Industry Challenge
- Hospitals, labs, and clinical systems operate across complex networks of EHR platforms, imaging archives, diagnostic equipment, and thousands of connected medical devices.
- Most of these systems rely on internal-CA X.509 certificates that cannot be renewed reliably at clinical scale, and certificate expiry can disrupt life-critical workflows.
- PHI stored in EHR, DICOM, and HL7/FHIR repositories requires strong encryption and governed key lifecycle, yet many organizations still track keys manually through spreadsheets or ad-hoc HSM scripts.
- Regulatory frameworks such as HIPAA and 21 CFR Part 11 demand auditability and controlled access, but manual key management cannot provide consistent, provable governance.
Amera® Solution
Certificate-Free Clinical Device Identity and Compliant Key Governance
- Deterministic, hardware-rooted identity for infusion pumps, monitors, diagnostic equipment, and other clinical devices — eliminating internal CA operations and certificate renewal cycles.
- HL7, FHIR, imaging, and lab-system connections use continuously rotating symmetric keys instead of static TLS certificates, preventing expiry-driven downtime.
- AmeraKey® governs encryption keys for EHR, DICOM, and FHIR data stores with deterministic derivation, rotation policies, and audit-ready logs that support HIPAA and 21 CFR Part 11 workflows.
- Genomic datasets, trial results, and regulatory submissions use policy-driven key rotation and logging to support controlled-access and audit requirements.
- All identity and key lifecycle operations run entirely inside the clinical network — no cloud dependency, no external trust chain.
Use Cases
PHI Encryption Key Lifecycle for Internal Data Stores
EHR databases, DICOM archives, and HL7/FHIR repositories require strong encryption and governed key rotation. AmeraKey® provides deterministic derivation, rotation, and audit logging for all data-at-rest keys, replacing manual HSM scripts and spreadsheet-based tracking.
Eliminating Device Certificates on Medical IoT Networks
Hospitals operate thousands of connected devices that rely on internal-CA certificates that cannot be renewed at scale. AmeraKey® replaces these certificates with deterministic, hardware-rooted identity that never expires and requires no PKI infrastructure.
Preventing Certificate-Driven Downtime in Clinical Integrations
Lab, pharmacy, imaging, and EHR systems often depend on manually renewed certificates that can expire unexpectedly. AmeraKey® replaces static certificates with auto-rotating symmetric transport keys, ensuring continuous operation of life-critical workflows.
Key Governance for Clinical Trial and Research Data
Genomic datasets, trial results, and regulatory archives require strict access control and auditability. AmeraKey® provides deterministic key lifecycle governance aligned with 21 CFR Part 11-related workflows.
Key Benefits
No internal CA for medical IoT
Eliminates certificate issuance and renewal across thousands of clinical devices.
Uninterrupted clinical integrations
Auto-rotating symmetric keys prevent certificate expiry from disrupting HL7/FHIR workflows.
Governed PHI encryption
AmeraKey® manages the full lifecycle of keys protecting EHR, imaging, and clinical data.
Audit-ready key events
Identity and key lifecycle events are logged and exportable as evidence for HIPAA and 21 CFR Part 11-aligned processes.
Private-network operation
All identity and key governance runs inside the clinical network with no cloud dependency.
Positioning Statement
Amera® protects patient data and connected medical devices with certificate-free identity and automated key governance — securing EHR, imaging, and clinical trial systems in alignment with HIPAA and 21 CFR Part 11 workflows, entirely on the private clinical network.