FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews
FDA updates its policy to accept de-identified real-world evidence to support drug and device application reviews, allowing the use of previously excluded registries, insurance claims, and EHR data.
GI Partners, TA Associates to launch Netsmart sale process in early 2026, sources say
The private equity owners of Netsmart will reportedly seek a buyer for the company for the second time.
Clinical documentation improvement company Enjoin acquires Pediatric Resource Group, which offers pediatric clinical documentation integrity and physician advisory services.
Senator Ron Wyden (D-OR) urges EHR vendors to adopt privacy features that give patients the ability to view and control access to their medical records.
FDA updates its policy to accept de-identified real-world evidence to support drug and device application reviews. This change allows use of registries, insurance claims, and EHR data that were previously excluded because they lacked patient-level confidential information.
FDA says it intends to review the same policy change in its guidance for drug and biologics.
From Dr.SickandTiredHIT: “Re: Texas versus Epic. Can we all just say the quiet part out loud? A conservative politician, who is running for statewide office and is looking to make a splash, is suing a company led by a liberal in a liberal city. The Texas v. Epic suit is nonsense beyond a politician trying to score points. Why can’t Epic say that?”
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Virtual cardiology company Auxira Health raises $7.8 million in seed funding. Auxira offers cardiology practices remote services that include access to advanced practice providers, care coordination, patient engagement, medication management, and system integration. MedStar Health (MD) launched Auxira in May through a collaboration with Abundant Venture Partners.
Healthcare technology, analytics, and services vendor Sentact acquires event and incident management company Performance Health Partners and Vizient’s Patient Safety Organization. Performance Health Partners founder and CEO Heidi Raines will join Sentact as chief strategy officer.
Lin Health announces $11 million in Series A funding. The company offers an app-based treatment program for the management of chronic pain.
The private equity owners of Netsmart will reportedly seek a buyer for the company for the second time.
Medify Health, which offers remote patient monitoring and chronic care management services for Medicare beneficiaries, shuts down.
Rakshay Jain, MBA (Innovaccer) joins DexCare as chief product officer.
Tebra incorporates DrFirst’s RxInform prescription notification tool into its EHR+ for private practices.
South Gippsland Hospital in Australia implements Altera Digital Health’s Sunrise EHR.
Children’s Minnesota will outsource its revenue cycle management to Ensemble Health Partners.
Manifest MedEx will provide the California Mental Health Services Authority with ADT notifications for people who are being seen by county behavioral health organizations.
Health insurer Fallon Community Health plan sues Innovaccer, alleging that the company’s software was worthless, didn’t improve risk adjustment revenue as promised, and was sold under fraudulent misrepresentation.
PenRad Technologies will pay $530,000 to settle federal allegations that it violated the False Claims Act by inadvertently causing providers to bill Medicare and MassHealth for medically unnecessary breast cancer screenings due to an overlooked software setting. Intelerad Medical Systems acquired PenRad in 2022.
Members of the House Veterans’ Affairs Technology Modernization Subcommittee voice concern over the soaring cost of the VA’s Oracle Health–based EHR Modernization program. The estimate has grown from an initial $10 billion to $37 billion, and the Institute for Defense Analyses projects at least $50 billion. Thirteen facilities are slated to go live next year, with full deployment expected by 2031. Subcommittee chair Tom Barrett (R-MI), a US Army veteran, has a personal stake in the rollout because four Michigan facilities that he uses for care will be the first to adopt the system since the 2023 pause.
An ASTP blog post outlines the similarities and differences between TEFCA and CMS-Aligned Networks.
University of California researchers find that automated outreach to patients offering help with advance care planning significantly increases the number of patients who complete ACP documentation.
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Auxira Health Raises $7.8M in Seed Funding
Cardiology practice extension company Auxira Health raises $7.8 million in seed funding.
Sentact acquires event and incident management company Performance Health Partners and Vizient’s Patient Safety Organization.
PenRad Technologies will pay $530,000 to settle federal allegations that it violated the False Claims Act by inadvertently causing providers to bill Medicare and MassHealth for medically unnecessary breast cancer screenings.
A friend reached out this weekend to ask my opinion about the risks of plugging medical information into ChatGPT and other publicly available AI tools. She wanted to know if I agree with a recent New York Times article about it.
My first concern is with the accuracy of the medical information that is being fed in. My own records have contained a variety of misinformation in the last several years, including documented findings from exams that didn’t occur, incorrect diagnoses, and at least one document that was scanned into the wrong chart.
Smaller errors also occurred, such as inaccuracies in dictation / transcription that weren’t caught in editing. Although they don’t materially change the content of the record, I wouldn’t want them taken out of context.
The article starts with a scenario where a patient receives abnormal test results. She is “too scared to wait to talk to her doctor,” so she pastes the lab report into ChatGPT. It tells her that she might have a pituitary tumor.
This is a prime example of the unintended consequences of giving patients access to their lab results before the ordering physician reviews them. It’s the law, and patients have a right to their information, but it can be harmful to patients in some circumstances. I’m glad to see care delivery organizations giving patients the choice of receiving their results before or after they are interpreted by the care team.
Another scenario involved a patient uploading a half-decade of medical records and asking questions about his current care plan. ChatGPT recommended that the patient ask his physician for a cardiac catheterization.
The procedure was performed and the patient did have a significant blockage. However, it’s difficult to know what the outcome might have been had the original care plan been followed. The write-up of the scenario didn’t include any discussion of how things went when the patient pushed for a procedure, or if other ramifications, such as insurance issues, resulted from the pursuit of a higher level of intervention.
Most of the patients I see don’t fully understand HIPAA. They think that any kind of medical information is somehow magically protected. They don’t know what a covered entity is in the role of protecting information. They give away tons of personal health information daily through fitness trackers and other apps without knowing how that information is used or where it goes.
I personally wouldn’t want to give my entire record to a third party by uploading it to an AI tool. I don’t know how the tool handles de-identification and I’m not about to spend hours reading a detailed Terms and Conditions or End User Licensing Agreement. Based on the number of people who share their information in this way, it’s clear that many aren’t worried about the risks.
One of the professors who was interviewed for the article noted that patients shouldn’t assume that the AI tool personalizes its output based on their uploaded detailed health information. Patients might not be sophisticated enough to create a prompt that would force the model to use that information specifically, or might not be aware of instructions within the model to handle that kind of information in a certain way.
Assuming that you will receive a response that is tailored specifically to you can be challenging, especially since much of the medical literature looks at how disease processes occur across populations rather than for an individual.
The comments on the article are interesting. One cautioned users to consider using multiple models, asking the same questions, and having the models evaluate each other in order to make sure the output is valid. I can’t see the average patient spending the time to do that.
Others talked about how they’ve used ChatGPT to drive their own care. One commenter mentioned that she also used it to research care for her pet and to make adjustments to the regimen prescribed by her veterinarian.
Concerns were also expressed about the possibility for bias and advertisements to creep in, especially with the discussion of particular medications that are still under patent.
Several readers shared stories about AI tools giving wildly inappropriate care recommendations that could have been harmful if patients hadn’t done additional research on the suggestions. One specifically mentioned the AI’s “mellow, authoritative reassurance of the answers, in a tone not different from talking to a trusted and smart doctor friend” despite being “flat wrong on several points.”
Another reader mentioned that tools like ChatGPT formulate their answers from materials that they find online. Unless you specifically ask for citations, it’s difficult to know whether the information is coming from a medical journal or an association dedicated to patients with a specific condition. Or, was simply made up.
Readers also called for certification of models that are being used for medical advice. One noted, “My doctor had to get a degree and be licensed. If he messes up bad enough, he can lose that license. There should be procedures for evaluating the quality of chatbot medical advice and for providing accountability for mistakes. Medical conversations with them aren’t like chatting with your neighbor about your problems.”
I hadn’t thought about it that way. It’s a useful idea that I may use when talking to patients who have been using the tools. The information they receive may or may not be better than what they would get over the fence from a neighbor, but it’s difficult to know.
One comment noted that since physicians are using these tools to do their jobs, it’s only fair that the patients have access as well. A follow-up comment noted that the writer “walked in on new residents Googling a patient’s symptoms.”
It makes one wonder how these tools will impact graduate medical education. Is the next generation of physicians building their internal knowledge and recall skills in the same way as previous generations? If they’re not, it’s going to be a rude shock the first time they have to live through a significant downtime or outage event.
It will also be interesting to see board exam pass rates change for physicians who trained in the post-AI era compared to those of us who didn’t have access to those tools.
What do you think about patients feeding their medical information into LLMs? Providers, under what circumstances would you recommend it? Leave a comment or email me.
Email Dr. Jayne.
A GAO report says that the VA must address several previously raised issues to support its accelerated Oracle Health rollout.
Mass General Brigham spins out AIwithCare, an AI-powered tool that matches patients to clinical trials.
Ritten Announces $35M Series B Investment Led by Five Elms Capital
Behavioral health IT vendor Ritten raises $35 million in Series B funding, bringing its total raised to $52.5 million.
A GAO report says that the VA must address several previously raised issues to support its accelerated Oracle Health rollout. Among them:
From Jacinto: “Re: Dr. Craig Joseph’s comments about packaging AI as cuddly robots to improve behavior change. This is blazingly insightful. I can think of quite a few examples where words on a screen or delivered by a faceless voice would be more effective.” His company blog post made me think about the patient care value of anthropomorphized AI speech that is delivered by a comforting, universally understood form factor (which also happens to be inexpensive). As he says, “People don’t struggle with anxiety or diabetes or rehab exercises because they are missing the right paragraph of text.” Potential uses that I can see:
Poll respondents are still trying to figure out if having a C-level AI advocate provides clear benefit.
New poll to your right or here, from the discussion above: Will socially assistive AI robots outperform chatbots when the goal is patient behavior change? I expect a lot of respondents to punt with the “need more evidence” option, but let’s see votes and comments from those who have firmer opinions.
A generation donation from Bill, amplified by matching funds from outside sources and my Anonymous Vendor Executive, fully funded these Donors Choose teacher grant requests:
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A report by The Information says that new fundraising by OpenEvidence values the company at $12 billion.
Mass General Brigham spins out AIwithCare, an AI-powered tool that matches patients to clinical trials.
A new reach for private equity tentacles shows up in software for volunteer fire departments. PE-backed ESO Solutions bought the $795-per-year system that is used by Norfolk VFD, shut it down, and offered a $5,000 replacement. Norfolk found a cheaper option, but ESO then acquired that vendor, too. ESO now serves 20,000 of the nation’s 30,000 fire departments, and its two largest rivals are also PE-backed. ESO’s majority owner is Vista Equity Partners, which also holds positions in Greenway Health, SimplePractice, and TigerConnect. Its president and CEO is Erick Beck, DO, MPH, who left his president / COO role at University Hospitals to join ESO in June 2022.
Investment banker and former FDA Commissioner Scott Gottlieb, MD says in a JAMA Health Forum article that AI has not boosted healthcare productivity because the industry depends on labor-intensive work that is better measured by outcomes than output. He predicts that AI will raise productivity by taking over some cognitive and physical tasks, which will free physicians to focus on work that requires human judgment. He argues that FDA should replace its static device framework with one that permits safe, iterative AI updates without full reapproval unless performance standards are violated. He adds that adoption lags because Medicare does not pay for technology directly and must remain budget-neutral, which forces any new payments to be offset by cuts to physician reimbursement.
Private equity firm Geneva PE launches the development and funding of NXXIM, an AI-powered enterprise medical imaging platform. The announcement provides few details, such as naming the “world-class leadership team of industry veterans” who are involved.
A San Francisco woman gives birth in the back seat of a Waymo driverless car that she had hailed for a ride to the hospital. The car noticed “unusual activity” and called emergency services en route.
Interesting: HIMSS members who participate in any of its volunteer committees, task forces, and workgroups are prohibited from recording the content (that’s reserved for HIMSS to package as its own content) and can’t use any AI devices or software to record or transcribe the meeting.
Not health tech related (yet), but fascinating. Google upgrades Translate so that users can hear real-time translations in their earbuds. It also translates the user’s speech into the other person’s language. The Gemini AI enhancement auto-detects the languages being spoken, filters ambient noise, and preserves the original speaker’s intonation and pacing. I can’t imagine traveling internationally without Translate and Maps on my IPhone’s homepage.
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Texas Files Antitrust Suit Against Epic Systems Over Health Data
Texas Attorney General Ken Paxton files an antitrust and consumer protection petition alleging that Epic maintains monopoly power and that the company misleads Texas children’s hospitals about its parental access rules.
HHS health IT chief hints at a new approach to EHR certification
Assistant Secretary for Technology Policy and National Coordinator Thomas Keane, MD, MBA tells STAT he’s hoping his office will soon do away with 34 certification criteria for EHRs and modify seven, with an eye to regulating EHR interoperability APIs in the coming months.
OpenAI’s “State of Enterprise AI” report names healthcare as one of the fastest-growing business sectors for ChatGPT use.
Texas Attorney General Ken Paxton files an antitrust and consumer protection petition alleging that Epic maintains monopoly power. It says that Epic controls more than 90% of US patient records, locks in hospitals through extreme switching costs, restricts competitor access to data, and imposes no-hire restrictions on employees. The petition also argues that Epic delays or limits access to medical records for providers and patients who are outside Epic’s system.
The lawsuit further accuses Epic of misleading Texas children’s hospitals about its parental access rules, which is likely the key issue of the lawsuit.
The lawsuit seeks injunctive relief to restore competitive conditions, civil fines, and court costs.
An Epic spokesperson provided this company response:
The action taken by Texas is flawed and misguided by its failure to understand both Epic’s business model and position in the market and the enormous contributions our company has made to our nation’s healthcare system illustrated by products like MyChart —software that tens of millions of Americans depend on every day. Every month, we improve quality of care by helping providers see a more comprehensive picture of their patient through over 725 million record exchanges—more than any other electronic health records vendor—and over half of these are with non-Epic systems. Health systems using Epic shared information with almost 1,000 patient-facing apps 2 billion times in the past year. Epic does not determine parental access to children’s medical records. Decisions about parental access to children’s medical records are made by doctors and health systems, not by Epic.
From Dr. Herzenstube: “Re: HELP committee’s inquiry into the American Medical Association. It sounds as if there are some very specific alleged practices around CPT codes that they are investigating.” Sen. Bill Cassidy, MD (R-LA) seeks information from organizations that have licensed CPT about their price structure, AMA’s willingness to negotiate contract provisions, and any other areas outside CPT in which AMA collects royalties.
None scheduled soon. Contact Lorre to have your resource listed.
Oracle announces Q2 results: revenue up 14%, EPS $2.10 versus $1.10, exceeding earnings expectations but falling short on revenue. ORCL shares fell 11% on Thursday over investor concern about rising AI infrastructure costs. Co-CEO Mike Sicilia said in the earnings call that 274 customers are live on Oracle Health’s clinical AI agent and that its new AI-based ambulatory EHR is generally available.
Nashville-based virtual clinic Joi + Blokes acquires women’s-health startup HerMD, creating one of the largest virtual care platforms for menopause, sexual health, and hormone therapy. HerMD previously raised $40 million in venture capital, then closed its five physical locations to focus on virtual care.
Healthmonix hires Bill Marella, MS, MBA (HealthShare Exchange) as COO.
OpenAI’s “State of Enterprise AI” report names healthcare as one of the fastest-growing business sectors for ChatGPT use, with eightfold growth in customers in the past 12 months.
Included Health expands its care navigation platform with an intelligent AI assistant that uses personalized medical, claims, and benefits data to guide employer-based members. It also nudges them toward preventive screenings and better benefits use.
A Microsoft review of 37 million Copilot conversations finds that it is most often used to answer health questions.
A new KLAS report on IT planning and assessment services finds that Chartis, Impact Advisors, Healthlink Advisors, Nordic, Deloitte, and Optimum Healthcare IT are the firms that are most frequently considered and selected.
More than 100 provider groups and medical societies ask HHS to withdraw its proposed cybersecurity rule that would expand HIPAA requirements, and instead collaborate with industry to develop practical, actionable, and less-burdensome cybersecurity standards.The 393-page Notice of Proposed Rulemaking would require providers, business associates, health plans, and clearinghouses to implement specific safeguards, perform annual compliance audits, document deeper analysis of technology assets, and maintain written documentation. Mandatory technical controls include encryption of EPHI at rest, multi-factor authentication, vulnerability scanning, and network segmentation.
Nordic Chief Medical Officer Craig Joseph, MD says healthcare is betting on the wrong AI horse in embracing purely digital chatbots, which have been found to be less effective in improving outcomes than packaging the same LLM as an inexpensive socially-assistive robot. He says that digital health apps aren’t good at improving behavior change and engagement because they can’t provide the emotional experience and physical presence that engages the brain. Excerpts:
Behavior change is not a content-delivery problem; it is an emotional-experience problem. People don’t struggle with anxiety or diabetes or rehab exercises because they are missing the right paragraph of text. They struggle because doing hard things alone is deeply, intrinsically difficult … humans need accountability, presence, encouragement, and social cues to persist when something feels uncomfortable. Motivation is not downloaded; it’s co-created … The truth is that healthcare already understands the importance of presence. Physicians know that the 30 seconds spent sitting instead of standing changes the perceived quality of a visit. Nurses know that touch conveys trust in ways chart messages never will. Behavioral health clinicians know that therapy is not powerful because of what is said, but because of who is saying it, how they are saying it, and where the interaction occurs. Embodied AI doesn’t replace this relational wisdom. It simply extends it into new settings where humans cannot always be.
Eli Lilly says that a clinical trial of its next-generation, three-hormone GLP-1 drug for obesity and diabetes shows that participants with obesity and arthritis lost an average of 29% of their body weight, about 71 pounds, which exceeds the results reported for Zepbound and Novo Nordisk’s Wegovy. Participants also saw major improvements in their arthritis symptoms. Demand for Lilly’s GLP-1 drugs has driven the company’s valuation to $1 trillion.
The founder of online mental health platform BetterLyf is arrested after he allegedly started a fire at a California winery, threw a wine bottle at employees, intentionally crashed his Tesla into two cars while fleeing, and then locked himself in his car and refused to surrender until police officers pepper sprayed him. Vikram Beri was charged with assault with a deadly weapon and resisting arrest.
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The Association of American Medical Colleges has released new data showing that medical school enrollment has hit an all-time high. Total enrollment for 2025 is 100,723 students. It’s also the largest first-year class in history at 23,440 students.
A few stats stood out to me:
Medical training can be a long, winding road, so congratulations to the entering class. For those on a semester schedule, go crush those finals.
I also saw an article about CMS contracting with Clear for identity verification as part of its quest to “kill the clipboard.” Eliminating manual and paper-based processes is a worthy goal, although technology alone never solves the problem. In my experience with process improvement work, the real challenge lies in understanding operations, culture, and history. Those often determine why a workflow looks the way it does.
My mammography center is a perfect example. It finally retired its wonky and duplicative paper questionnaire this year. I briefly celebrated not being handed a clipboard, but then was asked all the same questions verbally, regardless of whether or not the information was already in the chart.
The technician was rushed and misread my chart more than once. That led to a longer discussion than I cared to have while standing in a gown with half my body exposed.
I noted on my Press Ganey survey that these questions should be asked before patients disrobe. Whether anyone reads those comments is another story. Progress in healthcare tends to arrive as two steps forward, one step back.
As we coast toward year’s end, I’m watching healthcare IT projects nearly grind to a halt as team members take time off. Some absences were planned well in advance, especially for parents whose children are out of school, so those projects are only mildly affected. Others are chaotic as people realize, often too late, that their PTO is “use it or lose it.” The result is patchy staffing and sudden bottlenecks across teams.
I have worked under nearly every time-off model imaginable, from “unlimited” time away, subject to manager approval, to miserly accrual programs that make it hard for people to take more than a day or two off early in the year. Some employers allow a modest PTO bank before triggering “use it or lose it” rules. Others shut off rollover entirely. As a manager, I’ve always tried to explain the details to my team, including subtleties for remote employees who live in different states. I encourage people to spread their time off throughout the year unless they have a specific reason to save it.
Not everyone tracks their PTO or understands the fine print, and that can lead to scrambling at the end depending on organizational policies. I’m working on a multi-entity project in which time-off rules vary widely within the same metropolitan area. The most flexible arrangement allows employees four weeks of paid time off per year. Employees are required to take a minimum of two weeks away from the office, but can choose to have the other two paid out as wages. For those who don’t feel they need time away from work, that might be a good option.
A nearby organization uses what I call a “use it or else” policy. Employees cannot bank their PTO and cannot simply forfeit it. They must take all remaining days before December 31, even if doing so leaves co-workers hanging. Leadership announced the change over the summer, but many employees did not grasp the consequences, which is creating December chaos. Managers have been tasked to hold individual conversations to make sure everyone burns through their time. The official explanation is to avoid claims that workers aren’t allowed to use their time off. I’m sure there’s more to the story, but I don’t think the policy is working out as planned.
This year, I’m also seeing more people taking time off in December for health-related visits because they have already met their insurance deductibles. Hip and knee replacements seem to dominate. When I asked an orthopedic friend about it, she said her practice is running at full throttle to accommodate demand. The bigger problem, she said, is physical therapy. Local PT programs cannot keep pace with procedure volume, so her staff spends an extraordinary amount of time coordinating care to ensure patients are seen immediately after surgery. I don’t think that the folks who make healthcare policy and decide on our country’s patchwork of misaligned incentives understand these patient realities.
What is the atmosphere like in your workplace this holiday season? Are you racing to complete projects or taking a leisurely stroll towards the new year? Is it a ghost town due to last-minute PTO use? Leave a comment or email me.
Email Dr. Jayne.
Cincinnati startup HerMD secures exit months after co-founders buy back business
Virtual health and wellness clinic Joi + Blokes acquires HerMD, expanding its virtual care reach to all 50 states.
Margaret Mary Health (IN) will outsource its revenue cycle operations to Revology, laying off 55 employees in the process.
Canada’s Competition Bureau obtains a court order allowing it to move forward with its investigation of Well Health’s acquisition of Healwell, and if that acquisition has stifled competition within the AI transcription market.
Microsoft Research releases GigaTIME, an open-source, multi-modal AI system that researchers used to convert pathology slides into virtual images, then analyze them against patient data from Providence. The resulting virtual population allows researchers to study the associations between cell states and key biomarkers.
Nvidia CEO Jensen Huang warns that China can complete large construction projects, such as AI data centers, in a fraction of the time that is needed in the US. He added, “They can build a hospital in a weekend.”
Meditation and sleep app vendor Headspace, which is repositioning itself as a healthcare company, is shifting from consumer subscriptions to employer and health-plan distribution. CEO Tom Pickett is pushing hard into AI with Ebb, a chatbot that is intended for everyday emotional regulation, after he moved the company’s full-time therapists into part-time and contractor positions. Competition with Calm is intensifying as downloads fall, but Headspace says that enterprise and payer channels offer greater scale. The company reports $200 million in revenue and EBITDA profitability. Headspace acquired health coaching company Ginger four years ago in a deal that valued the combined company at $3 billion.
A charity study in England and Wales finds that 40% of teens who have been affected by youth violence have used AI chatbots for mental health support. They describe chatbots as being more private, non-judgmental, and accessible than traditional services that are bogged down by long waiting lists and reports of providers who show little empathy compared to chatbots. The teens also tout 24×7 availability and the ability of chatbots to learn and then mimic their conversational style.
A study finds that 28% of UK doctors are using AI tools to summarize encounters, help with diagnosis, and perform routine administrative tasks. A physician researcher at Nuffield Trust says that the government’s hopes that AI will transform the NHS are not reflected in the “Wild West” rollout of unregulated tools. The trust’s survey also found that doctors use their time savings from AI to self-care and rest rather than to see more patients.
A developer discovers a hidden link in ChatGPT to Apple Health, suggesting that the companies are testing integration between the apps.
A class action lawsuit alleges that Sharp HealthCare deployed Abridge’s ambient documentation solution in April 2025 without obtaining all-party consent as required by a California wiretapping law. The plaintiffs argue that Sharp committed electronic eavesdropping, violated the state’s Confidentiality of Medical Information Act by sending patient information to the vendor’s cloud, falsely documented that patients had consented to AI’s use, and told patients that they could not force the vendor to delete their information on request.
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Spare Tire raises $3M to save healthcare organizations from document downtime
Spare Tire, which offers on-demand access to inpatient historical data for workflow continuity during unplanned EHR downtime, raises $3 million in a Series A funding round.
Casera launches out of Pioneer Square Labs with $1 million in funding to help hospitals improve patient flow via its case manager digital agent.
Digital pediatric and neonatal patient and family engagement company AngelEye Health raises $9 million in a Series C funding round.
Global investment firm EQT seeks $1 billion for its 40% stake in CitiusTech.
EQT sold its majority stake in AGS Health to Blackstone for a similar amount in August.
CitiusTech, a global healthcare IT business, acquired Health Data Movers at around that same time.
Reader donations and matching funds provided Ms. O’s kindergartners with marble run sets for STEM learning. She reports, “By playing with building sets, my students are learning how to build all kinds of different structures. They are also learning engineering skills. That is STEM learning at its best! This project has been so important because giving students a strong foundation in math and literacy in their first year of school, makes a big difference by giving them a good start in their academic careers.”
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Spare Tire raises $3 million in a Series A funding round. The startup offers on-demand access to inpatient historical data for workflow continuity during unplanned EHR downtime.
Clinical trial software and services vendor Paradigm Health acquires Flatiron Health’s tech-enabled clinical research solutions. The companies will also partner on integrating Paradigm’s capabilities with Flatiron’s OncoEMR.
Patients report that hospitals are charging them for self-administered questionnaires. Novant Health bills the patient or insurer $5 to $10 for a screening questionnaire about social determinants of health. A patient says that a questionnaire that was asked to complete during online check-in resulted in a $17 bill for a “brief emotional and behavioral health assessment.”
ReferWell names Rich Smith (Axion Contact) SVP of sales.
UC San Diego Health promotes Alexander Khalessi, MD, MBA to chief innovation officer.
Smarter Technologies promotes Mike Gao, MD to CEO.
HaloMD names Nirnay Patel (Simplify Healthcare) chief data officer and Dan Heinmiller (Health Catalyst) VP of data integration and operations.
VHC Health in Washington, DC begins offering virtual urgent care services from HealthTap.
Bamboo Health announces GA of Bamboo Bridge, which assists providers and payers in connecting patients with the right level of behavioral healthcare.
A Joint Powers Authority arrangement between Palomar Health and UC San Diego Health will give Palomar clinicians access to UC’s Epic system.
Kontakt.io launches Access Agent, an AI tool designed to help outpatient clinics better anticipate and manage the allocation of exams.
Researchers determine that off-the-shelf AI tools such as ChatGPT can successfully de-identify EHR patient data without training, potentially reducing the cost and time required for preparing clinical data for research.
Donate Life America presents its Courage Award to Epic in recognition of its donor registration program that was launched in May 2025.
ASTP and its partners release a Standard Operating Procedure document that outlines using TEFCA to check an individual’s eligibility for Social Security disability benefits.
A study of newborn EHR data in Epic’s Cosmos database finds that 5% aren’t being given a vitamin K injection to prevent bleeding, doubling the 2017 rate. Pediatricians say that parents decline vitamin K either because they confuse it with a vaccind or distrust authority. Hospitals are reporting an increased number of cases of infant bleeding, which can be fatal in severe cases.
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EQT Partners lines up $1 billion CitiusTech exit
EQT Partners hopes to sell its 40% stake in CitiusTech for $1 billion.
Palomar Health, UC Pact Outlined
A Joint Powers Authority arrangement between Palomar Health and UC San Diego Health will give Palomar clinicians access to UC’s Epic system.
Clinical trial software and services vendor Paradigm Health acquires Flatiron Health’s tech-enabled clinical research solutions.
Sometimes it’s hard to keep up with everything that is going on in healthcare IT. Regardless of how many unread newsletters and blog notifications are in my inbox, I know I can count on HIStalk to deliver the curated content that helps me identify the topics that I need to dig into and those that I can let slide for a while.
This week, I appreciated Mr. H posting a link to an article about the strategy that the Department of Health and Human Services (HHS) plans to use as it expands the role of AI in healthcare. The document is 20 pages long and reads like an ode to the wonders of AI, with less attention to the documented risks and benefits.
As someone who has spent a good chunk of her career doing process improvement work, where evidence and outcomes are key, and who is squarely under the influence of evidence-based practice where patients are concerned, I’m all about the details. It isn’t enough to just say that you have a cool technology that’s going to be revolutionary. We had enough of that with Theranos and the pharma bros. Now we are in an era where people want to see results and understand fully how care might be impacted and how patients will be protected.
There are five key pillars in the document: creating a governance structure that manages risk, designing a suite of AI resources for use across the department, empowering employees to use AI tools, funding programs to set standards for the use of AI in research and development, and incorporating AI in public health and patient care.
It sounds like the “empowering employees to use AI tools” piece is well underway since HHS has made ChatGPT available to all its employees. Based on my own experiences, I initially hoped that they were not using it to look up health-related content, because I’ve seen some wild inaccuracies over the last year even with non-controversial queries, such as asking it to summarize a movie plot.
Unfortunately, plenty of media reports say that HHS leaders are planning to use it to “deliver personalized, context-aware health guidance to patients by securely accessing and interpreting their medical records in real time.” Unsurprisingly, that idea raises concerns about having third-party vendors accessing patient medical records and how that data might be protected.
HHS has already given the protected health information, including birth dates and Social Security numbers, of Medicaid enrollees to the Immigration and Customs Enforcement department, which is cringeworthy for those of us who have had to sit through decades of HIPAA training courses. Although it appears that HHS will prioritize risk mitigation, the clinical experts who I have spoken with have serious concerns about the organization’s ability to prioritize patient protection over political requests.
Those of us who are following the evolution of vaccine policy in the US have seen a disregard for the scientific method and the removal of world-renowned experts from the process. We have no reason to think that things will be different with AI. Given that we have decades of experience with vaccine efficacy and little experience with the impacts of AI, clinicians are understandably concerned.
A comment on the document noted that although safety measures are in place for individual patient information, no similar safeguards are listed for aggregated information that is being used by AI tools.
As I began to dig into it, I was surprised at how it differed from previous HHS publications over the last few decades. A glossy cover page was followed by a full-page photo of the secretary of Health and Human Services with a superimposed quote saying, “We are making HHS the template for the Utilization of AI.” When I’ve seen splashy graphics pages like that in the past, it’s been in the context of a major discovery or a noteworthy quote, but this just felt weird, for lack of a better word.
The document continues with introductory letters from the deputy secretary and the HHS chief AI officer. In the first letter, HHS Deputy Secretary Jim O’Neill notes that “By guiding innovation toward patient-focused outcomes, this administration has the potential to deliver historic wins for the public – wins that lead to longer healthier lives.”
What does he think that all of us healthcare and health tech people have been doing for the last two decades? We’ve been patient-focused and outcomes-driven for a long time. Maybe he thinks it’s something new or unique to this leadership.
My favorite statement is in the second letter. HHS Chief Information Officer and Acting Chief AI Officer Clark Minor, states, “This paradigm shift will unleash a new era of well-being for a healthier America.” I was reading this in a room with a dozen family physicians, so I asked them, “What one thing do you think will unleash a new era of well-being for a healthier America?” None of the answers included AI.
What they did include were concepts such as universal healthcare, eliminating healthcare inequity, increasing social services that directly impact health, mitigating the impact of food deserts, investing in preschool and early childhood education, strengthening nutrition education in the public schools, and increasing the primary care workforce through additional residency training spots and low-interest loans for those who pursue careers in primary care.
The ensuing discussion made me wonder how much the folks at HHS are actually talking to those who are on the front lines of public health and primary care. What do they need to help promote health and prevent disease? What are their pain points? Which solutions have they tried, and can they share an inventory of what worked and what failed?
I’m certainly not part of the policy-making apparatus in the US, but I know how I solve workflow hospitals in a hospital. It doesn’t involve putting all of my eggs in the AI basket. We use a rigorous methodology to analyze dysfunction and to propose solutions, and it actually works.
This idea of assuming that AI will solve all our problems and then taking action based on that hypothesis makes me feel like we’re all part of a giant unregulated experiment that wouldn’t pass the basic rigors of a middle school science fair, let alone the Institutional Review Board of a research institution.
I have to admit that I haven’t finished reading the document yet, largely because the level of rhetoric present was giving me a headache. I also have a time-consuming personal project that I’m trying to complete, so I decided to switch gears. I’m eager to hear from anyone who has read the whole thing.
What are your thoughts on how expanded AI at HHS will impact the greater US healthcare ecosystem? Do you think AI is going to be a major driver of change, or is it just another distraction from the difficult and often messy work that needs to be done to improve the health of a large and diverse population? Leave a comment or email me.
Email Dr. Jayne.
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