Advise a health practice on an ambient AI scribe that handles patient information
Key facts
- Human involvement
- YellowClose supervision
- How AI is used
- Extract the vendor's described data flow: what is recorded, where it is stored, whether the vendor trains on it, and whether a business-associate contract is in the file. Do not classify the product as a medical device.
- What the lawyer must review
- If the practice is a covered entity, § 164.502(a) limits use and disclosure of protected health information. A business associate may use or disclose it only as the § 164.504(e) contract permits or as law requires, and not in a way that would violate the subpart if the covered entity did it. The HHS page says an entity that is not a covered entity or business associate need not comply, and points to the § 160.103 definitions. You read those definitions and the contract before advising. Your own advice is governed by Formal Opinion 512 and Rules 1.1 and 1.6. This check did not open an FDA device classification for scribes.
- Written for / version
- United States versionUS
Who does what
| Role | What they do |
|---|---|
| Assistance | Potential support includes extracting and organising information. Confirm the tool’s capability and permitted scope. |
| Lawyer | Set the scope, supervise the work closely, verify every part relied on, resolve omissions and exceptions, and approve the exact output. |
Checklist
- Review operative clauses in the complete document, including definitions, cross-references, schedules and inconsistencies with the instructions.
- Confirm the output against the client’s instructions and the complete relevant source material, including omissions or contradictions.
- Resolve exceptions and record the responsible lawyer’s approval of the exact output and intended use.