HIPAA from India

Serving US healthcare clients from India.

HIPAA is a US law, but it follows the data through contracts, not borders. An Indian software, billing, coding or support company that handles patient data for a US client takes on HIPAA duties through a business associate agreement (BAA). This page covers when that happens, what the client will ask, and how India's own law fits alongside.

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01 · When HIPAA reaches you

The moment you become a business associate

Originate, take in, store or send on PHI for a US client, and you count as one.

  • Hosting or building a platform. Your product stores patient records, appointments or claims for a US provider or plan.
  • Revenue cycle and billing. Your team works claims, denials or payment postings.
  • Medical coding and transcription. Staff read clinical notes to code or transcribe them.
  • Support with production access. Engineers or agents can see live patient data while fixing issues.
  • Analytics on identifiable data. You build reports from data that still identifies patients.

You are not a business associate if you never touch PHI, or if you only receive data properly de-identified under one of the two methods HIPAA recognises. Check that claim carefully: removing names alone does not de-identify a dataset.

Business associates are directly liable under the Security Rule wherever they sit. In practice, the strongest lever on an Indian vendor is usually the contract with the US client.

02 · A worked example

Illustrative: a billing team in Pune

One client, three subcontractors, one chain of BAAs.

Illustrative scenario

A forty-person revenue cycle company in Pune signs with a US physician group. Claims data lives in the client's practice management system in the US; staff in Pune log in through a virtual desktop. The company also uses a US cloud for its own work queue, an email provider and a ticketing tool where screenshots sometimes land. The client sends its BAA template. The company signs it, then finds that the cloud, the email provider and the ticketing tool all touch PHI. Each now needs a BAA with the company, or PHI must be kept out of it.

The lesson is the chain. Your BAA with the client binds you to get equivalent written assurances from every subcontractor that handles the PHI. The ticketing tool is the one most often missed.

03 · The BAA, offshore

How the BAA flow usually runs offshore

Commonly the client's template, with offshore terms added.

  1. The client confirms you will handle PHI and sends its BAA, often alongside a master services agreement and a security schedule.
  2. You check the required terms: permitted uses, safeguards, incident and breach reporting, subcontractor flow-down, return or destruction at the end.
  3. You check the extra terms. A breach reporting window shorter than the rule's outer limit, audit rights, insurance and data location clauses are common.
  4. You confirm you can meet every term before signing, including the reporting window.
  5. You sign, and only then receive PHI.
  6. You put matching BAAs in place with each subcontractor that touches the PHI.

Some US clients ask for written approval before any PHI is accessed from outside the United States. Read the agreement for that clause specifically.

04 · Data location and access

Where the data sits, and how India reaches it

HIPAA has no data residency rule; contracts and programmes may.

HIPAA does not, by itself, forbid PHI from being stored or viewed outside the United States. Your risk analysis must still cover the offshore access path, and your client's contract or its own regulators may restrict it.

Clients in some US government health programmes face their own offshore reporting or restriction duties, which they pass down to you. Ask early whether any apply.

  1. AX.1
    Keep data in the client's regionAccess it from India through a virtual desktop or similar, so no copy lands on local devices.
  2. AX.2
    Block local storageDisable download, print, clipboard and USB on sessions that show PHI.
  3. AX.3
    MFA and named accountsNo shared logins; every action traceable to one person.
  4. AX.4
    Log and reviewRecord who viewed what and review it on a schedule.
  5. AX.5
    Secure the work areaControlled floor access, clean desks, no personal phones at PHI workstations where the risk calls for it.

05 · Training and vetting

Staff training and vetting

The client will ask for records, not assurances.

  • HIPAA training for every person with PHI access, at joining and periodically, with signed records.
  • Role modules: coders and billers on minimum necessary use; engineers on test data and logs.
  • Background checks commonly used in India, such as identity, education, employment and address or police verification, applied consistently and with the candidate's consent.
  • Confidentiality agreements that name PHI.
  • A written sanction policy for violations, applied and recorded.
  • Same-day removal of access when someone leaves.

06 · The client's review

What a US client's vendor review will ask

And what you should be able to put on the table.

Client questionWhat they are testingWhat to show
Have you done a HIPAA risk analysis?Whether you know your own risksA dated analysis covering the offshore access path
Who is your security officer?OwnershipA named person and appointment record
Where will our PHI be stored and accessed from?Data locationA data flow diagram and access method
Which subcontractors touch our data?The BAA chainA subcontractor list with BAAs
How fast will you tell us about an incident?Reporting windowYour incident procedure and its timings
What independent evidence do you have?Outside assuranceWhichever of a SOC 2 report or an ISO 27001 certificate you hold, plus a recent penetration test
Are your staff trained and vetted?People riskTraining records and background check policy

There is no HIPAA certificate to show. HHS certifies no one, and a badge from a private body is not a government approval. The answer to a request for one is your evidence pack, and if you have it, an independent report on your controls.

07 · India's DPDP Act

How India's DPDP Act sits beside HIPAA

Two laws, different subjects, both possibly in play.

The Digital Personal Data Protection Act, 2023 (DPDP Act) covers personal data in digital form whenever it is handled on Indian soil. Your employees' data is covered in full. For the US patient data you handle under contract, the Act carves out much of its scope for processing done in India for a contract with a person outside India, about people outside India.

Our reading is that reasonable security safeguards remain a duty even under that carve-out. In practice the safeguards you run for HIPAA will largely serve both. Neither law has a certificate.

  • Role confirmed. Written view of whether you are a business associate for each client.
  • BAA chain complete. Client BAAs signed; subcontractor BAAs in place.
  • Risk analysis current. Covers offshore access, devices and every subcontractor.
  • Access path locked down. Virtual desktop, MFA, no local copies, logs reviewed.
  • People controls. Training, vetting, sanctions, prompt leaver removal.
  • Incident plan. Meets the shortest reporting window in any client contract.
  • DPDP view. Employee data handled under the DPDP Act; client data carve-out confirmed with counsel.

Sources: 45 CFR 160.103 (definitions of business associate and subcontractor); 45 CFR 164.308, 164.314 and 164.502(e) (business associate safeguards and contracts); 45 CFR 164.514 (de-identification); 45 CFR 164.410 (notice by business associates); HHS guidance on business associates; the Digital Personal Data Protection Act, 2023.

Questions from Indian vendors

Our client is in the US. Do we need to register anywhere?

No. HIPAA has no registration for business associates.

There is no list to join and no licence to obtain. Your duties come from the rules and your BAA. What you need is evidence: a risk analysis, policies, records and signed agreements.

A client asked for our HIPAA certification. What do we send?

Explain there is none, and send evidence instead.

HHS does not certify anyone. Send a short statement of your HIPAA programme, your dated risk analysis summary, your BAA approach, and any independent report you hold, such as a SOC 2 report issued by a CPA firm.

Can our developers use real patient data for testing?

Avoid it; if unavoidable, treat test as production.

Use synthetic or properly de-identified data. If real PHI must be used, the test environment needs the same safeguards as production and must be in your risk analysis and BAA scope.

Do we report breaches to HHS ourselves?

Usually you report to the client, which notifies HHS.

As a business associate you report the breach to the covered entity promptly and inside the rule's outer limit, often sooner under the contract. The client normally sends the notices, unless the BAA says otherwise.

Be ready for your next US vendor review.

A HIPAA risk assessment covers your offshore access path, your subcontractors and the evidence clients ask for. Counsel should confirm how HIPAA and the DPDP Act apply to your contracts.