Healthcare Regulatory

The ever-changing landscape of healthcare regulation demands experienced legal and regulatory guidance. Goodwin advises companies on the full spectrum of healthcare regulatory issues.

Goodwin advises healthcare services, life sciences, digital health, and health technology clients concerning fraud and abuse laws such as the Anti-Kickback Statute and the Stark Law; coverage and reimbursement issues; facility and professional licensure; scope of practice; limitations on the corporate practice of medicine and other professions; Medicare and Medicaid; managed care issues; transparency and Sunshine Laws; clinical research; the regulation of telemedicine; and the privacy and security requirements of key legislation including the HITECH Act, HIPAA, the GDPR and the growing number of state laws concerning the privacy and security of health information. And we have a long track record of success defending clients in investigations related to fraud and abuse and qui tam litigation.

Additionally, our Washington, D.C.-based FDA practice offers deep experience in pre-market and post-market requirements, agency inquiries, corporate transactions, FDA due diligence and legislative issues with a keen understanding of how the FDA works and how to leverage regulatory mechanisms to achieve clients’ business objectives. We are savvy issue-spotters and regulatory advisors, often counseling clients on:

• Relationships with healthcare professionals, including both pre- and post-market
• Product development pathways and FDA interactions
• Clinical development
• Patient engagement and advocacy
• Designations and expedited programs
• Commercial ramp-up
• Company communications
• Diagnostics, including laboratory-developed tests
• Software, including mobile medical apps, digital therapeutics and clinical decision software
• Data presentations
• Transactions and capital raising