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's Digital Healthcare Group draws on the firm's 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.
WHO WE ARE Our Digital Healthcare Group 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. Our team includes trial lawyers with experience defending more than 100 cases involving class action and multidistrict litigation (MDL), as well as federal and state regulatory investigations and enforcement actions. 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.
WHAT WE DO Data Strategy, Privacy and Security Counsel healthcare providers and technology companies on operating within complex data ecosystems Advise on crisis management and incident response when devices or data systems are compromised, including theft of patient information, ransomware and other adverse events Advise on 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 Intellectual Property Provide counsel on the protection, licensing and commercialization of healthcare technology Advise on patents, copyrights, trademarks and licensing Provide representation to clients based both on our understanding of the law and underlying technologies
Blockchain 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 Advise on the legal and regulatory issues surrounding blockchain in a broad range of applications, including healthcare Includes team members with a high degree of technical understanding
Litigation Represent 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 Litigated successfully in a wide range of technology areas, including medical imaging technology, pharmaceutical products and biotechnology Possess 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
Transactions Represent clients in mergers and acquisitions where technology and intellectual property issues are drivers of a deal's value Provide counsel on all transactional healthcare matters, including due diligence of a merger partner's technology assets
Technology Agreements Write master service agreements between providers and technology companies, including proprietary software licenses, IP transfers, software as a service (SaaS) and cloud computing agreements Author technology agreements and Health Insurance Portability and Accountability Act (HIPAA) business associate agreements that support acquisitions and other transaction Regulatory Help clients to achieve their objectives by using our working relationships 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 Advise on all state and federal compliance requirements Guide clients through the uncertainties created by the use of emerging technologies and help them anticipate possible government responses
FDA Regulation and Compliance Assist clients in navigating the FDA and getting their products to market Advise clients unfamiliar with the FDA regulatory and approval process on best practices FDA has signaled that it wants to encourage more digital applications in medicine through such programs as precertification for companies producing digital products FDA also 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
Public Policy Assist in advancing the interests of hospitals, medical device and pharmaceutical companies, insurance companies and research institutions in Congress and the White House through collaborative efforts with the firm's lobbying practices, which have been ranked among the top in the United States
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.
PRIMARY CONTACTS Maximillian J. Bodoin Partner | Boston 617.573.5819 max.bodoin@hklaw.com
Shannon B. Hartsfield Partner | Tallahassee 850.425.5642 shannon.hartsfield@hklaw.com
Elizabeth R. Burkhard Partner | Boston 617.573.5850 elizabeth.burkhard@hklaw.com
Robert S. Hill Partner | Dallas 214.964.9421 robert.hill@hklaw.com
Glynna K. Christian Partner | Chicago 312.715.5714 glynna.christian@hklaw.com
Joshua C. Krumholz Partner | Boston 617.573.5820 joshua.krumholz@hklaw.com
Maria T. Currier Partner | Miami 305.789.7722 maria.currier@hklaw.com
Ieuan G. Mahony Partner | Boston 617.573.5835 ieuan.mahony@hklaw.com
Anthony E. DiResta Partner Washington, D.C. | 202.469.5164 Miami | 305.789.7499 anthony.diresta@hklaw.com
Mark S. Melodia Partner | New York 212.513.3583 mark.melodia@hklaw.com
Mark H. Francis Partner | New York 212.513.3572 mark.francis@hklaw.com Joshua Gutter Associate | Fort Lauderdale 954.468.7949 joshua.gutter@hklaw.com Jonathan N. Halpern Partner | New York 212.513.3512 jonathan.halpern@hklaw.com
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Michael J. Werner Partner | Washington, D.C. 202.419.2515 michael.werner@hklaw.com Eddie Williams III Partner | Tallahassee 850.425.5653 eddie.williams@hklaw.com Thomas J. Yoo Partner | Los Angeles 213.896.2425 thomas.yoo@hklaw.com