Category: Blog

Denying Medical Care to ICE Detainees: Treating Their Needs as Optional 

In just one year, the number of people detained by Immigration and Customs Enforcement (ICE) has increased by over 75%, with a record 73,000 people held in detention as of mid-January. As anti-ICE protests across the country call attention to detainees, there is an increasing need to understand the questionable, frequently opaque conditions within ICE detention centers

There is mounting evidence that demonstrates ICE detention centers lack the infrastructure to provide basic care to those in the custody of ICE. Consequently, detainees are subjected to persistent medical neglect. These conditions, at least in part, persist due to a lack of legal accountability and legal protections. Immigration detention operates in a state of lawlessness, not because no law applies, but because courts have refused to enforce the law that already exists. The result is a system where ICE detainees routinely fail to receive necessary medical care, while the constitutional limits on that failure remain unenforced.

For those in ICE custody, many remain detained for months or years while their immigration cases proceed. During that time, detainees depend entirely on the government, or its private contractors, for their medical care. Yet, reports and court records consistently document delayed diagnoses, untreated chronic illnesses, failures to provide medication, inadequate mental health care, and preventable deaths. These failures are not isolated incidents. They are repeated offenses, and the law’s ability to serve as a tool to fight against these conditions has been strikingly meager. 

The Supreme Court has long made clear that when the government takes a person into custody and deprives them of their ability to care for themselves, it assumes an affirmative constitutional obligation to meet basic human needs, including medical care. In the prison context, the Court held in Estelle v. Gamble that “deliberate indifference” to a prisoner’s serious medical needs constitutes cruel and unusual punishment under the Eighth Amendment. That case established the floor: Once the state confines a person, medical neglect can qualify as a constitutional violation. 

But immigration detainees are not prisoners. Immigration detention is formally civil, not punitive; it is governed by the Fifth Amendment’s Due Process Clause. Under settled doctrine, civil detainees may not be subjected to conditions that amount to punishment. The Court articulated this principle in Bell v. Wolfish, holding that conditions of civil confinement must be reasonably related to legitimate governmental objectives and not excessive in relation to those objectives. If a condition lacks such a justification, courts may infer that it is punitive and, therefore, unconstitutional. The Court reinforced this affirmative duty framework in Youngberg v. Romeo, holding that when the state confines individuals and renders them dependent on institutional care, due process requires reasonable measures to ensure their safety and basic well-being. 

In theory, this constitutional framework could provide greater protection to ICE detainees than to convicted prisoners; however, courts have done the opposite, instead reinforcing executive deference related to ICE detention conditions. COVID-19 litigation exposed this flaw starkly. In cases like Hope v. Warden York County Prison and Fraihat v. U.S. Immigration & Customs Enforcement, federal appellate courts overturned lower-court orders that sought to protect medically vulnerable detainees. The courts emphasized ICE’s institutional competence and its stated detention interests, while declining to meaningfully scrutinize whether conditions had become unconstitutionally punitive. The consequence is that constitutional rights may exist, but they have been functionally unused. 

From a health policy perspective, judicial inaction could delay essential care. When legal obligations are unclear or unenforced, medical care becomes discretionary. ICE detention is not an exception to constitutional governance; it is a test of it. As long as courts treat immigration detention as a zone of exceptional deference, detainees’ health will remain subject to policy choice rather than legal duty. Until courts reckon with this discrepancy, detainees will continue to suffer the consequences

Surprise Billing is “Banned”: So Why are Patients Still Being Billed? 

Surprise billing occurs when a patient with health insurance unknowingly or unavoidably receives care from an out-of-network provider and is billed directly for charges not fully covered by their plan. Before the No Surprises Act was passed, patients could be billed for the difference between what a provider charged and what their insurance paid, as well as for additional out-of-network fees. 

The No Surprises Act of  2020 protects individuals covered by group and individual health care plans from receiving surprise medical bills after most emergency services and certain non-emergency care at in-network facilities. Beginning in 2022, the law added additional protections to prevent surprise billing. For privately insured patients, these protections include limits on balance billing and a federal dispute resolution process. For uninsured patients or for those who choose not to use their health insurance for a service, the law requires good faith estimates to be provided before you undertake the service. 

Despite these additional protections, consumers continue to report disputed charges and billing confusion. According to data from CMS, roughly 1.2 million payment disputes were filed by providers and health insurances in the first half of 2025 alone. This was almost 40% higher than the last half of 2024. This increase has drawn attention to the statute’s Independent Dispute Resolution system (IDR), which is a federal arbitration process designed to settle payment disagreements between insurers and out-of-network providers. Under the IDR, insurers and clinicians submit competing payment offers to a certified arbitrator, who must select one amount rather than splitting the difference. Lawmakers adopted this structure to pressure both insurers and providers to submit realistic numbers instead of inflated demands. 

Although the system was designed to keep patients out of reimbursement fights, the large volume of disputes being filed, and surveys suggesting many filed cases may be ineligible under the statute’s terms have raised administrative and enforcement challenges within CMS’s implementation framework. Although the law prohibits balance billing for covered emergency and certain non-emergency services, the continued pace of arbitration filings and associated enforcement work shows that disputes over payment amounts can persist even after protections are in place. 

Patients sometimes receive bills while these payment disputes are pending, and they may not know whether the charge is lawful or subject to dispute, reflecting gaps in implementation and public awareness. This creates a legal issue because the No Surprises Act’s promise of protection depends on the proper operation of the arbitration and complaint processes rather than automatic relief, meaning patients can be left uncertain about their rights unless enforcement and administration keep up with disputes. The continuing volume of arbitration cases shows that the No Surprises Act’s consumer protections depend heavily on administrative systems that are clearly still under strain.

Full Coverage or False Promises? Inside Health Care Sharing Ministries

The front page of Samaritan Ministries’ website touts a reliable, Christian way to cover healthcare costs; a “… Biblical, non-insurance approach to health care,” if you will.  Users are given the impression that like health insurers, organizations like Samaritan will cover their basic healthcare costs; such as primary care, childbirth, prescription medicines, or emergency care. Upon first glance, the list of plans of different tiers with monthly prices listed against a backdrop of pastels make the website seem no different than any other health insurance company’s website. It bears a striking resemblance to websites for companies such as Aetna or United Healthcare. What this carefully curated image won’t reveal is a growing string of lawsuits, unpaid bills, and heartache

Health Care Sharing Ministries (HCSMs) are defined as, “…a form of health coverage in which members, who typically share a religious belief, make monthly payments to cover expenses of other members.” An August 2018 report from the Commonwealth Fund revealed that HCSMs do not include basic protections under the Affordable Care Act. These organizations do not offer coverage for pre-existing conditions, can charge higher rates based on health status, and may exclude essential health benefits. They may also decline to cover benefits without dollar caps on health care services, or fail to cap out-of-pocket costs to members. 

The lack of monitoring of HSCM activities has been drawing increasing attention from regulators and lawmakers. Most notably in 2024, the co-founders of Missouri-based Medical Cost Sharing, another HCSM, plead guilty to an $8 million wire fraud conspiracy in the Western District of Missouri. James McGinnis and Craig Anthony Reynolds collected $8 million in revenue and used only 3.1% of this amount to pay health care claims. Similarly, in 2023, an Atlanta-based health care sharing ministry called Trinity run by a company called Aliera declared bankruptcy, leaving behind $660 million in unpaid medical claims. Aliera is suing former CEO Shelley Steele for loans she received from the company and never repaid, including one loan of over $6 million. Liberty HealthShare, based out of Ohio, used $140 million of the $300 million they received in member fees to fund a boutique airline, a marijuana farm, buy real estate, and carpet stores; all while their health sharing subsidiaries Cost Sharing Solutions and Medical Cost Solutions LLC went bankrupt. 

In response to the ongoing cases of fraud and lack of regulations, states like Oregon and Washington State are stepping up to protect consumers from incurring crippling debt and hardship. Oregon Democrats introduced HB 2268 in 2025 which would require any individual or organization marketing or selling a health care cost sharing arrangement to register with the Oregon Director of the Department of Consumer and Business Services. The office of Washington State Insurance Commissioner (OIC) Patty Kuderer fined ClearShare Health $275,000 in 2025 for selling insurance plans, disguised as “memberships,” without permission from the OIC and using only $54,201 of the $524,095 they collected in fees between 2022 and 2024 to pay their members’ medical expenses. 

Unfortunately, with the extreme cost of healthcare, severe cuts to Medicare and Medicaid, and a myriad of misinformation, consumers may continue turning to health care sharing ministries to help cover the cost of healthcare. In spite of the widespread documented cases of fraud, both the previous and current Trump Administrations have shown support for healthcare sharing ministries. The current Trump Administration plans to ensure tax parity for healthcare sharing ministries as part of their larger plan to lower healthcare costs by deregulating the health insurance industry, Medicare, Medicaid, and other federal programs. These changes would impact more than 1.5 million Americans who are members of a health care sharing ministry.  

Consumers looking to save on health insurance or who do not believe that health insurance or federal programs align with their values, should think twice before purchasing a membership from a health care sharing ministry. With the federal government’s support of health care sharing ministries, it is up to state regulators to protect consumers. Increasing supervision of healthcare sharing ministries and imposing long overdue penalties on those engaged in fraudulent practices is long overdue. For an industry that has promised those in need so much, they have left thousands with even more debt, grief, and regret than before. 

Dietary Supplement Labels: Divided Opinions on the Relaxation of Regulations 

Vitamins, probiotics, minerals, and botanicals are among the many dietary supplements used by approximately 75% of Americans to support their diets and maintain their health. Although often found in the same aisle in stores, the FDA does not regulate supplements in the same way as drugs. The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines dietary supplements as a category of foods regulated by the FDA. The Act furthermore enacted labeling requirements, including rules on the placement and contents of disclaimers and nutrition labels. The disclosures are required to remind consumers that supplements are not FDA-reviewed for safety or effectiveness before they are sold. Recently, the issue has been how much a manufacturer must disclose on a label and specifically how many disclosures are required to appear on each “panel” of a supplement label. 

In a class action suit filed against Amazon in 2023, the plaintiffs, a group of consumers, claimed that Amazon promotes and sells products that lack mandatory disclaimers on their labels, making them dangerous, defective, and illegal. The plaintiffs alleged that Amazon advertised purported benefits of certain dietary supplements not approved by the FDA without providing the required disclaimers. While the case remains ongoing, Amazon recently filed a motion to pause the suit, claiming it hinges on a regulation that the FDA announced is under revision. 

On December 11, 2025, the FDA released a letter responding to requests to amend label regulation 21 C.F.R. 101.93(d), which governs the placement of disclaimers. The current regulation, added by DSHEA, provides that statements for supplements can be made if they contain a disclaimer in bold type that reads: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” The current rules require that the disclaimer appear on each panel of a product label where a claim is made. The FDA’s December letter asserted that, based on its initial review, revising the regulation to remove the requirement that the disclaimer appear on each panel of a supplement would “be consistent with section 403(r)(6)(C) of the FD&C Act while reducing label clutter and unnecessary costs.” The letter also acknowledges that the FDA has rarely enforced this requirement and is therefore likely to propose an amendment. There is no timeline for when the rule change might take effect; however, the letter states the FDA will not enforce the existing rule while it is under review. 

The regulations would still require the disclaimer to appear at least once on the bottle, however, many consumers and critics in the medical field believe the amendment would weaken the already deficient warning system. A study done between 2004 and 2013 found that consumers made more than 15,000 reports of health problems linked to supplements to the FDA’s central reporting system. Supplements that claim to help with weight loss, sexual function, energy and muscle building have been among those found to have potentially harmful undisclosed ingredients like prescription pharmaceuticals and steroids. Public health advocacy organizations and consumers have called for reforms to the supplement regulation process including proposals of mandatory product listing, FDA standards, and premarket review. 

Some supplement retailers advertise that their supplements are voluntarily self-regulated following industry-wide initiatives which created their own standards that complement or enhance government regulations. Voluntary programs like the Council for Responsible Nutrition and the Consumer Healthcare Products Association can promote enhanced product safety and fill the gaps of government regulation. Although they present certain benefits, these programs remain limited by their lack of enforcement power and voluntary nature. 

The letter proposing the relaxation of disclaimer requirements is a step in the wrong direction for advocates who have been fighting for heightened regulation. The plaintiffs in the Amazon case say the letter should not stop their suit, because their claims include many other disclaimer violations beyond the “each panel” rule. If passed, however, many believe the amendment will be the first step toward dangerously weak warnings on supplement labels.

OpenAI to Launch ChatGPT “Health” Amidst Shifting AI Regulatory Schemes Surrounding Privacy

On January 7, 2026, OpenAI announced plans to launch of ChatGPT Health (“Health”), a new model that will allow users to connect their health records and wellness applications to the chatbot. Every week, hundreds of millions of people use ChatGPT to enquire about health and wellness. OpenAI has set out the privacy protections and controls it intends to implement in handling highly personal and sensitive information, including data encryption, data isolation, user options to delete chats from its system, and restricting inputs to Health not to train the foundational model. Similar to its existing system, Health will use a large language model (LLM) to service its users in chatting about health, reviewing medical records, summarizing visits, and providing nutrition advice, among other functions. 

Executive actions have shifted towards limiting AI regulations, attempting to maintain the United States as a global leader in AI innovation, and encouraging industries to adopt automation. In December 2025, President Trump issued the Executive Order 14365 “Ensuring a National Policy Framework for Artificial Intelligence,” attempting to deter state regulations from creating a patchwork of regulatory regimes and instead create national consistency. This action alone does not prevent state-level AI or privacy laws, however, it does establish a task force to challenge them. The EO followed a previous action which removed Biden-Era regulations placed on AI, classifying them as a hindrance to innovation and free markets.

The Food and Drug Administration (“FDA”) regulates AI Health technology, classifying certain developments as software as a medical device (SaMD) under the Federal Food, Drug, and Cosmetic (“FD&C Act”). On January 6, 2026 the FDA provided guidance on their oversight of AI devices, distinguishing low-risk products used for general wellness not to be regulated as medical devices. Software that is “unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition” is not a medical device under the FD&C Act. The FDA explicitly classified software programs as general wellness products, likely putting Health into an regulation-exempt status under the FD&C Act. 

Systems which function solely to transfer, store, convert, format, and display medical device data are characterized as Medical Device Data Systems (MDDS) are subject to the FD&C Act. However, the FDA has also clarified that Non-Device-MDDS with software functions that store patient data, convert digital generated data, or display previously stored patient data are exempt from regulation as long as they do not analyze or interpret data. This contention produces uncertainty for Health’s classification because of the functional interaction between data input and user interactions.

The Health Insurance Portability and Accountability Act (“HIPAA”) Privacy Rule ensures covered entities and business associates properly handle protected health information (“PHI”). Users submitting medical records to Health would not render OpenAI a covered entity or business associate, leaving its status as a consumer health product outside of HIPAA’s regulatory scope. Data sharing, such as what Health sets out to do across Apple Health, MyFitness Pal, and other applications, falls outside of the HIPAA framework if it is disclosed for purposes other than for treatment, payment, healthcare operations or otherwise requiring authorization by the Privacy Rule 45 C.F.R. § 164.508.

The Federal Trade Commission (“FTC”) may serve as a backup for these regulatory rollbacks. The FTC regulates healthcare privacy by providing data breach notifications. Compliance is enforced through the Health Breach Notification Rule (“HBNR”), requiring vendors of personal health records to notify the FTC and consumers if a data breach occurs. A vendor under the HBNR is any Non-HIPAA entity or business associate that “offers or maintains a personal health record.” It is uncertain whether Health will be subject to regulation under this category, or any other, despite their handling of users’ personal health record uploads. As an alternative method of accountability, the FTC may bring litigation actions, such as the recent class action settled with Flo Health Inc. for sharing proprietary health data to Facebook, Google, and others without user consent.

As the regulation landscape surrounding Health is actively evolving, it is uncertain how privacy concerns will be handled. Federal agencies and the executive are giving broad autonomy to the developers for privacy practices as AI integrates healthcare practices, leaving much of the accountability to be exercised through litigation or FTC after-actions.

How America’s AI Action Plan Could Affect Brain-Computer Interfaces

On January 23, 2025, President Donald Trump signed Executive Order 14179, “Removing Barriers to American Leadership in Artificial Intelligence,” which sought to revoke existing AI policies and directives that act as barriers to American AI innovation. The federal government’s push for AI development may accelerate the availability of neurotechnologies that incorporate AI, while reducing regulatory oversight and consumer protections. 

Pursuant to the Executive Order, the White House released a comprehensive policy strategy entitled “Winning the Race: America’s AI Action Plan” in July of 2025. The policy includes a recommendation to remove red tape by “review[ing] all Federal Trade Commission (FTC) investigations . . . to ensure that they do not advance theories of liability that unduly burden AI innovation.” The policy also encourages the country to “establish regulatory sandboxes or AI Centers of Excellence around the country where researchers, startups, and established enterprises can rapidly deploy and test AI tools . . . enabled by regulatory agencies such as the Food and Drug Administration (FDA).” Implementing these recommendations may directly affect the development of neurotechnologies.

Brain-computer interfaces (BCIs) are neurotechnologies that allow for communication between the human brain and external output, such as a computer, mobile device, or prosthetic device. They are subject to FDA and FTC oversight, depending on their intended use. The primary FDA department responsible for regulating medical neurotechnologies is the Division of Neurological and Physical Medicine Devices (DNPMD). For direct-to-consumer technologies, the FTC oversees consumer protection and privacy. The Management of Individuals’ Neural Data Act of 2025 (the MIND Act) is proposed legislation that would direct the FTC to study how neural data are currently governed. 

Neuralink and Merge Labs are companies that are eager to incorporate AI in their BCI technologies. Neuralink, headed by Elon Musk, produces a BCI that is implanted in the brain near neurons of interest. Electrodes within the BCI then detect electrical signals from neurons and decode information. The goals of Neuralink are to “restore autonomy to individuals with unmet medical needs today, and to unlock superhuman capabilities across many people in the future.” The company aims to eventually connect brain neural networks to artificially intelligent networks outside the brain.

One month before the release of America’s AI Action Plan, Neuralink received FDA breakthrough device designation to restore communication for individuals with speech impairment. Musk has also benefited from his relationship with the Trump Administration and his former position as the leader of the Department of Government Efficiency (DOGE), which has significantly reduced the federal civil service. In February of 2025, DOGE reportedly fired the FDA employees responsible for overseeing Neuralink. Ten months later, Neuralink hired the former director of the FDA office responsible for regulating the company to lead its medical affairs division. 

Sam Altman, the CEO of OpenAI, has recently partnered with the Trump Administration on the Stargate Project, which “intends to invest $500 billion over the next four years building new AI infrastructure for OpenAI in the United States.” Co-founded by Altman, Merge Labs is researching a new approach that could combine gene therapy with an ultrasound device to create non-invasive BCIs. The company has a long-term mission of “bridging biological and artificial intelligence to maximize human ability, agency, and experience.” OpenAI is the largest investor in Merge Labs, which has raised $252 million of funding. Along with funding, OpenAI announced that it will collaborate with Merge Labs to accelerate progress, stating that “BCIs will create a natural, human-centered way for anyone to seamlessly interact with AI.” 

Merge Labs has not yet submitted technology for FDA approval. It is unclear how the technology would be classified, especially because the company’s mission is not explicitly related to medical uses and the technology aims to be non-invasive. With the release of America’s AI Action Plan, it is also unclear whether consumers can rely on the FTC for privacy protections regarding this technology. Removing red tape and enabling AI adoption may open the door to faster development and distribution of these life-changing technologies for people with disabilities. However, brain surgery and gene therapy that incorporate AI are potentially permanent medical procedures that could put Americans at risk of long-lasting health impacts and privacy invasions.