Digital technologies are leveraging exponential growth in computing power and connectivity to revolutionize health care. Digital health solutions hold the promise of improving diagnosis and care, facilitating general wellness, reducing health care costs, and empowering patients and consumers by providing enhanced access to information. Companies and health care providers developing cutting-edge digital health solutions confront a wide range of legal and regulatory challenges and uncertainties, as well as commercial and liability risks.
Akin Gump Strauss Hauer & Feld LLP’s digital health team comprises experienced lawyers and nonlawyers who leverage their government and industry experience in the areas of health care and life sciences; communications; cybersecurity, privacy and data protection; intellectual property; and antitrust to counsel clients in the digital health space across a broad range of legal regimes and government agencies. These include the U.S. Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services, U.S. Department of Health and Human Services, Office for Civil Rights, Office of the National Coordinator for Health Information Technology, Federal Communications Commission (FCC), Federal Trade Commission (FTC), state and federal courts, and the Patent Trial and Appeal Board. We advise on interdisciplinary issues of particular importance to digital health, including privacy, cybersecurity, telemedicine, intellectual property, product liability and public policy.
Our team helps a vast number of participants in the digital health space, ranging from medical device, clinical research and pharmaceutical companies, to technology companies and health care providers, spanning from early-stage companies to Fortune 100 companies. Specifically, our team assists with the following:
- advising on product development plans and marketing strategies for favorable regulatory treatment with the FDA and payment and coverage policies with Medicare, Medicaid, other government payers and private payers
- helping our clients protect their key innovations in this space through the pursuit of strategic intellectual property rights and ensuring that, once protected, those innovations are not taken by others in the market
- developing long-term regulatory strategies, guiding technologies through the FDA premarket review process, and responding to FDA compliance and enforcement inquiries
- preparing coverage and reimbursement strategies for innovative technologies and systems, interfacing with payers, building coalition support and preparing coding applications
- assisting clients on addressing privacy and data security challenges presented by digital health solutions, including advising on data collection and use strategies, crafting privacy policies and consent forms, assisting with complex contracting issues, and tailoring data breach response plans to accommodate new products and data streams
- advising companies on interfacing with the FTC regarding marketing and consumer protection for digital health technologies
- advising clients with respect to FCC mHealth and Connect2Health initiatives, including advice on FCC regulations that expand access to health care through the Healthcare Connect Fund and FCC regulations related to digital health technologies, including the following:
- Medical Body Area Networks, which include wireless sensors that transmit data on a patient’s vital health indicators to health care providers
- Medical Device Radiocommunications Services, which enable medical implant communications
- Medical Micropower Networks, which utilize wireless medical devices to restore function to paralyzed limbs.
- advising clients on state and federal telemedicine requirements, along with corporate practice of medicine laws, the Anti-Kickback Statute, and other fraud and abuse laws
- preparing investigational device exemption applications, negotiating clinical trial agreements, and advising clients on significant-and-nonsignificant risk medical device studies and inspections of clinical investigations
- reviewing marketing and promotional materials, developing policies and conducting training on marketing communications
- negotiating joint ventures and preparing joint venture and other corporate agreements, including ensuring that our clients’ innovations are protected with appropriate provisions for the retention of intellectual property rights and safeguarding confidentiality and nondisclosure agreements.