Author: Anabelle Faivre

The AI Doctor Will See You Now—But Is It Regulated?

In early 2025, two-thirds of doctors reported using artificial intelligence (AI) for a wide range of purposes, including “documentation of billing codes, medical charts, and visit notes; generating discharge instructions, care plans, and progress notes; providing translation services; supporting diagnostic decisions; and more.” Although the healthcare sector was initially hesitant to adopt AI, it has since accelerated its integration efforts and now implements AI technologies at twice the rate observed in other economic sectors. The escalating costs of healthcare have prompted the increased adoption of artificial intelligence, aimed at enhancing operational efficiency, optimizing resource utilization, and ultimately reducing expenditures.

AI in healthcare extends beyond addressing administrative inefficiencies, as regulator-approved applications, classified as Software as a Medical Device (SaMD), are already showing clinical promise; for example, one AI algorithm used in a U.S. mammography study improved breast cancer detection rates by 9.4% and reduced false positives by 5.7%. Ongoing research is exploring the efficacy of SaMD across fields such as dermatology, radiology, psychiatry, and personalized medicine, where AI’s capacity to process large datasets and continuously learn enhances diagnostic accuracy and enables more individualized treatment approaches.

Although artificial intelligence presents considerable potential for advancing the healthcare sector, it simultaneously generates substantial uncertainties, given that technological developments outpace the formulation and implementation of regulatory frameworks. According to Professor Dr. Heinz-Uwe Dettling, Partner, Ernst & Young Law GmbHand EY GSA Life Sciences Law Lead, this issue is often described as the ‘locked versus adaptive’ AI challenge; regulatory efforts are necessary, but the current regulations were not designed to keep up with the rapid pace of technological advancements like those seen in artificial intelligence.

In addition to ongoing uncertainties surrounding regulatory frameworks, AI remains inherently imperfect. A study conducted by Rutgers University demonstrated that AI algorithms can inadvertently perpetuate erroneous assumptions, largely because they rely on datasets that may result in broad generalizations about people of color. Furthermore, these algorithms often neglect essential social determinants of health, such as transportation accessibility, the cost of nutritious food, and variable work schedules, which play a critical role in influencing patients’ capacity to comply with treatment regimens requiring frequent medical appointments, physical activity, and other health-related interventions.

Concerns regarding the implementation of artificial intelligence in healthcare have prompted regulators, legislators, and healthcare practitioners to call for the development of more comprehensive regulations and guidelines within this dynamically evolving sector. A thorough understanding of biases inherent in traditional education and healthcare professionals is essential, requiring developers to have both domain-specific knowledge and technical expertise. Additionally, implementing more rigorous processes to review data inputs is crucial to preventing biases in algorithms that may exacerbate healthcare disparities.

Because AI touches every part of the healthcare system, it is essential to have cross-agency coordination as well as regulations at the state and federal levels. Currently, multiple federal agencies regulate AI in healthcare, including the FDA, the Department of Health and Human Services (HHS), and the Centers for Medicare and Medicaid Services (CMS). In addition, states have enacted legislation designed to ensure that artificial intelligence remains a tool, not a replacement, in the doctor’s office. These state-level regulations require “healthtech” companies to embed compliance measures from the earliest stages of product development, including conducting thorough audits and employing geofencing technologies to navigate the patchwork of differing state laws effectively. By prioritizing proactive compliance and transparent practices, companies can not only mitigate legal risks but also build greater public trust, thereby enabling smoother adoption and competitive advantage in an increasingly regulated and scrutinized market.

HALTing Progress: Congress Doubles Down on Failed Drug Policies

Congress recently passed the Halt All Lethal Trafficking (HALT) of the Fentanyl Act in an attempt to provide a solution for the ongoing opioid crisis. The bill would make the temporary class-wide scheduling order for fentanyl-related substances (FRS) permanent, ensuring law enforcement has the tools to keep these deadly drugs off the streets while allowing practitioners to research their effects on human health. Classifying fentanyl as a Schedule I substance means that those who manufacture, import, or possess FRS with the intent to distribute will face strict mandatory minimum sentences while also expanding mandatory minimums for drug analog prosecutions.

However, the HALT Act has received criticism, with public health experts, criminal justice advocates, and civil rights proponents opposing it. The Act is criticized for expanding mandatory minimum sentences, a proven failure in improving public safety, and warned it would worsen racial disparities in the criminal justice system. By permanently scheduling all fentanyl-related substances, HALT could hinder research on potentially life-saving treatments, as some FRS may have no harmful effects and share molecular similarities with effective antidotes.

The HALT Fentanyl Act would lower trafficking thresholds, making even a trace amount of fentanyl analog in a 10-gram sample subject to a five-year mandatory minimum sentence, compared to the current law where 10 grams triggers a five-year sentence and 100 grams results in 10 years.

In addition, the expanded mandatory minimums strip judges of the ability to tailor sentences based on a defendant’s background and circumstances, shifting more power to prosecutors, who are more likely to charge Black individuals with offenses carrying mandatory minimums, a pattern the HALT Fentanyl Act risks perpetuating and worsening.

Harsh federal drug laws and mandatory minimums have fueled the growth of the federal prison population, with no evidence that they deter crime or reduce drug use, while those convicted of drug offenses now make up 43.9% of the Bureau of Prisons population.

When asked why he voted against the bill, Oregon Senator Ron Wyden explained that it fails to address the root causes of addiction, saying, “The ‘war on drugs’ approach of criminalizing addiction with mandatory, one-size-fits-all minimum sentences has failed for decades to reduce drug use.” 

Susan Ousterman, founder of the Vilomah Memorial Foundation, who lost her son to a fentanyl overdose in 2020, criticized Congress for prioritizing punitive measures over meaningful solutions. She stated that her son died not due to a lack of laws but because he couldn’t access necessary care, calling it hypocritical for Congress to claim commitment to reducing overdose deaths while continuing to pass legislation that perpetuates stigma and incarceration. Ousterman urged Congress to focus on treatment, harm reduction, and addressing social determinants of health to create pathways to healing and recovery.

Harm reduction programs, often run by community or peer-led organizations and health departments, include initiatives like providing sterile syringes, distributing naloxone, offering fentanyl testing, and educating about overdose prevention and safer drug use to reduce the risks associated with drug use.

Harm reduction strategies are proving effective, with the U.S. Centers for Disease Control and Prevention (CDC) projecting a nearly 24% decline in drug overdose deaths in the U.S. for the 12 months ending in September 2024 compared to the previous year. The CDC credits this decrease to factors such as the widespread, data-driven distribution of naloxone, better access to evidence-based treatment for substance use disorders, and shifts in the illegal drug supply.

Ultimately, the HALT Act is a counterproductive effort to halt the opioid epidemic. Congress should focus more on improving harm reduction strategies around the country and less on promoting the war on drugs.