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
What is HIPAA compliance?
HIPAA sets US requirements for protecting patient health information (PHI) — relevant to Indian healthcare BPOs and health-tech serving US clients. Macksofy assesses administrative, physical, and technical safeguards and remediates gaps so healthcare processors can evidence HIPAA compliance.
HIPAA 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
What your HIPAA engagement puts on the table.
- 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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HIPAA — what compliance leads ask before signing.
HIPAA evidence starts with hands-on testing.
A clean HIPAA report rests on real technical assurance. These Macksofy assessments generate the vulnerability, penetration and control-effectiveness evidence your auditor expects to see.
Penetration Testing
Find what attackers will. Before they do.
Explore serviceVulnerability Assessment & Penetration Testing (VAPT)
VAPT done properly — not a scan with a cover page.
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Test web apps the way attackers (and bug bounty hunters) do.
Explore serviceMacksofy delivers this work to the following standards and regulator requirements. Definitions and controls are sourced from the issuing bodies below.
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- EC-Council ATC · CompTIA Authorized
- 20,000+ professionals trained
- India + UAE engagements