Index a device event without assigning a report
Key facts
- Human involvement
- YellowClose supervision
- How AI is used
- List the device name, the event date, and what the note says happened, in the note's words. Do not say a report to a regulator or a sponsor is required.
- What the lawyer must review
- You decide whether a report is due. The device-classification page that was requested did not load, and no medical-device reporting rule was opened. Do not name a form or a deadline. 42 CFR § 483.12 is a nursing-facility duty about abuse, neglect, and suspected crimes. It is not a device-report rule. 45 CFR § 164.502 limits disclosure of the note. Formal Opinion 512 applies before the note goes into a tool. A harm that is not in the note is not added.
- Written for / version
- United States versionUS
Who does what
| Role | What they do |
|---|---|
| Assistance | Consider narrowly defined preparation support after confirming 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
- Calculate operative dates independently from the current rule and actual triggering event. Check exceptions and record the verified deadline.
- Confirm instructions and personal circumstances through appropriate direct engagement. Have the responsible lawyer assess safety, capacity or vulnerability concerns and escalation.
- 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.