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Governing AI for Mental Health: Fragmented State Approaches and the Case for a Federal Framework
State-level regulation of AI used for mental health is emerging in the absence of a federal framework. States are taking different approaches to regulation, resulting in a fragmented regulatory landscape. This Viewpoint aims to identify the governance approaches that US states are using to regulate the use of AI in mental health and analyze the limitations of each. A 4-state case analysis was conducted using the statutory text of bills and laws in Illinois, Utah, New York, and Nevada. Two governance approaches were identified. The first regulates the use of AI in clinical contexts, and the second regulates the technology itself. Some states have combined elements of both approaches to address AI use more comprehensively. While these approaches aim to mitigate harm, they differ in where they believe risk lies in the use of AI for mental health support. The limitations of these divergent approaches include uneven protections for consumers and regulatory uncertainty for developers, vendors, deployers, and clinicians. Because AI in mental health operates across both clinical and consumer domains, neither approach alone can address the risks associated with its use for mental health support. A coordinated, risk-based federal regulatory floor is needed to ensure consistent protections across states.
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STAT+: From ‘lost cause’ to gold rush: Biotechs swarm to cure AATD
Biotechs are spending billions to cure a rare liver disorder most Americans have never heard of. The contentious race features dueling technologies, patent wars, a broken alliance, and a boiling competition between the U.S. and Chinese drug industries.
The disease, known as alpha-1 antitrypsin deficiency (AATD), is a slow-moving disaster for patients. Thanks to a single misspelled letter of DNA, their livers produce a mutant version of a protein that normally travels through the bloodstream and protects the lung from damage.
Parkinson’s Disease Medication Monitored with Fingertip Sweat Patch
Engineers and neuroscientists at the University of California (UC) San Diego have developed a soft, wearable fingertip patch that continuously tracks a Parkinson’s disease (PD) patient’s levodopa medication levels by measuring chemicals in their sweat, with no batteries required. Tests in healthy volunteers and in Parkinson’s disease patients showed that measurements generated using the device were comparable to those obtained by standard laboratory blood tests.
The wearable device offers a way to continuously track real-time concentrations of levodopa in the body and could enable doctors to precisely customize daily medication schedules for patients at home.
The research was led by Tamoghna Saha, PhD, a postdoctoral researcher in the lab of Joseph Wang, DSc, professor in the Aiiso Yufeng Li Family Department of Chemical and Nano Engineering at the UC San Diego Jacobs School of Engineering. Saha is co-first author of the team’s published paper in PNAS titled “A wearable patch for continuous levodopa monitoring in sweat: Towards exertion and power-free pharmacodynamic assessment in Parkinson’s disease.” In their paper the authors wrote in summary, “Overall, our easy-to-use, energy-efficient wearable supports real-time, stimulation-free monitoring, potentially enabling at-home dosage adjustments and paving the way for future autonomous closed-loop L-dopa therapeutic system development.”
Parkinson’s disease is the second most common and fastest-growing neurodegenerative disorder worldwide, the author wrote. “While no cure for PD exists, levodopa (L-dopa) is the most effective symptomatic treatment, which is typically administered via oral tablets or capsules, and in advanced cases, through inhaled powder or continuous intrajejunal or subcutaneous infusions.” Prescribing the right dose is challenging: reducing levodopa leaves patients unable to move, while too much triggers severe, uncontrollable jerking movements. Initially, the drug’s effects can last several hours.
But as the disease progresses, the therapeutic window narrows down to two hours. Currently, clinicians must rely on subjective patient diaries to adjust treatment. Unfortunately, these methods fail to catch dangerous dosing gaps. “Precision management of Parkinson’s disease (PD) requires frequent levodopa (L-dopa) dose adjustments, yet current monitoring relies on subjective symptom reporting and infrequent blood testing,” the team continued.
![Levodopa monitoring patch showing the assembly of the hydrogel and levodopa sensor with the paper fluidic channel on the fingertip. [Tamoghna Saha.]](https://www.genengnews.com/wp-content/uploads/2026/07/Low-Res_26-10453-2-232x300.jpg)
Saha and the engineering team developed the new finger patch technology in joint collaboration with the lab of Irene Litvan, MD, MPhil, professor in the department of neurosciences at UC San Diego School of Medicine. The project is part of a longstanding collaboration between the Wang and Litvan teams to develop wearable levodopa monitors that can improve personalized care for people living with PD.
Worn on the fingertip, which is packed with a high density of sweat glands, the patch is equipped with a specially engineered absorbent gel that acts like a sweat sponge. The gel contains a highly-concentrated mixture of salts and benign solvents—and that draws sweat out of the pores, since water naturally flows toward areas with higher salt concentrations. Collected sweat is drawn into a serpentine fluidic channel with a self-powered levodopa biosensor connected to a wireless transmitter.
When levodopa in the patient’s sweat comes into contact with enzymes embedded in the patch it triggers a chemical reaction, which in turn generates a small, measurable voltage. This chemical reaction is what powers the patch. The amount of voltage generated also serves as an indicator of the patient’s levodopa level, such that lower voltage signals low levels, while higher voltage signals high levels.
![Unassembled integrated levodopa monitoring patch. [David Baillot (University of California, San Diego, San Diego, CA).]](https://www.genengnews.com/wp-content/uploads/2026/07/Low-Res_2026-10453-3-300x200.jpeg)
Experimental results from three to five healthy participants and four individuals with PD indicated that levodopa concentrations in sweat measured by the patch are strongly correlated with blood concentrations measured by high-performance liquid chromatography. The patches captured pharmacodynamic responses and patient-specific levodopa clearance trends that could be used to calibrate dosage estimates for individuals.
The data revealed that individuals with Parkinson’s clear levodopa from their systems significantly faster than healthy individuals. This result explains why a patient’s Parkinson’s symptoms can deteriorate so suddenly, the researchers noted.
This technology could lay the groundwork for a closed-loop system, where a levodopa monitoring patch could communicate with a pump to automatically deliver the precise doses of the drug right when the body needs it, the authors suggested. “This approach establishes a foundation for real-time, at-home therapeutic optimization and advances the development of future closed-loop treatment systems for PD.”
The post Parkinson’s Disease Medication Monitored with Fingertip Sweat Patch appeared first on GEN – Genetic Engineering and Biotechnology News.
Lessons From Building a Large, Public HIV-Related Database in Support of the Ending the HIV Epidemic in the US Initiative
The HIV epidemic remains a national priority in the United States, and the Ending the HIV Epidemic initiative has renewed the call for expanded prevention and treatment strategies capable of reducing new HIV infections by 90% by 2030. Achieving this goal requires robust, integrated data for understanding HIV-related needs, barriers to care, and the effectiveness of interventions. However, despite the existence of numerous publicly available datasets, few integrate multiple domains such as HIV outcomes, social determinants of health, and community-level factors. The lack of unified data and difficulty linking datasets hampers efforts for meaningful cross-domain analyses to tailor HIV management and treatment strategies. The resulting fragmentation constitutes a methodological gap: implementation teams lack replicable guidance for constructing unified HIV and contextual databases from public sources. In this viewpoint, we describe our experience building a unified compilation of publicly available HIV and community data to identify factors influencing HIV outcomes and interventions. The completed database comprises 242 variables drawn from 8 public sources mapped across clinic, zip code, county, and state levels of geography. Rather than simply reporting what we built, we position four core decisions as transferable methodological advances: (1) treating source identification as a bounded phase before construction begins, (2) adopting automated data engineering tools from the outset rather than manual entry, (3) establishing a shared data dictionary before the first variable is entered, and (4) integrating quality control throughout the workflow rather than as a final phase. The build required approximately 350 total project hours and revealed an initial spot-check error rate of approximately 33%, which we attribute primarily to manual data entry. By sharing the approach used to develop this database and making the final resource publicly accessible through the Yale Center for Methods in Implementation and Prevention Science, we aim to reduce barriers to data access and encourage similar data integration efforts. The methodological framework described in this paper is intentionally designed to be replicable with modest resources, and we present it as a practical model for research teams operating without specialized infrastructure. Consolidating HIV, social determinants of health, and contextual variables into a unified data source is a critical step toward enabling deeper, more comprehensive analysis and supporting ongoing efforts to end the HIV epidemic in the US.
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Daily Multivitamin May Help Older Adults Maintain Cardiovascular Function
A daily multivitamin-mineral supplement modestly improved cardiovascular-related functional health in older adults over three years, according to a secondary analysis of the large COSMOS randomized clinical trial. The findings suggest that routine multivitamin use may help preserve day-to-day physical functioning as people age, particularly among those with certain preexisting cardiovascular conditions.
The research was presented July 27 at NUTRITION 2026, the annual meeting of the American Society for Nutrition.
The findings add to a growing body of evidence from the COSMOS trial suggesting that daily multivitamin supplementation may support healthy aging. Previous analyses reported modest improvements in cognitive function and slower biological aging, although multivitamins have not been shown to reduce major cardiovascular events.
The analysis included 16,027 participants from the COcoa Supplement and Multivitamin Outcomes Study (COSMOS), a randomized, double-blind, placebo-controlled trial that enrolled 21,442 U.S. adults without major cardiovascular disease at baseline. Men were at least 60 years old, and women were at least 65 years old when they entered the study.
Investigators evaluated participants’ responses to the Kansas City Cardiomyopathy Questionnaire (KCCQ), a validated patient-reported measure of cardiovascular health status. The questionnaire assesses physical function, symptom burden, and an overall clinical summary score reflecting the combined impact of both.
Participants assigned to receive a daily multivitamin experienced small but statistically significant improvements in symptom burden compared with those receiving placebo. While the supplements did not significantly improve physical ability scores overall, they produced a modest improvement in the overall clinical summary score.
“The results provide new evidence that a daily multivitamin modestly improved cardiovascular-related functional health, with more pronounced benefits in those with existing carotid stenosis,” the investigators concluded.
The largest benefits were seen in participants with carotid stenosis, a narrowing of the carotid arteries that increases the risk of stroke. Among the 122 participants with the condition, multivitamin supplementation produced clinically meaningful improvements in cardiovascular functional health scores, suggesting this subgroup may derive greater benefit than the broader study population.
The researchers noted that maintaining cardiovascular functional health has practical implications for older adults. Improvements in symptom burden may translate into greater ease performing everyday activities such as dressing, bathing, walking, climbing stairs, and completing household chores. Reduced fatigue, shortness of breath, and swelling could also help older adults remain active and independent.
The trial also evaluated cocoa extract supplementation, but it did not improve cardiovascular functional health in the study population overall. However, a subgroup analysis suggested cocoa extract helped preserve symptom burden scores among participants with heart failure, indicating that additional studies may be warranted in patients with established cardiovascular disease.
Unlike many nutrition studies that focus on disease prevention, this analysis examined how supplementation affected participants’ daily functioning and quality of life.
The investigators cautioned that the observed improvements with multivitamin use were modest and should not be viewed as a replacement for established healthy lifestyle measures such as maintaining a nutritious diet and engaging in regular physical activity.
Because this was a secondary analysis, the findings should be considered hypothesis-generating. The authors said future targeted clinical trials are needed to determine whether specific groups of older adults—particularly those with carotid stenosis or other cardiovascular conditions—may experience greater functional benefits from daily multivitamin supplementation.
The post Daily Multivitamin May Help Older Adults Maintain Cardiovascular Function appeared first on Inside Precision Medicine.
MapLight’s Schizophrenia Candidate Has Mixed Results at Phase II
MapLight Therapeutics announced this week that its candidate drug for treatment of schizophrenia had achieved its primary endpoint in a Phase II trial, but only at the twice daily dose tested in the trial.
As reported by the California-based company, while participants of the trial who were given the candidate drug, ML-007C-MA, once a day did show some signs of improvement it was not statistically significant.
ML-007C-MA is a combined muscarinic agonist (betovumeline) and peripherally acting anticholinergic (fesoterodine). It acts by turning on two receptors in the brain, M1 and M4.
M1 is the main receptor the drug is trying to stimulate in the brain cortex and hippocampus, where it is linked to cognition, attention, and possibly some aspects of psychosis. Turning on M4 also helps by acting like a brake on the overactive signaling that contributes to hallucinations and delusions. Betovumeline activates both M1 and M4 centrally, while fesoterodine is there mainly to block unwanted side effects outside the brain, like gastrointestinal issues.
In this study, MapLight randomized 307 adults with an acute exacerbation of schizophrenia to treatment with either a twice daily or once daily treatment with ML-007C-MA or placebo for five weeks.
At five weeks, patients given the twice daily dose had a statistically significant and clinically meaningful reduction in Positive and Negative Syndrome Scale (PANSS) total score of 4.5 points compared to placebo. Cognitive scores were also better in the twice daily group versus placebo.
While this result is positive overall, the non-statistically significant result for the once daily dose proved unpopular with investors and company shares on the Nasdaq fell 40% after the announcement.
In September 2024, Cobenfy, the first muscarinic M1/M4 agonist drug for treatment of schizophrenia was approved by the FDA. Now owned by BMS, Cobenfy will be the main competitor for ML-007C-MA if approved.
Cobenfy was groundbreaking because it was the first new mechanism of action for schizophrenia in decades, moving beyond dopamine blockade to a muscarinic approach and targeting both hallucinations and delusions as well as the more cognitive aspects of the disease, which are not well treated with other drugs.
Despite the approval of Cobenfy, a number of other competitors developing treatments for schizophrenia have failed in recent years. Whether MapLight can succeed at Phase III with ML-007C-MA—which is also being tested as a treatment for psychosis linked to Alzheimer’s disease—and compete with Cobenfy, remains to be seen.
The post MapLight’s Schizophrenia Candidate Has Mixed Results at Phase II appeared first on Inside Precision Medicine.
STAT+: Pharmalittle: We’re reading about a U.S. peptide panel’s votes, Amgen scuffling with the FDA, and more
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? To cope, we are relying, as always, on a cuppa stimulation. Our choice today is Earl Grey, an old standby. Feel free to join us. Remember, no prescription is required. Meanwhile, here are some items of interest to help you on your journey today, which we hope will be productive and meaningful. Best of luck and, of course, do keep in touch. …
A U.S. Food and Drug Administration advisory panel on Friday recommended that compounding pharmacies be allowed to manufacture the peptides epitalon and semax, but narrowly voted to recommend against manufacturing emideltide, STAT writes. The votes, which followed the panel’s decision on Thursday to recommend allowing pharmacies to make four other peptides, bring U.S. Health and Human Services secretary Robert F. Kennedy Jr. one step closer to his mission of making these unapproved compounds more available for Americans. Peptides have become increasingly popular in the U.S., driven by endorsements from social media influencers.
Amgen submitted new evidence to the FDA as it seeks a hearing to challenge the proposed withdrawal of its rare disease drug Tavneos from the U.S. market, Reuters says. In April, the agency proposed withdrawing the drug, which treats a rare autoimmune disease that damages blood vessels, citing a lack of proven effectiveness and false statements in its original marketing application. Amgen strongly disagrees with the FDA and noted its submission includes more than 70 real-world studies involving over 2,200 patients supporting the drug’s effectiveness and safety.
Historical trauma as a contributor to postpartum depression among Indigenous mothers
IntroductionPostpartum depression (PPD) is a significant public health concern. Moreover, research suggests that American Indian/Alaskan Native (AI/AN) mothers experience postpartum depression at higher rates than the general population (Heck, 2021; Ko et al., 2017). As a result, understanding the potential causes of higher PPD among AI/AN mothers is helpful to the development of better interventions to reduce PPD among AI/AN mothers. A potential cause of higher PPD symptoms among AI/AN mothers is historical trauma (HT). HT refers to the cumulative psychological wounding experienced across generations due to systemic oppression, colonization, slavery, and other traumatic events experienced by a group of individuals.MethodsTo test the theorized relationships between HT and PPD symptoms, we conducted an online survey of adult women who both identified as Indigenous and who give birth in the past five years (N = 56). The survey consisted of the psychometrically suitable measures of the Historical Loss Scale (HLS: Whitbeck at al, 2004) and the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987). .ResultsThe results indicated that a model of HLS scores as a predictor of PPD symptoms over and above the controls of income, mental health diagnosis, and the total number of children of the birth mother fit the data well (χ2 = 13.60; df = 10; p = .192; RMSEA = .081 [90% CI: .000, .178]; CFI = .949). Moreover, of all the predictors, the dimension of the HLS measuring mothers’ endorsement of the presence of oppressive governmental and institutional policies toward AI/AN was the strongest predictor of greater PPD (β = .28, p < .05). A Bollen Stine bootstrap test was also used to confirm the stability of the model. The Bollen Stine operates by comparing the theorized model to a model that perfectly fits the data. The results of the Bollen Stine test indicated that the theorized model was not significantly different than a model of perfect fit. .DiscussionSuch results suggest that a potential explanation of higher PPD symptoms among AI/AN mothers is the effects of HT. Future interventions to reduce PPD symptoms among AI/AN mothers may benefit from an additional focus on treating HT.
STAT+: As some medical schools embrace RFK Jr.’s nutrition push, they deftly sidestep MAHA priorities
When students return to McGovern Medical School at UT Health Houston this year, they will get to participate in hands-on nutrition experiences, including cooking demonstrations in the teaching kitchen, tours of the campus “holistic garden,” and the opportunity to take a culinary-medicine-focused elective.
These immersive programs are a response to health secretary Robert F. Kennedy’s call for medical schools to teach more nutrition — part of the Trump administration’s push to address the rising rates of chronic diseases in the United States. Kennedy has blamed the problem, in part, on doctors not routinely discussing diet and nutrition with their patients.
Lessons in culinary medicine are part of the 71 nutrition-related topics that the Department of Health and Human Services wants future physicians to be well versed in. Other topics in the department’s Advancing Nutrition Education push include enhancing nutrient bioavailability through soaking, sprouting, and fermenting foods as well as prioritizing food-based medicine as the primary approach to manage chronic diseases driven by metabolic dysfunction.
The vast majority of 163 M.D.-granting and 48 D.O.-granting schools aren’t yet part of Kennedy’s new initiative, including several leading institutions. So far, some 73 medical schools — 54 M.D. programs, 19 D.O. programs — across 36 states have signed on.
Even as some medical schools heed Kennedy’s call for more nutrition education, several told STAT that they plan to steer clear of topics that aren’t backed by evidence, including some that align with the priorities of the Make America Healthy Again political movement championed by the health secretary. Nutrition experts cautioned that some of those topics could lead to “wellness creep” in medical education.