Telemedicine & Digital Health

“Foley is the premier firm for telehealth counsel.”

“A market leader in telemedicine issues.”

“This is the Dream Team.”

“The firm’s team-based approach provides emerging companies with an entire team of deep subject-matter experts.”

“The firm’s telehealth expertise is excellent.”

“The team has a tremendous knowledge of all federal and state issues pertaining to telemedicine.”

“Foley & Lardner services its clients and collaborators with a stunningly high level of care and responsiveness.”

– Chambers USA: America’s Leading Business Lawyers (2020-2023)

Foley’s Telemedicine and Digital Health Industry Team helps organizations and entrepreneurs embrace emerging issues in virtual care, enabling them to provide innovative care for patients in new markets around the block and around the world. We are committed to helping clients fulfill their goals of harnessing new technology to reach patients anywhere and deliver care without borders or geographic limitations.  We help clients create fully fledged telemedicine offerings, delivering end-to-end legal services by coupling precise strategic guidance with rapid turnarounds to maintain that sense of urgency necessary to launch new initiatives and remain competitive in the marketplace.  One firm; all your digital health needs.

The depth and breadth of our experience, the qualifications of our attorneys, our unparalleled insight and knowledge of the telemedicine and digital health industry, and our work with some of the best and brightest household names in healthcare allows us to deliver unique value. Our approach to working with clients is collaborative, deliberate, and actionable.

Our dedicated and diverse Telemedicine & Digital Health Industry Team has:

• Completed dozens of different 50-state surveys and research analyses of telemedicine and digital health laws, and we continue to survey the digital health landscape to ensure we remain situated to help take our clients’ transformative ideas and manifest them in the marketplace.
• Conceived, developed, and refined new business models for technology-enabled healthcare entrepreneurs to launch highly-scalable solutions with low operating costs and elegant corporate architecture, while maintaining legal compliance with laws across all 50 states.
• Established itself as the preeminent thought leader on telemedicine law through continuous research, board-level volunteer service on key associations, writing hundreds of articles and book chapters on telemedicine law, and speaking at industry conferences nationwide.
• Been an integral part of the digital transformation of the health care industry by drafting key legislation in multiple states, signed into law to help patients and providers.
• Offer extensive options for fixed fee pricing, subscription-based services, and competitive hourly rates so our clients can receive outstanding quality with predictability on legal budget.

Our attorneys have the experience necessary to assist with telemedicine program assessment, development, and implementation, nursing hotlines and pharmacy call centers, and multi-state, web-based health care tools and services. We also are well-positioned to provide counsel on operational issues, including payer credentialing, patient verification, and medical record management.

By taking advantage of technological advances, health care institutions and entrepreneurs have the chance be at the forefront of health care delivery by expanding their service offerings to share their insight with patients independent of geography. With this opportunity comes challenges, as the laws and regulations struggle to keep up with the pace of innovation. It is critical to consult with a legal services provider with the experience and resources to help you grow your business while managing the evolving issues associated with this emerging field.

Representative Matters

• Asynchronous Direct to Consumer. Foley worked with venture-backed entrepreneurs to create a company that offers direct-to-consumer medical services using asynchronous (store & forward) telemedicine with vertical integration of laboratory tests and medication fulfillment. The work involved a broad scope of issues including advice on corporate practice of medicine, development of a scalable national medical group structure, licensing, FDA and FTC guidance, pharmacy and laboratory law requirements, privacy and security, strategic models for care delivery and revenue streams, state-by-state telemedicine modalities and practice standards, text messaging, multistate tax and registration requirements, and even helping ensure the product design of the patient-facing front-end interface complied with state and federal laws on telemedicine and e-commerce.
• Telehealth-Based Substance Use Disorder Treatment. Foley helped an emerging digital health company involved in the treatment of opioid use develop a direct to patient, virtual-only clinic for treatment of opioid use disorder. The advice included determining substance use disorder licensing requirements, controlled substance prescribing limitations, physician and nurse practitioner scope of practice, supervision requirements, and prescribing authority across multiple states. The work helped the company strategically determine potential market entry points for a successful launch.  The company subsequently closed a second funding round with Foley’s guidance and used the runway to further its expansion into third party reimbursement and Medicaid.
• Remote Patient Monitoring and Clinical Staff. Foley worked a digital health company that manufactures its own RPM devices and offers both B2B contracts to medical clinics, as well as direct to consumer virtual RPM services.  Foley helped develop their corporate structure to scale across the United States with a distributed staffing model of remote-based clinical staff and auxiliary personnel. The work included advising on billing considerations, incident to rules and supervision, telehealth practice nurse practitioner, nurse, certified nurse assistant, licensed vocational nurse, and medical assistant scope of practice and supervision requirements.  The work allowed the company to comply with regulatory requirements while providing a scalable, affordable staffing model for RPM, both as a B2B infrastructure play as well as a direct to consumer option.
• Direct to Consumer Hormone Replacement Therapy. Foley assisted an emerging start-up company to develop a direct-to-consumer testosterone replacement therapy service for men with hypogonadism using telemedicine technologies. The work involved legal advice on doctor-patient relationships, telemedicine prescribing of controlled substances under state law and the federal Ryan Haight Act, contractual arrangements with labs and compound pharmacies, and patient-facing e-commerce considerations. Drafted the suite of contracts and documents required for the clinic to successfully launch the service.
• School-Based Telehealth and Medicaid Enrollment. Foley advised a school-based telemedicine program offering telehealth services across multiple states, without any brick and mortar locations, on the requirements for enrolling in Medicaid programs.  The work allowed the company to create a corporate structure that fit within its strategic growth plan and adhered to state laws and payer requirements.
• COVID-19 Waivers. Foley advised a national telehealth company on navigating federal and state changes in provider licensure and telehealth modalities during the COVID-19 public health emergency.  The work allowed the company to immediately take action and expand its platform to rapidly provide services across multiple states.