HEALTHCARE · LIFE SCIENCES · MEDICAL DEVICES

Quantum-safe encryption for EHR, PHI and regulated medical devices.

Protected Health Information stays sensitive for a lifetime. A record encrypted today with RSA-2048 and exfiltrated by an adversary can be decrypted once a cryptographically relevant quantum computer exists. HIPAA and FDA 21 CFR Part 11 do not grant exceptions.

Regulatory drivers:HIPAA · FDA 21 CFR Part 11
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THE PROBLEM

HIPAA and FDA expect durable confidentiality

HIPAA requires covered entities and business associates to protect electronic PHI with appropriate safeguards. Long-lived clinical records make Harvest-Now-Decrypt-Later a real, current-day threat.

FDA 21 CFR Part 11 requires trustworthy and reliable electronic records and signatures for regulated medical devices and clinical systems — including cryptographic controls that must remain valid across the device lifecycle.

Legacy EHR, PACS, and medical-device stacks embed cryptography deep in application code, making algorithm migration slow and risky without an orchestration layer.

  • HIPAA Security Rule — technical safeguards for electronic PHI
  • FDA 21 CFR Part 11 — electronic records and electronic signatures
  • IEC 62443 / FDA pre-market guidance — medical-device cybersecurity
  • HITECH — breach notification obligations for compromised PHI

HOW ANKASECURE© HELPS

ANKASecure© capabilities that matter in healthcare

Discover hardcoded cryptography inside EHR, PACS, lab and medical-device firmware stacks.

Migrate PHI-protecting encryption to ML-KEM and digital signatures to ML-DSA without changing application logic.

Hybrid classical + post-quantum modes preserve interoperability with legacy devices and partner systems.

Centralized audit trail for HIPAA and FDA 21 CFR Part 11 — every algorithm choice, key operation and policy change is logged.

STANDARDS IN SCOPE

Standards most relevant to this sector

  • NIST FIPS 203 (ML-KEM) · FIPS 204 (ML-DSA) · FIPS 205 (SLH-DSA)
  • NIST SP 800-66 — HIPAA Security Rule implementation guidance
  • ISO/IEC 27799 — information security in health informatics
  • IETF — TLS and DTLS profiles used by EHR and device telemetry
  • BSI TR-02102 — hybrid post-quantum recommendations

SOCIAL PROOF

Why healthcare organizations choose ANKASecure©

ANKATech engages with hospital systems, payers and medical-device manufacturers preparing for the post-quantum transition. Specific references are shared under NDA during a scoping briefing.

YOUR NEXT STEP

Protect PHI for the decades it will live.

Five questions. An instant PQC risk score mapped to HIPAA and FDA 21 CFR Part 11.

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