Category:Healthcare Compliance
The FDA’s Handle on AI Regulation
Imagine a patient suffering from sporadic unconsciousness is hooked up to a heart monitor. Suddenly, an irregular heart rhythm begins but is flagged almost instantaneously. The irregularity was not spotted by a cardiologist analyzing an EKG but rather by AI trained on millions of other heartbeats. That’s not a scene from the future. It’s already routine.
The FDA has authorized the marketing of over 1,500 AI-enabled medical devices in the United States. The first one dates back to 1995, but the number of devices has sharply increased since then and continues to do so. However, the main caveat for AI devices is that their software can change after authorization, but the FDA’s monitoring of those changes doesn’t. In light of this, the FDA needs stricter and more continuous regulation of AI-enabled medical devices.
Disclosure of AI Use in Patient Care Should Be Mandated
AI use in health care is increasing. As of 2026, more than 80% of physicians reported using AI, double the rate reported in 2023. Physicians reported using health AI for assisting in diagnoses and drafting responses to patient portal messages. They believe that AI can be a useful tool for aiding patient convenience, work efficiency, and providing value based care. But do patients know that their providers are using AI? To ensure patients are making truly informed decicisons about their health, providers should be required to inform patients when AI is used in their treatment or care.
The Affordable Care Acts Regulatory Drawbacks
The recent government shutdown has brought the Affordable Care Act (ACA) to the center of American politics once again. While the law was able to successfully expand coverage to millions of Americans, the law’s continued reliance on subsidies shows its inability to lower premiums due to structural healthcare issues. The temporary subsidy program in particular, which was first expanded during the Covid-19 pandemic in 2021, was intended as short term relief and has now become essential for keeping premiums affordable for Americans. This overreliance on federal aid exposes a deeper structural weakness with the ACA, which is the law’s inability to sustain affordability without government intervention. As Congress debates whether to renew these subsidies, the question they must ask themselves is whether the ACA’s regulatory framework can ever function as a truly self-sustaining reform without significant subsidies.
Navigating the Complex Landscape of Reproductive Healthcare Compliance
In the constantly evolving field of reproductive healthcare, compliance with regulatory standards is both challenging and vital. As legal frameworks shift and new technologies emerge, healthcare providers, law students, practitioners, and compliance professionals must stay informed to ensure adherence to the law. Several key compliance issues in reproductive healthcare, including privacy concerns raised by biometric technology as it is tied to employers, offer insights into the challenges and strategies for maintaining regulatory compliance.
Profits Over Patients: The DOJ’s Fraud Investigation into UnitedHealth’s Medicare Practices
The Department of Justice (DOJ) has launched a civil fraud investigation into UnitedHealth’s Medicare billing practices, scrutinizing allegations that the company improperly inflated patient diagnoses to secure higher federal payments. While the investigation was publicly announced via the Wall Street Journal recently, it has been underway since 2024. This development follows the December 2024 death of UnitedHealth CEO Brian Thompson, which sparked renewed public discourse on the ethics of insurance companies. Many individuals came forward with stories of denied coverage for life-saving treatments, raising broader concerns about the practices of private insurers managing Medicare benefits.
Biden Ties Medicare Reimbursement to Sepsis Treatment
The Centers for Medicare and Medicaid Services (CMS), under the Department of Health and Human Services (HHS), finalized CMS-1785-P in August, a rule that links Medicare reimbursement to the treatment of sepsis. Previously, hospitals were required to report on their sepsis treatment patients, but there was no penalty for not adhering to treatment guidelines. Beginning in Fall 2024, hospitals must meet the specific treatment benchmarks integrated into Medicare’s Hospital Value-Based Purchasing Program (MHVBPP) specifically the provisions outlined in the Severe Sepsis/Septic Shock Management Bundle (SEP-1). Failing to meet these benchmarks could result in significant financial losses for hospitals, ranging from thousands to millions of dollars for larger entities. While hospitals should presently be aware of these requirements and implement plans to meet them, there are concerns about whether the proposed rule is the optimal solution for improving outcomes for sepsis patients.
AI Nancy Drew, Is That You?
The United States spends more money per person on health care than any other country, approximately $4.2 trillion in 2021. Unfortunately, our complex health care system and the large budget make fraud a significant concern for the U.S. Government, payers, and patients. The National Healthcare Anti-Fraud Association estimates that as much as 10% of annual healthcare spending is lost to scams, resulting in billions in losses yearly. To combat healthcare fraud, the Department of Health and Human Services Office of the Inspector General, in collaboration with state law enforcement and other governmental agencies has created special Strike Forces. These efforts have led to substantial recoveries of federal funds and criminal/civil prosecution of individuals or entities involved in Medicare and Medicaid fraud. Besides avoiding unnecessary or fraudulent claims, individual healthcare payers are motivated to prevent fraud due to severe penalties associated with the False Claims Act, Anti-Kickback Statute, Physician Self-Referral Law (Stark Law), and Civil Monetary Penalties Law. How can individual payers detect and try to prevent fraud? The answer is AI.
Neuropsychological Exams for Physicians: Good Practice or Discrimination?
Recent instances of politicians experiencing medical episodes in the public eye have sparked discussions regarding age limits for politicians. However, a parallel conversation is emerging about the healthcare professionals responsible for our well-being. About four years ago, a small number of health care institutions began implementing various forms of neuropsychological testing policies for older physicians. Since then – over the past few years – this practice has continued to grow and become increasingly controversial. The ongoing debate centers around determining the appropriate age to commence testing for physicians, the specific parameters to test for, and the ethics of mandating such testing. These questions remain subjects of ongoing debate, yet considering the rising demographic of physicians over the age of 60, there is a growing argument for integrating some form of neuropsychological examination.
Healthcare’s Red and Blue Pill: AI
Artificial Intelligence (AI) has gained widespread attention, often perceived as a buzzword. Recently, concerns about its potential dangers and issues with plagiarism have surfaced. However, AI holds immense promise for transforming industries reliant on data analysis and predictive algorithms, especially in healthcare. AI can significantly improve healthcare by aiding in diagnosis, optimizing patient outcomes, reducing costs, and saving time.
New Mental Health Parity Rules on the Horizon
On July 25, 2023, the Departments of Labor, Health and Human Services, and the Treasury (the agencies) proposed new rules placing heightened compliance standards on health insurers and plans regarding the use of Non-Quantitative Treatment Limitations (NQTLs) for mental health and substance abuse disorder (MHSUD) services. These new rules amend the current reporting requirements with the intent to establish ongoing reporting that more clearly demonstrates whether MHSUD services are provided in compliance with the law.