Digital Healthcare

The blending of healthcare and technology is revolutionizing patient care and creating unprecedented opportunities and challenges for every business and institution involved in the delivery of healthcare. In response, Holland & Knight has brought together a team to serve manufacturers, distributors, hospitals and other entities, insurers and plans, as well as the increasing number of digital companies and app developers offering services that providers, payers and patients depend upon to deliver efficient and lifesaving care.

Our Digital Healthcare Group draws on Holland & Knight's nationwide reach and diverse practice groups, and includes attorneys and government relations professionals with extensive credentials in healthcare and life sciences, intellectual property, data privacy, cybersecurity, regulatory compliance, corporate transactions, litigation and public policy. Our Healthcare & Life Sciences Team is one of the largest such practices in the United States and is supported by our 75-plus member Intellectual Property Group, which has experience in every aspect of protecting and securing commercialization opportunities in life sciences and healthcare. We draw on these extensive resources to advise healthcare clients who – perhaps more than in any other industry – are at the nexus of a technology revolution that is changing business models, altering relationships with government regulators and creating unprecedented opportunities to serve patients.

This allows us to stay current on emerging business trends, technology developments, legislation and pending regulations. Our integrated approach is essential in an industry where clinical and business decisions are driven by machines, systems and data that rest on technology platforms.

Advising on All Aspects of Telehealth

In many areas, the telehealth marketplace is far ahead of the law, and clients turn to Holland & Knight's knowledgeable lawyers for advice about the needs and challenges facing this growing arena. Telehealth is an innovative approach for providers to increase access to healthcare in rural communities, behavioral healthcare services, post-acute care and home health services. Our experience advising providers gives us distinct insights into this sector of the healthcare industry.

Our multidisciplinary team of lawyers helps providers and investors with compliance and operations issues, healthcare information technology matters, and data security and patient privacy regulations, including:

• working with providers, investors and telehealth technology companies on the implementation of strategies to improve access to care, enhance patient outcomes and reduce costs
• advising emerging companies with commercial finance and capital raising matters, as well as representing private investors funding telehealth providers
• monitoring emerging trend developments and educating clients on the applicable federal and state telemedicine laws as well as state licensing requirements for clinicians involved in telehealth, as well as guiding clients on medical liability risk management
• implementing pathways for third-party reimbursement under federal and state healthcare programs and within the private payer market

What We Do

Data strategy, privacy and security. Our Data Strategy, Security & Privacy Team counsels healthcare providers and technology companies on operating within complex data ecosystems, creating and utilizing data rights, and third-party risk management – including supply-chain vendors, customers and business partners – as well as on public- and private-sector regulatory requirements and industry standards for medical devices, software and online services. The team also advises clients on crisis management and incident response when devices or data systems are compromised, including theft of patient information, ransomware and other adverse events. Our team includes trial lawyers with experience defending 80-plus cases involving class action and multidistrict litigation (MDL), as well as federal and state regulatory investigations and enforcement actions.

Intellectual property. Holland & Knight draws on the experience of our 75-plus IP attorneys to offer advice on the protection, licensing and commercialization of healthcare technology. We have wide experience in patents, copyrights, trademarks and licensing, and we advise clients based both on our understanding of the law and underlying technologies.

Blockchain. The firm's Blockchain Technology Team is led by an attorney who wrote one of the leading reference books on this technology, The Blockchain: A Guide for Legal and Business Professionals, published by Thomson Reuters. We advise on the legal and regulatory issues surrounding blockchain in a broad range of applications, including healthcare, and our practice is distinguished by our high degree of technical understanding.

Litigation. Holland & Knight represents clients in patent and nonpatent technology as well as healthcare litigation and investigations, including defense of data breach and Telephone Consumer Protection Act (TCPA) matters, and we have litigated successfully in a wide range of technology areas, including medical imaging technology, pharmaceutical products and biotechnology. We have extensive experience applying strategies to resolve technology-related business disputes and have the resources to escalate these matters to litigation if it is in the client's interest.

Technology agreements. Holland & Knight writes master service agreements between providers and technology companies, including proprietary software licenses, IP transfers, software as a service (SaaS) and cloud computing agreements. We also author technology agreements and Health Insurance Portability and Accountability Act (HIPAA) business associate agreements that support acquisitions and other transactions.

Regulatory. The convergence of technology with traditional healthcare has outpaced the slower-moving regulatory regimes of federal and state governments. We guide clients through the uncertainties created by the use of telehealth and other emerging technologies and help them anticipate possible government responses. Our lawyers have extensive experience working with officials at the U.S. Food and Drug Administration (FDA) and navigating the regulations of HIPAA, the Health Information Technology for Economic and Clinical Health Act (HITECH) and myriad state privacy laws. We advise on all state and federal compliance requirements.

FDA regulation and compliance. The FDA has signaled that it wants to encourage more digital applications in medicine through such programs as precertification for companies producing digital products. At the same time, the agency is developing oversight policies governing wireless medical devices, health-related IT, telemedicine, software as a medical device (SaMD), clinical decision support technologies, cybersecurity and medical device data systems. Many technology companies may be unfamiliar with FDA regulatory and approval processes, and our attorneys have the experience to help them navigate the agency and get products to market.

Public policy. Holland & Knight has one of the leading lobbying practices in the United States, and we have advanced the interests of hospitals, medical device and pharmaceutical companies, insurance companies and research institutions in Washington, D.C. Our Public Policy & Regulation Group is particularly noted for organizing and managing coalitions of healthcare stakeholders to secure policy objectives through representation before Congress, the FDA, the Centers for Medicare & Medicaid Services (CMS) and other federal agencies.

Transactions. We represent clients in mergers and acquisitions where technology and intellectual property issues are drivers of a deal's value. Our corporate team provides counsel on all transactional healthcare matters, including contracts with telemedicine providers and due diligence of a merger partner's technology assets.

Representative Experience

Genomic data commercialization. We represented a major health research center in the indexing, licensing and commercialization of one of the nation's largest datasets of genomic information.

Clinical decision support technologies. We provide regulatory advice to developers of clinical decision support software, helping them navigate FDA regulations.

Artificial intelligence. Holland & Knight represents a leading player in artificial intelligence and advises on using its datasets in multiple relationships.

Smart apparel and wearable sensors. We advise a smart apparel manufacturer on data privacy standards, security controls and FDA regulations governing the collection and processing of data.

Internet of Things (IoT) devices. We represent a startup spun out of the Massachusetts Institute of Technology (MIT) in complex licensing transactions.

Cloud computing. We represent one of the world's largest cloud service providers in negotiating service and SaaS agreements with leading companies that involve sensitive data and mission-critical performance requirements.

Healthcare technology licensing dispute. We represented a hospital group in a licensing dispute with an entity that was commercializing healthcare technology developed by hospital researchers. The dispute involved patent portfolios, ongoing joint development work, licensing rights and downstream licensees.

Pharmaceutical merger. We were responsible for the IP elements of a transaction that combined institutional pharmacy businesses to create a $2 billion publicly traded company.

Genetic testing. We represent manufacturers of genetic tests as well as clinical labs that interpret such tests, advising them on the relevant regulatory requirements related to collection and transmission of genetic information.

Medical app development. We advise pharmaceutical and device manufacturers regarding the development of apps designed to assist with patient care, including analysis of applicable privacy and security regulations, developing consumer-facing disclosures, designing internal policies and procedures, and developing training modules.

Data privacy litigation. We defend healthcare companies in privacy class actions targeting hospital websites and patient care portals.

Healthcare regulatory advice. We advise pharmaceutical device manufacturers, telecommunications companies, hospital chains, health plans and myriad other entities regarding the navigation of complex healthcare laws and rules that relate to emerging technologies.

HIPAA. We advise international telecommunication companies and device manufacturers in HIPAA privacy matters.

Mergers and acquisitions. Represented a leading provider of teleradiology and IT services in the sale of its teleradiology platform to a global leader in healthcare technology. Our attorneys assisted the client by structuring the sale of the company and providing counsel on associated healthcare regulatory compliance issues.