year in review
The Trump administration's year in health tech
The Trump Administration made big moves to promote artificial intelligence and other technology use across the federal health department and remove barriers to AI adoption by hospitals, providers, and patients. The bulk of these actions are deregulatory and seek to achieve specific goals by nudging industry in the right direction. The whole STAT Health Tech team looked back at the year in Trump health tech policy and what lies ahead in a new story here.
As if to help us prove our point, ASTP/ONC, the government's top health IT regulator, dropped an anticipated proposed rule Monday, looking to eliminate 34 certification criteria for electronic health record software and updating seven others. Among regulations facing the axe are "model card" transparency requirements introduced by the Biden Administration for clinical decision support tools baked into EHRs. This just went into effect at the beginning of this year. Read more from Casey Ross on this latest news.
More updates on the administration's health tech agenda also released at the end of last week:
- The Medicare innovation center released a detailed Request for Applications for the new ACCESS model, which will experiment with paying providers for the health outcomes of their patients with chronic diseases, rather than for delivering discrete services meant to achieve those outcomes. It's over 60 pages, and I have not had the chance to fully digest it. The folks at Manatt have a useful summary here.
- ASTP/ONC released a new request for information on how the administration can promote the use of AI in clinical care. As discussed in the STAT story above, the last ASTP/ONC RFI was the precursor to a major initiative from the administration. To say the least, 2026 will be interesting.
- The Food and Drug Administration is requesting input on a potential new approach in which it would contract with venture capital firms so that their portfolio companies can compete for federal contracts. The approach would "streamline the procurement process for innovative technologies and services" and "provide a scalable mechanism for engaging with the startup ecosystem." It's meant as a work around to the high-bar for entry that favors big consulting shops and established contractors.
Pharma
AstraZeneca joins wearable obesity study with Lilly, Novo
AstraZeneca is the latest drugmaker to join a consortium including Eli Lilly, Novo Nordisk, and Roche backing wearable device research aimed at developing digital measures for use in obesity clinical trials. Convened by wearable and algorithm maker Ametris (formerly ActiGraph), the drugmakers hope the work will lead to mobility, physical activity, and sleep measures that will be accepted as endpoints by U.S. and European regulators. If successful, we could one day see drug labels informed by these measures and marketing that talks about improvements in physical activity or sleep.
The choice of obesity as a target for Ametris is a strategic no-brainer — GLP-1 drugs are selling very well, and there are more in the pipeline that promise even more dramatic clinical results. But it's a curious choice from other points of view. In some disease areas where drugmakers have sought to incorporate digital measures, like Parkinson's disease, the existing measures used in trials fail to capture fundamental aspects of the conditions. In obesity trials there is already a very good way of measuring outcomes: A scale.
A few months ago, I spoke to Karen Grant, head of global brand development for obesity at Lilly who underscored that patient's experience is more than just a number on the scale. While drugmakers have anecdotal information and some measures, like an in-clinic walking test, that begin to describe "functional" improvements due to drugs, they often lack validated ways to talk about them in ways that are meaningful to patients. "It's more impactful to a patient if they know, 'I can walk up and down the stairs without getting winded,'" said Grant. She added that even if these measures don't end up on labels they can still be used in publications that help advance the science backing up drugs.
It's also curious and amusing to see drugmakers like Lilly and Novo — who might otherwise be characterized as being in a fight to the death — working together on measures on which they will later compete with each other. The collaboration helps everybody spend a little less on emerging tech. It also gives Ametris the funding necessary to run studies as well as the buy-in to have a meaningful conversation with FDA.
Medical devices Zynex files for bankruptcy
Lizzy Lawrence writes: Pain management device maker Zynex Medical filed for bankruptcy last week. STAT wrote in 2024 about the company's practice of inundating pain patients with batteries they don't need, and then surprising them with bills their insurers refused to pay. The company then lost its reimbursement deal with Tricare, the federal health insurer for the military.
Zynex sells electrical stimulation devices that require a regular resupply of batteries and electrode pads. The company brought in $192 million in 2024, with about $132 million of that coming from supplies, including the batteries the company ships to patients. But six patients told STAT they received far more supplies than necessary. The constant shipments morphed from a minor nuisance into a billing nightmare when they were left on the hook for as much as $1,000.
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