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