HIPAA Compliance for Healthcare and Health-Tech

Indian health-tech companies and hospital groups encounter HIPAA through US patients, US customers or US partners. The obligation usually arrives as a business associate agreement, and the first thing anyone asks for is the risk analysis — which most organisations have never formally performed.

What HIPAA requires of healthcare providers

• Determination of whether you are a covered entity, a business associate, or both — the obligations differ materially.
• A documented security risk analysis covering all ePHI, which is the foundational requirement everything else references.
• Administrative, physical and technical safeguards implemented and evidenced, including access control, audit controls and transmission security.
• Business Associate Agreements in place with every vendor that touches ePHI, flowing down to sub-contractors.
• Breach notification procedures aligned to the HIPAA timelines, distinct from Indian DPDP breach obligations if both apply.

Evidence assessors actually ask for

Documentation is rarely the blocker — evidence that controls genuinely operate is. These are the artefacts requested first in this sector.

• The security risk analysis, dated and reviewed, with a risk management plan against it
• Access logs demonstrating audit controls actually record ePHI access
• Signed BAAs for every vendor in the ePHI path
• Workforce training records with dates and content
• Encryption standards for ePHI at rest and in transit

Where healthcare providers usually come unstuck

• Assuming a cloud provider’s HIPAA eligibility makes your deployment compliant — it does not.
• Treating the risk analysis as a one-time document rather than a maintained artefact.
• Overlooking DPDP obligations running in parallel where Indian patient data is also processed.

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