A new JAMA Viewpoint by UC San Francisco researchers says these hurdles show why making hearing aids available without a prescription, while an important step, has not been enough to ensure people can find and use the devices they need.

“Over-the-counter hearing aids have opened the door for many people who might otherwise never have gotten hearing aids,” said Kathryn A. Phillips, PhD, a UCSF professor of health economics and health services research. “But people still have to figure out what to buy, whether they can afford it, and where to get help.”

The U.S. Food and Drug Administration created the OTC category in 2022 for adults with perceived mild-to-moderate hearing loss, allowing them to buy hearing aids without a prescription or professional fitting.

The change has substantially lowered costs. OTC hearing aids are about $500 on average, compared with $3,400 for prescription devices, according to data cited by the authors. Among people buying hearing aids for the first time, 70% chose an OTC device.

But Phillips and co-author Christine K. Cassel, MD, found major obstacles remain.

Products vary widely in price, features, and ease of use, and consumers may have trouble determining whether a device is a regulated hearing aid. One study cited in the article found that only about one-quarter of Amazon listings marketed as OTC hearing aids could be verified as FDA cleared or registered.

Expert help can be hard to find, too. One in 5 OTC hearing-aid users reported receiving no professional assistance, while just 51% received the full range of services that can include evaluation, device selection, and fitting. Audiology practices have long bundled these services with prescription hearing aids, an approach that does not easily accommodate people who buy devices on their own.

Insurance adds another hurdle. Traditional Medicare does not cover hearing aids, and coverage varies among Medicare Advantage, Medicaid, and commercial insurance plans. Even plans that offer coverage may have requirements designed around prescription devices such as having to use certain vendors.

A policy breakthrough and what came next

Cassel, a UCSF professor of medicine and expert in geriatrics and health policy, helped lay the groundwork for making hearing aids available over the counter. She co-chaired a hearing-loss working group for the President’s Council of Advisors on Science and Technology, whose work helped inform the federal policy that led to the FDA rule.

“Making hearing aids available over the counter removed an important barrier, and that was a major advance,” Cassel said. “Now we need trustworthy information, professional help when people want it, and coverage policies that reflect the way hearing aids are sold today.”

For Phillips, the remaining gaps became clear when she developed hearing loss and entered the OTC market herself.

After struggling to find professional guidance, Phillips spent more than $2,000 on OTC hearing aids and months working with customer service to adjust them. Then the parent company of the brand she had purchased stopped servicing the devices in the U.S.

Her experience helped prompt her to examine the broader evidence on how well the new system was working.

“I study how new technologies move into health care and what policies help people benefit from them, and suddenly I was experiencing those questions myself,” Phillips said. “I realized that if I was having this much trouble navigating the system, other people were probably struggling, too.”

Making access work in practice

Phillips and Cassel suggest several ways to make the system easier to navigate. Consumers could receive copies of their audiograms and hearing-aid programming information, much as they can take an eyeglass prescription to the provider of their choice. Audiologists could offer stand-alone consultations to people who buy OTC devices, and insurers that cover hearing aids could explicitly include OTC products in their plans.

The authors also call for better data on who uses the devices, what people pay, how well the devices work across diverse populations, and how they affect audiology services and health care delivery. Future legislation that expands hearing aid coverage should account for OTC devices as well.

The lessons may extend beyond hearing care, Phillips said, as regulators consider moving other medical products from prescription to over-the-counter status.

“Changing a regulation can create access, but it doesn’t automatically create a system that people can navigate,” she said. “If we want these changes to improve people’s health, we have to pay attention to what happens after the product reaches the shelf.”

Authors: Kathryn A. Phillips, PhD, and Christine K. Cassel, MD, of UCSF.

Funding: The work was supported by the National Human Genome Research Institute (R01-HG011792).

Disclosures: Phillips reported receiving personal fees from the Institute for Clinical and Economic Review evidence review committee and previously consulting for Illumina, Roche, and Danaher outside the submitted work. No other disclosures were reported.

About UCSF: The University of California, San Francisco (UCSF) is exclusively focused on the health sciences and is dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. UCSF Health, which serves as UCSF’s primary academic medical system, includes highly-ranked specialty hospitals and other clinical programs, and has affiliations throughout the Bay Area. UCSF School of Medicine also has a regional campus in Fresno. Learn more at ucsf.edu.

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This is a public health concern, argue the researchers, and they call for immediate improvements to better protect patient safety and meet FDA standards.

US regulations require medical device makers to report malfunctions and adverse events to the FDA’s Manufacturer And User Facility Device Experience (MAUDE) database within 30 days to inform safety measures, such as product recalls, as part of the postmarket surveillance process.

MAUDE requires complete and accurate reporting to be effective, but earlier programs, notably the Alternative Summary Reporting (ASR) programme, let manufacturers submit millions of adverse events as bulk summaries rather than as individual reports in order to “reduce the burden on industry.”

Although the FDA ended the ASR programme in 2019 due to concerns that it masked safety signals, similar summary reporting exemptions remain in use, but their accuracy, completeness, and compliance with FDA rules are unclear.

To address this, researchers analysed all adverse event summary reports submitted to MAUDE over a six-year period (July 2019 to June 2025) for evidence of incomplete device problem identification, undercounting of adverse events, failure to correctly identify reports as summary reports, and delays in serious adverse event reporting.

A total of 6,308 summary reports were submitted to the FDA during the study period containing 159,503 adverse events, mostly involving high risk devices.

Of these, 57% identified no device or use problem, 38% reported insufficient information, 11% were incorrectly identified as non-summary reports, 7% incorrectly listed one event in the ‘number of events’ field, and 55% exceeded the FDA’s 30-day reporting deadline.

The researchers acknowledge the inherent limitations of passive adverse event reporting and the lack of publicly available information on the specific requirements governing summary reporting exemptions.

However, they say identifying and correcting the existing flaws highlighted in this study are vital, particularly given that the number of summary reports submitted to the FDA – and the number of adverse events contained within them – more than doubled between 2020 and 2024.

“Immediate improvements are needed to better protect patient safety and adhere to transparency principles outlined by the FDA,” they write. “Making serious adverse event reports fully visible and accessible is critical to patient safety.”

In a linked editorial, Koji Todaka at Kyushu University Hospital in Japan, says these findings raise concerns about transparency in a system intended to support public scrutiny of medical device safety.

To preserve public trust in postmarket surveillance, he says regulators should require accurate and timely summary reporting, standardised device identification, and clear links to registries. He also suggests that researchers integrate spontaneous reports, registries, and linked healthcare data rather than treating any single source as definitive.

He also notes that the FDA is currently transitioning to a new Adverse Event Monitoring System (AEMS), designed to consolidate existing reporting systems and publish adverse event reports in real time.

“Transparency builds trust, evidence improves safety, and both are essential to effective postmarket surveillance and safer medical devices,” he concludes.

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Pharmaceutical cartridges for 3D printing can be stored for six months and still produce printed oral doses that meet European Pharmacopoeia requirements, according to Léna Lemierre (MB Therapeutics and ICGM, Montpellier) and colleagues. The ability to store cartridges and print on demand, by means of semi-solid extrusion 3D printing, could give pharmacies considerable flexibility.

There is a growing need for personalised doses. Manual and semi-automated compounding suffer from operator-dependent variability and are difficult to scale up. Automated compounding by 3D printing offers greater reproducibility and flexibility. However, it requires semi-solid formulations that remain suitable for printing after storage.

In this study, five batches of a semi-solid formulation containing an active pharmaceutical ingredient – melatonin – were filled into cartridges. Printed oral dosage forms (POFs) were produced by semi-solid extrusion on a MED-U PROD® printer (MB Therapeutics). The team compared POFs made from freshly prepared cartridges with those made from cartridges stored for six months under long-term conditions before printing. Stability studies followed ICH Q1A(R2), under long-term (25°C) and accelerated (40°C/75% relative humidity) conditions. Drug content and content uniformity were assessed according to the European Pharmacopoeia (2.9.40), with an acceptance value of 15 or below considered compliant. Microbiological quality was tested according to the European Pharmacopoeia (5.1.4).

POFs made from fresh cartridges remained compliant throughout the study, which covered up to 12 months under long-term conditions and 6 months under accelerated conditions. Mean drug content was 97.7–99.8% of the label claim, and acceptance values ranged from 10.0 to 14.1. POFs made from cartridges stored for six months performed at least as well. Mean drug content was 97.6–101.8%, and acceptance values were 6.6–8.9, well below the limit. There was no evidence of degradation or increased variability. Microbiological quality was compliant in all samples: total aerobic microbial and yeast/mould counts were below the limits, and Escherichia coli was not detected.

The authors concluded that cartridges stored for six months produced POFs of comparable quality to those from freshly prepared cartridges. This supports a strategy of storing cartridges upstream and printing on demand to respond quickly to patients’ needs. The study of POFs from stored cartridges is ongoing.

Lemierre L, Guillotin S, Perez M et al. Impact of cartridge storage on the stability of 3D-printed oral dosage forms manufactured by semi-solid extrusion. Poster. GERPAC Congress 2026

This e-poster was awarded first prize in the Stability Studies/Formulation and Quality Control category.

Click to enlarge

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In-process quality control using augmented reality smart glasses (FlexOprep®) reduced risk levels and improved traceability in chemotherapy compounding, according to Loélya Istace (Pharmacy Department, Vivalia Hospital, Arlon, Belgium). The trade-off was a longer preparation time.

Anticancer drugs have a narrow therapeutic index and high toxicity, so medication errors during compounding are a major threat to patient safety. Current quality control methods have important limitations. The FlexOprep glasses are smart glasses equipped with artificial intelligence. After a chemotherapy prescription has been validated by a pharmacist, the information is loaded into the FlexOprep system. The glasses are entirely hands-free and voice-controlled, and they display context-specific instructions in the operator’s field of view at each step of the preparation. They check the pharmaceutical products, expiry dates, the type of bag, pump and diluent, the volumes drawn and the secondary lines, and they alert the operator to errors. Every step is recorded in a report, which provides full traceability. Ms Istace compared the system to an aircraft’s black box.

FlexOprep glasses

This study used a prospective before-and-after design. A multidisciplinary team of 12 people from three hospitals carried out a failure mode and effects analysis (FMEA). They compared risk priority numbers before and after the glasses were introduced. Preparation times were measured for eight drugs, chosen to cover all types of preparation (syringes, bags, pumps and reconstitution). Usability was assessed with the French System Usability Scale (F-SUS), and user experience with the User Experience Questionnaire (UEQ).

The FMEA identified 24 potential failure modes, and half of them became less critical after implementation. The overall risk priority score fell by 40%, and by 67% for the 12 failure modes directly affected by the glasses. All high-risk failures were downgraded, and most moderate risks were reduced to low risk. The largest improvements were in error detection, for example selecting the wrong medicine or volume, and in failing to detect a preparation error before release. However, some new technology-related risks emerged.

Preparation time increased significantly for all eight drugs (p=0.008). The median increase was 86 seconds per preparation (+34%), ranging from 19.2% for paclitaxel to 54.7% for fluorouracil bags. The increase did not depend on the number of preparation steps; preparations that were initially quicker showed proportionally larger increases. Ms Istace noted that the extra time was probably overestimated, because it was measured immediately after the glasses were introduced, without an adaptation period. Usability was rated excellent, with a mean F-SUS score of 86.7/100. UEQ results were positive in every dimension, particularly novelty and stimulation.

The authors concluded that augmented reality-assisted in-process quality control is a significant advance in the safety and traceability of chemotherapy preparations. In particular, it eliminates the need for a second checker during the compounding process and it was well accepted by staff. Rigorous validation and long-term follow-up will be needed. Next steps include documenting new failure modes, carrying out an ergonomic analysis, improving the reading of syringes and secondary lines, and automating report validation. Ms Istace concluded with an aviation analogy: better to take off late than never arrive.

During the discussion Ms Istace confirmed that technicians are able to wear the glasses all day without complaining of visual problems. The costs are similar to those of a fixed video camera but FlexOprep has the advantage that the pharmacy technicians can move from one isolator/cabinet to another because, in this case, the camera is mobile i.e. attached to the technician.

Istace L, Leynen O, Denoël M, Roland I. Impact of augmented reality-assisted in-process quality control (FlexOprep®) on the safety and traceability of chemotherapy preparations. Short communication. GERPAC Congress 2026

Image: Loélya Istace

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“By turning a familiar object like a lollipop into both a saliva collection device and a sensor, Lollylab can collect the sample and perform the measurement directly at the point of care.” – Sina Khazaee Nejad

Acetaminophen is an ingredient in many over-the-counter products, including pain relievers, cold and flu medications, and more. But taking more than the maximum recommended dose can cause serious side effects, such as liver damage. This is especially concerning for children who can be at risk of an unintentional overdose at low levels of the medication. Because acetaminophen concentrations in saliva closely reflect those in blood, Sina Khazaee Nejad, Maral Mousavi, and colleagues thought saliva could be a simple, noninvasive way to monitor the medication’s levels.

Mousavi says they were inspired by the saliva sampling system CandyCollect — a lollipop-like device meant to replace throat swabs — but those specimens need to be analyzed elsewhere. In this work, the researchers wanted to create a miniature laboratory-on-a-lollipop, or Lollylab. “By turning a familiar object like a lollipop into both a saliva collection device and a sensor, Lollylab can collect the sample and perform the measurement directly at the point of care,” says Nejad, the first author of the paper.

Lollylab is built from two plastic pieces (each with a round end and a thinner stem) snapped together, with holes at the top for saliva to enter through. The team coated the top of the device with a red, peach-flavored edible candy shell, which did not interfere with measurements. Saliva flows through the glass fiber paper-lined lollipop stem toward a graphene sensor at the bottom, which measures acetaminophen levels as changes in electrical current. The prototype device detected acetaminophen in both artificial and human saliva.

As proof of concept, six adults used Lollylab before and an hour after taking a standard adult dose of acetaminophen (650 milligrams). The device reliably measured the drug in the participants’ saliva in less than two minutes, and they said it was easy to use and more comfortable than typical saliva swabs.

“The main takeaway is that diagnostic testing can be made much easier and more comfortable, especially for children,” says Nejad. Next, the researchers plan to validate Lollylab’s acetaminophen measurements with more participants, including children, and develop it to detect other substances in saliva such as naturally occurring stress markers. “Our longer-term goal is to create a multi-assay platform capable of measuring several biomarkers, which could then be evaluated alongside acetaminophen in larger clinical studies.”

The authors acknowledge funding from the 3M Nontenured Faculty Award, Women in Science and Engineering at the University of Southern California, and the President’s Sustainability Research Award. The authors also thank Dr. Ashleigh Theberge for insightful conversations about the CandyCollect manufacturing.

Some of the authors have filed a provisional patent based on this device.

Image: The red, peach-flavored candy coating on Lollylab stimulates saliva production, and a sensor at the bottom analyzes it for acetaminophen.

View more Credit: Adapted from ACS Sensors 2026, DOI: 10.1021/acssensors.6c00691

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Automated compounding of 5-fluorouracil (5-FU) elastomeric infusion pumps cut preparation time and reduced the physical strain on pharmacy technicians, according to an ergonomic study presented by Romy Linossier-Rocher (Centralised Cytotoxic Preparation Unit of CH Victor Dupouy, Argenteuil).

Filling 5-FU infusion devices by hand involves many repetitive movements and increases the risk of musculoskeletal disorders. The pharmacy acquired a dual-channel compounding system, which uses a peristaltic pump for the diluent, a syringe pump for the 5-FU and an integrated balance. The researchers compared this automated system with the previous manual, gravimetry-assisted method of filling elastomeric pumps.

Pharmacy technicians completed a self-assessment questionnaire before the system was introduced and again one year later. The questionnaire recorded the location of any pain and its intensity, on a scale from no pain to unbearable pain. The two methods were also systematically observed using activity logs (Actograph® software). These assessed posture, joint ranges of motion, movements, grasping areas, interactions with the computer system and timing.

Automation reduced the preparation time from 8 min 30 s to 5 min 30 s. The number of movements fell from 13 to 8 per minute, and manual operations dropped from 90% to 48% of the preparation time. Interactions with the computer system halved, from 26% to 13% of the time. The working area became larger: the share of activity within the close reach zone fell from 76% to 57%. The proportion of time spent on checks increased from 62% to 73%, mainly to confirm correct filling of the 5-FU syringe.

Six questionnaires were analysed. The location of pain was unchanged, remaining mainly in the upper limbs, but its overall intensity fell. Reports of severe pain dropped from 5 to 0, moderate pain from 10 to 9 and mild pain from 3 to 2.

The authors concluded that automation reduced both preparation time and the physical strain on the upper limbs. It also transformed the technicians’ work, with less manual handling and a greater focus on visual inspection.

Rainotte-Santraine A, NeglokpeE, Fercocq C, Linossier-Rocher R et al. Automated compounding of 5-fluorouracil elastomeric infusion pump: impact on the prevention and reduction of musculoskeletal disorders (MSDs) through an ergonomic study. Poster. GERPAC Congress 2026

Click to enlarge

Image: Romy Linossier-Rocher

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A mechanical spring-driven pump for subcutaneous daratumumab improved ergonomics for nurses and reduced injection pain for patients, according to Wendy Johnson (Department of Pharmacy, AP-HP University Hospitals Paris-Seine-Saint-Denis, Avicenne site, Bobigny).

The Versapump system

Daratumumab is an anti-CD38 monoclonal antibody, mainly used to treat multiple myeloma. It is given as a subcutaneous injection over 3 to 5 minutes. Pushing the injection by hand against high resistance can cause musculoskeletal disorders in nurses, particularly thumb pain and postural discomfort. Organisational constraints meant that an electric syringe pump was not a feasible option in the haematology day hospital. The team therefore evaluated an alternative: the Versapump® (EMED Technologies). This is a calibrated mechanical spring pump with a passive flow regulator, connected to a 70 cm extension set with a 26G 9 mm needle.

A prospective study was carried out over one month. Nurses and patients completed questionnaires, and only patients who had previously received at least one manual injection were included. The evaluation covered ergonomics for nurses, administration time and patient comfort. The economic impact of the device was also assessed.

In total, 33 administrations by five of the six nurses dedicated to this activity were analysed. All the nurses were satisfied with the ergonomics of the device, and none reported thumb pain or postural discomfort during use. The majority of patients also reported less pain during injection. The mean administration time was 4.84 ± 0.50 minutes (range 4.3–6.4 minutes). The residual volume was 0.28 mL, or 1.87% of the 15 mL total, which was considered negligible. The device does add cost. For 2,000 administrations a year, the additional cost would be about €4,000 with a subcutaneous microperfuser set, or €10,000 with a hypodermic needle.

The authors noted some limitations. Flow rate control is less precise than with an electric syringe pump, and there is no passive needle safety system during needle withdrawal. However, the mechanical pump has practical advantages: it is quicker to set up than an electric syringe pump, administration time is short and it needs no power supply. They concluded that the ergonomic benefits for nurses and the organisational gains may offset the additional cost.

Johnson W, Laruelle C, Abomo Ngoo A et al. Evaluation of a new subcutaneous daratumumab administration device. Short communication. GERPAC Congress 2026

Image: Wendy Johnson

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An automated system for repackaging oral liquid medicines into unit-dose cups (ADP-20L, NOODDIS) showed no cross-contamination between products, even under worst-case filling conditions, according to Yara Habib (University of Lille and CHU Lille).

The ADP-20L repackages oral liquid medicines from up to 20 multidose bottles into unit-dose cups. Each medicine has its own dosing unit, consisting of the bottle, a pump, tubing and needle. A rotating carousel holds the bottles and a moving platform holds the cups. The researchers set out to assess the risk of cross contamination when different medicines were repackaged at the same time. The most likely potential source of contamination was thought to be splashes from one cup into an adjacent cup during filling.

Three test liquids were chosen to represent different types of oral liquid medicines. Water for injections (WFI) represented aqueous formulations, 70% glucose (G70) represented viscous formulations, and WFI/polysorbate 80 (80%/20%) represented foaming formulations. For each test liquid, the machine alternately filled a cup containing the test liquid with 2% fluorescein and a cup containing the test liquid alone. The two bottles were placed opposite each other on the carousel, so it rotated between every fill. Ten cups of each type were prepared per test liquid. Filling conditions were deliberately set to maximise the chance of splashing: the largest needle (14 G), the maximum cup volume (25 mL) and non-optimised filling parameters. Two operators inspected for splashes with the naked eye and under UV light. The 30 cups containing test liquids only were analysed for fluorescein by HPLC with fluorescence detection (limit of detection 0.015 ng/mL).

Filling with WFI and WFI/polysorbate 80 produced significant splashing, with 10–15 droplets around each cup. The droplets reached the platform around the filling position and the area beneath it. G70 produced at most one droplet per cup, because its higher viscosity limited droplet formation. Rotation of the carousel did not cause any drips. Despite the extensive splashing with the aqueous test liquids, no fluorescein was detected in any of the test liquid-only cups.

The authors concluded that despite the splashes observed under test conditions, the design of the ADP-20L, with sufficient spacing between cup positions, prevents cross-contamination between cups. The manufacturer has now introduced further design modifications to minimise the risk of cross contamination. In addition, work is under way to develop and validate an effective surface cleaning protocol.

The study was carried out as part of an industrial PhD fellowship (Cifre) with NOODDIS and the University of Lille.

Habib Y, Bouchfaa M, Négrier L et al. Assessment of the contamination risk in an automated system for the repackaging of oral liquid medications (ADP-20L). Short communication. GERPAC Congress 2026

Image: Yara Habib

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AEDs can often be located some distances apart, making timely access to them uneven, particularly in rural areas or in heavily congested urban environments. However, the research presented today showed that delivering AEDs by drone, combined with providing more fixed AEDs, significantly reduced the time between an out-of-hospital cardiac arrest (OHCA) being reported and the start of defibrillation.

“Out-of-hospital cardiac arrest is a major public health issue. Survival depends strongly on early cardiopulmonary resuscitation and timely defibrillation,” Dr Hillary Minka, an emergency physician at the Lariboisière Hospital in Paris, told the congress. “Every minute of delay before defibrillation reduces the chances of survival.

“We wanted to investigate whether drones could provide faster AED access than road-based retrieval of existing fixed AEDs and thereby improve access to defibrillation across the Ile-de-France region.”

Dr Minka and her colleagues used data on OHCAs in seven departments (administrative areas) in the Île-de-France, excluding central Paris, to conduct a computer simulation study that looked at three strategies:

• Strengthening the current network of fixed AEDs
• Using drones to deliver AEDs
• Combining fixed AEDs with drones.

They divided the region into units called Ilots Regroupés pour l’Information Statistique (IRIS), which are the smallest census areas used by the French National Institute of Statistics. They estimated the amount of time needed for an AED to arrive at the centre of each unit via each of the three strategies. They also evaluated several potential locations for drone deployment, including existing AED sites, mobile intensive care units (MICUs) and fire stations.

They found that access to AEDs was very mixed, with a scarcity in the countryside and in the areas on the outskirts of Paris. To improve access to fixed AEDs, a further 1,712 AEDs would need to be added to 1,893 existing AEDs, making a total of 3,605.

Using drones significantly reduced the time spent waiting for access to an AED. The researchers found this depended both on the number of drones deployed and their geographical positioning.

In the hybrid strategy combining fixed AEDs and drones, AED access times were reduced by an average of 3.76 minutes across all IRIS units. AEDs were delivered to more than 95% of OHCA cases within five minutes, compared to only 30-40% of cases when relying on transport from existing fixed AED locations via the road network. The researchers estimated that using 200 drone bases and 871 fixed AED sites could extend AED coverage to nearly all OHCAs (28,349 cases), achieving an overall coverage rate of 99.4%.

Dr Minka said: “Our study showed that drone delivery of AEDs could reduce the times to defibrillation across all the IRIS units by several minutes, with particularly large benefits in peripheral and highly congested areas. In some cases, the time saved exceeded ten minutes.

“Our findings also suggest that this hybrid strategy could provide very broad territorial coverage while limiting the need to install hundreds of additional AEDs. This would increase the range to 3,900 metres, compared to 500 metres for fixed AEDs only.”

The researchers envisage that the drones could be operated by specially trained people or automated systems under the supervision of emergency services. When the drone arrives at the scene of an OHCA, a bystander who is already present would collect the AED and start to use it on the patient, guided by the emergency services.

“Drones will never replace bystanders, resuscitation efforts or emergency medical teams,” said Dr Minka. “However, they could represent an additional link in the chain of survival and help make defibrillation available more quickly. This study also shows that improving access to AEDs depends not only on the number of devices available, but also on how they are geographically distributed and organised. In some areas, drones could therefore represent a complementary strategy to large-scale deployment of additional fixed AEDs.”

She said the study’s findings would need to be confirmed in prospective studies and real-world experiments.

“Our findings highlight the potential value of investing in innovative solutions aimed at reducing inequalities in access to emergency care and optimising the geographical distribution of emergency resources,” she concluded.

A strength of the study is that it analysed seven departments of the Île-de-France region using a detailed geospatial approach based on real-world cardiac arrest data. A limitation is that it is a simulation study, no drones were deployed and so their performance is based on theoretical models. The drone travel time was estimated using straight line distances (“as the crow flies”) and, therefore, did not account for regulatory, meteorological or operational constraints that could influence real-world deployment.

Dr Felix Lorang is a member of the EUSEM abstract selection committee. He is head of the emergency department at Klinikum Lippe, North Rhine-Westfalia, Germany, and was not involved with the research. He said: “Drones are being used for an increasingly wide range of purposes and this study shows how they could make an important contribution to the emergency services, enabling AEDs to reach people suffering heart attacks more quickly. However, it is vitally important that, in every country, as many members of the public as possible know how to provide cardiopulmonary resuscitation and how to use defibrillators. Without this training, someone suffering an out-of-hospital cardiac arrest would still have to wait for the arrival of the emergency services, even if an AED is positioned nearby or arrives quickly by drone.”

[1] Abstract no: OA066, “Optimizing automated external defibrillator access using drones: a geospatial analysis in the Paris region” by Hillary Minka, Best abstracts session, Saturday 26 September, 11:00-12:30 hrs CEST, room 142.

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A new study in Management Science finds that a human-plus-algorithm approach could help the FDA focus its limited review resources on medical devices whose safety is harder to assess, while potentially reducing future recalls. The study found that FDA could catch more unsafe devices and spend less time on the ones that don’t need scrutiny, with a 40.5% reduction in review workload, 32.9% improvement in the recall rate–FDA’s current recall rate is 10.3%–and up to an estimated $1.7 billion in annual healthcare savings from fewer device replacements.

Researchers from Indiana University, Harvard Kennedy School, and Emerging Health Consulting built a tool that flags which submissions are safe bets, which are risky enough to reject after a short scrutiny, and which need more careful human expert consideration. The machine-learning system estimating recall risk, and coupled with a data-driven policy, recommends which medical devices could be cleared or rejected algorithmically with minimal human oversight and which cases should be flagged for in-depth human review.

“AI is most useful in this setting when it works alongside human judgment, not when it tries to replace it,” said Soroush Saghafian, co-author. “An algorithm can systematically identify patterns in thousands of devices and their predicate histories, but there will always be cases where the evidence is ambiguous, or the stakes are too high for an automated decision. By reserving those cases for expert review, the FDA can use its human expertise where it matters most while making the overall process more efficient.”

The system works with predicate devices, or devices that may look similar enough, or “substantially equivalent,” to an existing approved device on the market that regulators could be reasonably confident is safe and effective. Researchers sought to make the comparison system more informative by looking systematically at the history of predicate devices, particularly how old the predicate devices were and their recall status, to estimate the likelihood that the new device would eventually be recalled.

For the devices, an optimization model set thresholds in an algorithm for three categories: devices that could be cleared, devices that may carry a high enough risk to be rejected and devices in between that should be reviewed by human experts, balancing the goal of identifying potentially unsafe devices with the FDA’s limited review capacity.

“Right now, the FDA has to devote substantial resources to reviewing medical devices even when the available evidence suggests they pose relatively little risk,” said Mohammad Zhalechian, lead author. “Our results suggest that a data-driven approach could help distinguish the straightforward cases from the ones that deserve a closer look. The goal isn’t to replace FDA reviewers—it’s to give them better information about where their time and expertise can have the greatest impact.”

The study and its findings coincide with an existing regulatory conversation. In 2023, the FDA put out a draft guidance about predicate selection best practices, proposing to evaluate predicate devices based on safety track record rather than just availability. The study’s model speaks directly to that proposal by tracking predicate recall history and age, a safety track record that the FDA’s own guidance pushes for. If tools like this can inform the direction the FDA takes, the result could be more safety, more efficient use of resources, and more money saved.

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The study — published in the journal JAMIA Open, and co-authored with University of Toronto professor Enid Montague and Dr. Onil Bhattacharyya of Women’s College Hospital — involved nine physicians completing simulated patient encounters both with and without the use of AI scribes. These digital tools are capable of recording audio and using it to generate structured, regulatory-compliant clinical notes for a patient’s medical chart — the record physicians use to document their care.

The researchers used video recordings of each appointment to analyze how physicians spent their time. They found that when the scribes were in use, the doctors spent significantly less time documenting.

“We know healthcare workers are experiencing burnout, which is associated with compromised patient safety and increased potential for errors, and can contribute to physician turnover,” says Murray.

“We also know that administrative tasks contribute to said burnout, so we want to find ways to reduce that strain.”

The study is part of a multi-phase project between University of Toronto’s Wellness and Health Enhancement Engineering Lab and the Centre for Digital Health Evaluation, Women’s College Hospital Institute for Health System Solutions and Virtual Care. The team’s previous research compared the usability and performance of six AI scribe products; only the three performing tools were then used in this subsequent study.

Without the AI scribes, physicians spent more than one-third of each simulated patient encounter on note taking. In addition to saving time during the patient interaction, Murray hopes incorporating AI will lead to more timely documentation.

“Documentation often gets delayed because there’s just so much to do and the days are so busy; this can make it less accurate,” says Murray.

“I hope with this technology we see a reduction in things like charting being done after hours or days later. That would also create a reduction in cognitive labour with physicians having to remember what happened during appointments that occurred days prior.”

Researchers also observed an unexpected change in how some physicians kept track of their thoughts during appointments where AI scribes were used. The shift in workflow highlighted the role note taking can play in diagnosis.

“The most interesting finding for me was seeing how physically creating the charts throughout the appointment prompted thinking and more clinical decision-making questions from the doctors,” says Murray.

“When the scribes were in use, we saw the adoption of scratch pads for note taking to help physicians remember to ask follow-up questions.”

With the scribes, instead of spending appointments switching between the patient and typing on the computer, physicians documented differently. Rather than charting throughout, physicians shifted toward reviewing and editing the AI-generated documentation after it had been produced. This resulted in fewer interruptions during the simulated encounters.

One of the overarching goals of the project is to generate Ontario-specific research around AI technology in healthcare as Ontario physicians operate within different privacy regulations than their U.S. counterparts, which could affect how AI scribes are integrated into clinical practice.

“When the studies were first coming out, we were seeing them come from these large U.S.-based hospital systems,” says Murray.

“So for us, it was really about focusing on the Canadian context and, even more specifically, within Ontario. It’s not to say that we were the only ones in the space, but there was a gap in the literature looking at how AI impacts primary care delivery and what that means for Canadian healthcare.”

Murray, who has been studying AI scribes since 2023, has seen changes to the technology itself, with more customizable features and better integration into existing platforms but also in the conversations around the technology’s potential. As the technology has become more widely adopted, expectations have also begun to change.

“When the technology was new, the conversation was very much that this would solve all our problems,” says Murray.

“Now that’s shifted to, ‘hey maybe this is just one piece of the overall documentation burden that we’re seeing,’ because charts are not the only administrative burden facing physicians. We’re also thinking about things like referrals, prescription orders, billing and regulatory expectations that are contributing to administrative work.”

While the study relied on simulated patient encounters, more research will be needed to understand how AI scribes perform in everyday clinical practice.

For example, as the technology is more widely adopted, Murray wants to know how receptive patients will be to the use of AI scribes in the course of their care.

“Are they appreciative of the differences in communication? Are there hesitancies in terms of being recorded and who has access to these recordings,” says Murray.

“I wonder about the impact for different patient populations as well. What happens when physicians who are almost always using AI scribes suddenly have one patient that doesn’t consent to it being used in their care? This research has opened a lot more discussions and possibilities to consider.”

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To bridge this gap, the paper introduces a “digital behavioral infrastructure”—a theory-driven approach that leverages digital health apps as essential structural companions, helping patients build sustainable habits during the medication’s peak efficacy window. The paper maps how two well-validated theories of behavior change, social cognitive theory and behavioral economics, can be leveraged to drive medication persistence, side-effect mitigation, and durable weight loss.

Geoff Cook, CEO of Noom, a leading behavior change company, suggests an idea called the “habit window.” By dialing down constant food cravings, described by patients as “food noise,” GLP-1 drugs free up mental energy, opening a unique opportunity for patients to build healthier daily routines. He also proposes that GLP-1 therapy, when combined with behavioral support, may spark lifestyle change via the “Fresh Start” effect.

Digital companion programs use targeted strategies to address the three biggest hurdles of GLP-1 therapy. Personalized digital reminders can help patients stay consistent with their medication, while interactive symptom management features can help reduce gastrointestinal side effects so patients do not quit early. Finally, structured skill-building can help users establish sustainable eating and exercise routines before biological appetite cues return to baseline when treatment stops.

“Given the high rate of GLP-1 discontinuation,” said Cook, “the objective becomes building healthy behaviors while the habit window is pharmacologically open. While the habit window is a hypothesis, the features suggested in the paper are not theoretical. In fact, these features are part of the Noom app today, as this is exactly how we’ve built Noom’s GLP-1 Companion to take advantage of fast and slow thinking, system 1 and system 2. Most exciting of all is we will be supporting the research program outlined in Table 1 of the paper with RCTs to shed light on the problems, mechanisms, and interventions raised in the paper.”

While early observational data shows promising results, the paper stresses that prospective, randomized trials are needed to fully test the “habit window” framework. Ultimately, pairing biological appetite control with digital behavioral coaching could mark the difference between temporary weight loss and a lifetime of improved health.

Cook G. Digital Behavioral Infrastructure for Glucagon-Like Peptide-1 Pharmacotherapy: Viewpoint on Persistence, Tolerability, and Postcessation Durability

J Med Internet Res 2026;28:e104227

URL: https://www.jmir.org/2026/1/e104227

DOI: 10.2196/104227

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