Texas Attorney General Ken Paxton is challenging Epic Systems’ handling of pediatric medical records, alleging unlawful limits on parental access and raising broader questions about data control, compliance, and oversight for providers and laboratories.
For clinical laboratory leaders, the growing legal and regulatory scrutiny of electronic health record (EHR) vendors is no longer a peripheral issue. How patient data are controlled, shared, and accessed has direct implications for test ordering, result reporting, compliance, and patient trust. That context frames a new lawsuit filed by Texas Attorney General Ken Paxton against Epic Systems Corporation, one of the nation’s most dominant health IT companies.
Paxton alleges that Epic has unlawfully monopolized the EHR market and engaged in deceptive practices that restrict parental access to minors’ medical records, in violation of Texas law. Epic’s software houses more than 325 million patient records, representing roughly 90% of the U.S. population, according to the complaint.
Providers and EHRs restrict parental access to adolescent records primarily to comply with state and federal privacy laws. In many states, including Pennsylvania, minors age 13 and older can legally consent to certain types of care—such as mental health services, substance use treatment, sexual and reproductive health, and some infectious disease testing—without parental involvement. When a minor has the right to consent, providers are legally required under state law and HIPAA to keep that related protected health information confidential.
EHR systems like MyChart enforce these rules by automatically limiting parental access when a child turns 13 and masking sensitive results or medications to prevent accidental disclosure. These controls also align with national clinical guidance, including recommendations from the American Academy of Pediatrics, which emphasize protecting adolescent confidentiality to ensure teens seek care and communicate openly with clinicians.
The lawsuit claims Epic uses “exclusionary tactics” to suppress competition, including interfering with hospitals’ ability to use their own patient data and limiting interoperability with competing software. Paxton argues these practices result in incomplete or outdated health records being shared among providers, diminishing care quality for Texas patients and increasing costs for hospitals.
For laboratories, these allegations raise concerns about data liquidity and timely access to diagnostic information. In fragmented or restricted EHR environments, lab results may not follow patients across care settings, potentially affecting clinical decision-making and continuity of care.
Parental Access to Pediatric Records at the Center of Legal Challenge
The suit also focuses on Epic’s handling of pediatric records. Paxton alleges the company automatically restricts parental access to medication lists, treatment notes, and provider messages once a child turns 12. The attorney general argues Epic does not own this data and has no authority to withhold it.
“These deceptive practices undermine the fundamental right of parents to direct their children’s healthcare,” the lawsuit states, citing Texas Health & Safety Code § 183.006, which grants parents “complete and unrestricted access” to their minor children’s medical records.
“We will not allow woke corporations to undermine the sacred rights of parents to protect and oversee their kids’ medical well-being,” Paxton said. “This lawsuit aims to ensure that Texans can readily obtain access to these records and benefit from the lower costs and innovation that come from a truly competitive electronic health records market.”
The Epic lawsuit is part of a broader enforcement push. Earlier this year, Paxton’s office reached a settlement with Austin Diagnostic Clinic requiring full restoration of parental proxy access for patients ages 12 to 17. Civil investigative demands have also been issued to other EHR vendors operating in Texas.
For lab leaders, the case underscores increasing regulatory attention on how diagnostic data are governed inside EHR systems. As states and regulators challenge vendor practices around data access, interoperability, and patient rights, laboratories may find themselves navigating new expectations for transparency, parental access, and compliance—while also reassessing their dependence on a highly consolidated health IT ecosystem.
Mark Cuban argues that fines for healthcare overbilling could drive accountability across the system, putting new pressure on insurers, hospitals, and clinical labs to defend pricing and billing practices.
Imagine your clinical lab got fined every time it overbilled. That’s what Mark Cuban is suggesting. Cuban is once again taking aim at what he calls systemic dysfunction in US healthcare—this time framing billing practices by insurers and providers as a source of both patient harm and missed accountability. For laboratory leaders, the comments land amid growing scrutiny of healthcare pricing, reimbursement transparency, and how frontline diagnostics fit into a system under pressure to justify costs.
In a post on X, Cuban argued that routine overbilling, improper claim denials, and misleading patient cost estimates are so widespread that meaningful enforcement could have enormous fiscal impact.
“If we fined insurers and providers $100 every time they over-billed, incorrectly denied care or misrepresented any amount of patient out of pocket, we could pay off the national debt,” Cuban wrote.
“If we fined insurers and providers $100 every time they over-billed, incorrectly denied care or misrepresented any amount of patient out of pocket, we could pay off the national debt,” Cuban wrote. (Photo credit: Wikipedia.)
Cuban Calls for Reform
He went further, describing a healthcare system he believes is intentionally complex and tilted against patients. According to Cuban, insurers and providers benefit from information asymmetry, leaving consumers overwhelmed by surprise bills, opaque pricing, and shifting out-of-pocket costs.
Cuban called for aggressive structural reform, starting with the insurance industry. He argued that major insurers should be broken up and forced to divest non-insurance businesses, followed by similar action targeting hospitals and pharmaceutical wholesalers. The objective, he said, is to restore competition and make healthcare markets more efficient.
The comments were sparked by a post from Tanner Aliff, founder of Scalpel Policy Solutions, who highlighted recent state laws that allow patients to receive “deductible credit” when they pay cash prices lower than typical insurance reimbursements. These policies let patients save money while still having their spending count toward their annual deductible.
Aliff pointed to high-cost imaging as a clear example. Instead of exhausting a deductible on a $6,000 MRI billed through insurance, patients in certain states can pay roughly $300 in cash for the same service and still receive deductible credit—dramatically reducing their out-of-pocket burden.
So far, only four states—Texas, Indiana, Tennessee, and Oregon—have enacted some version of this reform.
Opposition Voices Doubts
Cuban praised the effort and urged broader adoption, arguing that if cash-pay healthcare spending consistently counted toward deductibles, patients could comparison-shop more effectively. He encouraged people in other states to press lawmakers on why similar policies have not been implemented.
Critics pushed back, questioning whether patients can realistically navigate these options, particularly those managing serious or chronic illness. Financial planner Jae Oh argued that expecting consumers to coordinate cash payments and deductible credits is impractical and potentially harmful.
Cuban countered by pointing to his experience through Cost Plus Drugs, saying he regularly helps patients with deductibles and prior authorizations. While he acknowledged that having cash payments credited toward deductibles remains the hardest part, he insisted that the model already works for many patients.
For laboratory leaders, the debate is a reminder that pricing transparency, billing accuracy, and payer behavior are increasingly under the spotlight. As policymakers and high-profile industry voices push for reforms that empower patients, laboratories may face new expectations around cost clarity, reimbursement practices, and their role in a healthcare system being challenged to prove its value and fairness.
A growing measles outbreak in South Carolina, combined with rising cases nationwide, is putting renewed pressure on clinical and public health laboratories as the US risks losing its measles elimination status.
A rapidly expanding measles outbreak in South Carolina is reinforcing the critical role laboratories play in outbreak detection and response. State health officials report 188 measles cases statewide, with 185 linked to a concentrated outbreak in the Upstate region.
The outbreak is centered around elementary schools with low vaccination rates, a setting that often drives sudden spikes in testing demand. For laboratory leaders, these environments can translate into urgent diagnostic needs and close coordination with public health officials.
Health authorities say most new cases are tied to known exposures. Four recent infections were linked to household transmission, and one resulted from a previously reported school exposure.
However, signs of broader spread are emerging. The source of three new cases remains unknown, and another is still under investigation, suggesting transmission may be extending beyond clearly identified clusters.
As of the week of Dec. 29, 2025, 223 individuals in South Carolina were under quarantine following measles exposure. Each quarantine case increases reliance on timely laboratory confirmation to support isolation, contact tracing, and clearance decisions.
Photo credit: CDC
Vaccination status among patients is low and a likely contributor. Of the 185 cases in the Upstate cluster, 172 individuals were unvaccinated. Four had unknown vaccination status, and only one patient was fully vaccinated.
Children make up the vast majority of infections. Forty patients are under age five, while 123 are between ages five and 17, reinforcing the role of school-based transmission and pediatric testing demand.
Regional Spread Raises Stakes
South Carolina’s surge mirrors similar outbreaks in the western United States. Arizona has now reported 205 measles cases, while neighboring Utah is tracking 156.
Many of those infections are linked to a multistate outbreak centered in Mohave County, Arizona, and Southwest Utah. The pattern highlights how quickly localized outbreaks can expand across jurisdictions.
Nationally, the situation is becoming more serious. By the end of December, the United States surpassed 2,000 measles cases.
At that level, the country risks losing its measles elimination status, first achieved in 2000. Losing the designation would signal the return of sustained endemic transmission and likely intensify surveillance and reporting requirements.
For laboratory leaders, these developments may bring increased volumes of measles PCR and serology testing, particularly in pediatric and outpatient settings. Rapid turnaround times will remain essential for guiding quarantine and infection control decisions.
Public health laboratories may also face expanded workloads related to confirmatory testing and molecular tracking of transmission chains. As measles resurges, laboratories once again serve as a frontline defense—where preparedness, capacity planning, and coordination can directly shape outbreak control.
Researchers have identified thousands of protein-free, circular RNA molecules living inside human-associated bacteria, raising new questions for microbiology labs about how life is classified.
Laboratory leaders accustomed to classifying organisms as bacteria, viruses, or parasites may soon need to account for something entirely different. Researchers have identified a previously unknown class of RNA molecules living inside bacteria associated with the human body—entities that replicate but do not fit into any existing biological category.
The structures, called “obelisks,” are circular RNA molecules found primarily in bacteria from the human mouth and gut. They are neither living cells nor conventional viruses. Instead, they exist as short loops of RNA that replicate within microbial hosts through mechanisms that scientists do not yet understand.
Protein-Free RNA Replicators Emerge from Large-Scale Metagenomic Analysis
What makes obelisks particularly unusual is what they lack. According to the researchers, the RNA loops are “protein-free, RNA-only replicators.” They do not encode proteins, nor do they form protective capsids or membranes. This places them outside established definitions of viruses, plasmids, or other mobile genetic elements.
The discovery emerged from a large-scale analysis of publicly available metagenomic data drawn from human-associated microbial communities. Using computational tools designed to identify circular RNA structures, the research team screened vast genomic libraries from oral and intestinal microbiomes.
That effort revealed more than 3,000 distinct obelisk sequences, many of which appeared repeatedly across samples from different individuals and geographic regions. The work was led by Nobel laureate Andrew Fire of Stanford University and published as a preprint on bioRxiv.
To ensure the findings were not artefacts of sequencing or data processing, the team applied stringent filtering criteria. After removing false positives, they identified conserved genetic motifs shared among multiple obelisks. Many of the RNA loops were found embedded within bacterial genomes, suggesting they replicate inside microbial cells and may have adapted to specific bacterial hosts over time.
Unknown Function, Broad Implications for Microbiology and Evolution
Although obelisks resemble plant viroids, non-coding, circular RNAs that infect plants, the researchers note a key difference: obelisks have so far been identified only in bacteria associated with humans. Their biological role remains unknown.
At present, there is no evidence linking obelisks to disease. However, their presence in bacteria that support digestion, immune function, and other critical processes raises questions about whether they may have indirect effects on human health. Researchers also observed that different obelisk variants appear in specific body sites, hinting at localized adaptation within the microbiome.
Beyond immediate clinical relevance, the discovery has broader implications for microbial classification and evolutionary biology. Obelisks do not conform to known categories, challenging long-standing assumptions about what constitutes a replicating biological entity.
Some scientists suggest these RNA structures could inform theories about early life on Earth, when self-replicating RNA may have existed before cells and proteins. As one review in Royal Society Open Science notes, such entities sit at the edge of life as currently defined.
For laboratory leaders, the finding highlights the expanding reach of metagenomic sequencing and bioinformatics. As clinical and research labs generate and analyze ever-larger datasets, they are increasingly likely to encounter biological signals that defy traditional taxonomy.
Whether obelisks prove to be ancient evolutionary relics or modern molecular passengers, their discovery is a reminder that the microbiome—and the lab tools used to study it—still holds fundamental surprises.
Investigators identified more than 100 proteins linked to inherited cancer risk and dozens of existing drugs that could be repurposed for cancer prevention.
Researchers at Vanderbilt University Medical Center (VUMC) and the University of Calgary have developed a new analytical framework that integrates genomic, proteomic, and electronic health record (EHR) data to uncover proteins linked to cancer risk and to identify existing drugs that may be repurposed for cancer prevention. The approach, described in a study published Dec. 2 in the American Journal of Human Genetics, represents a step toward translating large-scale genetic discoveries into actionable prevention strategies across multiple cancer types.
For clinical laboratory directors, the new framework offers a glimpse of how combined genomic, proteomic, and EHR datasets could soon reshape biomarker discovery and test development.
Genome-wide association studies (GWAS) have already identified hundreds of genetic variants associated with increased cancer risk, particularly for breast, colorectal, and prostate cancers, as well as dozens of variants linked to lung, pancreatic, and ovarian cancers.
However, most of these studies have focused on genetic variation and gene expression rather than the downstream proteins that ultimately drive biological function and are more directly targetable by drugs.
Xingyi Guo, PhD, associate professor of medicine in the Division of Epidemiology at VUMC and a co–senior author of the study said, “Previous research, including our work, has identified hundreds of putative cancer susceptibility genes that could be regulated by these risk variants; however, most dysregulated gene expression has not been thoroughly investigated at the protein level.” (Photo credit: VUMC)
Integrating GWAS and Proteomics to Identify Druggable Cancer Risk Proteins
To bridge that gap, the investigators combined large GWAS datasets for six major cancers—breast, colorectal, lung, ovarian, pancreatic, and prostate—with population-scale proteomics data drawn from more than 75,000 participants. The data came from multiple large cohorts, including the Atherosclerosis Risk in Communities (ARIC) study, deCODE genetics, and the UK Biobank Pharma Proteomics Project. The goal was to identify proteins whose circulating levels are associated with inherited cancer risk.
“To deepen the understanding of causal mechanisms and enhance drug discovery efforts, it is imperative to explore data from transcriptomic to proteomic studies,” said Zhijun Yin, PhD, MS, associate professor of biomedical informatics at VUMC and co–senior author, along with Quan Long, PhD, associate professor of biochemistry and molecular biology at the University of Calgary.
Using this integrated approach, the research team identified 365 proteins associated with cancer risk across the six cancer types studied. Through additional analyses to prioritize the most robust findings, they narrowed this list to 101 risk proteins. Notably, 74 of these proteins had not been previously reported as being linked to cancer susceptibility, highlighting the potential of proteomics to reveal novel biology that may be missed by gene-level analyses alone.
The researchers then evaluated whether these risk proteins could be therapeutically targeted. By systematically annotating the proteins using multiple pharmaceutical and drug-development databases, they assessed whether any were already the targets of approved drugs or agents in clinical testing. This step was designed to identify opportunities for drug repurposing—using existing medications for new preventive indications.
“Traditional drug discovery faces challenges of escalating costs, lengthy timelines, and high failure rates. Drug repurposing is a promising strategy to identify new applications for existing drugs with well-documented characteristics,” Guo said.
Among the 101 prioritized proteins, the investigators identified 36 that were considered druggable and potentially targetable by 404 drugs that are already approved or undergoing clinical trials. Of these, 19 proteins were targeted by drugs currently approved or in development for cancer treatment, suggesting a possible extension of oncology therapeutics into the prevention setting.
EHR-Based Analyses Suggest Reduced Cancer Risk with Certain Approved Drugs
To explore real-world relevance, the team leveraged more than 3.5 million de-identified EHRs from VUMC. Using this data, they conducted simulated clinical trials to examine associations between drug exposure and cancer risk. Several approved medications showed signals consistent with reduced cancer risk. One example highlighted in the study was acetazolamide, a diuretic, which was associated with a reduced risk of colorectal cancer in the EHR-based analyses.
“Our findings offer additional insights into therapeutic drugs targeting risk proteins for cancer prevention and intervention,” Yin said. “It is essential to evaluate the effects of the reported candidate drugs through both in vitro and in vivo assays in future research.”
EHRs are rich in diagnostic data, so there is a clear connection between the researchers’ drug discovery efforts and the information that clinical laboratory test results can provide.
The agency says shifting certain companion diagnostic tests from Class III to Class II could reduce regulatory burden, shorten review timelines, and encourage more manufacturers to enter the market.
The US Food and Drug Administration (FDA) has released a proposal that could significantly alter the regulatory pathway for oncology companion diagnostics, aiming to reduce barriers to market entry while maintaining assurances of safety and effectiveness.
In a notice published Nov. 25 in the Federal Register, the FDA said it plans to reclassify certain companion diagnostic assays from Class III medical devices to Class II devices. The proposal applies to specific nucleic acid–based in vitro diagnostic tests that are indicated for use with a corresponding FDA-approved oncology therapeutic product.
Under the current framework, Class III devices require premarket approval (PMA), the
FDA’s most rigorous and resource-intensive review process. Class II devices, by contrast, are typically cleared through the 510(k) premarket notification pathway, which is generally faster and less costly for manufacturers.
FDA Cites Maturing Technologies and Robust Safety Data to Support Reclassification
According to the agency, Class II devices are those for which “general controls by themselves are insufficient,” but for which “there is sufficient information to establish special controls to provide assurance of safety and effectiveness.” These special controls can include performance standards, postmarket surveillance, patient registries, and the development of guidelines and recommendations.
The proposed reclassification would cover in vitro diagnostic devices intended to detect specific genetic variants or other nucleic acid biomarkers in human clinical specimens. These tests rely on nucleic acid amplification technologies and/or sequencing technologies and are specifically tied to approved cancer therapies.
“Based upon the extensive [premarket approval] data available to FDA … published peer-reviewed literature studying the longstanding and well-understood technologies, and data available to the agency demonstrating a lack of significant postmarket safety signals with oncology therapeutic nucleic acid-based test systems, FDA believes there is sufficient information to reclassify these devices from Class III (premarket approval) into Class II (special controls),” the agency wrote.
The FDA emphasized that the proposal reflects both the maturity of the underlying technologies and the agency’s experience overseeing these products once they are on the market. Many companion diagnostics have been used clinically for years, generating substantial performance and safety data.
Reduced Regulatory Burden Could Accelerate Market Entry and Patient Access
If finalized, the change could have meaningful implications for diagnostic developers and patients alike. The FDA said the reclassification would “decrease regulatory burden on industry” by allowing manufacturers to pursue the “less burdensome” and “generally more cost-effective” 510(k) pathway rather than PMA.
“A 510(k) typically results in a shorter premarket review timeline compared to a PMA, which ultimately may provide more timely access of these types of devices to patients,” the agency said. “FDA expects that the reclassification of these devices would enable more manufacturers to develop these types of devices such that patients would benefit from increased access to appropriately safe and effective tests.”
The proposal comes as demand continues to grow for precision oncology tools that match patients with targeted therapies based on genetic and molecular profiles.
Companion diagnostics are often essential for determining whether a patient is eligible for a specific cancer drug, making regulatory timelines a critical factor in how quickly new therapies can reach the clinic.
The FDA stressed that the proposal does not eliminate oversight, but rather shifts it to a framework the agency believes is more proportionate to the risk profile of these tests. Special controls would still apply, and manufacturers would remain responsible for demonstrating that their devices are safe, effective, and substantially equivalent to legally marketed products.
The agency is seeking public input before finalizing the order. Comments on the proposal will be accepted through Jan. 26, 2026, giving stakeholders across the diagnostics, pharmaceutical, and healthcare sectors an opportunity to weigh in on how the change could affect innovation, competition, and patient care.
If adopted, the reclassification could mark one of the most consequential regulatory shifts for oncology companion diagnostics in years, potentially accelerating development timelines while expanding access to precision testing for cancer patients.
