Regulatory

---
name: regulatory
title: Regulatory Practice
description: 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.
author: CaseMark
author_url: https://github.com/CaseMark/skills/tree/main/skills/legal/regulatory
license: Apache-2.0
version: 0.1.0
execution_mode: open
jurisdiction: us
practice: regulatory
language: en
tags: [research]
---

# 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

1. **Identify framework** — governing statute, implementing regulations, agency guidance, enforcement trends
2. **Map obligations** — permits, filings, reporting deadlines, recordkeeping
3. **Gap analysis** — assess current posture against regulatory requirements
4. **Design program** — policies, procedures, training, monitoring, internal audit
5. **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