Digital Health Regulation: Challenges & Opportunities – Randi Seigel Interview

The digital health landscape is rapidly evolving, fueled by advancements in telehealth, remote patient monitoring, and artificial intelligence. But this innovation is occurring alongside a complex and often unpredictable regulatory environment. According to health and technology law expert Randi Seigel, navigating this landscape is a critical challenge for healthcare organizations.

Seigel, a partner at Manatt, Phelps & Phillips, LLP, explained in a recent conversation with The Regulatory Review that while federal policy currently signals a commitment to accelerating the adoption of digital health technologies, significant hurdles remain. One of the most pressing concerns is the potential expiration of COVID-era telehealth flexibilities, which could dramatically reshape access to virtual care.

The Rise of Digital Health Tools

Providers are increasingly adopting a range of digital health technologies. Telehealth remains a cornerstone, utilized by both large and small practices, including those accepting insurance and those operating on a direct-pay basis. Beyond video consultations, remote patient monitoring (RPM) is gaining traction, leveraging wearables and connected devices to manage chronic conditions. Perhaps most notably, generative AI is being deployed to support clinical decision-making and aid in patient diagnostics.

However, Seigel cautions that the integration of these tools isn’t without risk. “AI tools can present the greatest risks if they are not evaluated properly prior to adoption and monitored for bias, model accuracy, and security,” she stated. This highlights the need for careful vetting and ongoing oversight to ensure these technologies are used responsibly and effectively.

Reimbursement and the Telehealth Cliff

A major regulatory question confronting healthcare organizations revolves around reimbursement. Many digital health tools, including RPM, AI-driven decision support, and even certain telehealth services, face inconsistent or nonexistent insurance coverage. This uncertainty creates a significant barrier to widespread adoption, particularly for providers reliant on predictable revenue streams.

The temporary telehealth flexibilities implemented during the COVID-19 pandemic were transformative, enabling millions to access care remotely. These flexibilities, initially granted through emergency waivers, allowed for broader use of telehealth modalities and ensured reimbursement parity. However, these measures are set to expire without congressional action, potentially reverting Medicare coverage to pre-pandemic restrictions. This “telehealth cliff,” as it’s often called, poses a substantial risk to providers who have invested in telehealth infrastructure and workflows.

Seigel emphasized the precarious situation: “Without congressional action to make [the flexibilities] permanent, Medicare coverage for telehealth will revert to pre-pandemic restrictions, requiring patients to be physically present to receive services. Without congressional action, providers will face a constant risk that their investments in telehealth infrastructure and workflows will become obsolete overnight, as well as the follow-up services that they provide pursuant to that initial telehealth encounter.”

The Pandemic’s Regulatory Impact

The COVID-19 pandemic acted as a catalyst for regulatory change in the digital health space. The urgent need for remote care prompted a rapid adaptation of the regulatory landscape. Initially, emergency waivers suspended requirements related to provider licensing and telehealth restrictions, allowing states to temporarily relax regulations. Over time, many of these temporary measures were replaced by permanent statutes and regulations explicitly authorizing telehealth at the state level. Numerous states also enacted laws mandating payor coverage for telehealth services, often at parity with in-person care.

The Role of Payment Models

Government payment models play a crucial role in shaping the adoption of digital health technologies. Medicare coverage, in particular, often sets the standard for commercial insurers, influencing both coverage decisions and reimbursement rates. The Centers for Medicare and Medicaid Services (CMS) recently announced the Advancing Chronic Care with Effective, Scalable Solutions Model, a new payment framework designed to support technology-enabled chronic care management. This initiative reflects a broader policy push to integrate digital tools into care delivery and establish sustainable reimbursement models.

Navigating the Evolving AI Regulatory Landscape

The regulatory landscape surrounding AI in healthcare is particularly complex and rapidly changing. In 2025, over 250 AI-related bills were introduced in 47 states, with 33 ultimately becoming law in 21 states. While most bills didn’t pass, the sheer volume of legislative activity underscores the growing attention to AI regulation. Federal action has also been significant, with the White House issuing an AI action plan and President Trump issuing an executive order aimed at preempting state laws on AI.

This patchwork of state and federal initiatives presents a significant challenge for multi-state healthcare organizations. The diverse requirements around transparency, consent, and clinical use necessitate careful monitoring and compliance efforts.

Advice for Future Health Law and Tech Professionals

For law students and new lawyers interested in pursuing careers at the intersection of health law and technology regulation, Seigel offers several recommendations. She advises prioritizing courses in administrative law, health law, and technology-related subjects, particularly those focusing on privacy. Networking with professionals in the field and gaining practical experience through internships or research projects are also crucial. “Proactive learning, hands-on experience, and strategic networking are key to developing expertise in this rapidly evolving area,” she said.

The future of digital health hinges on the ability of policymakers and healthcare organizations to navigate these complex regulatory challenges. As technology continues to advance, a clear and adaptable regulatory framework will be essential to unlock the full potential of digital health tools while safeguarding patient safety and privacy.