I met the Nabla management team two years ago. Two years later they have ridden the wave of AI scribing to be one of the leaders in the field. At HLTH this year, I caught up with CEO Alex Lebrun and COO Delphine Groll to check in on their growth (150 customers and 100K users) what the next little bit of ambient AI scribing will look like (more specialties, more integration) and whether they’re scared of Epic (no!).–Matthew Holt
When Your Cloud Provider Doesn’t Understand HIPAA: A Cautionary Tale
By JACOB REIDER & JODI DANIEL
Jacob: I recently needed to sign a Business Associate Agreement (BAA) with one of the large hosting providers for a new health IT project. What should have been straightforward turned into a multi-week educational exercise about basic HIPAA compliance. And when I say “basic,” I mean really basic, like the definitions in the statute itself.
Here’s what happened and why you need to watch out for this if you’re building health care technology.
I’m building a system that automates clinical data extraction for research studies. Like any responsible health care tech company, I need HIPAA-compliant infrastructure. The company (I’ll call them Hosting Company or HC) is good technically, and they’re hosting our development environment, so I signed up for their enhanced support plan (which they require before they’ll even consider a BAA) and requested their standard agreement.
The Problem
HC’s BAA assumes every customer is a “Covered Entity.” That means a health plan, a health care clearinghouse, or a health care provider that transmits health information electronically.
But that’s not me. I’m not a Covered Entity. I’m a Business Associate (BA). I handle protected health information on behalf of Covered Entities. When I need cloud infrastructure, I need my vendors to sign subcontractor BAAs with me.
The Back and Forth
When I told HC that I couldn’t sign their BAA as written, they escalated to their legal department. Days later, a team lead came back with this response:
“To HC, even if you are a subcontracted or a down the line subcontracted association. It would still be an agreement between the covered entity within the agreement and HC… So even being a business associate, it would still be considered a covered entity since it is your business that is being covered.”
I had to read it twice. This is simply wrong.
Jodi: Let me chime in here with the legal perspective, because this confusion is more common than it should be.
The terms “Covered Entity” and “Business Associate” aren’t interchangeable marketing terms. They have specific legal definitions in 45 CFR § 160.103. You can’t just redefine them because it’s administratively convenient. Generally… covered entities are (most) health care providers, health plans, and health care clearinghouses; business associates are those entities that have access to protected health information to perform services on behalf of covered entities; and subcontractors are persons to whom a business associate delegates a function, activity, or service.
Here’s what the regulations actually say:
Continue reading…Sachin Jain–How do we do better?
What are the practices that we have normalized that future generations will criticize us for? Sachin Jain, CEO of SCAN Health Plan, is perhaps the leading truth teller in health care who also runs a real health care organization. I had a really fun but serious interview with Sachin about what health care people are doing, what are the bad things that happen. How are good people letting this happen? How we should be changing what we are doing?–Matthew Holt
Kai Romero, Evidently
Kai Romero is Head of Clinical Success at Evidently. The company is one of many that are using AI to dive into the EMR and extract data to deliver it to clinicians. It works to get really great information from the EMR to various flavors of clinicians in a fast and innovative way. Kai leads me on a detailed exploration of how the technology gets used as a layer over the EMR. And Kai shows me the new version that allows and LLM to deliver immediate answers from the data. This is a demo you really need to see to understand how AI is changing, and improving, that clinical experience. Meanwhile Kai is fascinating. She was an ER doc who became a specialist in hospice. We didn’t get into that too much, but you can tell about her input into Evidently’s design — Matthew Holt
Life Is Geometry
By KIM BELLARD
In 2025, we’ve got DNA all figured out, right? It’s been over fifty years since Crick and Watson (and Franklin) discovered the double helix structure. We know that permutations of just four chemical bases (A, C, T, and G) allow the vast genetic complexity and diversity in the world. We’ve done the Humam Genome Project. We can edit DNA using CRISPR. Heck, we’re even working on synthetic DNA. We’re busy finding other uses for DNA, like computing, storage, or robots. Yep, we’re on top of DNA.
Not so fast. Researchers at Northwestern University say we’ve been missing something: a geometric code embedded in genomes that helps cells store and process information. It’s not just combinations of chemical bases that make DNA work; there is also a “geometric language” going on, one that we weren’t hearing.
Wait, what?
The research – Geometrically Encoded Positioning of Introns, Intergenic Segments, and Exons in the Human Genome – was led by Professor Vadim Backman, Sachs Family Professor of Biomedical Engineering and Medicine at Northwestern’s McCormick School of Engineering, and director of its Center for Physical Genomics and Engineering. The new research indicates, he says, that: “Rather than a predetermined script based on fixed genetic instruction sets, we humans are living, breathing computational systems that have been evolving in complexity and power for millions of years.”
The Northwestern press release elaborates:
The geometric code is the blueprint for how DNA forms nanoscale packing domains that create physical “memory nodes” — functional units that store and stabilize transcriptional states. In essence, it allows the genome to operate as a living computational system, adapting gene usage based on cellular history. These memory nodes are not random; geometry appears to have been selected over millions of years to optimize enzyme access, embedding biological computation directly into physical structure.
Somehow I don’t think Crick and Watson saw that coming, much less either Euclid or John von Neumann.
Coauthor Igal Szleifer, Christina Enroth-Cugell Professor of Biomedical Engineering at the McCormick School of Engineering, adds: “We are learning to read and write the language of cellular memories. These ‘memory nodes’ are living physical objects resembling microprocessors. They have precise rules based on their physical, chemical, and biological properties that encode cell behavior.”
“Living, breathing computational systems”? “Microprocessors”? This is DNA computing at a new level.
The study suggests that evolution came about not just by finding new combinations of DNA but also from new ways to fold it, using those physical structures to store genetic information. Indeed, one of the researchers’ hypothesis is that development of the geometric code helped lead to the explosion of body types witnessed in the Cambrian Explosion, when life went from simple single and multicellular organisms to a vast array of life forms.
Coauthor Kyle MacQuarrie, assistant professor of pediatrics at the Feinberg School of Medicine, points out that we shouldn’t be surprised it took this long to realize the geometric code: “We’ve spent 70 years learning to read the genetic code. Understanding this new geometric code became possible only through recent advances in globally-unique imaging, modeling, and computational science—developed right here at Northwestern.” (Nice extra plug there for Northwestern, Dr. MacQuarrie.)
Coauthor Luay Almassalha, also from the Feinberg School of Medicine, notes: “While the genetic code is much like the words in a dictionary, the newly discovered ‘geometric code’ turns words into a living language that all our cells speak. Pairing the words (genetic code) and the language (geometric code) may enable the ability to finally read and write cellular memory.”
I love the distinction between the words and the actual language. We’ve been using a dictionary and not realizing we need a phrase book.
Continue reading…Artificial Intelligence Renders the FDA’s Current Drug Approval Process to be Obsolete
By STEVEN ZECOLA
Artificial intelligence (“AI”) has taken root in the field of drug discovery and development and already has shown signs of running past the traditional model of doing research. Congress should take note of these rapid changes and: 1) direct the Department of Health and Human Services (“HHS”) to phase down the government’s basic research grant program for non-Ai applicants, 2) require HHS to redirect these monies to fund nascent artificial intelligence applications, and 3) require HHS to revamp the roadmap for drug approvals of AI-driven trials to reflect the new capabilities for drug discovery and development.
Background
There are four distinguishing features of the U.S. healthcare industry.
First, the industry’s costs as a percentage of GNP have increased from 8% in 1980 to 17% today, and are expected to exceed 20% by 2030. The federal government subsidizes roughly one-third of these costs. These subsidies are not sustainable as healthcare costs continue to skyrocket, especially in the face of an overall $37 trillion federal deficit.
Second, the industry is regulated under a system that results in an average of 18 years of basic research and 12 years of clinical research for each drug approval. The clinical cost per newly approved drug now exceeds $2 billion. The economics of drug discovery are so unattractive to investors that the federal government and charitable foundations fund virtually all basic research. The federal government does so to the tune of $44 billion per year. When this cost is spread among the 50 or so drug approvals per year, it adds a cost of roughly $880 million to each drug, bringing the total cost to over $3 billion per drug approval. Worse yet, the process is getting slower and more costly each year. As such, drug discoveries under the current research approach will not be a significant contributor to lowering the overall healthcare costs.
Third, the Trump administration has undercut the federal government’s role in healthcare by firing several thousand employees from HHS. Thus, the agency can no longer effectively administer its previously adopted rules and regulations, and therefore, cannot be expected to shepherd drug discovery into lowering healthcare costs.
Fourth, on the positive side, artificial intelligence software combined with the massive and growing computational capacity of supercomputers have shown the potential to dramatically lower the cost of drug discovery and to radically shorten the timeline to identify effective treatments.
Enter Artificial Intelligence (AI) into Drug Discovery
For the past decade, a handful of companies have been exploring advanced automation techniques to improve the many facets of the drug discovery process. Improvements can now be had in fulfilling regulatory documentation requirements, which today add up to as much as 30% of the cost of compliance. More significantly, Ai can be used to accurately create comprehensive clinical documents from raw data with citations and cross-references – and continually update and validate the documentation.
The top Ai drug discovery companies include Insilico Medicine, Atomwise, and Recursion, which leverage Ai to accelerate various stages of drug development, from target identification to clinical trials. Other notable companies are BenevolentAI, Insitro, Owkin, and Schrödinger, alongside technology providers like Nvidia that supply critical Ai infrastructure for the life sciences sector.
Continue reading…Justin Schrager demos Vital.io
Justin Schrager is the CMO of Vital.io. Their technology sits in the hospital telling patients what is going on with their care while they are in the hospital, particularly in the ER. Justin showed a deep demo about the patient experience of using Vital.io which includes what the patient can expect and guides them through the confusing workflow. It allows the patient to make requests, and also lots of guidance about what is happening to them, or for example what lab results might mean. It goes as far as helping people book appointments for follow up with the right doctor. We had a great chat about the product and also about the realities of running a tech company that has to integrate with Epic and many other EMRs.–Matthew Holt
Halo, Heresy, and Health Care
By KIM BELLARD
If you are of a certain age – say, mine, that is to say, a Baby Boomer – last week’s announcement that Microsoft was going to release a new version of Halo on Sony’s PlayStation console may have passed you by. So what, you might have said? If, on the other hand, you are one of the three-fourths of Americans who play video games, you might have more immediately grasped the significance.
The gaming industry is like porn industry in that it tends to be early on the technology front. Since I don’t follow the porn industry, I try to watch the gaming industry to see what trends in it may suggest for the future of other industries, especially healthcare.
In case you weren’t aware, Halo is a Microsoft game, and has historically been played on Microsoft’s Xbox console. Sony’s PlayStation is Microsoft biggest competitor, and has been winning the war handily. So making Halo available on PlayStation is a somewhat surprising move. As Zachary Small wrote in The New York Times: “It is the equivalent of Disney letting Mickey Mouse roam Universal Studios.”
Or, as Grant St. Clair marveled in Boing Boing:
I cannot possibly emphasize how big a deal this is, but odds are you already know yourself. Halo is bar none the biggest IP Xbox has, and historically one of the biggest draws to the console. It’d be like Nintendo suddenly putting Super Mario Galaxy on Steam. This is a tacit admission that Xbox has lost the hardware war — the writing was on the wall already, granted, but this italicizes and underlines it.
A gamer told BBC Newsbeat that the announcement was “massive” and “broke the internet a little bit.” She’s happy about the news, adding: “I know there’s a bit of controversy about it coming to PlayStation, but I don’t see any reason why it should be like that at all. I just think it’s a win for all gamers.”
So, whether you realize it or not, this is kind of a big deal.
Microsoft has desperately been trying to stay relevant in gaming. A couple years ago Microsoft shelled out $70 billion to acquire Activision Blizzard, and a couple years prior to that paid $7.5b for ZeniMax Media. Still, though, as Joost van Dreunen, a market analyst and professor at New York University, told Mr. Small: “When it comes to consoles, Xbox has always been the bridesmaid and never the bride. They just haven’t been able to outmaneuver PlayStation and Nintendo.”
It may have found a way. Earlier this year Microsoft made Gears of War and Forza Horizon 5 available on PlayStation, and Microsoft Flight Simulator will join them later this year. Indeed, Mr. Small points out: “Between April and July, six of the top 10 best-selling games on Sony’s consoles were Microsoft properties.”
I.e., if you can’t beat them, join them.
“We are all seeking to meet people where they are,” Matt Booty, the president of Xbox game content and studios, told Mr. Small. Even more interesting, he further explained: “Our biggest competition isn’t another console. We are competing more and more with everything from TikTok to movies.”
Lesson #1: your competitors are not necessarily the ones you think they are.
Continue reading…The Nobel Prize’s Amazing Track Record in Immunology
By MIKE MAGEE
With the announcement of the 2025 Nobel Prize in Physiology or Medicine last week, the American Association of Immunologists (AAI) took an understandable victory lap, stating: “This Nobel Prize demonstrates how immunology is central to medicine and human health. The ability to harness, modulate, or restrain immune responses holds promise across a vast range of diseases — from autoimmune conditions to cancer, allergies, infectious disease, and beyond.”
This year’s award went to Mary E. Brunkow, Fred Ramsdell and Dr. Shimon Sakaguchi, and it couldn’t have come at a better time as our nation’s scientific community and their governmental, academic and corporate science leaders push back against vaccine skeptic RFK Jr.
As the AAI proudly exclaims, “Since 1901, Nobel Prizes have been awarded to 27 AAI members for their innovation and achievements in immunology and related disciplines.” Make that 28 with the addition of Dr. Sakaguchi, a Distinguished Fellow of AAI.
The field of Immunology and the Nobel Prize in Physiology or Medicine have grown side by side over the past century.
Immunity has Latin roots from the word immunitas which in Roman times was offered to denote exemption from the burden of taxation to worthy citizens by their Emperor. Protection from disease is a bit more complicated than that and offers our White Blood Cells (WBCs) a starring role. These cells are produced in the bone marrow, then bivouacked to the fetal thymus for instruction on how to attack only invaders, but spare our own healthy cells.
WBC’s are organized in specialized divisions. WBC neutrophils engulf bacterial, fungi, and fungi as immediate first responders. Monocyte macrophages are an additional first line of defense, literally gobbling and digesting bacteria and damaged cells through a process called “phagocytosis.” B-cells produce specific proteins called antibodies, designed to learn and remember specific invaders chemical make-up or “antigen.” They can ID offenders quickly and neutralize target bacteria, toxins, and viruses. And T-cells are specially designed to go after viruses hidden within the human cells themselves.
The first ever Nobel Prize in Physiology or Medicine went to German scientist, Emil von Behring, eleven years after he demonstrated “passive immunity.” He was able to isolate poisons or toxins derived from tetanus and diphtheria microorganisms, inject them into lab animals, and subsequently prove that the animals were now “protected” from tetanus and diphtheria infection. These antitoxins, liberally employed in New York City, where diphtheria was the major killer of infants, quickly ended that sad epidemic.
The body’s inner defense system began to reveal its mysteries in the early 1900s. Brussel scientist Jules Bordet, while studying the bacteria Anthrax, was able to not only identified protein antibodies in response to anthrax infection, but also a series of companion proteins. This cascade of proteins linked to the antibodies enhanced their bacterial killing power. In 1919 Bordet received his Nobel Prize for the discovery of a series of “complement” proteins, which when activated help antibodies “drill holes” through bacterial cell walls and destroy them.
Victories against certain pathogens were hard fought. In the case of poliovirus, which had a predilection to invade motor neurons, especially in children, and cause paralysis, it required a remarkable collaboration between government, academic medical researchers and local community based doctors and nurses to ultimately succeed. The effort involved simultaneous testing in children of two very different vaccines.
Current vaccine skeptics like RFK Jr. argue against historic facts.
Continue reading…Let a Thousand DNA Flowers Bloom
By KIM BELLARD
When I saw a headline about “DNA flowers,” I was nonplused. I mean: aren’t all flowers made out of DNA, like every living thing on our planet? Well, it turns out that the DNA flowers are actually soft robots – make that nanobots – so my interest was definitely piqued.
The DNA flowers are out of the Freeman Lab at the University of North Carolina, led by Dr. Ronit Freeman, and the research about them was just published in Nature Nanotechnology with the less sexy title “Reversible metamorphosis of hierarchical DNA-organic crystal.” Had I seen that before “DNA flowers” I probably would have passed it over, so I’m glad someone has an eye towards marketing.
Designer Daniel Burham famously said: “Make no little plans,” and I kind of think he’d like Dr. Freeman. Her bio says she has formal training in computer science, chemistry, nanotechnology, and regenerative medicine (plus even ballroom dancing, if you’re counting), and she probably needs all that training, because her primary interest is “in supramolecular self-assembly, a field where common biological materials like DNA and proteins are seen not simply as information carriers, but also as tunable structural materials for next-generation sensors, nano robots, drug breakthroughs, and clinical tools.”
Accordingly, what the Lab has done now is to combine DNA with inorganic materials to allow them to respond to their environment. Professor Freeman says: “We take inspiration from nature’s designs, like blooming flowers or growing tissue, and translate them into technology that could one day think, move, and adapt on its own,”
Indeed, the Freman Lab prides itself on “bioinspired technologies,” the purpose of which is: “We engineer living and synthetic materials to accelerate healthier outcomes for global communities.” The website talks about “building block designs.” featuring hierarchical self-assembly, temporal structural reconfiguration, and adaptive behavior.
Hence, DNA flowers.
The flowers are actually shaped like flowers, although they are microscopic, and what makes them both interesting and potentially useful is that the various strands of DNA allow them to move, open or close, or trigger chemical reactions, based on environmental cues like temperature, acidity, or chemical signals. The DNA sequences guide nanoparticles to organize into complex structures, which can reverse shape as desired.
“People would love to have smart capsules that would automatically activate medication when it detects disease and stops when it is healed. In principle, this could be possible with our shapeshifting materials,” said Professor Freeman. “In the future, swallowable or implantable shape-changing flowers could be designed to deliver a targeted dose of drugs, perform a biopsy, or clear a blood clot.”
Yeah, I’d love that, and I bet you would too.
The team acknowledges that the technology is in the early stages, but see a future where, say, a DNA flower is injected into a cancer patient, in whom it travels to a tumor, whose acidity causes the petals to release a medication or even take a tiny tissue sample. When the tumor is gone the DNA flower would deactivate until/unless new environmental triggers reactivate it.
Thinking beyond healthcare, the team sees their creations helping to clean up environmental contamination, or as a great digital storage device — up to two trillion gigabytes in just a teaspoon.
The fact that the DNA flowers can sense and respond to their environment makes the team believe these are a major step forward in bridging the gap between living systems and machines. We’re going to see more of that in the rest of the 21st century.
Continue reading…
