Healthcare Regulatory

Latham’s healthcare and life sciences regulatory team draws on market-leading experience and deep industry knowledge to advise healthcare and life sciences companies, digital health and technology providers, private equity, investment banks, venture capital firms, and other industry stakeholders. We advise on regulatory counseling, fraud and abuse compliance, reimbursement and related matters, data, privacy, and security, licensure, accreditation, quality management, controlled substances regulation, as well as on the regulatory aspects of mergers and acquisitions and other corporate transactions in the sector.

Latham helps clients achieve their business objectives by providing best-in-class experience and industry acumen to manage sophisticated federal and state regulatory and legislative strategies. We have been exceptionally successful helping companies in the sector to successfully navigate the full range of challenging regulatory issues they face by drawing on our longstanding relationships with key federal and state government agencies, including the US Department of Health & Human Services, Centers for Medicare & Medicaid Services, Office of the Inspector General, Office for Civil Rights, the US Drug Enforcement Agency, and the US Department of Justice, as well as their corollary state agencies. We provide comprehensive advice and emphatic defense to clients across every aspect of business subject to healthcare and life sciences regulation and enforcement authorities, including civil, criminal, administrative, and congressional matters.

With deep expertise and experience in fraud and abuse counseling, we advise life sciences companies and healthcare providers of all sizes on the full spectrum of related matters — from structuring advice, to day-to-day compliance counseling, to developing, implementing, and auditing compliance programs, managing internal and external audits and investigations, and defending clients in government enforcement actions. Complementing this work, our reimbursement and government pricing lawyers work closely with emerging and mature companies to develop governmental and commercial reimbursement strategies for new technologies and novel products, as well as to help clients navigate the increasingly complex government pricing and transparency requirements.

As clients navigate the rapidly evolving laws at the intersection of healthcare and technology, we provide a business savvy commercial approach, and global perspective to help clients work through health information and other data privacy and security matters.

The team works with clients to identify, address and resolve critical regulatory issues in hundreds of transactions each year, spanning mergers and acquisitions, joint ventures, affiliations, securities offerings, IPOs and other capital market transactions, financings and venture capital investments. We efficiently assess company regulatory profiles, calibrating our diligence to identify the most important areas of risk, and coordinating with our corporate team and clients to achieve the right result. We also negotiate and structure service agreements, operating, technology, and other contractual agreements with providers, payors, manufacturers, distributors, vendors, and suppliers.