Regulating Digital Health Technologies | The Regulatory Review

In a conversation with The Regulatory Review, health and technology law expert Randi Seigel discusses pressing challenges and emerging opportunities in regulating digital health technology.

Seigel explains that the growing use of telehealth, artificial intelligence (AI), and remote monitoring by medical professionals can increase access to care and enhance clinical decision-making. She cautions, however, that health care organizations must navigate a complex and unpredictable regulatory landscape. Seigel emphasizes that recent federal policy signals a strong commitment to accelerating the adoption of digital health technologies, but she warns that the potential expiration of COVID-era telehealth flexibilities could undermine virtual care delivery.

Seigel is a partner at Manatt, Phelps & Phillips, LLP, where she provides legal and strategic counsel to hospitals, insurers, and technology organizations. She is an expert on health care regulation, including telehealth, AI, and provider licensing and reimbursement. Seigel previously served as vice president of compliance and regulatory affairs at VNS Health.

The Regulatory Review is pleased to share the following interview with Randi Seigel.

The Regulatory Review: What digital health technologies do providers use most often? Which ones pose the greatest promise as well as the gravest concerns?

Seigel: Telehealth continues to be widely used and adopted by large and small providers, including those that accept insurance and those that require patients to pay out-of-pocket. Many providers are leveraging remote patient monitoring tools, such as wearables or connected devices, to manage chronic health conditions. More and more providers are deploying generative AI to support care delivery, including clinical decision-making and patient diagnostic tools. AI tools can present the greatest risks if they are not evaluated properly prior to adoption and monitored for bias, model accuracy, and security.

TRR: What are the most pressing regulatory questions that health care organizations confront about these digital technologies?

Seigel: Many digital health tools—such as remote patient monitoring, AI-driven decision support, and even certain telehealth services—are either not reimbursed at all by insurance or are reimbursed inconsistently across insurance payors. In addition, the telehealth flexibilities that were introduced during the COVID-19 pandemic were transformative, enabling millions of patients to access care remotely and providers to get paid for that care. These flexibilities, however, are temporary. Without congressional action to make them 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.

TRR: How did the COVID-19 pandemic alter the regulatory landscape for digital health technologies?

Seigel: COVID-19 made digital health care essential, and the regulatory landscape quickly adapted. During the pandemic, telehealth was permitted across multiple modalities, including audio/video, asynchronous methods, and often, audio-only. Initially, these flexibilities were granted through emergency waivers of requirements of laws governing providers, such as federal Medicare and Medicaid law and state licensure laws, allowing states to suspend laws and regulations that previously restricted telehealth. Over time, most of these temporary waivers were replaced by permanent statutes and regulations that explicitly authorize telehealth at the state level.

In addition, many states enacted laws requiring payors to cover telehealth services—often at parity with in-person services. These changes created a foundation for rapid adoption of telehealth by providers, transforming virtual care from an emergency measure into a mainstream component of health care delivery.

TRR: What role do government payment models play in facilitating or slowing the adoption of digital health technologies by health care providers, insurers, and other stakeholders?  

Seigel: They play a critical role, particularly for traditional health systems that serve large populations who are covered by government programs such as Medicare and Medicaid. Medicare coverage often sets the baseline for what commercial insurers will cover and how much they will pay. Some insurer contracts peg reimbursement rates to match Medicaid rates. These coverage decisions strongly influence innovators, who frequently design digital health products with commercially insured patients in mind.

The Trump Administration has signaled a strong commitment to accelerating digital health adoption. A prime example is the Centers for Medicare and Medicaid Services’s (CMS) recently announced Advancing Chronic Care with Effective, Scalable Solutions Model, which introduces a new payment framework for technology-enabled chronic care management. This initiative reflects a broader policy push to integrate digital tools into care delivery and ensure sustainable reimbursement models for providers.

TRR: What are the biggest challenges that health care organizations face given the current state of AI regulation?

Seigel: The landscape is evolving quickly and varies across states. In 2025, over 250 AI bills impacting health care were introduced in 47 states. Thirty-three of those bills were enacted into law in 21 states. Even though most of the bills did not become law, there are a lot of developments to monitor, especially for multi-state health care organizations. States have introduced diverse requirements around transparency, consent, and clinical use. Although Congress has not passed any laws directly regulating AI, last year saw significant federal action from the executive branch in the form of numerous executive orders and the release of the White House AI action plan. Most recently, President Trump issued an executive order looking to preempt state laws on AI through various directives to administrative agencies.

TRR: What advice do you have for law students and new lawyers who are interested in exploring careers at the intersection of health law and technology regulation?

Seigel: Law students should prioritize courses in administrative law, health law, and subjects that intersect with technology, privacy, and health care. The principles from administrative law are invaluable in practice. Students should also connect with adjunct professors working in these areas and consider internships or writing papers for credit to gain practical insight. Young lawyers should seek opportunities to engage in this space—by volunteering to draft thought leadership pieces with partners or assist in preparing webinar presentations. They should also build a strong network with professionals in the field—these connections can open doors now or in the future. Proactive learning, hands-on experience, and strategic networking are key to developing expertise in this rapidly evolving area.