HIPAA · PHI · 45 CFR 160.103 / 164.502(e)

We can’t mishandle PHI we never receive.

The cleanest PHI architecture is the one where the vendor never touches protected health information. Blueprint runs inside your systems — the covered entity holds the PHI, not us — so there’s typically no business associate relationship and no BAA to negotiate.

On-premNo vendor access to PHINot legal advice

Who says so: HHS — “the mere selling or providing of software … does not give rise to a business associate relationship if the vendor does not have access to the [PHI].” HHS FAQ 256 ↗

The requirement

It all turns on one word: access.

HIPAA defines a “business associate” by whether you handle PHI. No handling, no relationship — and no BAA.

160.103
A “business associate” is defined by access to PHI
  • A business associate creates, receives, maintains, or transmits PHI on behalf of a covered entity.
  • HHS: “the mere selling or providing of software … does not give rise to a business associate relationship if the vendor does not have access to the PHI.”
Source: 45 CFR 160.103 (govinfo) ↗
164.502(e)
A BAA is needed only if the vendor touches PHI
  • A covered entity must have a written BAA with any business associate.
  • HHS names the triggers: the vendor hosts the software (and its PHI) on its own server, or accesses PHI when troubleshooting — then it is a business associate.
Source: 45 CFR 164.502(e) (govinfo) ↗
The problem

Why a hosted UI vendor becomes a business associate.

1

A hosted UI vendor that stores or proxies your screens’ data is handling PHI — and per HHS, even storing without viewing makes them a business associate. Now you need a BAA and they’re in your risk surface.

2

Remote support sessions, telemetry, or error logs that carry PHI quietly create a business-associate relationship you didn’t plan for.

3

The “conduit exception” (courier / ISP) is narrow and the wrong doctrine for a UI runtime — the correct basis is “no access to PHI,” not “we’re a conduit.”

The answer

Why Blueprint stays out of the BAA, point by point.

Basis
What it says
How Blueprint sits outside it
160.103 · BA definition
A BA creates, receives, maintains, or transmits PHI.
Blueprint does none of those — it’s code that runs inside your systems; the PHI stays with you, so the definition isn’t triggered.
164.502(e) · BAA
A written BAA is required with any business associate.
With no access to PHI there’s no BA relationship — so typically no BAA to negotiate. (Confirm for your deployment.)
HHS FAQ 256 · software vendors
Providing software ≠ BA, absent PHI access.
Blueprint is provided software you self-host; the vendor has no access to your PHI.
Access triggers
Hosting or troubleshooting access → BA.
No vendor hosting, no telemetry with PHI. If a support workflow ever needs PHI access, a BAA would then apply.
The evidence

What a privacy officer sees: no PHI leaving your walls.

A change to the screen is a reviewable diff; the runtime that serves it receives nothing.

contracts/patient-intake.json · PR #337 · reviewed by @privacy
{ "type": "form", "id": "patient-intake",
  "fields": [
    { "type": "text", "label": "Diagnosis" }
    { "type": "select", "label": "Diagnosis (ICD-10)" }
  ] }

PHI the vendor received

0records, ever

Data path

  • Runs on-prem yes
  • Vendor access to PHI none
  • Telemetry with PHI none

The honest part

Blueprint isn’t “HIPAA-compliant” — HIPAA doesn’t certify software, and compliance is the covered entity’s obligation. What’s true: if Blueprint never accesses PHI (no vendor hosting, no PHI in support or telemetry), it isn’t a business associate, so there’s typically no BAA. Business-associate status turns on your actual deployment — confirm with your privacy officer or counsel. This page is informational, not legal advice.

For your security review

The questions your compliance team will ask.

Are you HIPAA-compliant?

HIPAA doesn’t certify software — compliance is your obligation as the covered entity. Blueprint’s role is architectural: run on-prem, never touch PHI, so we aren’t a business associate.

Do we need a BAA with you?

Typically not — a vendor with no access to PHI isn’t a business associate (HHS FAQ 256). This depends on your deployment (no vendor hosting, no telemetry or support access to PHI); confirm with counsel.

What if support needs to see PHI?

Then that access would make us a business associate for that purpose, and a BAA would be required. The default is no access.

Does PHI in logs matter?

Yes — if error logs or telemetry carry PHI off your systems, that’s PHI handling. Blueprint’s default is no PHI egress; keep it that way.

Sources

Verify it yourself.

Every claim on this page traces to HHS or the Code of Federal Regulations.

Bring us your hardest audit

No access to PHI. No business associate. No BAA to negotiate.