HIPAA Compliance Audit
HIPAA + HITRUST audits for healthcare entities and business associates.
End-to-end HIPAA Privacy + Security + Breach Notification rule audits for covered entities and business associates. Includes US OCR enforcement readiness, BAA review, EHR / PHI security validation and HITRUST CSF mapping where required by US health-system customers.
- HIPAA Privacy Rule (45 CFR 164 Subpart E)
- HIPAA Security Rule (45 CFR 164 Subpart C)
- HIPAA Breach Notification Rule
- HIPAA Omnibus Final Rule (2013)
- HITRUST CSF v11 (where required by health-system customers)
- 21st Century Cures Act — Information Blocking
Compliance is leverage, not paperwork.
OCR HIPAA settlements crossed $135M cumulative; per-record penalty under the Omnibus Rule reaches $50,000. Indian + UAE healthtechs and BPOs serving US payers / providers are increasingly contractually required to demonstrate HIPAA — often via HITRUST. Macksofy bridges Indian operations with US HIPAA expectations end-to-end.
- US health systems' Indian / UAE BPO partners
- Healthtech SaaS storing PHI for US customers
- Telehealth + remote monitoring providers
- Medical billing + RCM operations
- Clinical research organisations (CROs)
Aligned to the regulations that matter.
How we run a HIPAA engagement.
Interactive walkthrough — every phase clickable, every activity documented, every artefact regulator-ready.
- Phase 01
1 · PHI inventory + BAA review
- PHI flow mapping (intake, processing, storage, transmission)
- Business Associate Agreement review + uplift
- Subcontractor BAA tracking
01Station 0101Phase 011 · PHI inventory + BAA review
- PHI flow mapping (intake, processing, storage, transmission)
- Business Associate Agreement review + uplift
- Subcontractor BAA tracking
- Phase 02
2 · Privacy Rule audit
- Notice of Privacy Practices
- Patient rights (access, amendment, accounting)
- Minimum Necessary + de-identification controls
02Station 0202Phase 022 · Privacy Rule audit
- Notice of Privacy Practices
- Patient rights (access, amendment, accounting)
- Minimum Necessary + de-identification controls
- Phase 03
3 · Security Rule audit
- Administrative safeguards (workforce, training, sanctions)
- Physical safeguards (workstation, media)
- Technical safeguards (encryption, audit logs, integrity)
03Station 0303Phase 033 · Security Rule audit
- Administrative safeguards (workforce, training, sanctions)
- Physical safeguards (workstation, media)
- Technical safeguards (encryption, audit logs, integrity)
- Phase 04
4 · Breach notification readiness
- Breach risk assessment workflow
- 60-day notification SOP
- OCR-template + state-AG mapping
04Station 0404Phase 044 · Breach notification readiness
- Breach risk assessment workflow
- 60-day notification SOP
- OCR-template + state-AG mapping
- Phase 05
5 · HITRUST mapping (optional)
- HITRUST CSF v11 control mapping
- Self-assessment / Validated assessment readiness
- External assessor coordination
05Station 0505Phase 055 · HITRUST mapping (optional)
- HITRUST CSF v11 control mapping
- Self-assessment / Validated assessment readiness
- External assessor coordination
Everything you need to satisfy auditors.
- PHI inventory + flow diagrams
- BAA template + uplift recommendations
- Privacy + Security + Breach Notification audit report
- Workforce sanctions + training program
- Breach notification SOP + tabletop scenario
- HITRUST gap analysis (where in scope)
HIPAA + HITRUST CSF readiness
Outcome: First-attempt HITRUST validated assessment passed; all five US health-system customer audits cleared without rework
HIPAA Security Rule audit + ADHICS overlay
Outcome: Cross-jurisdiction PHI architecture validated; UAE NHS + US OCR overlap reduced effort 35%
The shape of a HIPAA engagement.
Every number below is grounded in how Macksofy actually runs the engagement — not aspirational marketing copy.
What we actually examine.
Each pillar is a distinct workstream inside the engagement — scoped, evidenced, and signed off independently before the audit pack is assembled.
- Administrative safeguards3 pts
- Physical safeguards3 pts
- Technical safeguards3 pts
- Breach-notification rule3 pts
- Privacy rule alignment3 pts
- OCR audit pack3 pts
§164.308 — policies, training, contracts, BAAs that OCR reviewers ask for first.
- Security-management process + risk analysis
- Workforce-training + sanction policy
- Business-Associate Agreements (BAA) review
§164.310 — workstation, facility and device controls covering ePHI.
- Facility-access + visitor controls
- Workstation use + secure-disposal evidence
- Device & media controls for ePHI storage
§164.312 — access, audit, integrity and transmission security on ePHI systems.
- Unique-user-ID + emergency-access workflow
- Audit-controls coverage (logging completeness)
- Encryption-at-rest + in-transit for ePHI
§164.400-414 — the 60-day / 500-record / OCR-portal workflows.
- Breach-risk-assessment methodology
- 60-day individual & media notification flow
- OCR portal submission pack
§164.500-534 — NPP, minimum necessary, individual rights.
- Notice of Privacy Practices (NPP) review
- Minimum-necessary use + disclosure controls
- Individual-rights workflow (access, amend, account)
Everything Office for Civil Rights needs in their preferred format.
- Documentation-retention 6-year evidence
- Self-audit + corrective-action plan
- Workforce-training completion records
From kick-off to regulator-ready report.
The horizontal flow below shows the typical week-by-week shape of a HIPAA engagement. Click any station for detail in the methodology section above.
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Things compliance leads ask before signing.
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- CERT-In Empanelled
- EC-Council ATC · CompTIA Authorized
- 20,000+ professionals trained
- India + UAE engagements