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

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New dissolvable heart monitors could help cardiologists battle AFib

Michael Walter starts the coverage this week with his article in Cardiovascular Business online. Researchers have developed new heart monitors that dissolve inside the body when no longer needed, sharing their work in Science Advances. The new-look devices are soft, flexible, transparent, and roughly the size of a postage stamp. The goal is to implant the device following a significant cardiac event or procedure so that it can restore normal heart rhythms, like a pacemaker, and stream data directly to the patient’s physicians. It can then be left to dissolve, helping patients avoid going through an additional procedure and saving healthcare providers the extraction costs.

Why it’s important – Several serious complications, including atrial fibrillation and heart block, can follow cardiac surgeries or catheter-based therapies. Many deaths that occur following heart surgery or a heart attack could be prevented if doctors had better tools to monitor and treat patients in the delicate weeks and months after these events take place.

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Infographic of the week – From Halle Tecco – Large companies are playing an increasingly important role in the VC ecosystem. In fact, 26% of deals in Q1 of this year included corporate venture capital (CVC), an increase from 20% in 2022 and 11% in 2010. Here are 65 strategic healthcare investors, from health systems to biotech to health insurance companies, investing in startups and everything you should know about taking their money. Read her blog post here: http://www.halletecco.com/blog/strategic-cvc-healthcare-investors

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Bridging the Digital Divide Through On-site, Health Center–Based Internet Clinics

Link Health, a Boston-based program that utilizes a three-pillar, community-based strategy, increased access to the Internet in marginalized communities by leveraging the Affordable Connectivity Program. Their program was featured in this article in NEJM Catalyst online. Link Health is a grassroots initiative designed to increase uptake of the ACP by establishing on-site, health center–based Internet clinics in historically underserved communities throughout the Greater Boston, Massachusetts area. By working with local community health centers and community-based organizations, Link Health functions as the intermediary between lower-income populations who qualify for the ACP and Internet service providers by raising awareness of the ACP and assisting individuals through the eligibility and sign-up process. In this article, the authors detail the strategies employed to maximize the uptake of the ACP in low-income communities.

Why it’s important – Increasing uptake of the ACP in vulnerable communities is possible by establishing on-site, health center–based Internet clinics in neighborhoods with high proportions of lower-income patients. Cultivating close partnerships with community-based organizations and healthcare sites is critical to reach the populations of interest effectively. Effective outreach and enrollment in target communities are possible by utilizing a get-out-the-vote framework and grassroots organizing strategy.

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New Technologies, Ideas Push the Hospital at Home Concept Forward

Eric Wicklund in Health Leaders online interviews eight different health systems who said the future may lie in modifying the model to suit each organization’s specific care needs and resources, even if that means bypassing Medicare reimbursement for now. More than 270 hospitals in more than 120 health systems follow that model, with the CMS waivers remaining in place until the end of 2024. Lobbying efforts are underway to make those waivers permanent, but the uncertainty of continued Medicare support affects how health systems map out scalability and sustainability.

Why it’s important – While many hospitals are following the CMS model for Medicare reimbursement, others are trying their own ideas, mixing virtual and in-person care to target specific care gaps or populations. Confusing state laws and the uncertain future of the CMS model will continue to inspire health leaders to develop their own strategies for delivering care at home.

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First U.S. Patients Implanted with Innovative FIRE1 Remote Heart Failure Monitoring System in Early Feasibility Study

In an article online at Diagnostic and Interventional Cardiology, FIRE1 announced that the first U.S. patients had been successfully implanted with its FIRE1 System for remote heart failure monitoring in an Early Feasibility Study. The study will assess FIRE1’s novel solution to improve outcomes for heart failure patients. The first patient was implanted at Austin Heart, Texas, where Kunjan Bhatt, MD, leads the study as Principal Investigator, and Thomas McMinn, MD, performed the implants.

Why it’s important – Quoting from the article: “This device may offer a completely new way of measuring chronic heart failure,” said Nir Uriel, MD, National Principal Investigator for the study and Director of Heart Failure, Heart Transplant, and Mechanical Circulatory Support programs at New York-Presbyterian. “The data gathered outside of the U.S. has been promising, and we look forward to studying its use in the U.S.”

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

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This wearable AI device reads your sweat to tell you about your heart’s health

The Jerusalem Post’s Zachy Hennesey begins the coverage this week. YOPI Technologies, an Israeli hi-tech company founded by experienced entrepreneurs Hemi Re’em and Dr. Menachem Genut, has successfully completed the development phase of YOPI, a wearable AI-based device designed to monitor sweat and detect early signs of heart function deterioration. YOPI (an acronym for “Your Online Personal Instructor”) represents a significant innovation in sports monitoring and heart health tracking. Worn on the arm, the device incorporates a unique sensor developed by the company to allow for online tracking of training intensity and personalized physiological adjustments.

Why it’s important – The developers contend that this wearable device will allow continuous monitoring of heart health and sports medicine.

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Infographics of the week – Dr. Bertalan Meskó and his team at The Medical Futurist Institute have compiled a comprehensive #ChatGPT prompt engineering cheat sheet. With this resource, you’ll find explanations of key terms, along with 10+1 invaluable tips accompanied by illustrative examples. These tips will undoubtedly enhance your proficiency in prompt engineering and maximize your utilization of ChatGPT’s capabilities. Furthermore, the cheat sheet talks a bit about the limitations of ChatGPT and sheds light on the best plugins currently available. So you’ll not only gain insights on how to optimize your interactions but also discover the best tools to augment your experience. Great tool!

The second infographic is from Dr. Tazeen Rizvi. In today’s connected world, mobile devices have become ubiquitous, including digital wearables that provide real-time information on physical activity, heart rate, sleep, oxygen saturation, and other clinical parameters. Digital wearables are continuously evolving to monitor specific health concerns to present valuable data for disease monitoring. As the penetration of these devices increases, more health data can be integrated into clinical and research settings. Effectively leveraging the potential of remote monitoring tools can truly democratize healthcare, bring quality care at lower costs, improve access, and allow early intervention to drive preventive models of care to advance public health meaningfully.

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New Generative AI App Measures Vital Signs Through A Selfie

HIT’s Syed Hamza Sohail reports that Dr. Renee Dua and Nick Desai — who previously founded and built visionary doctor house call company Heal — introduced Together by Renee, the first app to use generative AI to complete and manage cumbersome healthcare tasks for aging adults, those with chronic diseases and their overwhelmed caregivers. Together is the first U.S. app that measures vitals, including blood pressure, heart rate, heart rate variability, respiratory rate, and blood oxygen, just by having users smile for a selfie, a breakthrough in ease and usability. This device less, hassle-free “always with you” ability to track vitals is invaluable both for those with chronic diseases and worried caregivers, who can make sure their loved ones are doing well from far away.

Why it’s important – The Annals of Internal Medicine reports that less than 50% of adults take all their medications correctly. The Centers for Disease Control and Prevention states that less than 10% of adults get necessary preventive exams, and stunningly, the Agency for Healthcare Research and Quality reveals that less than 15% of adults even have the health literacy to assist in their own care. Together uses AI to know their doctor’s name, determine when the user needs an appointment, and then uses voice AI to automatically call the doctor’s office, schedule the appointment for the user and add it to their calendar.

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Podcast of the week – From Sg2’s Perspectives podcast series, they discuss clinically integrated networks (CINs) with Sg2 Associate Principal Joseph Maher. Joe outlines how CINs have evolved; their challenges and advantages; and how they can help improve health outcomes, patient experience, and costs. You can listen to the episode here.

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Harmonizing Recovery: Robotic Glove Helps Stroke Survivors Relearn Music

From Neuroscience News comes this story about a ‘smart hand exoskeleton,’ a custom-made robotic glove that can aid stroke patients in relearning dexterity-based skills like playing music. The glove, equipped with integrated tactile sensors, soft actuators, and artificial intelligence, can mimic natural hand movements and provide tactile sensations. The ‘smart hand exoskeleton,’ weighing just 191g, features soft pneumatic actuators and an array of 16 flexible sensors, mimicking natural hand movements and providing tactile feedback. The glove’s design was taught via machine learning to discern correct from incorrect piano play, showcasing its potential in helping stroke patients relearn music and other complex tasks.

Why it’s important – Stroke is the most important cause of disability for adults in the EU, which affects approximately 1.1 million inhabitants each year. After a stroke, patients commonly need rehabilitation to relearn to walk, talk, or perform daily tasks. The authors foresee that patients might ultimately wear a pair of these gloves to help both hands independently to regain dexterity, motor skills, and a sense of coordination. Challenges remain, however. These include improving the accuracy and reliability of tactile sensing, enhancing the adaptability and dexterity of the exoskeleton design, and refining the machine learning algorithms to better interpret and respond to user input.

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Apple’s Vision Pro: The dawn of screenless computing is upon us – opinion

Brian Blum’s opinion piece in The Jerusalem Post contends that what most pundits have gotten wrong about the Vision Pro is that it’s not about virtual reality at all. It’s the dawn of screenless computing. Apple will undoubtedly pursue its standard new product playbook. “Start with a 1.0 version that’s equally praised and damned for its differentness. Then keep fixing, fixing, fixing over the years, chipping away at the specs, features, and cost,” until the product is a hit.

Why it’s important – I think Blum’s on to something here. Apple is positioning the Vision Pro as a productivity device more than as a new piece of hardware on which to play games. The Vision Pro is not there yet. At $3,500, it’s a long way from a mass-market consumer product. And it won’t even be released until 2024. Give it a few years. Remember Apple’s track record. Let’s not forget that the first version of the iPhone had no GPS, no front-facing selfie camera, and not even an app store. Let’s not forget how the naysayers went after the iPad – “who needs something that’s bigger than an iPhone but less functionality than a laptop? There’s no market,” the pundits cried – before directing their ill-fated ire on the Apple Watch. Apple now makes the world’s most popular smartwatch.

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This Stanford professor developed a new form of chemistry. Now she’s deploying it against cancer

Fast Company’s Adam Bluestein interviews Carolyn Bertozzi, who says, “I had no idea people would have to pronounce this when I coined it—it’s a mouthful!” of the term she invented to describe the scientific breakthrough that won her the 2022 Nobel Prize in Chemistry (shared with Morten P. Meldal and Karl Barry Sharpless). “Bioorthogonal” chemistry refers to methods of performing chemical reactions inside living cells, animals, or people—rather than in beakers, flasks, and test tubes. “In the 1990s,” she explains, “we had all these ideas for ways you could study biology and make new medicines if you could design reactions where the chemicals totally ignore the biological system, but when they see each other, boom, they react. ‘Orthogonal’ means ‘no interaction,’ so ‘bioorthogonal’ means ‘no interaction with biology.’”

The technology can be used in medical imaging—attaching chemical markers to a tumor, for example, so that it’s visible in a scan. Or it can be used to append a chemical target to particular cells to help deliver a drug or radiation that becomes active only where it is needed. Bertozzi’s lab at Stanford currently uses bioorthogonal chemistry to study sugars that are produced on the surface of cells (a discipline called glycobiology) and show how they can shield cancer from the immune system.

Why it’s important – It’s an area of biology that’s been overlooked. But it is central to cancer and inflammatory and autoimmune diseases, too. An experimental drug based on this research, which works “like a lawn mower” to cut the sugar “camouflage” off cancer cells, is in Phase 1 clinical trials and was developed by Palleon Pharmaceuticals, where Bertozzi is a co-founder. She hopes that “glyco-immunology” will improve outcomes for the majority of patients who don’t respond to current immunotherapies.

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AI Could Find Best Meds for High Blood Pressure

A new artificial intelligence program may help doctors better match people with high blood pressure to the medication most likely to work for them. Boston University posted this research on Futurity online. The new data-driven model aims to give clinicians real-time hypertension treatment recommendations based on patient-specific characteristics, including demographics, vital signs, past medical history, and clinical test records. The model, described in a study published in BMC Medical Informatics and Decision Making, has the potential to help reduce systolic blood pressure—measured when the heart is beating rather than resting—more effectively than the current standard of care.

Why it’s important – For the nearly half of Americans with hypertension, it’s a potential death sentence—close to 700,000 deaths in 2021 were caused by high blood pressure, according to the US Centers for Disease Control and Prevention. It also increases the risk of stroke and chronic heart failure. The new model generates a custom hypertension prescription using an individual patient’s profile, giving physicians a list of suggested medications with an associated probability of success. The researchers aimed to highlight the treatment that best controls systolic blood pressure for each patient based on its effectiveness in a group of similar patients. In the past, machine learning in health care has also been hampered by incomplete or inaccurate data, as well as sparse patient histories, which can skew prediction results. An essential aspect of this study was to ensure data was transparent and that clinicians—particularly those without technical expertise—clearly understood how the algorithm worked and how and why the model proposed specific therapeutic recommendations.

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$400M Apple Face ID inventors create tiny robot to treat brain disease

Matthew Kalman in The Times of Israel reports that Bionaut Labs is testing its technology at a Mayo Clinic facility and is poised to begin clinical trials with five top-tier US medical centers as it applies for FDA approval. Bionaut is currently raising a Series B-1 funding round, as featured on the OurCrowd investment platform. The company’s Bionaut, a tiny micro-robot smaller than a grain of rice, is guided through a patient’s central nervous system into a targeted spot in the brain where it can perform minor surgery, deliver therapeutic drugs, or return with tissue for a biopsy.

Why it’s important – Pharma giants are targeting a wide range of neuro-degenerative conditions, including Parkinson’s, Huntington’s, Alzheimer’s, epilepsy, glioblastoma, and many more. Still, they all face the challenge of getting the drugs to the point where they are needed inside the brain. The Bionaut, guided by a physician using a powerful magnet, can release a payload of targeted therapy directly into a tumor or any other localized target– even deep inside the brain – and head for home. A Bionaut can carry a therapeutic payload and deliver it directly to the targeted area, which avoids flooding the entire central nervous system. Instead of drilling through several centimeters of brain tissue, the Bionaut can be guided through internal fluids to within millimeters of its target.

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

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Survey: Employers Aren’t Doing Enough To Support Employees’ Mental Health

A Northeast Business Group on Health survey published Monday found that 26% of employers never identify the needs of employees nor the “awareness and effectiveness” of their mental health programs. About three in ten respondents don’t have messaging campaigns through social media and internal platforms on mental health. Maria Plescia provides the details in her MedCity News article. The Northeast Business Group on Health survey, published Monday, found that 26% of employers never identify the needs of employees nor the “awareness and effectiveness” of their mental health programs. About three in ten respondents don’t have messaging campaigns through social media and internal platforms on mental health.

The survey included responses from 140 large employers in the U.S. It used a tool Northeast Business Group on Health launched in November called Well Gauge. The tool asks participants a series of questions through four sections: communicating a commitment to mental health, engaging leadership at all levels, demonstrating a commitment to mental health, and fostering environments that support total health. Users of the tool also receive recommendations to improve mental wellness support at their organization.

Why it’s important – The survey shows that while employers know that mental health support is vital, more work needs to be done. Based on these findings, employers need to help reduce the stigma around mental health and show that the company cares. Additionally, leaders need to ‘walk the talk’ and demonstrate they are engaged in supporting their employees and their own mental health to help normalize conversations around mental health.

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Infographics of the week – KFF Survey Shows Complexity, Red Tape, Denials, Confusion Rivals Affordability as a Problem for Insured Consumers, With Some Saying It Caused Them to Go Without or Delay Care – Most (58%) people with health insurance say they encountered at least one problem using their coverage in the past year, with even larger shares of people with the most significant health care needs reporting such problems, finds a new KFF survey of consumer experiences with health insurance.

This week’s second infographic comes from healthcare IT guru Herman Oosterwijk in his SIIM23 report for DICOM Systems. He’s adapted the Gartner Hype Cycle curve to give his opinion on where certain technologies fall today

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What if the ambulance doesn’t come? Rural America faces a broken emergency medical system

Nada Hassanein, a national correspondent at USA TODAY, reports that as rural hospitals shutter across the nation, dwindling emergency medical services also must travel far to the nearest hospital or trauma center. Experts and those in the field say EMS needs a more systematic funding model to support rural and poorer urban communities. Few states designate EMS as essential services. In the U.S., local governments mainly fund EMS, and not all states allocate supplemental funds toward the services.

“The EMS profession needs a home. EMS kind of sits on two sides. … So, when you don’t have a home, sometimes you just get left behind. On a federal level, I’d like to see some initiative to maybe get us a little bit more rooted into that health care system.”

PJ Ringdahl, regional adviser, North Dakota EMS Association

Why it’s important – Nearly 4.5 million people across the U.S. live in an “ambulance desert” – 25 minutes or more from an ambulance station – and more than half of those are residents of rural counties, according to a new national study by the Maine Rural Health Research Center and the Rural Health Research Centers. As rural hospitals shutter across the nation, dwindling emergency medical services also must travel far to the nearest hospital or trauma center.

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Podcasts of the week – This week’s recommendation is Device Weekly’s episode featuring Mike Favet, CEO of NeuroPace, who talks about how the company’s RNS technology is helping to transform the lives of patients with drug-resistant epilepsy. NeuroPace, one of the pioneers in neurostimulation, has the only FDA-approved neurostim treatment for epilepsy. Favet took over as CEO four years ago from the founding CEO, so we discuss his background, the changes he made at the company, and how NeuroPace is building a market for a medical device to treat a disease that typically can be managed only by pharmaceuticals. You can listen to the episode here.

My second Podcast recommendation this week is a special program on the ‘NMP’ Problem in Medicine. NMP stands for ‘not my patient, not my problem,” an infection in medicine so broad and so deep that even the best of the best develop blind spots (implicit or confirmation bias) while we, the patient, often pay a very steep price. In this case, Greg Masters’ son Anthony John Masters may be its latest victim. Host Gil Bashe interviews his colleague and executive producer of Health UnaBASHEd on the untimely and avoidable death of his 38-year-old son Anthony John Masters.

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The iPad was meant to revolutionize accessibility. What happened?

For people who can’t speak, there has been depressingly little technological innovation that helps them communicate. Julie Kim, in MIT Technology Review, reports on her research into augmentative and alternative communication (AAC) technology for her daughter, who is five years old and also non-speaking. Underwhelmed by the available options—a handful of iPad apps that look (and work) as if they were coded in the 1990s—I’d delved into the speculative, more exciting world of brain-computer interfaces. Because the reality is this: the last significant advance in AAC technology happened 13 years ago, an eternity in technology time. On April 3, 2010, Steve Jobs debuted the iPad. What for most people was a more convenient form factor was something far more consequential for non-speakers: a life-­changing revolution in access to an attractive, portable, and powerful communication device for just a few hundred dollars. Like smartphones, iPads had built-in touch screens, but with the critical advantage of more space to display dozens of icon-based buttons on a single screen. And for the first time, AAC users could use the same device they used for speaking to do other things, like text, FaceTime, browse the web, watch movies, record audio, and share photos.

Why it’s important – A piece of hardware, however impressively designed and engineered, is only as valuable as what a person can do with it. After the iPad’s release, the flood of new, easy-to-use AAC apps that LoStracco, Shevchenko, and their clients wanted never came. Today, there are about a half-dozen apps, each retailing for $200 to $300, that rely on 30-year-old conventions asking users to select from menus of crudely drawn icons to produce text and synthesized speech. Beyond the high price point, most AAC apps require customization by a trained specialist to be helpful. This could be the reason access remains a problem.

There aren’t many other options available, though the possibilities do depend on the abilities of the user. Literate non-speakers with complete motor control of their arms, hands, and fingers, for example, can use readily available text-to-speech software on a smartphone, tablet, or desktop or laptop computer. Those whose fine motor control is limited can also use these applications with the assistance of an eye-controlled laser pointer, a physical pointer attached to their head, or another person to help them operate a touch screen, mouse, or keyboard. The options dwindle for pre-literate and cognitively impaired users who communicate with picture-based vocabularies.

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YouTube video of the week – From this year’s Aspen Ideas Festival, from revolutionary advancements aiding paralysis patients to the therapeutic treatment of PTSD, brain-computer interfaces (BCIs) possess the boundless potential for merging human biology with cutting-edge technology in unprecedented ways. Three visionaries in this field demonstrate what’s possible now and offer insights into the future trajectory of this technology.

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The Best ChatGPT Plugins: How To Add Browsing, Learning, Wolfram And More

Andrea Koncz from The Medical Futurist Institute provides this overview of the new plugin universe. ChatGPT plugins are like additional apps, enhancing the AI’s skills. They can be added from the “plugin store” and offer a wide range of features, from work-related tasks to games and lifestyle assistance. She notes that privacy risks associated with these plugins require careful attention, especially with plugins accessing personal information or accounts.

Why it’s important – Despite the current limitations, these plugins represent a glimpse into the future of AI technology, showcasing possibilities for a more personalized and versatile AI assistant. They are in the early stages of development and make mistakes—lots of them. Remember that they are imperfect, so use their outputs with a good pinch of salt.

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‘It’s like Groundhog Day’: The cancer drug shortage isn’t new — and neither are the solutions

Stat’s Angus Chen brings us this important information in his latest article. The current shortage of cancer drugs stems from the shutdown of Intas Pharmaceuticals’ massive plant near Ahmedabad, India. AS STAT previously reported in November of last year, inspectors from the U.S. Food and Drug Administration arrived at the plant to discover a garbage truck filled with shredded documents. The generic drug supplier was trying to delete evidence of quality control issues.

“These shortages are really omnipresent. In the modern era, it’s not even the new normal. It’s the normal. From 2011, they have really never gone away. It’s like Groundhog Day.”

Yoram Unguru, Pediatric Hematologist, Children’s Hospital at Sinai, Johns Hopkins School of Medicine

The result is that many doctors, particularly those at smaller community clinics and hospitals, haven’t been able to give drug combinations that would have given many patients an excellent chance of a cure for their cancer.

Why it’s important – Providers have to switch to less-than-ideal regimens, which may overall be less effective in the treatment of their disease. Providers have to decide who gets what. We’ve had patients who are not only worried about their diagnosis, which is life-changing, but the emotional toll they get — feeling like maybe I’m not getting the best treatment for my condition. That’s a big deal.

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How Can Health System Leaders Collaborate Efficiently When Adopting New Tech?

MedCity News’ Katie Adams reports that Health system executives discussed what these strategic conversations should ideally look like during a virtual panel Thursday, which was co-hosted by Matter and Avia. They stressed it is vital to assemble a diversified decision-making team and that leaders should prioritize addressing the organization’s challenges and opportunities rather than being captivated by flashy new products.

“It just brings a lot more credibility to the project when you have some sort of a clinical champion.”

Taylor Hamilton, Chief Consumer Officer, Ballad Health.

Why it’s important – When a health system considers rolling out a digital initiative or adopting a new technology, its C-suite leaders usually become involved in a circuitous decision-making process involving many stakeholders. For example, when drawing up implementation plans for a new digital tool, health systems often discover that their organization has a lot of unnecessary variation. In a situation like this, leaders should work to standardize the data points in their respective departments instead of ignoring the problem or hoping someone else can fix it. This type of responsibility and cooperation helps digital projects progress faster and more smoothly.

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Healthcare costs to jump 7% in 2024: PwC

Healthcare costs will increase by a projected 7 percent in 2024 as the healthcare industry continues to face high inflation, rising wages, and other costs, which are compounded by workforce shortages, according to a report from the PwC Health Research Institute. Here are some of the highlights:

• The 7 percent spike is higher than the projected medical cost trend in 2022 (5.5 percent) and 2023 (6 percent).
• Key drivers of the cost growth include new gene therapies — which can cost millions of dollars — and the weight loss drug space, as well as increased consolidation among hospitals and other healthcare facilities.
• Hospitals and physicians are expected to seek higher rate increases in contract negotiations. Workforce shortages and physician consolidation can further amplify the inflationary effects on providers, with burnout and rising patient demand expected to keep the pressure on clinical workforces across the U.S.
• Payers are negotiating pricing with hospitals while provider profit margins continue to erode, according to the report. Health plans also feel the squeeze of higher median prices for new drugs and increasing prices on existing drugs.
• Some positive changes in the pharmaceutical market and care setting — including biosimilars coming to market and care shifting to outpatient settings — are expected.
• Many health plans continue to invest in the total cost of care management initiatives, such as value-based care, that helped maintain year-over-year trends, according to the report. National health plans generally demonstrated better cost management and subsequently achieved lower cost trends. As these national plans grow, they are projected to have a deflator effect overall on medical cost trends.

These are the areas that PwC will be following over the next year to track and forecast medical cost trend.

Why it’s important – The medical cost trend, or growth rate, is primarily influenced by changes in the price of medical products and services and prescription medications, known as unit cost inflation, and changes in the number or intensity of services used or changes in per capita utilization. We’re in an emerging age of omnichannel health care where many patients feel and act more empowered to shop for medical appointments (say, via ZocDoc), leverage digital front doors via telehealth or encrypted messages on patient portals with providers, and take advantage of tele-mental health therapy with counselors who were not so available pre-pandemic. While the cost of treating patients is rising, I do not doubt that the patient-as-payor will determine much of that spending. Click here to read the full report.

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Have a wonderful Independence Day holiday!

“The happiness of America is intimately connected with the happiness of all mankind; she is destined to become the safe and venerable asylum of virtue, of honesty, of tolerance, and quality and of peaceful liberty.”

Marquis de Lafayette

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

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Wrist-worn wearable could detect sickle cell pain episodes

Nick Paul Taylor begins the coverage this week with his article in MedTech Dive. He reports that a wrist-worn wearable could provide early warning of the severe acute pain episodes that affect patients with sickle cell disease. Researchers at Children’s Hospital Los Angeles (CHLA) tested the idea that the narrowing of blood vessels predicts the events in a clinical trial that reported data in 2019. They partnered with Biostrap to develop the blood flow biomarker that year. The studies showed that photoplethysmography (PPG), a way to measure changes in blood volume used in pulse oximeters, can predict the painful vaso-occlusive crises affecting sickle cell patients. PPG monitors blood volume by measuring changes in light absorption, and the researchers used the technology to record the median magnitude of vasoconstriction (Mvasoc).

Why it’s important – Wrist-worn wearables could make Mvasoc more useful for people with sickle cell disease. Rather than manually attaching a sensor, patients could wear a device on their wrist and automatically collect Mvasoc data. That thinking led the researchers at CHLA to partner with Biostrap in 2021. Researchers hope the wearable will be able to detect the onset of a pain crisis days before the patient feels it. That early detection would be vital for administering medications or other interventions early, lowering the risk of severe pain or complication, or hospitalization.

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Infographics of the week – To provide a clear contrast between the old and the new, Dr. Bertalan Meskó and his team at The Medical Futurist Institute collated data from numerous sources into an infographic that outlines the differences between traditional drug-based therapies and digital therapeutics. Digital therapeutics are more than just a novel concept. They hold the promise of improved health outcomes, greater accessibility, and cost-effectiveness in patient care when used based on proper evidence.

2023 Scorecard on State Health System Performance – Every year, the Commonwealth Fund’s Scorecard on State Health System Performance uses the most recent data to assess how well the health care system works in every U.S. state. This year, Massachusetts achieved the best overall score, consistently placing among the top states on the seven dimensions of health system performance we evaluate. Hawaii, New Hampshire, Rhode Island, and Vermont round out the top five. The lowest-ranked states overall are Arkansas, Texas, Oklahoma, West Virginia, and Mississippi.

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Continued declines in screening mammogram volumes could have ‘worrisome implications,’ experts warn

More than three years after the height of COVID, the volume of screening mammograms still has not returned to pre-pandemic levels, according to new data from Brigham and Women’s Hospital. Health Imaging’s Hannah Murphy reports that a group of experts from the hospital recently analyzed screening trends there in the years leading up to and following the onset of COVID. They observed a persistent decrease of five monthly screening mammograms beginning in June 2021. In contrast, between October 2016 and March 2020, the group noted a steady increase of 65 screenings per month. The group’s findings also highlighted a shift in screening locations, with outpatient clinic screenings increasing from 35.8% before COVID to just under 45% in the years following.

Why it’s important – While the long-term effects of declining screening mammogram rates are not yet fully understood, the group cautioned that there could be “worrisome implications for the future of breast cancer diagnosis and treatment” to come if rates do not improve. The study abstract is available in Clinical Imaging.

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YouTube Video of the Week – From Alex Lindsay and Office Hours comes this inaugural episode of Accessibility Hours, where they will begin a series of discussions around disabilities and learn from people with lived experiences, their work, and the barriers they face in various aspects of life. You will gain insights into the importance of inclusivity and accessibility and how we can create a more equitable society for individuals with disabilities. Engage in thought-provoking conversations and discover practical ways to foster a more inclusive environment. This is one of the most comprehensive conversations around accessibility and inclusion I’ve ever seen. Well worth viewing for anyone creating online and in-person meetings, conferences, and conversations.

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Israeli researchers reach ‘breakthrough’ in fight against skin cancer

A new study conducted at Tel Aviv University (TAU) and the Sheba Medical Center at Tel Hashomer reveals how melanoma cancer cells affect their close environment to support their needs by forming new lymph vessels in the dermis (inner layer of the skin) to go deeper and spread through the body. Judy Siegel-Itzkovich, the health and science reporter at The Jerusalem Post, reports on the development.

“Melanoma that remains on the skin is not dangerous. So the most promising direction for fighting melanoma is immunotherapy – developing a vaccine that will arouse the immune system to combat the melanosomes and specifically to attack the lymphatic endothelial cells already invaded by the melanosomes. If we can stop the mechanisms that generate metastases in lymph nodes, we can also stop the disease from spreading.”

Shoshana Greenberger, Professor, Sheba Medical Center at Tel Hashomer

Why it’s important – Melanoma, the deadliest of all skin tumors, starts with the uncontrolled division of melanocyte cells in the epidermis – the top layer of the skin. In the second stage. the cancer cells penetrate the dermis and metastasize through the lymphatic and blood systems. In previous studies. a dramatic increase was observed in the density of lymph vessels in the skin around the melanoma – a mechanism researchers have not understood until now. Since melanoma is not dangerous at the premetastatic stage, understanding the mechanism by which the metastases spread via the lymphatic and blood systems could contribute to developing a vaccine against this deadly cancer.

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FDA Approves First Gene Therapy for Duchenne Muscular Dystrophy

Sarepta Therapeutics’ Elevidys is now the first FDA-approved gene therapy for Duchenne muscular dystrophy. Elevidys is an engineered version of a gene intended to restore function lost to the mutation at the root of the inherited muscle disease. Frank Vinluan covers the story in MedCity News online. FDA approval of the therapy, Elevidys, covers children ages 4 and 5, which is within the age range during which disease symptoms begin to appear. Those patients must have the ability to walk and a confirmed genetic mutation for the disease. Patients must also have no pre-existing medical reason that prevents them from receiving the therapy.

Why it’s important – The Duchenne muscular dystrophy drugs now available only treat the symptoms of the rare muscle-wasting disorder. Duchenne is caused by a mutation in the gene that codes for dystrophin, a protein that helps keep muscle cells intact. A deficiency of this protein leads to progressively worsening muscle weakness that manifests as walking and running difficulty, frequent falls, and fatigue. As the disease progresses, it affects the heart and lungs. Duchenne predominantly affects males, who typically live only into their 20s or 30s before succumbing to heart or respiratory failure. It’s important to note, however, that scientists detailed a long list of concerns with the company’s research, particularly a mid-stage study that the company submitted for FDA review. Overall, it failed to show that boys who received the therapy performed significantly better on measures like standing, walking, and climbing than those who got a dummy treatment. However, the results were better in younger kids.

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Oura Will Now Share Its Sleep Scores With CGM Providers

Katie Adams reports that Oura — a company selling a ring that tracks peoples’ biometrics — announced new partnerships with three providers of continuous glucose monitors: January, Supersapiens, and Veri. These companies will now be receiving sleep scores and other biometric data from Oura so they can see how these measurements affect users’ glucose levels and overall health.

Why it’s important – Oura pursued these partnerships because glucose monitoring is a key piece of the overall picture of a person’s health. In the past, CGMs were primarily used by people with diabetes to monitor their body’s glucose levels. However, these devices are becoming increasingly popular with a broader audience nowadays — especially among people seeking to improve their athletic performance, lose weight or boost their energy levels. The new integrations could provide more insights into the relationship between sleep quality and blood glucose levels. Lack of sleep — specifically deep sleep — significantly reduces glucose tolerance and insulin sensitivity. Evidence also suggests that there might be a link between less-than-ideal sleep quality and impaired glucose metabolism.

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Scientists successfully unfroze rat organs and transplanted them — a ‘historic’ step that could someday transform transplant medicine

From Stat’s Marion Renault comes this important research published this month. She describes the rat kidney as peculiarly beautiful — an edgeless viscera about the size of a quarter, gemstone-like and gleaming as if encased in pure glass. Then researchers at the University of Minnesota restarted the kidney’s biological clock, rewarming it before transplanting it back into a live rat — who survived the ordeal. In all, five rats received a vitrified-then-thawed kidney in a study whose results were published in Nature Communications. It’s the first time scientists have shown it’s possible to successfully and repeatedly transplant a life-sustaining mammalian organ after it has been rewarmed from this icy metabolic arrest.

Why it’s important – Outside experts unequivocally called the results a seminal milestone for the field of organ preservation. If researchers someday successfully translate those results into humans, experts told STAT, organ cryopreservation, and rewarming could revolutionize transplant medicine — and potentially save tens of thousands of lives each year in the U.S. alone. At any given moment, about 100,000 adults and children in the U.S. await a replacement organ. Last year, 41,225 got them. Each was dictated by time above all else: right now, doctors must sprint to obtain and then transplant organs within the tight, hours-long window they can stay alive outside the human body.

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

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Study finds AI can predict cybersickness in VR users

Artificial Intelligence (AI) could be used to help combat nausea, headaches, and dizziness among virtual reality (VR) users and make the technology more accessible, according to a new study with Charles Darwin University (CDU). The study by CDU and Torrens University researchers explored using AI techniques and machine learning algorithms to predict cybersickness for potential users of VR technology with headsets.

“We are moving towards the times where we use VR devices for essential activities such as servicing manufacturers remotely and teaching, to less essential but more fun activities like looking into the outer space through VR lens.”

Niusha Shafiabady, Associate Professor

Why it’s important – In the era of technology and especially after the COVID-19 pandemic, the need for remote access and virtual education has grown significantly. Cybersickness is one of the factors that hinder users from using VR devices because of the significant discomfort due to the VR experience.

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Infographic of the week – We can expect a Great Reconsideration, or churn, among healthcare providers who fast-adopted and pivoted to telehealth and remote patient monitoring, based on new research of health execs from Panda Health and Sage Growth Partners. The team explored 24 digital health applications, with 11 shown here in The Churn Index table from the report. Note that telemedicine and e-visits, and remote monitoring, are expected to exhibit high “churn” as healthcare providers re-consider their early investments into these two areas and may seek to replace, strip out, or otherwise change vendor partners for these tools. Other areas, like patients’ ability to self-schedule and care coordination, are expected to essentially stay in place.

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Doctors Are Using Chatbots in an Unexpected Way

Gina Kolata reports that despite the drawbacks of turning to artificial intelligence in medicine, some physicians find that ChatGPT improves their ability to communicate empathetically with patients in her New York Times article. In one survey, 85 percent of patients reported that a doctor’s compassion was more important than waiting time or cost. In another survey, nearly three-quarters of respondents said they had gone to doctors who were not compassionate. And a study of doctors’ conversations with the families of dying patients found that many were not empathetic.

Why it’s important – Skeptics like Dr. Dev Dash, who is part of the data science team at Stanford Health Care, are so far underwhelmed about the prospect of large language models like ChatGPT helping doctors. In tests performed by Dr. Dash and his colleagues, they received replies that occasionally were wrong but, he said, more often were not helpful or were inconsistent. If a doctor is using a chatbot to help communicate with a patient, errors could make a difficult situation worse. Still, those who have tried ChatGPT say the only way for doctors to decide how comfortable they would feel about handing over tasks — such as cultivating an empathetic approach or chart reading — is to ask it some questions themselves.

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How Penn Medicine’s Telemedicine Program Saved It $113 Per Patient Visit

MedCity News reporter Katie Adams reports that Penn Medicine recently published a study in the American Journal of Managed Care on the economics of providing telemedicine — it showed that when the health system began offering virtual urgent care services to its employees, the visits ended up being 23% less expensive to conduct than in-person appointments. The study analyzed how much it costs to provide visits via Penn Medicine OnDemand — a 24/7 copayment-free telemedicine program that Penn Medicine established for its employees in the summer of 2017.

Why it’s important – Despite the growing availability of telemedicine programs provided by employers, many health systems have been hesitant to embrace this approach. One reason for this is that past research has shown that the cost of care is not reduced when employers offer telemedicine via third-party platforms, the study said. The study authors argued that health systems are uniquely positioned to establish homegrown, money-saving telemedicine programs — they can use the providers they already have, make in-system referrals, and coordinate better follow-up care.

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YouTube videos of the week – Last week’s headlines were all about the entry of Apple into the consumer AR space with their VisionPro. But what about health? I shared some thoughts in my blog post about WWDC 2023. But this video from Dr. Atul Gupta, Chief Medical Officer of Philips Image Guided Therapy, is a terrific look at the potential for the technology in healthcare.

And here’s another great video summary from Dr. Rafael Grossmann from the NextMed Conference.

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NYU Langone Health LLM can predict hospital readmissions

Researchers at New York University’s Langone Health academic medical center developed a large language model, now deployed at three of its hospitals, that predicts a patient’s risk of 30-day readmission and other clinical outcomes. Andrea Fox from Healthcare IT News reports that coinciding with its study published in Nature this week, the release of the NYUTron model’s code base in GitHub enables other healthcare organizations to train their own LLM and provide doctors with insights that could help them identify which patients may require intervention to reduce readmissions. The model has been used to evaluate 50,000 patients discharged from NYU’s healthcare system. NYUTron shares its predictions of readmission risk with physicians by email. NYU partnered with NVIDIA to develop and run its LLM on several of its artificial intelligence platforms – its stack, library, and software.

Why it’s important – Research published in the Journal of Multidisciplinary Healthcare last year said that nearly 15% of all hospital patients are readmitted to the hospital within 30 days after initial discharge. Readmission rates are affected by countless variables – including five common treatments at emergency departments – that not only impact a patient’s overall care but they can also divert beds and resources from patients that may have more intensive healthcare needs. “Not all hospitals have the resources to train a large language model from scratch in-house, but they can adopt a pre-trained model like NYUTron and then fine-tune it with a small sample of local data using GPUs in the cloud,” said Dr. Eric Oermann, assistant professor of neurosurgery, radiology, and data science at NYU Langone Health, said in a blog post on NVIDIA’s website.

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Recommended video – There have been multiple articles on the use of large language models in healthcare recently. One of the annual conferences I follow is the World Medical Innovation Forum, held in Boston. They just posted a video of the session on Generative AI, ChatGPT, and the Rapidly Changing Role of AI in Healthcare. They discussed the opportunities for these cutting-edge technologies in the short- and long-term while keeping a close eye on potential biases in their development and their impact on equity in care. They also highlighted the role of AMCs (Academic Medical Centers) in preparing for LLM integration, the ins and outs of insurance approvals and appeals, and the regulatory landscape for LLMs in clinical practice, research, and operations. Plus, they reviewed the unique assets for building and validating LLM datasets and approaches to industry collaboration and brainstormed ways to ensure safe and liability-free LLM implementation.

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Uber Health Launches Grocery, Over-the-counter Delivery Service for Patients

MedCity News Maria Plescia reports that Uber Health is jumping on the food-as-medicine train. The company is adding grocery and over-the-counter delivery services to its platform, it announced Tuesday. San Francisco-based Uber Health is the healthcare arm of the transportation company Uber. Its solution offers non-emergency medical transportation and prescription delivery. Providers, payers, and case managers can use the same web-based platform they use for these services for grocery and over-the-counter delivery. Other companies that offer healthy food delivery services include FarmboxRx, Instacart, and Kroger. Several payers have also launched food-as-medicine programs, including Kaiser Permanente and Highmark Health.

“To me, it’s all about making the experience convenient and frictionless for patients and providers, and really connecting the entire healthcare ecosystem together.”

Caitlin Donovan, global head of Uber Health

Why it’s important – There is a growing understanding that supporting healthy food and nutrition can reduce costly healthcare incidents down the road. A recent study found that if payers provided medically-tailored meals to patients who need them, 1.6 million hospitalizations could be avoided annually, and payers could save $13.6 billion. Uber Health will be paid for these services through insurers’ benefit plans. Most (especially Medicaid and Medicare plans) cover transportation and delivery for prescriptions, groceries, and over-the-counter items. Still, some providers, particularly value-based providers, will pay for the benefits out of pocket. Patients won’t have to pay for the service.

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Most People With Heart Disease Don’t Use Health Trackers

Christina Frank for Yale University writes in Futurity online that fewer than 1 in 4 people with or at risk for heart disease use wearable health trackers. Only half of those who wear them do so consistently. The population-based, nationally representative study, published in JAMA Network Open, included 9,303 participants from the Health Information National Trends Survey (HINTS). Eighteen percent of people with established CVD and 26% at risk for CVD reported using wearable devices compared with 29% of the general population.

Why it’s important – Older age, lower educational attainment, and lower household income were associated with significantly lower odds of wearable device use, likely due to these populations having less access to these devices or discomfort with using the technology. The people who benefit the most tend to use them the least. Part of it is awareness. People may not recognize the potential value of these devices to the health side, especially since the evidence for their value to health is still evolving. And the other piece is their cost and the fact that people who have health disorders might actually have additional costs to take care of, so these things may seem frivolous to them.

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Singapore smart vending machines offer teleconsultations for pharma-only meds

Adan Ang reports that Pharmacy-only medicines can now be accessed via new smart vending machines at Changi General Hospital in his article in Healthcare IT News. Developed by pharmacists, the Pharmacy Smart Interface System (PharmaSis) was authorized by the Health Sciences Authority in April to dispense pharmacy-only medicines with guidance from a CGH pharmacist via teleconsultation. A user first seeks a teleconsultation with a CGH pharmacist, who will assess them before recommending appropriate health advice and medications. They will be guided on selecting medicines, which include those for common minor ailments such as cough, colds, diarrhea, constipation, and fever. PharmaSis also dispenses a range of OTC medicines, as well as hearing aid batteries and other audiology products.

Why it’s important – There is increased interest in developing these types of solutions globally. Two years ago, a similar vending concept was introduced by Fullerton Health, powered by US-based SmartRx’s proprietary drug dispensing hardware and software, to increase access to healthcare for thousands of migrant workers in Singapore amid the pandemic-induced lockdown. In Malaysia, health tech startup Qmed Asia also supports employees’ health by developing and launching the Qmed GO workplace telehealth kiosk. It features medical IoT devices that can measure up to 16 vital parameters, which are then transmitted to and accessed via a patient app and employer dashboard. Docty in India has also developed its own telehealth kiosks, which are being set up across rural and urban poor communities in the country to improve healthcare access.

Here’s what concerns me about the photo of the implementation above. Based on the image, how is patient privacy ensured? If someone stands behind the user, they can hear the whole conversation between the patient and the pharmacist.

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A cyberattack is partly to blame for St. Margaret’s Health closing all operations

Two rural Catholic hospitals in Illinois are closing all operations as of Friday, June 16, due in part to a 2021 cyberattack. Healthcare Finance Executive Editor Susan Morse reports that St. Margaret’s Health in Peru and Spring Valley will be closing all current operations as of Friday, June 16, according to a notice on the St. Margaret’s Health website. A ransomware attack in 2021 hit SMP Health, which includes the hospitals of St. Margaret’s Health. The attack halted the hospital’s ability to submit claims to insurers, Medicare or Medicaid for months, sending it into a financial spiral.

Why it’s important – Last year, a report from the American Hospital Association highlighted the variety of causes that resulted in 136 rural hospital closures from 2010 to 2021 and a record 19 closures in 2020 alone. Cyberattacks both threaten patient safety and are costly to hospitals. The most expensive healthcare cyberattack cost an average of $4.4 million in the past 12 months, according to a Ponemon Institute study, including $1.1 million of productivity loss.

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Cala Health Launches Wearable Device to Treat Hand Tremors

Katie Adams from MedCity News reports that Cala Health recently launched its kIQ system — which it calls the first noninvasive wearable device cleared by the FDA to temporarily relieve tremors in people with essential tremor and Parkinson’s disease. The kIQ system is an on-demand, at-home therapy used to manage action hand tremors — those which occur when the patient’s hand is undergoing a voluntary movement, such as typing, picking up a glass of water, or writing a note.

The wrist-worn device senses each patient’s unique tremor signature and individualizes stimulation. It then delivers transcutaneous afferent patterned stimulation (TAPS) therapy, which means it applies specific electrical stimulation patterns through the skin to modulate neural activity and promote therapeutic effects. Using TAPS, the device noninvasively counteracts the patient’s tremor through the nerves on the wrist. After the patient completes an at-home therapy session, they can view their body’s responses via the MyCala.com patient portal.

Why it’s important – More than 7 million Americans struggle with essential tremor (ET), but only one in 10 ET patients is satisfied with their current treatment. The klQ system is prescribed by movement disorder specialists and neurologists for patients with ET or Parkinson’s. Researchers say more studies are needed to determine whether wearable devices can create long-lasting tremor relief from a single session — beyond reducing tremors for an hour or two at a time. They also suggest that further research is needed to solidify wearables as a standalone treatment for essential tremor patients.

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

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AI-powered scribe tool enables more patients, less burnout

A major issue with primary care, especially value-based care, is how much documentation burden there is for providers: It means hours of “pajama time” with the electronic health record after dinner and hours of more charting at home on weekends. Bill Siwicki of Healthcare IT News interviews Dr. Kendell Cannon, who describes how her primary care practice sifted through the hype of artificial intelligence and found a scribe that does what it promises.

Why it’s important – “This space has been full of marketing hype for a very long time, with companies claiming they have technology that works or promising that it will be here soon,” Cannon advised. “When evaluating AI technologies, I would recommend you try it for yourself before you believe anything. If a vendor cannot do live, unscripted demos, they’re not ready for production. “You should be able to bring your team to pressure test it across a range of realistic scenarios before deciding to invest any resources,” she concluded. “I’ve seen too many examples of AI companies making promises and wasting a lot of our time and resources because they never ended up delivering on those promises.”

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Infographic of the week – This was a tough week in many areas of the country because of smoke from the wildfires in Canada. The Environmental Protection Agency released the graphic below to help people understand the health effects of air pollution.

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Google strikes deal with Mayo Clinic to comb patient records using generative AI

Casey Ross of Stat Health Tech reports that Google will embed its generative AI technology into computer systems at Mayo Clinic and other health systems to make it easier to search vast repositories of patient data and automate administrative tasks, the organizations said Wednesday. The technology is designed to function like a super-charged Google search for health records, allowing hospitals to find and link information about patients to improve care and research. Google said it had configured its generative AI tools, which can be used to create conversational chatbots, to comply with the federal privacy law known as HIPAA.

“Accessing insights more quickly and easily could drive more cures, create more connections with patients, and transform health care.”

Cris Ross, Chief Information Officer, Mayo Clinic

Why it’s important – The rapid-fire effort to deploy the technology comes amid increasing competition with Microsoft and other large companies vying for business from healthcare companies eager to use a more powerful form of AI. It remains to be seen whether the technology will produce enough benefits to justify its costs. While generative AI systems have improved and shown the potential to understand medical information and generate useful replies, large models trained on web-scale data also have significant drawbacks. They are expensive to run and consume massive amounts of energy. They also hallucinate and provide inaccurate information.

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Podcast of the week – Abraham Verghese is an American physician and Professor of the Theory and Practice of Medicine and Vice Chair of Education at Stanford University Medical School. He is also the author of four best-selling books, two memoirs, and two novels. In his first Fixing Healthcare interview, Verghese talks about his newest work of fiction, “The Covenant of Water,” which sits at No. 4 on the New York Times list and is an Oprah book-club selection. The discussion takes listeners on a journey into the mind of an exceptional physician and writer. Verghese compares his approach to writing vs. medicine and concludes, “the gaze is the same.” And because he sees the world similarly, whether he’s sitting in front of a keyboard or a sick patient, he shares a fascinating perspective on physician leadership, end-of-life care, and myriad issues that transcend healthcare. You can listen here.

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Programmable 3D printed wound dressing could improve treatment for burn, cancer patients

Researchers from The University of Waterloo have developed intelligent hydrogel materials for use as a reusable wound dressing. In developing the dressing, the researchers conducted a 3D scan of the patient’s face and body parts to customize it to an individual’s needs. This enables the dressing to make good contact with surfaces like noses and fingers, making it ideal for creating personalized wound dressings for burn patients.

Why it’s important – One of the challenges in treating burn victims is the frequency of dressing changes, which can be extremely painful. This new dressing could enhance the healing process for burn patients and have potential applications for drug delivery in cancer treatment and the cosmetic industry. The material also has applications for cancer treatment. In traditional chemotherapy treatment, a patient may need to be in a clinic for hours, which can be tiring and uncomfortable. This dressing can provide a constant drug release outside the clinic setting, alleviating some of the challenges associated with traditional methods.

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Novocure’s electric fields device prolongs survival in lung cancer, but doubts remain

Stat’s Adam Feuerstein reports that a medical device made by Novocure that creates electric fields in the lungs via wearable skin patches extended the survival of patients with lung cancer in a clinical trial. Novocure’s study achieved its primary goal and showed a survival benefit for patients with lung cancer that progressed following initial chemotherapy. But those data don’t fit the current medical practice for patients with lung cancer because nearly 70% of study participants didn’t receive initial treatment with an immune checkpoint inhibitor such as Merck’s Keytruda, which has come to dominate current therapy.

The Optune device, also called tumor treating fields, consists of four wired patches applied with skin adhesive to the upper body surrounding the lungs. When connected to an external, battery-powered generator, the patches create an electrical field tuned to interfere with the cell division of tumor cells while sparing healthy cells. Patients are instructed to wear the device for up to 18 hours daily.

“This was a positive study, but the biggest problem is that we don’t use immunotherapy in the second line anymore. I don’t see that going anywhere,” Herbst said. “There was very little benefit, it wasn’t statistically significant and the world is moving away from docetaxel.”

Roy Herbst, Deputy Director of the Yale Cancer Center

Why it’s important – The findings could lead to a new approval for the Optune device beyond its current marketing clearance to treat a type of brain cancer. Delivering additional sales, however, could be a significant challenge. The device did not delay tumor progression or shrink tumors better than standard therapy. The most commonly reported side effect was minor skin irritation caused by the patch adhesive.

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Avatar Medical wins FDA clearance for VR surgical planning tech

Avatar Medical announced on June 6th that its virtual reality (VR) surgical planning technology received FDA 510(k) clearance. Sean Whooley reports on the development in his article in Mass Device online. The company designed its proprietary technology based on four years of research in human-data interaction and machine learning. Avatar Medical conducted this research at the Institut Pasteur and Institut Curie. Use of the platform in the U.S. to date spans more than 100 surgeons across 20 different hospitals and universities. The system’s uses include case studies, student education, and patient engagement, Avatar Medical said.

Why it’s important – Patient “avatars” generate instantly from CT scans or MRI for use with the VR platform. It features underlying technology developed by the company, which has a U.S. subsidiary in Mountain View, California. The company said its platform serves as a valuable tool for pre-operative planning. It can also be displayed during surgical procedures.

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FDA’s letter to medical device maker iRhythm is a warning for the industry

Stat’s Lizzy Lawrence reports that heart monitoring company iRhythm is in hot water with the Food and Drug Administration, which issued a stern warning letter to the device maker this week for marketing its product for “high-risk” patients and changing its algorithm without seeking the FDA’s permission. iRhythm sells a wearable monitor called the Zio AT system that detects irregular heartbeats for up to two weeks. Its monitors do not present this data in real time, so they are not intended for patients in critical care. But according to the FDA, iRhythm told customers that its devices provided “near real-time monitoring” and could be used for “high-risk patients.”

The FDA first raised its concerns after an agency investigation in August 2022. The company responded to the FDA’s various concerns with seven separate letters. The FDA wasn’t satisfied and instead issued the warning letter. The FDA also slammed the company for not adequately informing doctors and patients about its device’s transmission limit. iRhythm’s monitor can automatically detect up to 500 arrhythmias. After that, the device must be replaced. The FDA said iRhythm did not make this limitation clear — with serious consequences.

“The warning letter is a clear message to industry that FDA will enforce against manufacturers when changes are made to software that could impact safety and efficacy of the device.”

Kyle Faget, Attorney, Foley & Lardner LLP

Why it’s important – The letter highlights the FDA’s growing scrutiny of digital health and patient monitoring tools — as well as the grave impacts even small device glitches can have on patients. The FDA routinely issues warning letters to enforce patient safety, but regulators holding a digital health company accountable for making unapproved claims and changes remains rare. The FDA has only recently begun seriously regulating digital health technology, particularly in the artificial intelligence space. Multiple investigations by STAT have found that software tools can deliver inaccurate results that advise doctors poorly, send false alarms, and add bias to health care.

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Another huge US medical data breach confirmed after Fortra mass-hack

Hackers stole another half a million people’s personal and health information during a ransomware attack on a technology vendor earlier this year. Zach Whittaker from Tech Crunch reports that Intellihartx, a Tennessee-based company that handles patient payment balances and collections, said in a notice filed with the Maine attorney general’s office that 489,830 patients had information stolen in the cyberattack targeting its vendor, Fortra. According to the notice, the hackers stole patient names, addresses, dates of birth, and Social Security numbers. The breach also compromised patient medical billing and insurance information, as well as diagnoses and medication.

Why it’s important – Millions of patients across the United States also had their health information stolen in the cyberattack, including children’s data. The impact of Clop’s ransomware attack prompted the U.S. Department of Health and Human Services to publish an alert warning that the ransomware group was targeting the healthcare industry.

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