HIPAA COMPLIANCE SOFTWARE FOR COVERED ENTITIES & BUSINESS ASSOCIATES
Manage HIPAA across the Security Rule’s 54 safeguards, the Privacy Rule’s patient-rights workflows, the 60-day breach notification process, and the Business Associate Agreement lifecycle — without the binder.
What is HIPAA and who must comply? The Health Insurance Portability and Accountability Act (45 CFR Parts 160, 162, 164) is the US healthcare privacy and security law. The Security Rule (164.308–312) sets administrative, physical, and technical safeguards for electronic Protected Health Information; the Privacy Rule (164.502–530) governs use and disclosure of PHI; the Breach Notification Rule (164.400) requires notice within 60 days. Compliance is mandatory for covered entities (health plans, healthcare clearinghouses, most healthcare providers) and their business associates.
EVERY ADMIN, PHYSICAL, AND TECHNICAL SAFEGUARD TRACKED
The HIPAA Security Rule (45 CFR §§ 164.308–312) requires 54 implementation specifications across Administrative, Physical, and Technical Safeguards. Venvera renders each as a control with status, owner, evidence link, and the Security Rule citation. The 22 "addressable" specifications carry an explicit decision record: implemented as-is, equivalent alternative, or documented reason for non-implementation — the reasoning OCR auditors actually want to see.
- 32 required + 22 addressable specifications across §§ 164.308–312
- Explicit decision record on every addressable spec
- Risk Analysis (164.308(a)(1)(ii)(A)) tracked at the threat-source level
- Workforce training register tied to 164.308(a)(5)
- Cross-mapping to ISO 27001 Annex A and NIST CSF 2.0
PRIVACY RULE POLICIES, PATIENT RIGHTS, MINIMUM NECESSARY
The Privacy Rule (45 CFR §§ 164.502–530) governs how Protected Health Information may be used and disclosed. Venvera maintains your Notice of Privacy Practices, your minimum-necessary policies, and the patient-rights workflow: access requests, amendment requests, accounting of disclosures, restrictions, confidential communications. Each request is timed against the regulatory deadline (30 days for access, 60 for amendment) with overdue alerts.
- Notice of Privacy Practices version-controlled and patient-facing
- Patient access requests (164.524) — 30-day deadline tracking
- Amendment requests (164.526) — 60-day deadline tracking
- Accounting of disclosures (164.528) for the prior 6 years
- Minimum-necessary policy with role-based PHI access matrix
60-DAY NOTIFICATION WORKFLOW WITH THE CLOCK SHOWING
Subpart D of 45 CFR Part 164 sets the breach notification rules: individual notice within 60 days of discovery, HHS OCR notice (immediate for breaches affecting ≥500 individuals; annual for under 500), and media notice for any breach affecting ≥500 individuals in a single state. Venvera starts the clock at incident discovery, walks the four-factor risk-of-compromise analysis (164.402), and produces the notice templates ready for review.
- 60-day countdown from incident discovery
- Four-factor risk-of-compromise analysis structured per 164.402
- Individual notice generator (postal + email)
- HHS OCR breach report — immediate (≥500) and annual (<500)
- Media notice template for breaches affecting ≥500 in a single state
BUSINESS ASSOCIATE AGREEMENT LIFECYCLE
Every business associate (and their subcontractors, since HITECH) needs a written agreement under 164.504(e). Venvera’s TPRM module registers each BA, attaches the executed BAA, tracks expiry, schedules annual due-diligence questionnaires, and on termination triggers the mandatory return-or-destruction attestation for any PHI in the BA’s possession.
- BA register with executed BAA, expiry, and renewal scheduling
- Annual due-diligence questionnaire per BA
- Subcontractor (BA-of-BA) chain visibility post-HITECH
- Return-or-destruction attestation on termination
- PHI flow mapping per BA (incoming, outgoing, types of PHI)
CONTINUOUS RISK ANALYSIS, NOT A YEARLY DOCUMENT
OCR’s most-cited finding in HIPAA settlements is "no enterprise-wide risk analysis". Venvera’s risk register treats 164.308(a)(1)(ii)(A) as a living process: every information system asset is identified, threats are enumerated against the OCR Guidance (NIST 800-30 methodology), likelihood and impact are scored, and risk-treatment decisions are tracked. The risk analysis updates whenever a system is added, retired, or significantly changed.
- Asset register tied to PHI flows
- Threat enumeration against OCR Risk Analysis Guidance
- NIST 800-30 likelihood × impact scoring
- Risk treatment: mitigate / accept / transfer / avoid
- Continuous refresh — not an annual sprint
OCR PHASE 2 AUDIT PROTOCOL — EVIDENCE READY
OCR Phase 2 audits work from a 180-inquiry protocol for covered entities (45 for business associates). Venvera maps every Security Rule and Privacy Rule control to the OCR audit inquiry it satisfies, and exports the response package with linked evidence. When the audit notice arrives, you’re responding the same week — not panicking for two months.
- OCR Phase 2 Audit Protocol mapped to controls (180 / 45 inquiries)
- Evidence package export per inquiry, with file references
- Pre-built response narratives editable per inquiry
- Auditor read-only portal with magic-link, time-bound access
- Submission tracking with OCR-acceptable formats
HIPAA COMPLIANCE: VENVERA VS MANUAL TRACKING
54
Security Rule implementation specifications
22
Addressable specifications (decision required)
60
Days for individual breach notification
180
OCR Phase 2 audit inquiries (CE)
FREQUENTLY ASKED QUESTIONS ABOUT HIPAA
COMPLETE YOUR COMPLIANCE STACK
STOP UPDATING THE HIPAA BINDER.
START RUNNING THE PROGRAMME.
14-day free trial. Import your current Risk Analysis and Notice of Privacy Practices; Venvera maps them to the Security and Privacy Rules and surfaces what’s missing for OCR. No credit card required.