The global health care industry is both complex and evolving. Multinational companies must navigate a landscape that includes often conflicting and constantly changing regulations in one of the most highly regulated industries in the world. They must also manage risks associated with foreign affiliates, agents, and third parties that may unknowingly implicate U.S. law. The intensive regulatory approach and business practices of other jurisdictions raise many challenges for companies, including issues involving data-flow and privacy restrictions, technology and information, export-control risks, intellectual property protection, anti-corruption, licensing, recordkeeping, rulemaking, and compliance, and can burden companies with significant risk.
Foley has deep experience assisting with health care industry project assessment, development, and implementation. Through our years of work with health care providers, we have insights into how other countries’ domestic laws apply in multiple sectors, including the health care sector, and how to address compliance obligations and risks.
As your trusted adviser, Foley’s International Health Care Team delivers high-quality legal counsel to meet your needs by creating connections, forming alliances, identifying opportunities, and minimizing risks around the world.
Guiding Health Care Infrastructure Investments — Outside of the United States
The world’s rapid health care system development continues to provide opportunities for entrepreneurs and health care institution partners involved in, or considering investments in, foreign health care infrastructure and systems.
Our team monitors international telemedicine developments, addresses interpretive issues with the authorities, and develops models to manage evolving compliance obligations and risks.
Our team is experienced in vetting both inbound and outbound medical tourism programs, proposals, and third-party service providers with a particular focus on minimizing compliance and litigation risks.
Licensing requirements are a core focus of many of today’s regulatory programs governing medical professionals and the institutions at which they work.
Jurisdictions outside of the United States have developed regulatory programs governing internet-assisted online medical and health information, and diagnosis and treatment services.
Counseling on Trade and Anti-Corruption Compliance
Trade controls and anti-corruption measures are a critical part of any compliance and related risk management program involving foreign health care institutions and other parties.
The development, protection, and commercialization of intellectual property assets are of critical importance to health care companies hoping to have a sustainable success in foreign countries.
Health care industry acquisitions, collaborations, and programs involving physician, nurse, and other employee travel to foreign sites for work, training, or other purposes may involve a wide range of labor and employment law requirements.
Most countries have developed a robust array of regulatory requirements applicable to medical devices, pharmaceuticals, biologics, and other products critical to the health care sector.