In a landmark decision on June 28, 2024, the Supreme Court
overturned a 40-year-old legal precedent known as
Chevron deference. Established in 1984,
Chevron deference mandated that judges defer to federal agencies concerning interpretations of ambiguous laws, as long as those interpretations were reasonable. This doctrine has been a cornerstone of administrative law, significantly impacting the way federal agencies operate and implement regulations.
Chief Justice John Roberts, writing for the 6-3 majority, described the framework as “unworkable,” arguing that it allowed federal agencies to change course without congressional oversight. The decision marks a substantial shift in power from regulators to the courts by granting courts, rather than agencies, the power to interpret ambiguous statutory guidance, fundamentally altering the landscape of federal rulemaking.
Why Chevron Was Overturned
The crux of the argument against Chevron deference lies in its perceived imbalance in judicial review. Critics argued that the framework unfairly tipped the scales in favor of government regulators, requiring judges to systematically favor federal agencies over challengers. This, they contended, led to inconsistency, as agencies could impose different rules with each new administration. Chief Justice Roberts echoed these concerns, stating that Chevron deference has led to courts abdicating their responsibility to interpret laws, thereby violating the Administrative Procedure Act.
Impact on Healthcare and AI in Medical Research
The healthcare sector, particularly agencies like the U.S. Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), and the Centers for Medicare & Medicaid Services (CMS), will immediately feel the impact of this ruling. These agencies, which issue numerous regulations and guidance annually, will now face heightened scrutiny and an increased volume of legal challenges, potentially slowing the pace of agency regulations and response to new and emerging technologies and other rapidly evolving situations. Rather than deferring to agency interpretations of statutory provisions, courts will now exercise independent judgment in deciding whether an agency has acted within the bounds of its statutory authority. While this change may help prevent agencies from changing their positions with each new Presidential administration, it may also cause agencies to slow the pace of regulations rather than risking costly, drawn-out legal challenges that could weaken agency authority. The new framework may provide opportunities for challengers to raise new arguments opposing agency’s interpretations of highly regulated industries, including life sciences and medical technology. Thus, while the new framework may not formally impact agencies until they attempt to enforce regulations, as a practical matter, it may cause a chilling effect that inhibits regulatory efforts by causing agencies to be more conservative in their efforts to regulate new areas.
Healthcare Policy and Agency Responsiveness
Health law experts worry that overruling Chevron is particularly concerning for healthcare policy. Agencies rely on their expertise to address emergencies, adapt to evolving technologies, and improve health outcomes. The rollback of Chevron could slow down regulatory responses during public health emergencies and reduce agencies’ ability to adequately regulate emerging medical technologies, including the rapid advances in artificial intelligence and its potential uses in medical research. Machine-learning algorithms have the potential to revolutionize clinical trials by optimizing candidate selection and improving safety monitoring.
Optimizing Clinical Trials
AI can analyze vast datasets to identify suitable candidates for clinical trials, reducing recruitment costs and time. However, the increased legal scrutiny on agency rulemaking could slow down the approval and implementation of AI-driven methodologies. Agencies may become more cautious in enacting regulations and face additional legal challenges drawing out the implementation of new regulations, delaying the adoption of innovative technologies that could expedite clinical research. Additionally, AI enables real-time data access and remote monitoring of trial participants, enhancing the accuracy of biological data and early identification of adverse reactions. The heightened legal challenges to agency regulations could impede the deployment of such technologies, potentially slowing advancements in clinical trial safety and the possible development of breakthrough drugs and medical devices.
AI Risks
On the other hand, advocates of overturning Chevron deference argue that the power to make rules regarding these important emerging technologies properly resides with Congress, rather than federal agencies, especially regarding a potentially transformative technology like AI in healthcare. Policymakers in particular have expressed concern regarding potential algorithmic bias with AI systems that, in the healthcare setting, could result in inaccurate diagnoses or treatments in certain patient populations. Introducing this bias into clinical trials could have far-reaching consequences for the development of new medical technology. Furthermore, allowing AI access to sensitive patient health data presents numerous privacy and data security risks that may be better evaluated by Congress rather than federal agencies.
Conclusion
The Supreme Court’s decision to overturn Chevron deference is a seismic shift in administrative law, with far-reaching implications for healthcare policy and the adoption of AI in medical research. While the ruling aims to restore judicial responsibility in interpreting laws, it also risks slowing regulatory processes and stifling innovation. As agencies navigate this new landscape, the healthcare sector and AI-driven medical research will need to adapt to a more litigious and cautious regulatory environment.
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