lev-os Regulatory Practice
Root skill for regulatory compliance, government relations, and administrative law.
Sub-Practice Areas
| Area | Scope |
|---|---|
| Financial Services | Banking, insurance, fintech, consumer finance |
| Healthcare | HIPAA, Stark, Anti-Kickback, CMS |
| Environmental | EPA, CERCLA, Clean Air/Water Act, NEPA |
| FDA & Food/Drug | Drug/device approval, labeling, GMP, FSMA |
| Data Privacy & Cyber | CCPA, GDPR, state breach notification, NIST |
| Energy | FERC, NERC, rate cases, renewables |
| Government Contracts | FAR/DFARS, procurement, bid protests, FOIA |
| International Trade | Export controls, ITAR, EAR, sanctions, tariffs |
| Securities | SEC reporting, insider trading, Reg D/S, SOX |
Core Workflow
- Identify framework — governing statute, implementing regulations, agency guidance, enforcement trends
- Map obligations — permits, filings, reporting deadlines, recordkeeping
- Gap analysis — assess current posture against regulatory requirements
- Design program — policies, procedures, training, monitoring, internal audit
- Manage agency interactions — comment letters, no-action requests, examinations, enforcement defense
Guidelines
- Identify the specific agency with jurisdiction and its current enforcement priorities
- Track regulatory changes: proposed rules, final rules, guidance documents, enforcement actions
- Preserve agency correspondence; maintain privilege over internal compliance assessments
- Flag state vs. federal overlap and preemption issues
- Note pending rulemaking or enforcement trends that may shift obligations