Digital Health

Innovative Models Expanding the Reach of Health Care

Mintz has more than 20 years of experience representing digital health clients. We collaborate across practices to provide highly integrated counsel to each of our clients. We advise start-ups to Fortune 100 companies as unprecedented investment, health industry focus, and consumer demand for innovative delivery models seek to increase productivity, drive down cost, and improve care coordination and outcomes while also leveraging access to health care data to drive digital health forward.

Awards

Chambers USA 2024

Health Law Practice recognized Nationally and in Massachusetts, Washington, DC and California.

U.S. News and Best Lawyers®

Nationally ranked Tier 1 for Health Care

Our Experience

Providing Strategic and Regulatory Guidance to Folx Health

Mintz has provided strategic guidance to Folx Health, a digital company serving the LGBTQ+ community, on federal and state regulations, corporate practice issues and telehealth requirements, an internal restructuring, and day-to-day legal issues.

Advised Health Care Analytics Software Provider on Health Data Access Rights

Mintz advised a health care analytics software provider on its rights to health data and the compliance responsibilities of electronic health record (EHR) vendors under the National Coordinator for Health Information Technology (ONC)’s Information Blocking Rule.

Mintz Advises Digital Health Company in Chronic Care Management Space

Mintz has advised a digital therapeutics company focused on the management of chronic conditions on complex state and federal regulatory landscape, key contracts, FDA rules, and privacy and data security issues.

Our Approach

Mintz is at the forefront of advising innovation leaders on the development and deployment of virtual care and technology-enabled health care solutions.

We know the digital health industry – from telehealth to health coaching and wellness, to digital therapeutics and treatments, to digital care management, and beyond. We understand the evolving nature of the business and the complex federal and state legislative, regulatory, reimbursement, and enforcement environment within which our digital health clients operate. We work in cross-practice client service teams built to be responsive to each company’s unique needs, market position, and business goals.

Service and Knowledge Areas

State and federal regulation (telehealth platform requirements, online prescribing, multistate licensure, oversight of mid-level practitioners)
FDA (approval pathways, clinical decision software and other applications, artificial intelligence, machine learning, remote clinical trials)
Privacy and security (data breaches, use of tracking technologies, interplay of HIPAA and state data privacy laws, FTC)
Financing (including angel, venture capital, and strategic investments)
Corporate structuring (state corporate practice rules, multistate and national rollouts of telehealth services
Data (interoperability, information blocking, monetization)
Contracts and arrangements (IT vendors, software licenses, pharmacy, lab, provider networks)
Technology (licensing, outsourcing)
Intellectual Property (patent prosecution, trademark)
Compliance (proactive development and implementation)
Payment and reimbursement (government, commercial, self-insured employers)
Audits, enforcement, and investigations (state boards, CMS, HHS, FDA, and DEA)

Experience Representing Clients Across the Digital Health Ecosystem

Telehealth and Hybrid
o Primary care
o Women’s health
o Teletherapy and behavioral health
Innovation Adopters
o Hospitals
o Laboratories
o Medical device companies
o Pharmacies, PBMs, and other actors in the pharmaceutical supply chain
o Urgent care providers
Health Coaching and Wellness
o Heart health
o Longevity and nutrition
o Alcohol and substance use
Digital Therapeutics and Treatment
o Chronic care management
o Remote patient and therapeutic monitoring
o Prescription digital therapeutics
o Virtual reality (VR) treatment and therapies
Digital Care Management
o Care coordination and navigation
o Medication and health risk management
o Digital pharmacies
o Community support
o Medtech

What Our Clients Are Saying

“We would not have been able to navigate the last year without…[Mintz]…we are so grateful. . . I have only amazing things to say about [the Mintz team] and our experience."

Digital Health Client

Meet Mintz

Our team has worked with the digital health industry since its inception, guiding clients through legal and regulatory issues and helping them leverage market opportunities.