Multi-State Telehealth Companies
Setting up a telehealth business that operates in multiple jurisdictions can be challenging, especially when it comes to state-specific requirements such as scope of practice and licensure. And many digital health platform companies are evolving into digital clinics–we’re seeing dozens of companies each month in need of a compliant model to bring new clinical solutions to the market. Our expertise extends to vendors to multi-state telehealth companies, too (including digital health platforms, outsourced lab testing/pharmacy, and white-labeled clinical infrastructure providers). Our team understands the unique challenges of telehealth startups as well as for digital health platforms adding clinical care components.
Digital Therapeutics and Medical Devices
If your business is launching digital therapeutics or Software as a Medical Device (SaMD) applications, you’ll need legal experts who understand the rules of national regulatory authorities like the U.S. Food and Drug Administration (FDA). We can help you navigate the risk-based regulation framework for SaMD and give you guidance on proving your device’s safety and effectiveness.
Veterinary Telehealth, aka “TelePet” or “VirtualVet”
The US veterinary telehealth market was valued at $149.5 million in 2022, and it is projected to reach $510 million by 2030. As early proponents of TelePet, our firm is uniquely positioned to help build and scale your Veterinary Telehealth business on a firm foundation of compliance.
Remote Physiologic Monitoring and Remote Therapeutic Monitoring Companies
Remote Physiologic Monitoring and Remote Therapeutic Monitoring companies are among a rapidly growing segment of the digital health and device landscape. As nationally recognized experts in remote monitoring, we can guide your business in developing corporate and revenue strategy, closing deals with customers, and advancing your influence with policymakers shaping the industry
Virtual Care Management Companies
The virtual care management industry exploded in 2019 with CMS and commercial payors now reimbursing directly for remote patient monitoring and chronic care management services. In this era of value-based medicine, our legal experts can help you integrate virtual care management into your offerings through a combination of devices, software, and clinical staff.
Virtual/Augmented Reality Companies
The augmented reality (AR) and virtual reality (VR) market in healthcare is expected to reach $9.7 billion in the next 5 years. Virtual and extended reality healthcare technology companies rely on our expertise to navigate complex regulations so they can commercialize their solutions as they advance healthcare and patient services.
Women’s Health
We’re on a mission to help innovative companies disrupt and transform the global women’s health sector. If your company is launching its own femtech or womens’ health product, we can help you with all the legal considerations of idea conception, fundraising, scaling, and exiting. (Be sure to check out our Invest in Women VC list through the menu option: The Latest!)
Care at Home
Hospitals, Health Systems, and essential Care at Home support entities such as Home Health Agencies, Physician and Nurse Staffing Agencies, Mobile Phlebotomy Labs, Mobile Healthcare Services (phlebotomy, radiology, urgent care, etc.) as well as linking to the remote monitoring content, Durable Medical Equipment Providers, Transport Agencies, and Virtual Care Management Technology Companies rely on our innovation and regulatory expertise in this next stage of healthcare delivery. This includes mobile healthcare services (phlebotomy, radiology, urgent care, etc.) as well as linking to the remote monitoring content (since these services are a big component of care at home)
Behavioral Health and Substance Use Disorder Platforms
Behavioral Health and Substance Use Disorder platforms are a rapidly growing part of the digital health landscape. Nixon Gwilt Law helps innovative healthcare companies navigate the shifting reimbursement landscape and solve access hurdles that have created historical gaps in behavioral health and addiction care.
Healthcare Data/Predictive Analytics
Data is rapidly becoming one of the most valuable assets in the healthcare market, putting digital health companies that collect and process large amounts of personal data at higher risk than many other types of businesses. As nationally recognized experts in the legal aspects of healthcare data and predictive analytics, including how it applies to AI, Machine Learning, Large Language Models (LLM)/Chatbots and more, we can guide your business through developing business models, staying compliant with state and federal regulations, and navigating privacy and security laws.