Industries ยท 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
Frameworks built in
ORCA Opti ships with the frameworks US customers and auditors ask about, and keeps your evidence audit-ready.
SOC 2
SOC 2
Continuous evidence and audit-readiness for the report your customers ask for.
NIST CSF
NIST CSF
Cyber maturity against the NIST Cybersecurity Framework, with every control owned and evidenced.
NIST SP 800-53
NIST SP 800-53
The control catalogue behind US federal security programs, with each control tracked, tested and evidenced.
CIS Controls
CIS Controls
Prioritised baseline safeguards, tracked against your own implementation.
PCI DSS
PCI DSS
Cardholder data controls across payments, tracked and evidenced.
ISO 27001
ISO 27001
Information security management, pre-mapped to your controls.
ISO/IEC 27701
ISO/IEC 27701
Privacy information management, with privacy impact assessments over your data processing.
AI governance (ISO/IEC 42001)
AI governance (ISO/IEC 42001)
Responsible, accountable AI, with an AI system inventory and impact assessments managed against ISO/IEC 42001.
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.
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