Health Tech News This Week – October 23, 2021

What happened in health care technology this week – and why it’s important.

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Papa and Uber Health team up on curbing social isolation among seniors

Senior assistance company Papa is partnering with Uber Health to provide transportation and decrease social isolation among seniors. As reported by Emily Olsen in MobiHealthNews. The collaboration with Uber will allow Papa’s care team to work with Pals and seniors to get rides to medical appointments and other events and find transportation for running errands.

Why it’s important – Transportation generally can be a challenge for older adults, especially if they can’t drive. A report from the National Academies of Sciences, Engineering, and Medicine found nearly one-fourth of adults age 65 and older are considered to be socially isolated. That can have serious health risks, including an increased risk of premature death and dementia.

Quris combines AI with ‘patient on a chip’ to speed drug development and reduce animal testing

The necessity of animal testing is a sad one for the process of drug discovery. Still, there’s seemingly no reasonable alternative to mice, even though they’re not particularly accurate human analogs. Devin Coldeway reports on an alternative in his article on Tech Crunch. Quris claims to have the first real option in its combination of AI with data from a “patient on a chip” that provides remarkably robust testing and automation, all at a considerably lower cost — no mouse required. The Israel-based company’s approach builds on a major study at Harvard concerning the use of so-called “organs on a chip.” These systems, still relatively new but established in the field, use a small amount of stem cell-derived tissue (“organoids”) as a testbed for drugs or treatments — providing a good idea of how, for example, a human liver might respond to a combination of substances.

Quris, which will initially focus on uncommon genetic illnesses that cannot be modeled in animals, has said that it is preparing the platform’s first medicine for clinical trials in 2022. The first Quris medication is intended to treat Fragile X syndrome (FXS), the most prevalent genetic cause of autism and intellectual disability worldwide.

“It’ll no longer be just doing expensive experiments for pharma companies. In five-10 years time this may well be what hundreds of millions of people are doing.”

Isaac Bentwich, CEO and co-founder, Quris

Why it’s important – The basic idea makes perfect sense: build a better small-scale simulation of a human body and use it to gather data that a machine learning system can easily interpret. Considering drug candidates can cost hundreds of millions to get to the clinical stage, it’s more than worth spending even a small fortune (think tens of millions) to weed out a few destined for failure. If the technique is accurate — and indications are that it is — then the risk is practically nil, and it will pay for itself if even a single expensive dead-end is avoided.

DarioHealth launches MSK platform Dario Move

Digital therapeutic company DarioHealth is launching a digital, physical therapy and musculoskeletal (MSK) care platform dubbed Dario Move. As reported by Emily Olsen in MobiHealthNews, Dario Move includes a biofeedback sensor, real-time feedback and support from physical therapists and coaches, and personalized exercise programs designed by therapists.

Why it’s important – Musculoskeletal conditions are the leading contributor to disability worldwide, affecting about 1.71 billion people, according to data compiled by the World Health Organization. Physical therapists are also in demand; the Bureau of Labor Statistics reports the employment of physical therapists is expected to grow 21% between 2020 and 2030.

In a First, Surgeons Attached a Pig Kidney to a Human, and It Worked

Surgeons in New York have successfully attached a kidney grown in a genetically altered pig to a human patient and found that the organ worked normally, a scientific breakthrough that one day may yield a vast new supply of organs for severely ill patients. The New York Times’ Roni Caryn Rabin reported on research being conducted at N.Y.U. Langone Health where surgeons, with the family’s consent, attached the pig’s kidney to a brain-dead patient who was kept alive on a ventilator and then followed the body’s response while taking measures of the kidney’s function. It is the first operation of its kind.

The transplanted kidney was obtained from a pig genetically engineered to grow an organ unlikely to be rejected by the human body. In a close approximation of an actual transplant procedure, the kidney was attached to blood vessels in the patient’s upper leg, outside the abdomen.

“This is a huge breakthrough. It’s a big, big deal.”

Dorry Segev, M.D., Professor of transplant surgery at Johns Hopkins School of Medicine

Why it’s important – As reported, a steady supply of organs from pigs — which could eventually include hearts, lungs, and livers — would offer a lifeline to the more than 100,000 Americans currently on transplant waiting lists, including the 90,240 who need a kidney. Twelve people on the waiting lists die each day. An even larger number of Americans with kidney failure — more than a half-million — depend on grueling dialysis treatments to survive. In large part, because of the scarcity of human organs, most dialysis patients do not qualify for transplants, which are reserved for those most likely to thrive after the procedure.

Many questions remain to be answered about the long-term consequences of such an operation. While the procedure will not be available to patients any time soon, as there are significant medical and regulatory hurdles to overcome, this is a big advance for xenotransplantation.

VR treatment for lazy eye in children gets FDA approval

Nicole Wetsman’s article on The Verge reported on the recent FDA approval of a virtual reality-based treatment for children with the visual disorder amblyopia, or lazy eye. Patients watch modified TV shows or movies through a virtual reality headset to improve their vision. Luminopia’s approach uses TV and movies to develop the weaker eye and train the eyes to work together. Patients watch the show or movie through a headset that shows the images to each eye separately. The images shown to the stronger eye have lower contrast, and the images are presented with overlays that force the brain to use both eyes to see them correctly.

Image Credit: Ophthalmology, the journal of the American Academy of Ophthalmology

Why it’s important – Around 3 percent of children have amblyopia, which develops when the brain and eyes stop communicating correctly. The brain favors one eye, which leads to vision problems in the other eye. It’s the leading cause of vision problems in children. The authors of the clinical trial wrote that they think that the option to pick popular videos might be one reason users stuck to the program — people followed the treatment plan 88 percent of the time. Less than 50 percent of patients adhere to eye patches or blurring drops.

Machine Learning Can Make Lab Testing More Precise

In his blog this week, Dr. John Halamka, President of the Mayo Clinic Platform, highlighted work being done to move beyond standard lab value ranges to personalize lab testing. Almost every patient has blood drawn to measure a variety of metabolic markers. Typically, test results come back as a numeric or text value accompanied by a reference range representing normal values. If the total serum cholesterol level is below 200 mg/dl or serum thyroid hormone level is 4.5 to 12.0 mcg/dl, clinicians and patients assume all is well. But suppose Helen’s safe zone varies significantly from Mary’s safe zone. If that were the case, it would suggest a one-size-fits-all reference range misrepresents an individual’s health status. That position is supported by studies that found the distribution of more than half of all lab test results, which rely on standard reference ranges, differ when personal characteristics are considered.

“In the ‘era of big data and analytics,’ it is almost unconscionable that we still use ‘normal reference ranges’ that lack contextual data, and possibly statistical power, to guide clinicians in the clinical interpretation of quantitative lab results.”

William Morice, M.D., Ph.D., chair of the Department of Laboratory Medicine and Pathology (DLMP) at Mayo Clinic and president of Mayo Clinic Laboratories

Quoting from the blog post: “With these concerns in mind, Israeli investigators from the Weismann Institute and Tel Aviv Sourasky Medical Center extracted data on 2.1 billion lab measurements from EHR records, taken from 2.8 million adults for 92 different lab tests. Their goal was to create “data-driven reference ranges that consider age, sex, ethnicity, disease status, and other relevant characteristics.” To accomplish that goal, they used machine learning and computational modeling to segment patients into different “bins” based on health status, medication intake, and chronic disease. That, in turn, left the team with about half a billion lab results from the initial 2.8 million people, which they used to model a set of reference lab values that more precisely reflected the ranges of healthy persons. Those ranges could then be used to predict patients’ “future lab abnormalities and subsequent disease.”

Why it’s important – This approach offers the potential to diagnose certain diseases much earlier and helps clinicians determine more effective therapies at the N of 1. It also opens the door to things like more equitable organ transplant risk calculations, early identification of cardiac risk, and more. Really impressive stuff!

The Death of Expertise? – COVID scientists & Health Officials in the public eye need protection from threats.

“There is a cult of ignorance in the United States, and there always has been. The strain of anti-intellectualism has been a constant thread winding its way through our political and cultural life, nurtured by the false notion that democracy means that “my ignorance is just as good as your knowledge.”

Isaac Azimov
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I’ve been holding off on posting this for over two weeks now (primarily because of the Azimov quote at the beginning). But these Tweets describing recent comments by Florida’s new political Surgeon General Joseph Ladopo, and Peter Navarro calling Dr, Fauci “the most evil man I ever met” finally pushed me over the edge:

Image from H. Soch’s Twitter Timeline, 10/21/2021
Image from H. Soch’s Twitter Timeline, 10/22/2021

My original intended post follows:

A few weeks ago, I posted an article on this blog about Medtwitter and the personal attacks being leveled at highly respected medical professionals in the public arena, many of them for the first time. Every day, researchers are interviewed in the media, advise policy-makers and write social media posts. They might be discussing the latest coronavirus data, explaining and interpreting new research, or commenting on government policies. Some are now as recognizable as celebrities. For many, the attention has had unpleasant consequences.

Nature has surveyed a subset of researchers who have spoken to the media about COVID-19 and found that 47 people — some 15% of the 321 respondents — had received death threats and that 72 had received threats of physical or sexual violence.

Image Credit: Nature analysis

In response to other survey questions, the researchers who reported the highest frequency of trolling or personal attacks were more likely to say that it had affected their willingness to speak to the media in the future.

Image Credit: Nature analysis

But the examples cited around COVID-19, although sobering enough on their own, reflect a general trend that has been accelerating in recent years – an attack on expertise of any kind. While expertise isn’t dead yet, it’s in trouble. We do not just have a healthy skepticism about experts: instead, we actively resent them, with many people assuming that experts are wrong simply by virtue of being experts. And it doesn’t help when anyone can attach titles like “subject matter expert” or “thought leader” to profiles on social media sites like LinkedIn or Twitter.

Lest you think I’m exaggerating here, I highly recommend you read an excellent book by Tom Nichols titled “The Death of Expertise: The Campaign against Established Knowledge and Why it Matters.” In the book, Nichols shows how this rejection of experts has occurred: the internet’s openness, the emergence of a customer satisfaction model in higher education, and the transformation of the news industry into a 24-hour entertainment machine, among other reasons.

“I fear we are witnessing the death of the ideal of expertise itself, a Google-fueled, Wikipedia-based, blog-sodden collapse of any division between professionals and laypeople, students and teachers, knowers and wonderers—in other words, between those of any achievement in an area and those with none at all.”

Tom Nichols, The Death of Expertise: The Campaign against Established Knowledge and Why it Matters

Nichols’ assertion is never have so many people had so much access to so much knowledge and yet have been so resistant to learning anything. Americans now believe that having equal rights in a political system also means that each person’s opinion about anything must be accepted as equivalent to anyone else’s. The issue, Nichols says, is not indifference to established knowledge; it’s the emergence of a positive hostility to such knowledge. This is new in American culture. It represents the aggressive replacement of expert views or established knowledge with the insistence that every opinion on any matter is as good as every other. This is a remarkable change in our public discourse. And when this trend is applied to medicine and public health, the results can be disastrous.

My take – Intimidation is unacceptable on any scale, and the Nature survey findings should be of concern to all those who care about scientists’ well-being. Such behavior also risks discouraging researchers from contributing to public discussion — which would be a huge loss, given their expertise, during the pandemic. Taking steps to support scientists who face harassment does not mean silencing robust, open criticism and discussion. The coronavirus pandemic has seen plenty of disagreement and changing views as new data have come in, as well as differing stances on which policies to adopt. Scientists and health officials should expect their research to be questioned and challenged and should welcome critical feedback that is given in good faith. But threats of violence and extreme online abuse do nothing to encourage debate — and risk undermining science communication at a time when it has never mattered more.

Some Straight Talk on Nanotechnology in Health Care

“If we can reduce the cost and improve the quality of medical technology through advances in nanotechnology, we can more widely address the medical conditions that are prevalent and reduce the level of human suffering.”

Ralph Merkle, Senior Research Fellow, Institute for Molecular Manufacturing
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I’m probably one of the few people reading this that can remember seeing the 1966 film Fantastic Voyage in the theater. The film is about a submarine crew who are shrunk to microscopic size and venture into the body of an injured scientist to repair damage to his brain. The team faces many obstacles during the mission. An undetected arteriovenous fistula forces them to detour through the heart, where cardiac arrest must be induced to, at best, reduce turbulence that would be strong enough to destroy Proteus. This was science fiction speculating on the development of nanotechnology as introduced by Richard Feynman in 1959. (More on that in a bit.)

Image Credit: 20th Century Fox

Today, we are living at the dawn of the nanomedicine age. If you think that nanorobots and engineered nanoparticles are only part of the world created by the writers of Fantastic Voyage, you might not have heard about the winners of the 2016 Nobel Prize in chemistry. It was awarded to scientists Jean-Pierre Sauvage, Sir J. Fraser Stoddart, and Bernard L. Feringa for having developed molecules with controllable movements. Although molecular nanotechnology is still in its infancy, by awarding the Nobel Prize to these three scientists, the Royal Swedish Academy of Sciences is acknowledging nanotechnology’s huge potential.

In his historic 1959 lecture, “There’s Plenty of Room at the Bottom,” physicist Richard Feynman introduced the world to the concept of nanotechnology. He envisioned a world where we could directly manipulate individual atoms, arranging and rearranging them into useful shapes and configurations. But theory is one thing. Demonstrating feasibility is entirely another. And it’s at this critical nexus point where the work of Sauvage, Stoddart, and Feringa is being acknowledged. All three are being honored for developing molecules with controllable movements and for creating tiny devices that can perform a task when energy is added.

The size of the global nanomedicine market is estimated to grow $291.15 billion by 2026 from $159.43 billion in 2021, growing at a CAGR of 12.80% during the forecast period according to a Market Data Forecast report published in April of this year. So what does the development of nanotechnology mean for the future of health care?

First, some basics – Essentially, nanotechnology comprises science, engineering, and technology conducted at the nanoscale, about 1 to 100 nanometers. It is a well-established branch of science having significant applications in a wide range of medicine. The ability to manipulate structures and properties at the nanoscale in medicine is like having a sub-microscopic lab bench on which you can handle cell components, viruses, or pieces of DNA, using a range of tiny tools, robots, and tubes. Here are a few examples of how this is used in health care:

Researchers from the Max Planck Institute have been experimenting with exceptionally micro-sized – smaller than a millimeter – robots that swim through your bodily fluids and could be used to deliver drugs or other medical relief in a highly targeted way. These scallop-like microbots are designed for swimming through non-Newtonian fluids, like your bloodstream, around your lymphatic system, or across the slippery goo on the surface of your eyeballs.

A team of researchers at the University of Twente (Netherlands) and German University in Cairo has developed sperm-inspired microrobots called MagnetoSperm that can be controlled by weak oscillating magnetic fields. MagnetoSperm can be used to manipulate and assemble objects at nanoscales using an external magnetic field source to control their motion.

Drexel University engineers have developed a method for using electric fields to help microscopic bacteria-powered robots detect obstacles in their environment and navigate them. It means that robots navigate with the help of electric fields, and they can be programmed into getting to a certain point or changing their route, or avoid/go through objects. Bacteria-powered robots might bring tremendous changes in healthcare, which include delivering medication precisely to the point where it is needed, manipulating stem cells to direct their growth, or building a microstructure, for example.

Image Credit: Drexel University

Clottocyte nanorobots function similarly to platelets that stick together to form a blood clot that stops bleeding. They could store fibers until they encounter a wound and then disperse them to create a clot in a fraction of the time that platelets do. Blood–related microbivore nanorobots act like white blood cells and could be designed to be faster and more efficient at destroying bacteria or similar invasive agents.

Respirocyte nanorobots act like red blood cells, but they would have the potential to carry much more oxygen than natural red blood cells do for patients suffering from anemia. They might also contain sensors to measure the concentration of oxygen in the bloodstream.

What are some of the use cases for nanotechnology in health care? – The real advantage of having robots on the nanometer scale is having them work in large groups. Nanotechnology applications in medicine deal with the diagnosis, treatment, monitoring, and prevention of diseases. The recent focus has been shifted toward applying nanoparticle contrast agents in the early characterization of conditions at the cellular and molecular levels, such as atherosclerosis and cardiovascular abnormalities.

The advancement in the nano-based strategies might assist in combining the imaging techniques with conventional drug delivery systems to expedite personalized medicine. Moreover, the development of nano-based, highly efficient markers and detection devices for the early diagnosis and monitoring therapy response will have a significant role in patient management, lowering mortality rates, and improving the quality of life of patients in cases of deadly diseases like cancer and Alzheimer disease. Some specific examples follow below:

Targeted drug delivery – The most significant potential in nanodevices lies in their ability to deliver drugs to the exact location needed. There are many diseases – including cancer – where treatment causes lots of serious side effects precisely because the active substance in the medication cannot differentiate between healthy and diseased tissues. In the future, nanotechnology could provide a great solution.

Imagine programmable nanoparticles, which might help tackle the day-to-day miseries of chronic diseases, such as diabetes. They might deliver insulin to initiate cell growth and regenerate tissue at a target location. In the case of neurodegenerative diseases such as Parkinson’s, nanodevices could deliver drugs, implant neurostimulators, or transport intelligent biomaterials across the blood-brain barrier to direct regeneration within the central nervous system.

Nanotechnology allows primary detection of Alzheimer’s disease – The potential for early detection of AD emerged after two studies conducted in February 2005. The proposed strategies for disease detection in those studies were Localized Surface Plasmon Resonance (LSPR) and Bio- Barcode assay (BCA).

Nanotechnology in liver diseases – Many treatments like targeting hepatitis B virus (HBV) in the liver by adefovirdipivoxil with monostearin-containing solid lipid nanoparticles, in vivo delivery of siRNA against liver fibrosis, lipid-based carrier treatments, OX-loaded nanoparticles in overwhelming HCC drug resistance have been used for various treatments.

Applications of nanotechnology in cardiology – Nanotechnology has applications in cardiology and various vascular processes, which can be diagnostic and therapeutic. They are used to target atherosclerotic lesions, which are further detected by imaging techniques. Genes associated with coronary artery diseases (CAD) can be seen by employing biosensors composed of carbon nanotubes that can interact with the DNA. From the nanotube-DNA interactions, multiple genes can be identified.

Antimicrobial activities of nanoparticles – Studies have shown that silver, zinc, gold, and magnesium NPs possess strong antibacterial activities. Silver nanoparticles have proven to be the most effective antimicrobial agents against bacteria, viruses, and other eukaryotic micro-organisms.

My take – Recent years have seen an explosion in the number of studies showing the variety of medical applications of nanotechnology and nanomaterials. In this post, I’ve highlighted just a small cross-section of this vast field. However, across the range, considerable challenges exist, the greatest of which appear to be how to scale up production of materials and tools and how to bring down costs and timescales. But another challenge is how to quickly secure public confidence that this rapidly expanding technology is safe. And so far, it is not clear whether that is being done. More research is needed to ensure that regulatory agencies can effectively assess the safety of products before they are allowed onto the market. The National Cancer Institute says there are so many nanoparticles naturally present in the environment that they are “often at order-of-magnitude higher levels than the engineered particles being evaluated.” In many respects, they point out, “most engineered nanoparticles are far less toxic than household cleaning products, insecticides used on family pets, and over-the-counter dandruff remedies,” and that for instance, in their use as carriers of chemotherapeutics in cancer treatment, they are much less toxic than the drugs they carry. It would appear, therefore, whether actual or perceived, the potential risk that nanotechnology poses to human health must be investigated and effectively and publicly reported. When technology advances rapidly, knowledge and communication about its safety need to keep pace for it to benefit, especially if it is also to secure public confidence.

Has the Theranos Debacle “Poisoned the Well” for Blood Testing Companies?

“It was such a visible event, and everybody had made those associations and wanted to double-check that it wasn’t a widespread phenomenon in every blood testing company.”

Tim Blauwkamp, Co-founder and Chief Scientific Officer, Karius
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Once famous for a supposedly innovative approach to blood testing, now infamous for allegedly faking it, the names Theranos and Elizabeth Holmes aren’t fading away anytime soon, especially since the Holmes’ trial is currently underway, prompting new podcast and other media coverage. All of this has had a ripple effect for other companies that, like Theranos, were trying to make blood drawing and diagnostics easier for consumers. Even before Theranos imploded, its outsize presence was felt by other companies in the blood testing industry, for better and worse. Blood testing companies had to, in one way or another, come up with convincing explanations about how they were different from Theranos.

So I thought it would be interesting to revisit the competitive landscape of blood testing companies to see whether the “Theranos-Effect” has resulted in a shakeout of companies looking to drive change in that area. And it turns out that competition is alive and well, with several companies making strides in delivering options to assist consumers with more accessible blood testing products and services. Here’s a review of some of the companies out there today:

Genalyte out of San Diego, founded in 2007, has raised about $91.8 million in disclosed funding for its Maverick Detection System. Its backers include top venture capital firms like Khosla Ventures. The company claims that the Maverick Detection System can run up to 26 different tests on a single finger prick of blood in under 15 minutes and can handle approximately 250 patients per day. The platform is built around a disposable array that contains 12 of these silicon chips that can detect in real-time when proteins or antibodies bind to the sensors. Here’s a short video describing how the technology works:

A Silicon Valley startup that got its start in 2016, Athelas has a $3.5 million vote of confidence from Sequoia Capital, another major player in the tech VC world, bringing total funding to about $3.7 million. Its 60-second at-home blood test, housed inside what looks like an Amazon Echo, can reportedly test for diseases such as the flu, bacterial infections, and even cancer. Currently, the device is being used for cancer patients to monitor white blood cell counts for chemotherapy. More importantly, the company has been very transparent (the word appears twice on its website!) and even has FDA clearance for using its device for imaging diagnostics. Here’s a one-minute video showing the Athelas One device:

Silicon Valley-based Karius, founded in 2014, also has a connection to Stanford University, where the company’s pathogen-detection technology was first developed. It has raised $254 million to date, including a sizable $50 million Series A in August that included Khosla and Chinese tech giant Tencent. While requiring a full blood draw, the company can detect more than 1,000 pathogens (whether viral, bacterial, or fungal) by analyzing fragments of DNA in the blood. Here’s a video of a presentation by the Karius Chief Technology Officer Sivan Bercovici at a recent Amazon Healthcare and Life Sciences Symposium:

On the East Coast in Massachusetts, Day Zero Diagnostics, an early-stage biotech company founded in 2016, has reportedly taken in about $11.6 million in funding to date. Day Zero is developing a rapid, whole genome sequencing-based diagnostic that identifies the strain and antibiotic resistance profile of a bacterial infection from the blood within hours. Its machine learning algorithm Keynome uses MicrohmDB, a proprietary microbial resistance database, to determine antibiotic resistance from genomic data. The idea is to avoid using broad-spectrum antibiotics, which is contributing to the global crisis of antibiotic-resistant bugs. This past week, Day Zero Diagnostics was named one of the winners of the 3rd Annual UCSF Health Awards. Here’s a short promotional video:

Finally, Israeli company Sight Diagnostics has developed a Sight OLO product that provides 5-part CBC results with 19 parameters and sophisticated flagging capabilities. It is FDA 510(k) cleared for blood taken directly from either a finger prick or a venous sample. Sight OLO has been validated for patients aged three months and above in a variety of CLIA certified moderately complex clinical settings such as oncology, pediatrics, and urgent care. Sight OLO uses a disposable cartridge per test, eliminating the need for reagent procurement, storage, and liquid waste disposal. Here’s a brief video on the Sight OLO system:

Covering the entire blood testing industry is beyond the scope of a single blog post. In addition to those highlighted above, one could include companies like Grail. Clinical Genomics, CellMax Life, 20/20 Gene Systems, Brainshake, X-Zell, and Innamed to the mix. All are working on blood tests for diseases like cancer, Alzheimer’s, and various metabolic markers.

My take – The demise of Theranos doesn’t seem to have deterred startups or investors from trying to disrupt the blood diagnostic industry. Maybe the global blood testing market, valued at $73.9 billion in 2020 and expected to expand at a compound annual growth rate (CAGR) of 8.3% from 2021 to 2028, is one incentive. One common element in each of these companies is that they are the opposite of Theranos. They are run by actual scientists who take seriously the responsibility of delivering accurate blood tests quickly; they are carefully developing blood tests that work — one at a time; and they share results in peer-reviewed journals and comply with regulatory requirements.

Health Tech News This Week – October 16, 2021

What happened in health care technology this week – and why it’s important.

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Detecting retinal diseases with advanced AI technology

An international group of researchers has successfully applied AI technology to real-world retinal imagery to detect possible diseases more accurately and on a larger scale. As reported in an article by Monash University in Medical Xpress online, the Comprehensive AI Retinal Expert (CARE) system was developed by an international group of researchers from Sun Yat-sen University, Beijing Eaglevision Technology (Airdoc), Monash University, University of Miami Miller School of Medicine, Beijing Tongren Eye Centre and Capital Medical University.

The CARE system was trained to identify the 14 most common retinal abnormalities using 207,228 color fundus photographs derived from 16 clinical settings across Asia, Africa, North America, and Europe, with different disease distributions.

Why it’s important – The CARE system’s performance was similar to that of professional ophthalmologists, and the system retained strong identification performance when tested using the non-Chinese datasets. These findings indicate that the system is accurate when compared to the outcomes of a professional and could allow for more testing to be carried out on a larger scale.

Sneaking drugs into cells using new nanoparticle materials

Scientists have difficulty getting siRNA to where they need to be in the body because, as drugs, they are unstable and generate an immune response, prompting the body to dispel them quickly. Sarah Barron, in an article in Advanced Science News, reported on research being done at the University of Utrecht, the Netherlands, in developing an advanced delivery system to overcome this limitation. The team created hybrid nanoparticles to package and protect siRNA from enzymes that would degrade them.

Why it’s important – By altering the ratio of EV to liposome in the hybrid formulation, it is possible to choose which cells will take up the drug selectively. Multiple cell types, including kidney, nerve, and ovarian cells, could take up the hybrid particles without any toxic effect or adverse effect. These are essential factors when designing new drugs because, in the body, hybrids have to potential to target only diseased cells types and limit unwanted side effects. As with any new drug formulation, however, the team still has some hurdles to overcome before this treatment platform can become commercially available.

Watch for a more detailed discussion on the use of nanotechnology in health care in a post coming next week.

Detector Mask – Biological Circuits for Garments Reveal COVID-19 and More

Masks and testing have been vital to the ­COVID-19 pandemic response—and now devices that combine the two may be on the way. As published in Nature Biotechnology, Harvard University and Massachusetts Institute of Technology researchers used synthetic biology to create a face mask that accurately detects the ­COVID-causing virus. Previous efforts have used engineered bacteria in these sensors, but living cells bring chal­lenges (like keeping them fed) and biohazard risks. The new research makes wearable devices with freeze-dried “cell-free” circuits built from genes, enzymes, and other cell components, which can be placed on porous, flexible materials and easily stored. The technique makes versatile, “programmable” sensors that could be quickly adapted to detect virus variants.

Why it’s important – The prototype mask activates with a push-button that rehydrates the sensor, starting reactions that break the virus apart and amplify its DNA for detection. The complete process produces a color change within 90 minutes of activation—say, when worn by a hospital patient. The single-use masks need no power source nor operator expertise and work at typical room temperature and humidity. Sensitivity was similar to most lab tests. They hope to commercialize the mask to sell for around $5.

Custom 3D-Printed Wearables Never Need To Recharge

Researchers have developed a wearable device they call a “biosymbiotic device,” which has several benefits. Emily Dieckman authored an article in Futurity online that described research being done at the University of Arizona. Wearable sensors to monitor everything from step count to heart rate are nearly ubiquitous. But for scenarios such as measuring the onset of frailty in older adults, promptly diagnosing deadly diseases, testing the efficacy of new drugs, or tracking the performance of professional athletes, medical-grade devices are needed. The new devices are custom 3D-printed and based on body scans of wearers, but they can operate continuously using a combination of wireless power transfer and compact energy storage.

Why it’s important – Current wearable sensors face various limitations. Smartwatches, for example, need to be charged, and they can only gather limited amounts of data due to their placement on the wrist. The ability to specialize sensor placement allows researchers to measure physiological parameters they otherwise couldn’t. Because these biosymbiotic devices are custom fitted to the wearer, they’re also highly sensitive. The biosymbiotic device that the team has introduced uses no adhesive, and it receives its power from a wireless system with a range of several meters. The device also includes a small energy storage unit so that it will function even if the wearer goes out of the system’s range, including out of the house.

These “Focused Research” Organizations Are Taking On Gaps in Scientific Discovery

Adele Peters’ article in Fast Company online reports on a new organization called Convergent Research, spun out of Schmidt Futures, the philanthropic initiative founded by former Google CEO Eric Schmidt and his wife Wendy, explicitly designed to take on the problems that can’t easily be addressed elsewhere. Inside Convergent Research, new “focused research organizations,” or FROs, will each take on specific challenges, with a startup-like team under a CEO aiming to deliver a solution that can help accelerate the field—without worrying about grants or making a commercially viable product.

A FRO called Cultivarium, for instance, will work to develop a platform that reduces the time, cost, and risk of studying and engineering different microbes that aren’t currently used in synthetic biology. Another FRO, called E11 Bio, will work on a platform for mapping the architecture of the whole brain. Convergent plans to launch similar organizations to tackle other gaps in technology for problems like climate change, developing new antibiotics, or generating data for preventing disease.

Why it’s important – Some scientific and technical challenges slip through the gaps of existing research because they’re not quite a fit for academic labs, or startups, or other organizations doing R&D. Creating these focused research organizations allows researchers to take on complex challenges that wouldn’t get funding or additional resources and removes structural obstacles that hinder essential research.

‘Virtually painless’ needle-free injections developed in Netherlands

Researchers in the Netherlands are creating laser technology to enable “virtually painless” injections without needles in what they call a breakthrough that will ease fear and lower the threshold for vaccinations. As reported in Reuters by Esther Verkaik, David Fernandez Rivas, a professor at Twente University and research affiliate at the Massachusetts Institute of Technology, has developed The “Bubble Gun,” which uses a laser to push tiny droplets through the outer layer of the skin.

Within a millisecond, the glass that contains the liquid is heated by a laser; a bubble is created in the liquid, pushing the fluid out at a velocity of at least 100 km per hour (60 mph). That allows them to penetrate the skin without damage. You don’t see any wound or entry point.

Why it’s important – Roughly one in five Dutch people are afraid of needles, so it is expected that the invention will not only help more people get vaccinated but will also prevent the risk of contamination by dirty needles and reduce medical waste. It could, however, take 1-3 years for the method to be available to the general public, depending on the progress of research and regulatory issues.

iHuman? – Some Straight Talk on Brain/Computer Interfaces (BCI) in Health Care

“The applications for neural interfaces are as unimaginable today as the smartphone was a few decades ago.”

Chris Toumazou FREng FMedSci, FRS, co-chair, the Royal Society Steering Group on Neural Interface Technologies
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Brain-computer interfaces (or BCIs) are the ultimate examples of convergence. They sit at the intersection of nearly everything discussed on this blog, including biotechnology, nanotechnology, and materials science. There’s also quantum computing, which allows us to model complex environments like the human brain, and artificial intelligence, which helps us interpret what we’ve modeled. And high-bandwidth networks that would enable us to upload neurological signals into the cloud.

A new UK Royal Society report called “iHuman: blurring lines between mind and machine” is for the first time systematically exploring whether it is “right” or not to use neural interfaces – machines implanted in or worn over the body to pick up or stimulate nervous activity in the brain or other parts of the nervous system. It also sets out recommendations to ensure the ethical risks are understood and to set up a transparent, public-driven but flexible regulatory framework that will allow the UK to lead innovative technology in this field.

Many people worldwide already benefit from medical neural interface technologies. In many cases, their conditions have proved drug-resistant, and ‘electroceuticals’ have achieved what pharmaceuticals could not. Cochlear implants that substitute damaged parts of the ear provide hearing for around 400,000 people. Thousands of people with conditions such as Parkinson’s disease, dystonia, and essential tremor have been treated with deep brain stimulation. External, wearable interfaces include a range of devices that assist people who have had a stroke in their rehabilitation. People otherwise unable to communicate have been able to spell out words using brain signals alone, providing them with an invaluable means of interaction.

Other treatments are still being explored in the laboratory, such as transcranial direct current stimulation (tDCS) for depression. Others are in the early stages of medical use, such as DBS used for epilepsy or the ‘Mollii Suit’ body garment that delivers electrical stimulation to people with muscle spasticity caused by conditions like stroke or cerebral palsy. By 2040, according to the Royal Society report, conditions like Alzheimer’s disease will probably be treated using a BCI.

“In 10 years’ time this is probably going to touch millions of people.”

Tim Constandinou, Co-Chair, Royal Society Steering Group on Neural Interface Technologies

What’s the best way to segment the brain-computer interface space? – As with all emerging technologies, there are multiple ways to segment the neural interface market. The method that I’ve found works best for me in discussing this topic is to segment by whether the technology is invasive (sub-segmented into recording and stimulating categories) or non-invasive (also sub-segmented into recording and stimulating categories). In the two sections that follow, I’ll list some of the technologies in each category. (For a detailed description of each technology, see the entire Royal Society report pages 30-33, using the link above.)

Invasive technologies

Non-invasive technologies

Recording category

Recording category

  • ECoG – electrocorticography
  • Cortical implant
  • Neural dust
  • Neural lace
  • Neuropixels
  • Stentrodes
  • Optogenetics
  • EEG – Electroencephalography
  • MEG – Magnetoencephalography
  • fMRI – Functional magnetic resonance imaging
  • fNIRS – Functional near-infrared spectroscopy
  • MMG – Mechanomyography

Stimulation category

Stimulation category

  • Cochlear implants
  • DBS – Deep brain stimulation
  • VNS – Vagus nerve stimulation
  • Retinal implants
  • Vestibular implants
  • FES – Functional electrical stimulation
  • tDCS – Transcranial direct current stimulation
  • TENS – Transcutaneous electrical nerve stimulation
  • TMS – Transcranial magnetic stimulation

Where we are today – Scientists in this pioneering field make it clear that we have not even scratched the surface of the potential applications of brain-computer interfaces, which could not only help solve medical issues like dementia, epilepsy, untreatable depression, and obesity but could help people communicate without sound and even without words. We could share sensory experiences with others far away, as by sending “neural postcards,” letting others visually experience their trip or “taste” the food they are eating, by sharing the brain’s neural activity.

In its 2018 report, The Market for Neurotechnology: 2018 – 2022 (recently updated to 2020-2024 – purchase required), Neurotech reports projected that the overall worldwide market for neurotechnology products – defined as “the application of electronics and engineering to the human nervous system” – would be $8.4 billion in 2018, rising to $13.3 billion in 2022. The 2018 figure represents less than 1% of the estimated total 2018 global spending on research and development of around $2 trillion or less than 5% of all estimated life science research and development spending.

Probably the most publicized effort in the BCI space has been Neuralink, Elon Musk’s initiative that will allow paralyzed people to use computers to communicate using their thoughts alone. This could improve the quality of life for people with locked-in syndrome, for instance, where the brain is normal but is cut off from the rest of the body. However, Musk has plans that are far in advance of helping people to replace something they have lost. He foresees that artificial intelligence (AI) could advance so rapidly and so much that it forces humans to become subsidiary, something like a house pet. Installing an AI layer would be an excellent way to stay in step with AI instead, he says, and the “neural lace” interface his company is producing is an initiative designed to do just that. He plans to begin clinical trials of these neural threads next year. Here’s a brief video showing how Neuralink works:

Neuralink plans a two-gigabit-per-second wireless connection from the brain to the cloud and wants to begin human trials by the end of 2021.

The other startup receiving a ton of press coverage is Kernel, funded by Bryan Johnson, who sold his payments company to Pay Pal for $800 million in 2013. Johnson then started a venture fund called the OS Fund, which aims to “rewrite the operating systems of life” for the benefit of humanity. Johnson has courted some big names in the neuroscience field from the MIT community. Ed Boyden, a professor of biological engineering and brain and cognitive sciences at MIT, has signed on as a chief scientific advisor. And Adam Marblestone, a neuroscientist who focuses on improving data collection from the brain, is now Kernel’s chief strategy officer, having worked in the past with Boyden’s Synthetic Neurobiology Group.

“Brain science is the new rocket science.”

Bryan Johnson, Kernel founder

In addition to these two big-budget, high-profile companies, other researchers and companies are exploring the development of neural interfaces. BrainGate is a long-running multi-institution research effort in the US to develop and test novel neurotechnology to restore communication, mobility, and independence in people whose minds are okay but who have lost bodily connection due to paralysis, limb loss, or neurodegenerative disease. Paradromics is focused on many more and smaller electrodes but aims for an even higher density of probes over the face of its neural implant. Synchron, based in Australia and Silicon Valley, has a different approach. The device avoids open brain surgery and scarring because it is inserted using a stent through a vein in the back of the neck. Once in position next to the motor cortex, the stent splays out to embed 16 metal electrodes into the blood vessel’s walls from which neuronal activity can be recorded.

And recently, a newly formed MIT research center was announced that is explicitly studying the fusion of the human body with advanced technology like robotic exoskeletons and brain-computer interfaces — with the ambitious goal of developing systems to restore function for people with physical and neurological disabilities. The new research center will fall under the leadership of MIT Media Lab professor Hugh Herr, who is a double amputee himself and has come to be known as a leader in the field of robotic prosthetics. In the MIT announcement, Herr said he sees this new initiative as an essential step toward eliminating physical disabilities altogether.

“We must continually strive towards a technological future in which disability is no longer a common life experience.”

Hugh Herr, MIT Media Lab

The MIT faculty working within the new research center will have three primary goals, according to the announcement. The first is to develop what MIT is calling a “digital nervous system,” or tools that circumvent spinal cord injuries by stimulating muscles that have been cut off from the central nervous system — which is remarkably similar to an unrelated neural implant currently being tested in human volunteers. On top of that, the center aims to improve exoskeleton technology to help people with weakened muscles move around naturally, as well as to develop new bionic limbs that can restore a complete, natural sense of touch.

What are the ethical issues raised by the development of brain-computer interfaces? – Some of the most prominent are: how, if at all, should use of the technologies be limited; what ‘normality’ means; how can privacy be protected and which specific concerns, for example around surveillance, might be felt strongly by particular social groups; whether neural interfaces may contribute to widening inequalities; and what it means to be human.

“As our experience with social media has shown, we do need to think ahead to guard against possible harmful uses. If recent experience has shown us anything, it’s that individual consent and opting in or out is not enough to protect either individuals or society more widely.”

Sarah Chan, Co-author, iHuman: blurring lines between mind and machine

My take – Brain-computer interfaces hold enormous promise as life-changing technologies for people with a variety of conditions. However, the technique is still in its infancy, and designing sensors that can effectively and safely monitor brain activity is a work in progress. Part of the issue is the complexity of the brain, and capturing this using a single sensor or affixing enough sensors in place which is extremely difficult. The future impact of BCI in terms of patient care is slowly starting to come into focus. As with most emerging technologies, regulatory, privacy, and reimbursement issues lag the development of the technology itself. For these and other reasons, the clinical use of these BCI technologies will be limited to Universities and health systems with comprehensive neuro service line programs for the foreseeable future.

Some Straight Talk on the Internet of Medical Things (IoMT) in Health Care

“There’s no doubt that the emerging IoHT has vast implications for the healthcare industry, but it will equally impact those who are not in the business of healthcare. Soon, anything will be able to link up to the IoHT.”

Joseph Kvedar, M.D., Senior Advisor, Virtual Care, Mass General Brigham
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In healthcare, the Internet of Things is not a new concept. The healthcare industry has been using telemetry for many years. Telemetry is similar in that it gathers data remotely and transmits it via radio or cellular signal. Still, the healthcare industry has made little progress in incorporating Internet of Medical Things technologies into healthcare in recent years. The technologies we see today may offer a glimpse of what is to come. Hospitals, clinics, diagnostic laboratories, and surgical centers worldwide are already using various implanted, stationary, and wearable medical devices for patients. Web applications also incorporate the technology of the Internet of Medical Things to improve workflow management, patient monitoring, medication management, telemedicine, and more.

If you are interested in a comprehensive discussion on the Internet of Medical Things, the best resource I’ve found is this book by Dr. Joseph Kvedar, Vice President, Connected Health, Partners HealthCare. Connecting to the IoHT presents a huge opportunity for all sectors of business and society, including payers, providers, pharma and biotech companies, technology vendors, and newcomers to the space with fresh, creative ideas. This book shares Dr. Kvedar’s observations as a 20-year veteran in the field.

First, some basics – The Internet of Medical Things (IoMT) is an amalgamation of medical devices and applications that connect to information technology systems using networking technologies. The IoMT market consists of intelligent devices, such as wearables and medical/vital monitors, strictly for health care use on the body, in the home, or in community, clinic, or hospital settings; and associated real-time location, telehealth, and other services.

The best depiction of what the IoMT might be like is shown in this excellent video from Cable Labs. I’ve shown this in conference presentations over the years, and it always strikes an emotional chord with the audience.

How I like to segment the IoMT market – If you review the literature on the topic, you’ll find multiple segmentation models proposed by different stakeholders in the industry. In my previous work, I’ve found that the easiest way to communicate the breadth of applications for the IoMT was to use a segmentation model by location, namely: on the body, in the home, in the community, in the clinic, or in the hospital settings. Let’s look at each in a bit more detail:

On the body applications – The on-body segment can be broadly divided into consumer health wearables and medical and clinical-grade wearables. Consumer health wearables include consumer-grade devices for personal wellness or fitness, such as activity trackers, bands, wristbands, sports watches, and smart garments. Clinical-grade wearables include regulated devices and supporting platforms that are generally certified/approved for use by one or more regulatory or health authorities, such as the U.S. Food and Drug Administration. These devices are used with expert advice or a physician’s prescription (e.g., Kardia ECG device).

In the home applications – The in-home segment includes personal emergency response systems (PERS), remote patient monitoring (RPM), and telehealth virtual visits. A PERS integrates wearable device/relay units and a live medical call center service to increase self-reliance for homebound or limited-mobility seniors (e.g., LifeAlert). RPM comprises all home monitoring devices and sensors used for chronic disease management, which involves continuous monitoring of physiological parameters to support long-term care in a patient’s home to slow disease progression; acute home monitoring, for continuous observation of discharged patients to accelerate recovery time and prevent re-hospitalization; and medication management, to provide users with medication reminders and dosing information to improve adherence and outcomes. (For a more detailed look at Remote Patient Monitoring, check out my previous blog post on the topic here). Telehealth virtual visits include virtual consultations that help patients manage their conditions and obtain prescriptions or recommended care plans.

In the community applications – This is a fairly broad segment that generally consists of five applications. Mobility services allow passenger vehicles to track health parameters during transit. Emergency response intelligence is designed to assist first responders, paramedics, and hospital emergency department care providers. Kiosks are physical structures, often with computer touchscreen displays, that can dispense products or provide services such as connectivity to care providers. Point-of-care devices are medical devices used by an advanced practice provider outside of the home or traditional health care settings, such as at a medical camp. Logistics involves the transport and delivery of health care goods and services, including pharmaceuticals, medical and surgical supplies, medical devices and equipment, and other products needed by care providers.

In the clinic applications – This segment includes IoMT devices that are used for administrative or clinical functions (either in the clinic, in the telehealth model, or at the point of care). Examples include Rijuven’s Clinic in a Bag, a cloud-based examination platform for clinicians to assess patients at any point of care, or the Tytocare platform.

In the hospital applications – This segment is divided into IoMT-enabled devices and a larger group of solutions in several management areas:

  • Asset management monitors and tracks high-value capital equipment and mobile assets, such as infusion pumps and wheelchairs, throughout the facility.
  • Personnel management measures staff efficiency and productivity.
  • Patient flow management improves facility operations by preventing bottlenecks and enhancing patient experience—for example, monitoring of patient arrival times from an operating room to post-care to a patient room.
  • Inventory management streamlines ordering, storage, and use of hospital supplies, consumables, and pharmaceuticals, and medical devices to reduce inventory costs and improve staff efficiency.
  • Environment (e.g., temperature and humidity) and energy monitoring oversees electricity use and ensures optimal conditions in patient areas and storage rooms.

Where we are today – The IoMT brings together the digital and physical worlds to improve the speed and accuracy of diagnosis and treatments and monitor and modify patient behavior and health status in real-time. It also improves health care organizations’ operational productivity and effectiveness by streamlining clinical processes, information, and workflows. The global IoMT market was valued at $44.5 billion in 2018 and is expected to grow to $254.2 billion in 2026, according to AllTheResearch. The smart wearable device segment of IoMT, inclusive of smartwatches and sensor-laden smart shirts, made up for the largest share of the global market in 2018, at roughly 27 percent, the report finds. This area of IoMT is poised for even further growth as artificial intelligence is integrated into connected devices and can prove capable of the real-time, remote measurement and analysis of patient data.

My take – If you’ve been following this blog for any time, you’re probably seeing a pattern developing. Many of the technologies I’ve been reporting on are linked. That’s the beauty of exponential growth technologies. An increase in functionality in one technology has a multiplier effect on others. The potential for the Internet of Medical Things is promising. As more healthcare providers successfully adopt these technologies, approval for more devices will increase. This increase will likely be cautious, but it will change how we give and receive care for the better. Inclusion of IoMT devices into healthcare will enhance efficiency, reduce costs, save time, improve health record storage, foster informed decision making on delivering proper treatment to patients, and improve the operational efficiency of systems and processes, all leading to the creation of an intelligent patient-centric healthcare system.

Health Tech News This Week – October 9, 2021

What happened in health care technology this week – and why it’s important.

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Alexa launches service to help caregivers remotely monitor and assist seniors

Emily Olsen reported on this product release in an article on MobiHealthNews Global edition. Alexa Together allows multiple family members or caregivers to check in on an aging loved one. They can set customized alerts, such as a warning if their family member hasn’t used Alexa for a certain amount of time, and remotely help their loved one, like setting a reminder to take medications or managing a shopping list. The subscription, which Amazon will release later this year in the U.S., will cost $19.99 a month and builds on the company’s Care Hub features that debuted in November 2020. The subscription also includes a 24/7 urgent response service, and it’s compatible with third-party fall detection devices.

Why it’s important – The demand for remote monitoring for seniors is growing as baby boomers age. By 2030, all members of the massive baby boom generation will be older than 65, and the Census Bureau predicts older people over 65 will outnumber children under the age of 18 for the first time in U.S. history by 2034. As I’ve discussed in previous posts, Amazon has expanded its reach in the healthcare and digital health space. Just this past month, Amazon announced a beta program for a personal Alexa-powered robot. (Subscription required) Named Astro, the robot is designed to keep a watchful eye on your home — and you. The robot comes equipped with a periscope camera and microphone, as well as a touchscreen. It can autonomously navigate your house to investigate security issues or follow you around while you’re on a video call. It’s expensive, and the medical applications have not been clearly defined. The significant risk with Astro is that it never makes it to a formal product and is another Fire Phone. Interesting work – but no guarantees on this one.

Abu Dhabi on track to operate world’s first city-wide medical drone network

Using drones to transfer and deliver medical supplies is now a step closer to becoming a reality in the United Arab Emirates (UAE) capital. As reported by Rachel McArthur in MobiHealthNews global edition, Abu Dhabi’s Department of Health (DoH) has announced it is in the process of testing an advanced drone network for the healthcare sector in the emirate. Said to be a “first of its kind” project in the Middle East and North Africa (MENA) region, the new network – made up of 40 drone stations – is expected to be established in 2022.

The project aims for drones to safely transfer medical supplies, medicine, blood units, vaccines, and samples between laboratories, pharmacies, blood banks, and healthcare facilities in the city. Phase One of testing has reportedly already been completed, with Phase Two now being run and scheduled to conclude by the end of the year.

And, the UAE is not alone in experimenting with drone delivery in health care. This article highlights other unique global projects utilizing drones in delivering care in countries including India, Nepal, Fiji, Uganda, and Rwanda.

Why it’s important – Since this is a large-scale project, the intention is to help in emergencies and contribute to reducing occupancy rates in healthcare facilities and enhancing the quality of patient outcomes. The Authority added that the network is also expected to reduce carbon dioxide emissions and traffic congestion.

Apple study finds Watch can detect more types of irregular heartbeats

New findings from the Apple Heart Study indicate that Apple Watches can identify irregular heartbeats other than atrial fibrillation arrhythmias. Mallory Hackett published an article in MobiHealthNews global edition highlighting ongoing research at the Stanford University School of Medicine, which has been ongoing since 2017. It has enrolled 419,297 Apple Watch and iPhone owners across the U.S. to study the company’s irregular heart rate-detecting algorithm.

The most common arrhythmias detected were premature atrial contractions, premature ventricular contractions, atrial tachycardia, and nonsustained ventricular tachycardia, according to the study. Additionally, the researchers found that almost a third of participants notified of arrhythmia but didn’t have atrial fibrillation on the subsequent ECG reading were eventually diagnosed with atrial fibrillation later in the study. This signals that the Apple Watch could have detected early signs of atrial fibrillation that the ECG patch missed.

Why it’s important – The researchers say that defining care options for patients with arrhythmias other than atrial fibrillation “is important as AF detection is further investigated, implemented, and refined.” Also, it’s another example of Apple’s continuing efforts in health care research, which includes work in asthma, Women’s health, hearing, and depression.

Scientists reverse pancreatic cancer progression in ‘time machine’ made of human cells

What makes pancreatic cancer so deadly is its covert and quick spread. Now, a “time machine” built by Purdue University engineers has shown a way to reverse the course of cancer before it spreads throughout the pancreas. Purdue University News posted an article on their research}.

“These findings open up the possibility of designing a new gene therapy or drug because now we can convert cancerous cells back into their normal state.”

Bumsoo Han, Purdue professor of mechanical engineering and program leader of the Purdue Center for Cancer Research

The time machine that Han’s lab built is a lifelike reproduction of a pancreatic structure called the acinus, which produces and secretes digestive enzymes into the small intestine. Pancreatic cancer tends to develop from chronic inflammation when a mutation has caused these digestive enzymes to digest the pancreas itself.

Why it’s important – If there were a way to go back in time to reprogram the cancerous acinar cells that produce those enzymes, then it might be possible to reset the pancreas completely. The model that Purdue researchers developed overcomes a significant challenge in accurately capturing the anatomical complexity of the acinus, a circular cavity lined with cells. Han’s lab is currently conducting experiments exploring a possible gene therapy based on these findings.

A ‘Historic Event’: First Malaria Vaccine Approved by W.H.O.

As reported in multiple news outlets this week, the world has gained a new weapon in the war on malaria, among the oldest known and deadliest infectious diseases: the first vaccine shown to help prevent the disease. The new vaccine, made by GlaxoSmithKline, rouses a child’s immune system to thwart Plasmodium falciparum, the deadliest of five malaria pathogens and the most prevalent in Africa.

The World Health Organization on Wednesday endorsed the vaccine, the first step in a process that should lead to wide distribution in developing countries. The vaccine, called Mosquirix, is not just a first for malaria — it is the first developed for any parasitic disease.

“It’s a huge jump from the science perspective to have a first-generation vaccine against a human parasite.{

Pedro Alonso, M.D., Director, W.H.O. global malaria program

Why it’s important – Malaria kills about half a million people each year, nearly all of them in sub-Saharan Africa — including 260,000 children under 5. A modeling study last year estimated that if the vaccine were rolled out to countries with the highest incidence of malaria, it could prevent 5.4 million cases and 23,000 deaths in children younger than five each year. The next step is for Gavi, the global vaccine alliance, to determine that the vaccine is a worthwhile investment.

AI Finds Potential Treatment for Incurable Pediatric Brain Cancer

Cami Rosso in Psychology Today The Future Brain reports on a new study published in Cancer Discovery that shows how AI machine learning can identify a new possible treatment for incurable pediatric brain cancer. Diffuse intrinsic pontine glioma (DIPG) is an incurable infiltrating glioma. The median overall survival of DIPG ranges from nine months to a year, according to the scientists at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, who led the research study. DIPG is a type of malignant brain tumor found in the pons region of the brainstem that mainly affects children between the ages of five to seven years of age, according to

The researchers sought to find medications targeting ACVR1 mutations in diffuse intrinsic pontine glioma by using the over 40 million documents with more than a billion relationship edges in the BenevolentAI’s knowledge graph. The BenevolentAI knowledge graph enables scientists to computationally discover novel insights such as ways to repurpose existing medications for new treatments.

“Using Artificial Intelligence, we identify and validate the novel combination of vandetanib and everolimus in these children based upon both signaling and pharmacokinetic synergies, experimentally and clinically.”

From the Cancer Discovery study

Why it’s important – 25% of patients with the incurable brainstem tumor DIPG harbor somatic activating mutations in ACVR1. However, no approved drugs are targeting the receptor. The researchers assessed the AI-predicted drug combination of vandetanib and everolimus with four children with DIPG and confirmed ACVR1 mutations. The next step is to expand testing and enter full-scale clinical trials to evaluate if this can help children with diffuse intrinsic pontine glioma.

Some Straight Talk on Digital Therapeutics (DTx) in Health Care

“Digital therapeutics (DTx) deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders.”

The Digital Therapeutics Alliance
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A novel trend coming out of the fast-growing mobile health market, digital therapeutics are software products used to treat medical conditions. These products are designed to enable patients to take greater control over their care, similar to consumer wellness apps but with one key difference: Digital therapeutics focus on delivering clinical outcomes.

Particularly important in the definition above is that digital therapeutics are evidence-based, clinically evaluated software. However, while digital therapeutics are software-based, they are subject to the same regulatory oversight that traditional medicines undergo. This ensures that the product is safe to use, effective as well as has a clinical impact. They can also be prescribed independently or in concert with other medications or treatments to optimize patient outcomes.

First, some basic information on digital therapeutics – DTx products represent a new category of evidenced-based therapeutic technologies that support clinicians in delivering high-quality patient care. They address a range of disease states and provide a wide variety of software-based interventions. As defined by The Digital Therapeutics Alliance, DTx products are used independently or in concert with other medical therapies to:

  • Directly impact disease state measures and clinical outcomes
  • Expand access to safe, confidential, and effective medical treatments
  • Provide therapies for previously un- or undertreated conditions
  • Extend clinicians’ ability to care for patients
  • Maximize patient engagement
  • Close gaps in care
  • Lower overall healthcare costs

Digital therapeutics are not at a conceptual stage but are well within the production and delivery stages. DTx targeting chronic medical and mental conditions have been developed over the past 15 to 20 years. The Digital Therapeutics Alliance even has a product library of DTx. This list can be essential as it helps differentiate DTx that physicians can prescribe from unregulated apps that overpopulate online app stores. The organization says that all products claiming to be digital therapeutic must adhere to these foundational principles:

Image Credit: The Digital Therapeutics Alliance

Where are we today? – Extracting some examples from the product library referenced above gives us a sense of some diseases that can benefit from digital therapeutics.

One such product is Insula, a prescription-only software that assists type 2 diabetics in managing their condition. It recommends patients’ personalized insulin doses as well as acts as a coach in managing their diabetes. A randomized trial conducted in France showed that a precursor to the software helped improve glucose control compared with standard care.

Another example is Kaiku Health. The app supports cancer patients by allowing them to report potential symptoms that they might encounter; subsequently, it shares self-care instructions with them. Through Kaiku Health, patients can also message their care team. Studies have shown that such forms of digital monitoring lead to good patient adherence and satisfaction, as well as save time by reducing in-person visits or even phone consultations.

What are some of the challenges in implementing digital therapeutics?Reimbursement and oversight are two significant areas of concern in health care systems, yet the regulatory landscape surrounding DTx is still in flux. The first question that must be answered is who is responsible for regulating DTx. The second is the relation of DTx to machine learning and whether changes in software or updated machine learning algorithms would require reapproval or new approvals. The Total Product Lifecycle approach currently under consideration by the FDA could address some of these concerns.

System-level challenges of DTx also include cybersecurity. DTx interfaces with, and is reliant on, multiple nonmedical entities, including internet, phone, and cloud storage service providers. There are no global answers to these issues, but patients and clinicians alike will be reluctant to transmit sensitive health data over unsecured channels. Moreover, reimbursement for DTx is moving slowly. Some private insurers pay for DTx as prescribed, but nationwide reimbursement codes remain uncommon.

A yet unexplored problem is adherence to DTx use once prescribed; as large-scale implementation becomes a reality, this issue will need to be appropriately addressed. “App burnout,” a phenomenon referring to the short-term use of apps, may be relevant to DTx as the prescribed length of time (i.e., weeks, months, years) increases.

My take on the future of digital therapeutics – Digital therapeutics are not just a fad. They have the potential to address unmet patient needs that traditional treatments and therapies have been unable to meet. The ability of companies that leverage digital therapeutics to address these gaps, in combination with the much faster product development timelines, could give them a significant advantage over traditional life sciences companies.

“Digital therapeutics are poised to shift medicine’s emphasis from physically dosed treatment regimens to end-to-end disease management based on behavioral change.”

The Digital Therapeutics Alliance

The potential of digital therapeutics has players across multiple industries weighing their options. Technology giants are interested in developing and acquiring digital therapeutics to enter and change the health care landscape. Payers are exploring whether digital therapeutics can deliver better quality of life and outcomes while maintaining or reducing the overall cost of care in specific disease areas while independently analyzing how patient data, which could be collected through such products, can be leveraged to inform coverage. Start-ups are coming up with innovative digital therapeutic ideas to attract investors.

Thus far, the main DTx developments have been delivering already proven treatments via electronic/software means. However, the future of DTx will likely include higher-order constructs and products that address comorbid disorders.

Leveraging DTx to improve mental and physical health is likely to be the biggest, paradigm-shifting change that medicine has known since the invention of antibiotics. However, how to apply these tools remains an area that needs operationalization. DTx is at the nexus of digital innovation and scalability/wide-scale use of digital interventions, with more investment and exciting developments on the horizon.

Some Straight Talk on Quantum Computing Applications in Health Care

“Nature isn’t classical, dammit, and if you want to make a simulation of nature, you’d better make it quantum mechanical.”

Richard Feynman, Nobel Prize-winning theoretical physicist
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Quantum computing remains a nascent technology, but its potential is already being felt across many sectors. Quantum computers will soon be able to tackle some problems much faster than any conventional computer. These capabilities could significantly impact how businesses approach challenges involving a daunting number of variables and potential outcomes — like simulating chemical interactions, optimizing logistics, or sorting through massive datasets. Health care is one industry that stands to benefit from the use of quantum computing. But, as with any emerging technology, there are potential upsides and downsides to its adoption.

First, some basics – Quantum physics describes the behavior of atoms and fundamental particles, like electrons or photons. A quantum computer operates by controlling the behavior of these particles, which is very different from how our traditional computers work. It isn’t by chance that quantum computers don’t measure their performance in bits, but qubits – while the former resembles either ones or zeros, and thus the mathematical description of problems, the latter signifies states, which can simultaneously take up ones and zeros, or anything in-between. This means qubits have fluid identities or represent certain percentages and probabilities between two endpoints.

As phenomena in nature are not necessarily describable by ones and zeros, quantum computing could open up better ways to simulate nature. (See the quote from Richard Feynman above)

How might quantum computing impact health care? – Quantum computers could impact healthcare in many ways. For example, Google recently announced using a quantum computer to simulate a chemical reaction, a milestone for the nascent technology. Though the specific interaction was relatively simple — current classical computers can model it too — future quantum computers should be able to simulate complex molecular interactions much more accurately than classical computers. So what are some of the potential use cases for quantum computing in health care?

Accelerating drug discovery and design – Developing pharmaceuticals through lengthy and costly clinical trials is definitely passé: scientists and pharma companies started to experiment with alternative ways, such as using artificial intelligence, human organs-on-chips or in silico trials, to speed up the process and make drug discovery and development more cost-effective. Running searches on quantum computers could unfold, looking through all possible molecules with unimaginable speed, drug target tests conducted in every potential cell model or in silico human tissues and networks in the shortest amount of time possible.

Several pharma giants have shown interest in quantum computing. Merck’s venture arm, for instance, participated in Zapata’s $38M Series B round in September 2020. Meanwhile, Biogen partnered with quantum computing software startup 1QBit and Accenture to build a platform for comparing molecules to help speed up the early stages of drug discovery.

Making in-silico clinical trials a reality – In silico clinical trials mean that no humans, no animals, not even a single cell is required for testing a particular therapy, treatment option, or drug, yet its impact can be perfectly charted. It means an individualized computer simulation used in the development or regulatory evaluation of a medicinal product, device, or intervention. Quantum computing could significantly advance the building of ‘virtual humans’ and complete simulations. It would not only massively shorten the time necessary for such trials but also improve their quality and completeness.

Near real-time DNA sequencing – Although the technical conditions, the time, and the cost of sequencing genomes were reduced by a factor of 1 million in less than ten years, the revolution lags behind. Quantum computing could give a significant push to the area: faster sequencing, as well as a more comprehensive and faster analysis of the entire genome, will be possible with it. Plus, predictions will be more reliable as quantum computers could take into account even more information than traditional computers, and they could even build every piece of genomic data into health records.

Processing boatloads of patient-generated data and putting it in context – In the future, health sensors, wearables, and tiny medical gadgets could send zettabytes of data about patients into the cloud. In 2013, the amount of digital data encompassed 4.4 zettabytes, and last year the information created measured 44 zettabytes or 44 trillion gigabytes. Quantum computers will be able to make sense of these enormous amounts of data, including bits and pieces of health information. Moreover, surveillance of patients through connected sensory systems might render physical hospitals useless – and genuinely make patients the point of care. (For a more in-depth discussion on digital sensors in health care, see my previous post here) Using quantum computers, fed by vast amounts of health parameters, genetic information, sensory data, and other personal health information, might be able to give a comprehensive prediction about a given person’s future health.

Safeguarding medical data – In her TED talk, Shohini Ghose mentioned the use of quantum uncertainty for encryption as one of the most probable applications of quantum computing. She believes it could be used for creating private keys for encrypting messages sent from one location to another – so that hackers could not copy the key perfectly due to quantum uncertainty. They would have to break the laws of quantum physics to hack such keys. Imagine that level of security applied to sensitive medical information: electronic health records, genetic and genomic data, or any other private information that the health system generates about our bodies.

What are the potential downsides of using quantum computing in health care? – The same data applications covered above, however, is where quantum computing poses a real threat that regulators and tech developers alike are seeking to solve. (For a more detailed look at ransomware in health care, see my previous post here) Powerful quantum computers threaten to break cryptography techniques like RSA encryption that are commonly used today to keep sensitive data and electronic communications secure.

“If I was a payer right now, security and ransomware would be keeping me up at night. Simply complying with HIPAA is not enough. New technology like quantum computing will make it more difficult to stop hackers, especially state actors.”

Roy Wyman, a partner with the legal firm Nelson Mullins

So, where are we today? – Quantum computing is becoming more common but still very expensive. Announcements like the ten-year partnership between IBM and The Cleveland Clinic to deploy a quantum computing system will be rare. As noted in the statement, “it takes a very forward-looking organization to invest heavily in quantum computing today. It’s one thing for a nation-state to start working with this nascent technology, given the potential it has in a wide variety of fields, but it’s another for a nonprofit to make a similar bet.”

Individual health systems may not be able to afford their own quantum computing systems. One potential solution for health plans: banding together to create security cooperatives to share resources, group data where appropriate, and segment it where critical firewalls are needed. This could be accomplished via a joint venture, one of healthcare’s favorite ways to turn competitors into collaborators, that is funded by participating members. Data partnership companies like Truveta are uniquely positioned to capitalize on the adoption of quantum computing. Truveta has access to health data representing 15% of the U.S. through its 17 healthcare system members. And, their partnership with Microsoft gives them a solid tech partner who can invest time, money, and resources to build out a stable platform to meet their current needs and scale as required to foster future growth opportunities.

My take – This is genuinely very nascent technology, and we don’t fully understand the cost/benefit calculation when considering deploying quantum computing systems in health care. CB Insights notes that while quantum computing “faces several hurdles, … the payoff may still be worth it. Some think that quantum computing represents the next big paradigm shift for computing—akin to the emergence of the internet or the PC.”

But, we also need to consider the necessary regulatory and security revisions that will need to be put into place to capitalize on the potential benefits and minimize the inherent risks in implementing the technology. We either need to revise HIPAA to put more resources behind it or, even better, take a step back to reassess privacy and security and how we deal with them. Quantum computing and regulatory frameworks remind us that it will take collaborative, integrated, and simultaneously occurring reforms—along with redefined business models and value chains—for sustained healthcare reform.