In a recent JAMA article, former FDA Commissioner Scott Gottlieb advocates for a return to earlier regulatory frameworks concerning artificial intelligence in healthcare. Highlighting the uncertainties introduced by recent policy changes, Gottlieb argues that a more lenient approach could foster innovation while ensuring patient safety.

Restoring Certainty and Innovation in Healthcare Technology

The Evolution of Regulatory Policy

The landscape of medical device regulation has undergone significant shifts in recent years. The advent of advanced technologies, particularly those leveraging artificial intelligence (AI), has posed unique challenges for regulatory bodies. In his tenure from 2017 to 2019, Scott Gottlieb, former FDA Commissioner, oversaw a period marked by progressive policies aimed at fostering innovation. However, subsequent adjustments have introduced ambiguities that complicate the development and deployment of AI-driven tools.Gottlieb’s perspective is rooted in the belief that the FDA should revert to an earlier interpretation of the 21st Century Cures Act. This would exempt a broader range of clinical decision support software from premarket review, provided these tools do not autonomously make diagnostic or treatment decisions. By doing so, developers could innovate without the burden of costly and uncertain regulatory processes, ultimately benefiting both clinicians and patients.

Navigating Uncertainty in a Changing Administration

The transition between administrations has brought uncertainty to the regulatory environment. With the appointment of a new FDA commissioner still pending, stakeholders are left to speculate on the direction of AI oversight. Martin Makary, nominated for the role, awaits confirmation, while key figures like Troy Tazbaz, who previously led the Digital Health Center of Excellence, have departed.President Trump’s executive order, signed in the early days of his administration, signaled a shift towards deregulation, aiming to eliminate barriers to American AI innovation. This move has sparked discussions about potential rollbacks of policies established during the Biden administration, including the final guidance on clinical decision support software issued in 2022. This guidance brought several risk-scoring tools under FDA scrutiny, addressing concerns around automation bias and the integration of multi-source data.

Impact on Software Development and Clinical Practice

The revised guidance has had far-reaching implications for electronic medical record (EMR) developers. Many companies have intentionally limited their software features to avoid triggering stringent regulations. This cautious approach may stifle innovation, as developers opt for less sophisticated tools to circumvent complex oversight. Standalone modules, developed by outside entities, can be integrated into EMRs but often lack the seamless functionality needed for optimal clinical use.Gottlieb emphasizes the importance of balancing regulation with innovation. Tools designed to augment clinician decision-making, rather than replace it, should not face the same rigorous review as autonomous systems. This nuanced approach would encourage developers to create more robust and useful applications, enhancing patient care without compromising safety.

Addressing Automation Bias and Data Integration

One of the critical concerns addressed by the FDA’s final guidance was automation bias—the tendency for clinicians to overly rely on AI recommendations. The guidance also considered scenarios where clinical decision support software might be used in time-sensitive situations, potentially impacting patient outcomes. Additionally, the integration of data from multiple sources, such as imaging and laboratory results, raised questions about how these tools should be classified and regulated.The scrutiny of a sepsis risk-scoring tool developed by Epic, a leading EMR provider, highlighted the need for careful evaluation. Despite its widespread adoption, the tool struggled to accurately predict sepsis, underscoring the importance of thorough testing and validation. By reverting to earlier regulatory interpretations, Gottlieb argues, the FDA can strike a balance between promoting innovation and safeguarding patient welfare.

Fostering Innovation Without Compromising Safety

Ultimately, Gottlieb’s call for revisiting AI regulation seeks to restore clarity and certainty in the development of medical devices. By adopting a more flexible approach, the FDA can facilitate the creation of advanced tools that enhance clinical decision-making without imposing undue burdens on developers. This balanced framework would ensure that innovative solutions reach the market more efficiently, ultimately benefiting healthcare providers and patients alike.In advocating for this shift, Gottlieb underscores the importance of aligning regulatory policies with the evolving needs of modern healthcare. As technology continues to advance, finding the right balance between innovation and oversight will be crucial in shaping the future of medical practice.