PRODUCT UPDATES · AUG 14, 2026 · 5 MIN READ
PHI isolation: patient data behind its own boundary, and one CTCAE catalog for manual entries
Burna AI completed PHI isolation: patient data moved into its own plane, and manual adverse events now use the canonical CTCAE v6.0 catalog.
Burna AI Team
In week 33 of 2026 (10 to 16 August), Burna AI completed PHI isolation for its clinical AI platform: patient and clinical data now live in a PHI plane with its own database, apart from the control plane that holds accounts, organizations and billing. The same week, manual adverse events moved onto the canonical CTCAE v6.0 catalog the grading workflow reads, every event in review began opening to its evidence, and clinical notes became read-only in review. The work serves the security and IT reviewers who ask where patient data lives, and the clinicians and coordinators who review grades before an investigator signs them.
What PHI isolation means in a clinical AI platform
Protected health information (PHI) is the patient data a clinical AI platform reads: names, records, visit notes, grades and files. PHI isolation puts that data behind a boundary the rest of the system has no way to cross, so the protection holds as a property of the architecture rather than as a rule every engineer has to remember.
On 10 August, one merge moved every patient-facing table and route into a dedicated PHI plane and removed the earlier backend that had held patient data and accounts together. The patient data boundary now looks like this:
| Control plane | PHI plane | |
|---|---|---|
| What it holds | Identity, organizations, roles, billing and operations | Patients, visits, grading, trials, files and clinical conversations |
| What it knows about a patient | Opaque references that point at nothing readable | The clinical record itself |
| How a request reaches it | One sign-in token | The same token, verified against the control plane's published keys |
| Retention and purge of patient data | Nothing to retain, because it holds no patient data | Run on a schedule inside the PHI plane, next to the data they govern |
One sign-in and one organization model still cover everything a clinician does. Patient data does not follow identity into the control plane, because the control plane has no table to put it in. The audit trail of access to patient data sits inside the PHI plane too, beside the records it describes.
What a security reviewer can check
A boundary built into the architecture is one a reviewer can verify by reading the design. Burna AI runs a HIPAA-aligned architecture with PHI isolated in a dedicated plane, and it is built for HIPAA and 21 CFR Part 11. The architecture a security review asks about is set out on one page, and the security page covers who gets in, who else touches the data and how to report an issue.
How a 21 CFR Part 11 grade sign-off is linked to its record
The same merge closed the 21 CFR Part 11 sign-off chain. Section 11.70 requires an electronic signature to be linked to its record "to ensure that the signatures cannot be excised, copied, or otherwise transferred". A workflow's output can be re-run, so it cannot be the thing a signature covers.
A grade sign-off is now a signature over an immutable snapshot of the reviewed findings:
- The server decides what the signature covers. The signer does not choose it.
- An edit after signature stops a filing. A filing to the medical record is refused once the content no longer matches what was signed.
- A second sign-off adds a version. It is stored as a new version and the first one stays untouched.
Continuation or recurrence: how a repeat adverse event is recorded
The same work settled how a repeat adverse event is recorded, using only what the record already holds and no invented time window:
| What the record shows | How the event is recorded |
|---|---|
| No earlier occurrence of the term | A new event |
| Exactly one earlier occurrence, still open | A continuation, keeping its original onset date |
| The latest earlier occurrence resolved, and the event seen after it | A recurrence |
| Anything else | A question for the clinician; nothing is written until they answer |
A continuation asks for a new signature only when its grade changes, because a signature attests to a grade.
Every adverse event in review opens to its evidence
Encounter review used to give full rationale and evidence to the highest-graded event and very little to the rows below it. Every event is now the same kind of control: any row opens to its rationale, the evidence behind it and its actions, and the highest-graded row opens by default.
- Acceptance is confirmed. Accepting a grade asks for confirmation first, because acceptance locks the grade for sign-off.
- Columns scroll on their own. On desktop, the note, the assistant and the grading panes sit in columns bound to the window, so a long evidence list no longer pushes the clinical note out of view.
- The assistant keeps its place. Switching panes leaves an open conversation with the assistant where it was.
Every grade traces to the line in the medical record that produced it, and the review surface now makes reading that trace the easy path.
Manual adverse events use the canonical CTCAE v6.0 catalog
Adding an adverse event by hand used to mean typing a term against a dictionary held per organization, which was often incomplete. Two events describing the same thing could carry different terms depending on whether a person or the grading workflow recorded them.
Manual entry now picks from the canonical catalog of 850 CTCAE v6.0 terms, the same catalog the grading workflow reads, searched on the server. Choosing a term fills in its MedDRA code and its system organ class. Manual and workflow-graded events come out in the same shape, so the difference never surfaces later in a monitor's query or a cross-site reconciliation.
Why clinical notes are read-only in review
A grade cites the line in the note that produced it. If the note could be edited from the review surface after a grade was signed, the citation and its source could drift apart with nothing in the record to show it.
Notes are read-only in review and are edited upstream, where they are captured or synced from the medical record. The feature set is smaller and the guarantee is stronger: the source a grade cites stays put.
Healthnotes becomes its own app for trial participants
Trial participants now have an app of their own. Healthnotes, the participant app sponsors deploy through sites, became a separate mobile app from Care Journal, the consumer app. Every surface that exists because a sponsor, a protocol or an IRB asks for it belongs to Healthnotes.
Protocol ingestion and the rest of week 33
- Protocol documents, ingested end to end. A trial protocol can be uploaded and put through extraction, with its processing state visible while it runs and a readable error if it does not finish. Files are checked against the formats the extractor reads, so a document it cannot read is refused with a reason.
- A patient assigned while the encounter is created. A clinician picks or creates the patient in the same step as starting the encounter. Search covers name and record number and shows date of birth, and imported patients that search used to miss are found.
- Documents in Files. The organization knowledge library became a Documents category in Files, with a Retrieval column showing whether each document is indexed, indexing, failed or not indexed, and an action to index it.
- Invitations that open the right page. Invitation emails link to the web app, and a configuration that would send broken links stops the service at startup.
- Exports that download. Clinical exports save to disk as files.
- A guided profile step. After sign-in, new users are asked for specialty, role, institution, location, NPI number and a short biography. Skipping never blocks access; the step returns at the next sign-in until it is answered.
- One provider web app. The same merge retired the older provider web app; the platform runs at app.burna.ai.
Since then: The CTCAE v5.0 vocabulary joined v6.0 on the platform in late August 2026, as the week 35 update describes. Protocol reading also became its own Burna AI product line in September 2026: Protocol Studio, where a research site can start with a free protocol conformance report.
AI suggests, clinicians decide. Human-in-the-loop, always.
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