# Intended use

MedSeek is a DeepSeek Harness plugin that helps licensed healthcare
professionals draft documentation and retrieve cited reference material
during routine, non-emergency work.

It is software for clinicians. It is not a medical device, not a diagnostic
service, and not a substitute for clinical judgment. Topic inclusion under
`dsh-plugin` is not an endorsement by DeepSeek and is not a regulatory
clearance.

## Who it is for

Physicians, advanced practice providers, nurses, hospitalists, residents,
pharmacists, and outpatient clinicians using dsh as a chat agent. The
operator (the person or organization that installs dsh) hosts the process
and chooses the model endpoint.

## What it does

- Restructures clinician-supplied notes into SBAR / I-PASS handover,
  discharge-summary, SOAP / APSO progress-note, and admission H&P
  scaffolds, then checks those drafts against published checklists.
- Scores a clinician-authored patient-instruction draft against a 6th-8th
  grade reading target and lists leftover jargon. The tool does not rewrite
  the text; the agent does, then calls the tool again to re-score.
- Scrubs HIPAA Safe Harbor identifier categories from pasted text. This
  assists de-identification; it does not certify it.
- Retrieves FDA label sections, MedlinePlus education pages, PubMed
  citations, and ClinicalTrials.gov records, each with source, identifier,
  link, and retrieval date.

Every generated artifact is a draft. A named clinician reviews it before
it is used.

## What it does not do

- Diagnose, prescribe, compute a dose, rank a differential, score a
  drug-drug interaction, or assign a billing code level. Note structures
  document problems, data, and risk descriptively; any code-level judgment
  stays with the clinician.
- Read or write an EHR.
- Accept images, waveforms, audio, or device signals.
- Make time-critical recommendations. Decline emergency framings.
- Send patient identifiers to NLM, NIH, or FDA. Lookup arguments are
  terms and codes only; the PHI guard denies network calls that look like
  they carry identifiers.

## FDA non-device CDS

The design maps to FD&C Act section 520(o)(1)(E) as read in FDA's
January 2026 Clinical Decision Support Software guidance:

1. Text only. No images or acquired signals.
2. Inputs are clinician notes and published medical information (FDA
   labels, peer-reviewed studies, government patient education).
3. Outputs are drafts and source displays, not treatment directives or
   patient-specific scores.
4. Every lookup carries source, identifier, link, and retrieval date so
   the user can independently review the basis.

See `docs/regulatory-checklist.md` for the per-tool mapping.

## HIPAA

The project distributes source code, not a hosted service, and never
receives PHI. No business associate agreement with the MedSeek project
exists or is needed. Obligations sit with the deploying organization.
See `docs/permissions-and-data.md`.
