introduce critical vulnerabilities: unauthorized dosage modifications, patient telemetry eavesdropping, and firmware bricking. MedicalHSM embeds certified cryptographic silicon into clinical hardware, ensuring that therapy commands, drug dispensing orders, and firmware updates are cryptographically authenticated before physical execution.

Core Engineering Areas

Technical Publications

Related Cluster Architecture Specifications