ORCA Opti

Industries · United States

Healthcare

HIPAA and HITRUST for providers, payers and health tech. ORCA Opti brings your risks, controls and AI governance into one living system of record, inside your Safe Zone.

Regulation

Built for US compliance

ORCA Opti maps to the standards US customers and regulators expect, and keeps your evidence audit-ready.

SOC 2

SOC 2

Continuous evidence and audit-readiness for the report your customers ask for.

HIPAA

HIPAA

Protect PHI and meet healthcare privacy and security obligations.

NIST CSF, 800-171 & CMMC

NIST CSF, 800-171 & CMMC

Cyber maturity for federal work and the defense supply chain.

FedRAMP & FISMA

FedRAMP & FISMA

Security expectations for government agencies and cloud service providers.

State privacy (CCPA/CPRA)

State privacy (CCPA/CPRA)

Navigate the growing patchwork of US state privacy laws.

PCI DSS

PCI DSS

Protect cardholder data across payments.

ISO 27001

ISO 27001

Information security management, pre-mapped to your controls.

AI governance (NIST AI RMF)

AI governance (NIST AI RMF)

Safe, accountable AI aligned with the NIST AI Risk Management Framework.

For Healthcare

See ORCA Opti for U.S. Healthcare

Health systems, payers, physician groups, digital health and life-science partners all sit on the most regulated and most-targeted data in America. HIPAA, HITRUST, OCR settlements that reach tens of millions of dollars, FDA cybersecurity for medical devices and ransomware that takes hospitals off the air have moved evidence-grade controls from nice-to-have to non-negotiable.

PHI stays in the Safe Zone

PHI stays in the Safe Zone

EHR, claims and patient data inside the Safe Zone, with AI Guardian blocking accidental PHI disclosure to external AI.

HIPAA and HITRUST audit-ready

HIPAA and HITRUST audit-ready

HIPAA Security and Privacy Rules plus HITRUST CSF v11 controls mapped, with evidence current between certifications.

Ransomware response, on the clock

Ransomware response, on the clock

Pre-built CIRCIA, HIPAA breach notification and state reporting workflows so the next ransomware attempt is contained and reported in hours.

Governed AI for care and operations

Governed AI for care and operations

Run AI for clinical decision support, prior auth, coding and revenue cycle with the audit trail OCR, FDA and payers expect.

The pressure

What CIOs and CMOs are facing

OCR enforcement, ransomware paralysis and AI in every clinical workflow have collided. Evidence-grade controls are the new operating license.

OCR settlements at record levels

OCR settlements at record levels

Eight-figure HIPAA settlements and Right of Access enforcement keep growing. Evidence of a working security program is what shrinks the bill.

21st Century Cures Act and TEFCA

21st Century Cures Act and TEFCA

Information blocking rules, FHIR APIs and TEFCA participation require interoperability backed by access, audit and consent evidence.

PHI leakage via consumer AI tools

PHI leakage via consumer AI tools

Clinicians pasting patient notes into ChatGPT is now a documented disclosure path. AI Guardian inspects every prompt before it leaves.

Hospital ransomware in 2024-2026

Hospital ransomware in 2024-2026

Healthcare is the most-attacked sector in the United States. System downtime now measurably increases mortality, and outages reach state attorneys general within days.

Frameworks built in

Every healthcare obligation, one program

ORCA Opti ships with the obligations U.S. healthcare actually runs on. Controls pre-mapped, evidence structured and reporting current.

HIPAA Security & Privacy

HIPAA Security Rule, Privacy Rule, Breach Notification and Omnibus Rule controls mapped to evidence and management review.

HITRUST CSF v11

Comprehensive HITRUST CSF mapping with e1, i1 and r2 assessment paths supported by automated evidence collection.

State privacy & WPHL

California CMIA, Washington My Health My Data Act and the wider state health-data patchwork mapped to a single consent and evidence model.

FDA medical-device cyber

FDA premarket and postmarket cybersecurity guidance, SBOM and vulnerability management for connected medical devices.

CIRCIA & breach reporting

CISA CIRCIA incident reporting, HHS breach notification and state attorney-general reporting handled by one workflow.

ISO 27001 & NIST CSF 2.0

International security management and NIST CSF 2.0 mapped alongside HIPAA and HITRUST for global health partnerships.

See ORCA Opti for Healthcare in United States.

Work through a guided check with Opti Assist and get an immediate view of where you stand.

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