regulatory

Navigates regulatory compliance, government relations, and administrative law across financial services, healthcare, environmental, FDA, privacy, energy, government contracts, trade, and securities domains. Use when handling agency interactions, compliance programs, enforcement defense, rulemaking comments, or administrative proceedings.

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