Healthcare has never been more complex and the rate of change is accelerating. Intricate, overlapping federal and state regulation, intense competition, and significant fiscal challenges confront everyone involved in the healthcare industry. The Troutman Sanders Healthcare Practice brings decades of experience and cutting-edge knowledge to these challenges, whether it means advising clients on daily operations or pursuing strategic ventures. Our ability to think creatively allows us to find thoughtful solutions to our clients’ legal obstacles so that they can put their focus back on pursuing innovative solutions to their own challenges: delivering treatment, paying for care and developing the next generation of medical devices, technology and medications.
As principal outside counsel to numerous healthcare organizations, we provide day-to-day legal advice and assistance on all aspects of corporate and commercial operations, including corporate governance issues, regulatory compliance issues, commercial contracts and vendor agreements, directors’ fiduciary and legal responsibilities, corporate formations, and an array of other corporate issues.
We regularly advise clients on the complex legal and policy issues that arise in the following areas:
We represent clients from every part of the Healthcare sector, including:
We recognize the demands that healthcare providers face when operating in a complex regulatory environment with significant fiscal challenges. Our depth of experience and acute awareness of these industry realities help us understand how operational decisions uniquely affect health systems, hospitals and physicians every day. We remain at the forefront of industry developments so that our clients receive optimal advice regarding emerging issues.
Health Information Technology
Technology continues to transform every aspect of healthcare. From the bedside to the boardroom, healthcare providers and payors must address complex legal and regulatory issues related to Health Information Technology (HIT). We have extensive experience negotiating complex IT contracts, navigating federal safe harbors for donation of electronic medical records (EMRs) and other HIT, and investigating and responding to health data breaches. At the national, regional, state and local levels, we have successfully worked with diverse stakeholder groups to develop the legal and governance infrastructure necessary to support a Health Information Exchange Organization (HIEO). Our HIEO clients include health systems, payors and others that develop private-sector HIEOs.
We provide select services to several large health plans related to state bureau of insurance matters and legislative support. As payors evolve into Integrated Delivery Networks (IDNs), we advise them on the array of federal and state legal issues that apply to providers of healthcare services.
Pharma and Medical Device Manufacturers
Our Life Sciences lawyers advise a broad range of clients within the life sciences and associated technology industries on issues that arise at every stage: from product conception and development, through clinical testing and regulatory approval, to sales and marketing initiatives and post-marketing claims of product liability. We provide counsel in federal regulatory issues involving the U.S. Food and Drug Administration (FDA), Federal Trade Commission (FTC) and Department of Agriculture (USDA). We also advise clients on clinical development, intellectual property prosecution, litigation and freedom to operate, product liability litigation, International Nonproprietary Names (INN) creation and approval, compliance, commercialization, corporate matters and finance.