HIPAA Compliance & Security Risk Assessment for US Healthcare
Infilux AppSec delivers HIPAA Security Rule compliance for US healthcare entities, digital-health startups, and business associates — including the mandatory annual Security Risk Assessment under 45 CFR §164.308(a)(1)(ii)(A), ePHI control implementation, breach-notification playbooks, business-associate agreement reviews, and OCR audit-readiness packages.
Every US covered entity and business associate that handles electronic protected health information (ePHI) must conduct a HIPAA Security Risk Assessment annually — and demonstrate the remediation. The Office for Civil Rights (OCR) has issued seven-figure settlements for organisations that couldn't produce a current SRA when audited.
Our HIPAA engagement starts with a §164.308–§164.312 gap analysis against your administrative, physical, and technical safeguards. We then design and implement the controls — encryption at rest and in transit, access logs with two-year retention, multi-factor authentication for ePHI systems, audit trails, and the incident-response playbook with 60-day breach-notification timing under §164.402.
Healthcare-adjacent SaaS is the fastest-growing segment of our HIPAA practice. Telehealth platforms, claims-processing vendors, RPM device manufacturers, and AI-medical-imaging startups have used Infilux to ship the HIPAA readiness their hospital customers demand — without hiring an in-house compliance team.
Key controls we implement
Security Risk Assessment
The §164.308(a)(1)(ii)(A) annual SRA — required by every HIPAA-covered entity and business associate.
Administrative safeguards (§164.308)
Workforce security, access management, training, contingency planning.
Physical safeguards (§164.310)
Facility access controls, device + media controls, workstation security.
Technical safeguards (§164.312)
Access control, audit controls, integrity, transmission security, MFA.
Business Associate Agreements
BAA review, sub-BAA mapping for downstream vendors.
Breach Notification readiness
60-day notification timing under §164.402; OCR portal submission readiness.
OCR audit preparation
Documentation package + walk-through for HHS OCR Phase 2 audits.
Frequently asked
Who needs HIPAA compliance?+
How often must we conduct the Security Risk Assessment?+
We're a digital-health SaaS, not a hospital. Does HIPAA still apply?+
How long does HIPAA readiness take?+
What's the typical cost?+
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