We Understand Your Business
The healthcare and life sciences industry is simultaneously a new frontier and the backdrop for the daily lives and well-being of millions of people. Industry players deal with an ever-evolving slate of issues as they work toward the ultimate goal to improve peoples' lives, such as:
- The life sciences sector overall is seeing a post-recession resurgence in merger and acquisition (M&A) activity and consolidation, driven partly by pharma interest in biotech offerings. As Big Pharma gears up for the looming "patent cliff" stemming from the expiration of many blockbuster patents, the M&A, joint venture and partnership trend should continue as companies look for new revenue streams. We are also seeing similar consolidation in both the provider sector and the medical device industry.
- With the ever increasing cost of healthcare at both the federal and state government levels, the government has increased its efforts at reducing fraud, waste and abuse in the healthcare system. States Attorney General, the Office of Inspector General for Health and Human Services and various U.S. Attorneys' offices have stepped up their efforts to prosecute companies under multiple theories of fraud and abuse.
- Across the healthcare and life sciences industry, activities ranging from facilities construction to research and development (R&D) efforts are being driven by demographic and health concern shifts. Geriatric care, obesity and diabetes treatment, pain management, gene therapies and personalized medicine continue to see growth.
- New value-based reimbursement models and bundled episodic care payments are driving clinical integration on a national scale. Implementing these structural changes is challenging in an existing federal and state regulatory paradigm that is, in many respects, inconsistent with the integration trends in the industry. A rapidly changing legal landscape is by necessity emerging and the industry will need substantial guidance as this reform process continues over the next several years.
- Accountable Care Organizations (ACOs) are one hot topic to come out of the Healthcare Reform package, but despite the scramble to form ACOs, the waters remain murky regarding structure, compliance procedures, cost savings to healthcare organizations or patients and whether antitrust issues may arise out of further consolidation among provider segments.
Is your company positioned to succeed?
We Can Help
With nearly 100 years of combined experience in the industry, members of our Healthcare & Life Sciences Team are on the leading edge of industry developments, and we can help you adapt your business strategy to effectively seize opportunities while avoiding risks. We represent the full range of healthcare-related businesses, including all providers along the care continuum, managed care organizations, health plans, third party administrators, provider networks, integrated delivery systems, management services organizations, managed care companies, manufacturers, healthcare technology companies, distributors, suppliers, pharmacies, pharmaceutical companies, medical device companies, biotechnology firms, venture capital firms and private equity firms, in all aspects of their regulatory issues and business operations, including:
- Corporate Services: Our team has extensive experience handling healthcare transactions and can assist you with business planning and structuring, contracts and agreements, mergers and acquisitions and tax planning, all with an aim toward helping you operate more effectively and efficiently.
- Data Privacy and Security: It is critical for healthcare and life science companies to effectively manage data privacy and security matters and comply with the growing number of related regulations, best practices and regulator guidance. We can provide you with highly experienced technical and legal counsel on a wide array of issues, from de-identifying clinical trial data sets and patient information, managing mobile and Bring Your Own devices, working with mobile apps and network-aware medical devices, and complying with HIPAA and HITECH, to handling website data collection, use and sharing. We can also help prevent or deal with data and security breaches, assist you in responding to government investigations and provide guidance on international data transfer compliance.
- Financial Services: Healthcare and life sciences operations require significant financial capital and our team can help you secure the necessary funding to achieve your business objectives, whether you are just getting started or are expanding your business.
- Insurance: With the prevalence of liability issues confronting the healthcare and life sciences industry, we can help you anticipate risks and protect your interests through effective insurance planning.
- Intellectual Property: In the highly competitive world of life sciences, protecting your intellectual property is critical to your success. Members of our team can help you safeguard your innovations by prosecuting patents; maintaining your portfolio; registering, protecting and litigating your patents and negotiating licensing agreements.
- International: Our team can help you capitalize on the expanding global market by helping you address international trade compliance issues related to your medical devices and products.
- Labor, Employment and Benefits: We can assist you in managing your company's most valuable asset - your human capital - by guiding you through common employment issues such as policies, training and benefits as well as issues that are critical to the healthcare and life sciences industry such as the safeguarding of trade secrets and enforcement of non-competes.
- Litigation and Dispute Resolution: Disputes are a common occurrence within the healthcare and life sciences industry and, when a dispute arises, our team will quickly respond to defend your interests and seek the most desirable outcome possible so you can get back to business.
- Nonprofit and Tax-Exempt Organizations: If you are a healthcare provider or research organization that is structured as a nonprofit entity, we can help you safely navigate the evolving rules and regulations that govern tax-exempt organizations.
- Public Policy & Regulation: While public policy related to healthcare and life sciences is often contentious and always evolving, our team has a thorough understanding of legislative and regulatory proceedings and can help you advance your interests. In addition, we can provide you with regulatory counseling, including early guidance and advice, so you can achieve and maintain compliance with healthcare regulations such as HIPAA, HITECH and the Affordable Care Act.
- Real Estate: We can assist you with the unique issues that accompany the acquisition, development, structuring, leasing, financing and disposition of properties that are used in connection with healthcare and biotechnology operations.
- White Collar Defense and Investigations: Participants in the healthcare industry face increased risk and potentially devastating consequences arising from allegations of fraud and abuse. We can help you protect your interests by advising you on compliance with federal fraud and abuse statutes – including the False Claims Act, the Anti-Kickback statute, the Stark Self-Referral Rules and safe harbors. In the event of an allegation, we can defend your interests in enforcement actions as well as investigations by the U.S. Department of Health and Human Services Office of Inspector General and the U.S. Department of Justice.
Guidance You Can Trust
The combination of our thorough knowledge, our extensive experience and our sincere commitment to provide responsive service is why clients entrust our Healthcare & Life Sciences Team to handle their legal needs.
These attributes are also the reason why members of our team have been recognized among the top legal professionals in the country by leading publications, including Chambers USA – America's Leading Lawyers for Business, Best Lawyers in America and Florida Trend Magazine - Legal Elite. These publications base their rankings and commentary on input provided by those who are best positioned to evaluate our capabilities - our clients and other attorneys in the industry.
Recent honors earned by our team include:
- Holland & Knight received national first-tier rankings in the 2020 U.S. News – Best Lawyers® "Best Law Firms" guide in Health Care Law, and metropolitan first-tier rankings in the following markets: Miami and Tallahassee
- The 2020 Chambers USA guide ranked Holland & Knight partners from Florida and Massachusetts for Healthcare law.
- Holland & Knight received top recognition in the American Bar Association's Health Law Section - Annual Top 10 Law Firms in the Northeast, DC and Southeast rankings.
- Holland & Knight is ranked among the top 25 largest healthcare law firms nationwide by Modern Healthcare magazine.
Visit the Holland & Knight Healthcare Blog for timely updates on healthcare fraud and abuse, technology, health plans, facility operations, long-term care, life sciences and public policy.