Digital Health

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Regulators and courts are expanding enforcement against digital health apps and online platforms that share sensitive health data without true consent, though these companies fall outside the scope of the Health Insurance Portability and Accountability Act (“HIPAA”). In order to reach non-covered entities, agencies and private claimants are now drawing on a patchwork of authorities to rein in misleading or undisclosed data practices:Continue Reading A New Era of Privacy Enforcement: Lessons for Digital Health Players

I. Overview of Telehealth and Tele-Prescribing Landscape

Since the end of the Public Health Emergency (“PHE”) exceptions in 2023, states have continued to re-evaluate the broad telehealth and tele-prescribing flexibilities granted during the pandemic. Over the past year, many jurisdictions, including New York, California, Delaware, Florida, New Hampshire, and Texas, have either enacted or proposed legislation codifying, modifying, or rolling back pandemic-era waivers related to remote patient care. These regulatory changes touch on several key areas of remote care, including the use of telehealth modalities for the initial “in-person” visit requirement for prescribing controlled substances remotely and remote visitation protocols in institutional specialty care. Concurrently, the federal government has also extended certain temporary flexibilities through the end of 2025. During this period, the federal government is developing a longer-term regulatory framework around the use of telehealth and tele-prescribing for controlled substances. Healthcare providers, digital health startups, and their respective regulatory counsel must remain diligent in navigating the complex legal landscape shaped by overlapping federal rules and increasingly divergent state laws.Continue Reading Telehealth and “In-Person Visits”: Tracking Federal and State Updates to Pandemic Era Telehealth Exceptions

The proposed New York Health Information Privacy Act (NYHIPA), currently awaiting Governor Kathy Hochul’s signature, represents a major step in the state’s approach to protecting personal health data in the digital age. At its core, the bill aims to establish stronger privacy protections and restrict the use and sale of health-related data without explicit user consent. Supporters see it as a necessary evolution of data privacy laws, addressing gaps in federal regulations like HIPAA and responding to growing consumer concerns.Continue Reading New York’s Health Information Privacy Act: A Turning Point for Digital Health or a Roadblock to Innovation?

The healthcare sector is undergoing a transformative phase due in large part to the integration of digital technologies into every-day care. At the forefront of this revolution is Remote Patient Monitoring (“RPM”), a technology that appears poised to redefine the industry’s approach to care. In the ninth episode of Sheppard Mullin’s Health-e Law Podcast, Vipul Kella, M.D., Chief Medical Officer at Physio AI, sheds light on how RPM is revolutionizing the healthcare landscape, with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.Continue Reading Remote Patient Monitoring Innovating Health Tech: A Discussion with Dr. Vipul Kella

In the rapidly evolving landscape of digital health, gamification has emerged as a powerful tool to enhance patient engagement and improve health outcomes. In the fifth episode of Sheppard Mullin’s Health-e Law Podcast, Craig Lund, co-founder and CEO of Mightier, shed light on this innovative technology with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.Continue Reading Gamification – Playing for Health: A Discussion with Craig Lund

The 21st-century healthcare landscape has been dramatically shaped by the rise of digitized healthcare solutions aimed at making healthcare more accessible, affordable, and personalized. In the third episode of Sheppard Mullin’s Health-e Law Podcast, Viveka Rydell-Anderson, the CEO of Pacific Vision Foundation, delved into the increasing relevance of digital health technology, particularly in the area of specialized care, with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.Continue Reading Digital Health to the Rescue – Improving Access to Specialized Care: A Discussion with Viveka Rydell-Anderson

Recent developments in Artificial Intelligence (AI) have been transforming several sectors, and the healthcare industry is no exception. In the second episode of Sheppard Mullin’s Health-e Law Podcast, Jim Gatto, a partner at Sheppard Mullin and the co-leader of its AI Team, explores the significant implications and challenges of incorporating AI into the healthcare industry with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.Continue Reading AI as an Aid – Emerging Uses in Healthcare: A Discussion with Jim Gatto

In the inaugural episode of Sheppard Mullin’s Health-e Law podcast, renowned expert Dr. Laura Tully, Vice President of Clinical Services at ChatOwl, discussed emerging issues for health-tech’s data collection and use activities with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.Continue Reading In Tech We Trust? The Case for Transparency: A Discussion with Dr. Laura Tully

The digital health market, as represented by the HLTH showroom floor, is packed with companies focused on care coordination and care management for various health and wellness specialties, diseases, and chronic conditions, as well as organizations focused on increasing consumer access to various types of healthcare. Despite the growth of data analytics and interoperability, the constellation of companies and points of access are decentralized and disconnected. While the abundance of choice and options enhancing accessibility for healthcare consumers are positive indicators of progress in this space, the lack of holistic care coordination across this fragmented landscape affects patient outcomes, causes patient confusion and decision fatigue, and leads to potential care and resource duplication and waste.Continue Reading At HLTH 2023: The Digital Health Symphony, A Care Coordination Orchestra with No Maestro

As more and more states are enacting privacy laws, organizations in the health care industry may be wondering what the impact these laws will have on them. At this point, there are privacy laws in 12 states, with one more (Delaware) likely to be signed by the governor soon. Those laws are in California, Colorado, Connecticut, Florida, Indiana, Iowa, Montana, Oregon, Tennessee, Texas, Utah, and Virginia. (There is also a new law in Delaware currently pending the governor’s signature). Not all are in effect. Only the laws in California, Connecticut, Colorado and Virginia are effective. The others will go into effect between December of this year and 2026, as follows:Continue Reading State Privacy Law Roundup: What Health Care Companies Need to Know

On April 27, 2023, the state of Washington enacted a landmark privacy law aimed at protecting the privacy of health data not covered by HIPAA. This law, named the “My Health My Data Act,” covers a very wide range of entities, consumers, and data. It also contains a private right of action. Companies should soon begin evaluating the scope of this law and its requirements before it comes into effect March 31, 2024 (for “small businesses,” June 30, 2024).Continue Reading Washington State Enacts Landmark Privacy Law Aimed at Digital Health Industry