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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:
The global healthcare marketplace is in a constant state of transformation. Structural shifts in reimbursement models, consolidation, the development and commercialization of new and disruptive technologies, a trend toward consumerism and a complex and evolving regulatory landscape is challenging the status quo and creating opportunities for companies and investors in the healthcare space.
Regulatory pressures and structural shifts in healthcare delivery models are driving the development and commercialization of new and disruptive technologies, and consumerism in the healthcare technology and digital health markets is shifting the status quo for industry participants.
Goodwin knows that making deals in the healthcare industry a reality comes with significant regulatory and transactional challenges. Our cross-functional healthcare team understands the key regulatory issues and helps clients to navigate regulatory complexity.
The global healthcare marketplace is in a constant state of transformation. Structural shifts in reimbursement models, consolidation, the development and commercialization of new and disruptive technologies, a trend toward consumerism and a complex and evolving regulatory landscape is challenging the status quo and creating opportunities for companies and investors in the healthcare space.
Regulatory pressures and structural shifts in healthcare delivery models are driving the development and commercialization of new and disruptive technologies, and consumerism in the healthcare technology and digital health markets is shifting the status quo for industry participants.
Goodwin knows that making deals in the healthcare industry a reality comes with significant regulatory and transactional challenges. Our cross-functional healthcare team understands the key regulatory issues and helps clients to navigate regulatory complexity.