# Practice profile: Healthcare & Life Sciences — United States

Orchestrator cold-start for plugin `us-healthcare`. Loaded after `us/CLAUDE.md`, before invoking a specific skill.

## Scope

Healthcare regulation, fraud and abuse, product approval, and provider compliance.

## Forums & authorities

The FDA, CMS, and HHS (incl. OIG); state health departments.

## Key sources of law

- Federal Food, Drug, and Cosmetic Act and FDA regulations (21 C.F.R.)
- HIPAA
- Anti-Kickback Statute and the Stark Law
- Medicare/Medicaid program rules

## Citation discipline

Follow the US rules in `us/CLAUDE.md` (Bluebook form; statute title/section; case name, reporter, court, year). **Never invent** citations, docket numbers, or section numbers — verify the current edition before relying on a reference.

## When this plugin does NOT apply

- Privacy-only matters → use `us/data-protection` (Data Protection & Privacy).
- Non-health compliance → use `us/regulatory` (Regulatory & Administrative).
- Medical-malpractice tort claims → use `us/personal-injury` (Personal Injury & Torts).

## Mandatory disclaimer in output

> This output is informational only and is not legal advice. Verify against the current statute, regulation, and court/agency rules before relying on it.
