HIPAA isn't one checklist, but it can be turned into one. Below are the requirements, grouped the way the rules are written, with the evidence you'll be asked for.
Step 1: Confirm whether HIPAA applies
- ☐ Are you a covered entity (health plan, healthcare provider that bills electronically, or healthcare clearinghouse)?
- ☐ Do you create, receive, store or transmit PHI on behalf of a covered entity or another business associate? If yes, you're a business associate.
- ☐ List every system, vendor and location that stores or processes PHI.
Step 2: Security Rule: administrative safeguards
- ☐ Risk analysis: a documented, organisation-wide assessment of risks to electronic PHI. This is the requirement regulators cite most often.
- ☐ Risk management plan: how you'll reduce the risks you found, with owners and dates.
- ☐ Security officer: a named person responsible for the security program.
- ☐ Workforce security: procedures for authorising, supervising and removing access.
- ☐ Security awareness training: for all staff, with records.
- ☐ Incident response procedures: how you identify, respond to and document security incidents.
- ☐ Contingency plan: data backup, disaster recovery and emergency mode operations.
- ☐ Periodic evaluation: a regular review of whether your safeguards still work.
- ☐ Business associate agreements: signed BAAs with every vendor that handles PHI for you.
Step 3: Security Rule: physical safeguards
- ☐ Facility access controls for offices and data centres.
- ☐ Workstation use and security policies.
- ☐ Device and media controls: disposal, re-use and tracking of hardware and storage media.
Step 4: Security Rule: technical safeguards
- ☐ Access control: unique user IDs, emergency access, automatic logoff, and encryption where appropriate.
- ☐ Audit controls: logging of activity on systems with PHI.
- ☐ Integrity controls: protecting PHI from improper change or destruction.
- ☐ Authentication: verifying that users are who they claim to be. Use multi-factor authentication.
- ☐ Transmission security: encryption of PHI in transit.
Step 5: Privacy Rule
- ☐ Policies on uses and disclosures of PHI, including the minimum necessary standard.
- ☐ Notice of Privacy Practices (covered entities).
- ☐ Procedures for patient rights requests: access, amendment, accounting of disclosures.
- ☐ Privacy training for staff who handle PHI.
Step 6: Breach Notification Rule
- ☐ A process to assess whether an incident is a reportable breach.
- ☐ Notification to affected individuals without unreasonable delay and within 60 days of discovery.
- ☐ Notification to HHS; for breaches affecting 500 or more people, also to prominent media in the affected state.
- ☐ Business associates: notify the covered entity as your BAA requires.
Step 7: Documentation
- ☐ Written policies and procedures for all of the above.
- ☐ Keep documentation for six years from creation or last effective date.
- ☐ Review and update policies when your environment changes.
The evidence customers and auditors ask for
| Requirement | Evidence |
|---|---|
| Risk analysis | Current risk analysis report and risk register |
| Policies | Approved, dated policies and procedures |
| Training | Training records for all staff |
| Access control | User access lists and access review records |
| Logging | Log configuration and review records |
| Vendors | Signed BAAs and vendor risk reviews |
| Incidents | Incident log and response records |
| Contingency | Backup and recovery test results |
Is there a HIPAA certification?
No. HHS does not certify organisations as HIPAA compliant. When a customer asks for "HIPAA certification", they usually want evidence that you've done the work: a recent risk analysis, policies, BAAs, training records, and often an independent third-party assessment or attestation. For the difference between a HIPAA audit and an AT-C 315 attestation, see HIPAA audit vs AT-C 315.
HIPAA for Indian companies
Many Indian companies (medical billing and coding firms, healthcare BPOs, health-tech product companies and offshore development teams) handle PHI for US clients. They are business associates, and their US clients will expect a signed BAA and evidence of the safeguards above. Building a HIPAA program alongside ISO 27001 or SOC 2 avoids doing the same work twice.

