HIPAA compliance for startups
HIPAA is law, not a voluntary framework. If your product handles PHI for a covered entity, you need the Security Rule safeguards in place, and enterprise healthcare buyers will want evidence.
What the sources say
- The Security Rule sets national standards for ePHI and requires administrative, physical and technical safeguards. It applies to covered entities and their business associates. [HHS]
- There is no HIPAA certificate. Health systems usually ask for more than a self-attestation, such as a SOC 2 report with HIPAA mapped in, or HITRUST for larger deals. [Cost of Compliance]
- HHS and ONC offer a free Security Risk Assessment Tool for small and medium-sized practices and business associates. [HHS]
In this section
| HIPAA compliance software | 5 of the 8 platforms we track list HIPAA. Includes pricing references. |
|---|---|
| HIPAA compliance cost | Published ranges for year one, attributed to their sources. |
| HIPAA & HITRUST auditors | 26 firms in our directory that list HIPAA or HITRUST. |
Frequently asked questions
Is there an official HIPAA certification?
No certificate is issued under the HIPAA Security Rule itself. Cost of Compliance notes there is "no certificate to buy and no auditor who signs you off." Buyers often ask for SOC 2 with HIPAA mapped in, or HITRUST, as evidence.
When does HIPAA apply to a startup?
The Security Rule covers electronic protected health information created, received, used or maintained by a covered entity or its business associate, per HHS. If you sell to providers or payers and touch PHI, you are likely a business associate. Confirm with counsel.
Do I need SOC 2 as well?
Not legally. In practice, health system buyers often ask for an independent report. See SOC 2 for healthtech.
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Last verified 2026-10-19. Not legal advice.