No. Any organisation can pursue HITRUST certification. In practice, most certified organisations are not covered entities at all. They are business associates and technology vendors: SaaS platforms, cloud providers, revenue cycle and BPO firms, analytics and AI companies, and offshore IT service providers that handle data for US healthcare customers. Non-healthcare sectors also use it.
Who are covered entities and business associates?
Under HIPAA:
- Covered entities are health plans, healthcare clearinghouses and providers that transmit health information electronically.
- Business associates perform services for covered entities involving PHI. Subcontractors of business associates are business associates too.
HIPAA obligations flow down this chain by law and by BAA. HITRUST requirements flow down the same chain by contract.
Who actually gets HITRUST certified?
| Organisation type | Why they certify |
| Health tech SaaS and digital health | Enterprise customers require it |
| Cloud, hosting and managed service providers | To allow customers to inherit controls and to qualify as vendors |
| Revenue cycle, billing, coding and transcription firms | High PHI volume, payer and provider contracts |
| Claims processors and TPAs | Payer requirements |
| Data analytics and AI vendors | Large datasets, model training on sensitive data |
| Offshore IT and BPO providers in India, the Philippines and elsewhere | US client flow-down, differentiation |
| Global capability centres of US healthcare companies | Parent company policy |
| Payers and large health systems | Own programme structure and to set vendor standard |
| Life sciences and medical device companies | Connected devices, clinical data |
| Financial services and insurers | Prescriptive, certifiable framework mapped to NIST |
Why would a non-healthcare company choose HITRUST?
The name suggests healthcare, but the HITRUST CSF is industry agnostic. Reasons non-healthcare organisations adopt it:
1. One framework, many mappings. NIST CSF, NIST SP 800-53, ISO/IEC 27001, PCI DSS and privacy regulations in one control set.
2. Certifiable and scored. Unlike NIST CSF, which has no certification, HITRUST produces a third-party validated result.
3. Consistent assurance. Central QA makes reports comparable across vendors.
4. Healthcare adjacency. Fintech, HR tech, benefits and insurance platforms increasingly touch health data.
What about companies outside the United States?
HIPAA reaches offshore vendors through the BAA, and customers enforce it through audit rights. For service providers in India, the UK and the Middle East, HITRUST is often the most efficient answer to a US customer asking “how do we know our PHI is safe offshore?”
Points for international organisations:
- HITRUST assessments can be performed remotely by an Authorized External Assessor anywhere in the world.
- Scope should include offshore delivery centres, remote workers and the connectivity between them and the client environment.
- Local privacy laws still apply. For Indian organisations, the Digital Personal Data Protection Act obligations sit alongside HITRUST. A well-run HITRUST programme supplies much of the security safeguard evidence, but it is not a DPDP compliance certificate.
- European operations should consider GDPR alongside.
When is HITRUST not the right fit?
- You handle no sensitive or regulated data.
- Your customers specify ISO 27001 or SOC 2 and nothing else.
- You are a very small provider practice with no contractual requirement. A HIPAA risk analysis and basic safeguards are the priority.
How do you decide? A five question test
1. Do you create, receive, maintain or transmit PHI for US organisations?
2. Has any customer, prospect or partner asked about HITRUST?
3. Do competitors display HITRUST certification?
4. Is US healthcare enterprise a stated growth segment in your plan?
5. Would a single certifiable framework reduce the number of audits you undergo?
Two or more “yes” answers justify a scoping conversation.
Which level suits which organisation?
| Profile | Suggested starting level |
| Start-up, limited PHI, first enterprise pilot | e1 |
| Mid-size SaaS or BPO with PHI from several clients | i1 |
| Cloud provider, clearinghouse, payer, high PHI volumes | r2 |
| Non-healthcare enterprise seeking NIST-aligned certification | i1 or r2 |
Key takeaways
- HITRUST is open to any organisation in any country.
- Business associates and technology vendors are the largest group of adopters.
- The framework is industry agnostic and maps to NIST, ISO and PCI.
- Offshore providers use it to evidence safe handling of US PHI.
- HITRUST complements but does not replace local privacy law compliance.
Frequently asked questions
Is HITRUST only for healthcare?
No. The HITRUST CSF is industry agnostic, though adoption is strongest among organisations serving US healthcare.
Do business associates need HITRUST?
Not by law, but many covered entities require it contractually from business associates handling significant PHI.
Can a company outside the US get HITRUST certified?
Yes. Organisations worldwide certify, and assessments can be performed remotely.
Can financial services companies use HITRUST?
Yes. Some use it as a certifiable framework that maps to NIST and other standards.
Does HITRUST cover India’s DPDP Act?
HITRUST supports security safeguards relevant to DPDP obligations but is not a DPDP compliance certification.
About Finstein
Finstein is a HITRUST Authorized External Assessor. Our team includes CCSFP and CHQP qualified HITRUST professionals, CISA certified auditors and ISO 27001 lead auditors, led by Chartered Accountants. We support readiness assessments, validated e1, i1 and r2 assessments, interim assessments and recertification for organisations in the US, India, the UK and the Middle East that serve US healthcare, using an efficient remote delivery model. Check whether HITRUST applies to your business.
