List the medicine facts before any access request is written
Key facts
- Human involvement
- RedLawyer-led
- How AI is used
- List the medicine name, the strength if the file states it, and the condition in the file's words. Do not name a form and do not write an application.
- What the lawyer must review
- You write any request for an unapproved medicine. No special-access or unapproved-drug rule was opened, so you do not name a pathway or a form number. 45 CFR § 164.502(a) limits use and disclosure of the patient's information. Model Rule 1.6(a) limits revelation of information relating to the representation. Model Rule 1.6(c) requires reasonable efforts against inadvertent disclosure. Formal Opinion 512 requires informed consent before that information goes into a self-learning tool whose output could disclose it. The patient's name stays in the file unless you decide a disclosure is permitted.
- Written for / version
- United States versionUS
Who does what
| Role | What they do |
|---|---|
| Assistance | Supporting preparation only. Consider narrowly defined preparation support after confirming the tool’s capability and permitted scope. The tool writes nothing into the document. Substantive advice, judgement and any restricted content remain with the responsible human. |
| Lawyer | Perform the substantive analysis and decisions. Independently check any permitted supporting work and approve the exact output for its intended use. |
Checklist
- 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.