Digital Health
Regulatory Advice

Before the COVID-19 pandemic, digital health and telemedicine solutions were already being adopted at a rapid rate. The rate accelerated during the height of the pandemic. Now that rate is likely to stabilize and some regulatory parameters will stay permanent. During the pandemic, the Centers for Medicare & Medicaid Services (CMS) broadened access to telehealth so that beneficiaries can receive a wider range of services from their doctors and allied health professionals without having to travel to a healthcare facility. Right now, in the context of the post-pandemic, many waivers have been made permanent, additional regulations issued or restrictions lifted for telemedicine and telehealth services. These include reimbursement access, Stark Law and Anti-Kickback waivers and the ability to treat patients across state lines–though not ALL these waivers or suspensions are here to stay. State specific guidelines are ever-changing. Telemedicine providers and practitioners should stay abreast of best practices, be aware of fraud and abuse issues, and keep a close eye on post-pandemic fallout.

Digital health encompasses telemedicine and we review and provide legal advice for a variety of platforms and service solutions like web-based analysis, wearable devices,, remote patient monitoring platforms, that can now be used to monitor and diagnosis a wide variety of conditions that ultimately will be treated by a healthcare professional. These include allergies, asthma and COPD, bronchitis, musculoskeletal pain, conjunctivitis, back pain and sprains and strains, diabetes, hypertension disease, cardiac arrhythmia, end-stage renal disease, behavioral health conditions, neurodegenerative diseases, and many more.

However, even digital health solutions have to comply with all the other healthcare regulations. For practices and companies that offer digital health service lines, these regulations are often state-specific, such as provider licensing, corporate practice of medicine, and data privacy laws. As a legal advisor to healthcare businesses we developed a strong focus on expertise in telemedicine and other digital health solutions as they become an integral part of many practices, and we stay current with its rapid legal, regulatory and technological evolution. We can help your organization make optimum use of these healthcare solutions, to the benefit of both your patients and your organization, by increasing efficiency and productivity while adhering to laws and regulations that are very much still state- and insurance-payor-specific. Whether you’re an established healthcare organization or in the process of forming a new entity, we are available to guide you through the adoption of this newly generalized model of care.

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