December 08-11, 2023

MedTech Impact 2023

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Category: Insights

MedTech Insider: FDA Clears First AI X-Ray System

 

FDA Clears First AI X-Ray System

The U.S. Food and Drug Administration has provided clearance to a new artificial intelligence-powered X-ray device developed by GE Healthcare in partnership with UC San Francisco. Named Critical Care Suite, the technology uses AI algorithms to scan X-ray images and detect pnuemothorax, or collapsed lung–a condition that affects about 74,000 within the United States each year. The suite provides for automated AI  quality check features which monitors acquisition errors and alerts technologists to make necessary corrections. “The health-care industry is producing huge amounts of data from images to digital health records,” GE Healthcare CEO Kieran Murphy said in an interview with CNBC, “We strongly believe that you have to turn that data into information and insight to improve outcomes.”

 

Microsoft, Google, & Amazon Compete To Store Health Data

Tech giants, Microsoft, Google, and Amazon are engaged in a fast and growing competition to provide hospitals and health organizations with cloud software to store health data. In July, Providence St. Joseph Health announced a data storage agreement with Microsoft. Shortly after EHR company Cerner Corp, revealed a cloud storage agreement with Amazon Web Services–the companies cloud computing unit. Earlier this week Google announced a 10 year partnership with Mayo Clinic to store the hospitals medical, genetic and financial data. The announcements mark the accelerated move towards cloud storage within major healthcare systems, while highlighting the heightened need for deftly advanced data security.

 

Smartphone Urinalysis Startup Closes $60 Million Funding Round

Healthy.io, a smartphone urinalysis startup has completed a $60 million Series C funding round  led by Corner Ventures, Ansonia Holdings, Aleph and Samsung NEXT. Alongside the successful funding round, the company announced a second FDA 510 (k) clearance to support the diagnosis of chronic kidney diseases. The company’s primary product, Dip.io is a smartphone enabled testing kit with a disposable strip, testing cups, and colored panel. The diagnostic technology generates readings and directly provides users with their results. The new clearance covers an albumin-to-creatinine (ACR) test kit that can detect kidney impairment. Now, the diagnostic tool can be used at any pharmacy, urgent care center, or health clinic within the U.S. In a released statement, Yonatan Adiri, founder and CEO of Healthy.io shared: “The smartphone has the potential to be the great equalizer of healthcare. To unlock this potential, companies must adhere to the highest clinical standards. Our second FDA clearance and additional funding allows us to expand access to critical tests and care beyond our first 100,000 patients in Europe and Israel, making it a reality for millions of Americans suffering from diabetes and hypertension, who are at risk for chronic kidney disease.”

 

New Privacy Guidelines for Consumer Health Data

The Consumer Technology Association have developed a new set of guidelines for dealing with consumer health data. With members includings organizations such as Doctor on Demand and IMB among others, the association released the “Guiding Principles for the Privacy of Personal Health and Wellness Information”  to assist medical technology companies navigate the unique and complex obstacles in handling sensitive patient health data. While the guide provides useful advice on building and maintaining consumer confidence, security guidelines, and existing legal frameworks, the guideline also notes that, as by nature the industry is continually evolving, medical companies would do well to continually remained informed on the latest updates and trends: “Consumer preferences and their comfort with technology will evolve, and a company’s approach to communication should evolve, too. […] Stay informed about changes to and interpretation of privacy laws that apply to you. You can sign up for alerts and mailings from your applicable regulators, outside counsel, and industry groups.”

 

 

 

MedTech Insider: FDA Clears First AI X-Ray System
MedTech Insider: HHS Awards $107 Million to Health Centers

MedTech Insider: HHS Awards $107 Million to Health Centers

 

National U.K. Health Data Watchdog Sets Line on App Development

National Data Guardian (NDG), the United Kingdom’s health data watchdog has released a correspondence  between her office and the Information Commissioner regarding data sharing by Royal Free London NHS Foundation Trust. The correspondence informed the ICO’s 2017 findings that data-sharing agreement between and NHS Trust and the Google-owned DeepMind broke the law.

The arrangement allows for the sharing of 1.6 million medical records between the two entitites without patient consent. In a release statement, National Data Guardian, Dame Fiona Caldicott shared, “I do champion innovative technologies and new treatments that are powered by data. The mainstreaming of emerging fields such as genomics and artificial intelligence offer much promise and will change the face of medicine for patients and health professionals immeasurably… But my belief in innovation is coupled with an equally strong belief that these advancements must be introduced in a way that respects people’s confidentiality and delivers no surprises about how their data is used. In other words, the public’s reasonable expectations must be met.”

 

 

Hospital Study Supports Machine-Learning Based Medical Decisions

Recent research published in the Journal of American Medical Informatics Association (JAMIA) examines the clinical impact of health IT vendor MedAware’s machine learning based patient safety platform. Designed to minimize medication-related risks, the MedAware technology was integrated into the center’s existing EHR system. The technology monitored all medical prescriptions issued over 16 months, with staff assessing alerts for accuracy, usefulness,  and clinical validity, recording physicians responses to all alerts generated. The results were then analyzed in a single medical ward, from a hospital-wide implementation. In a statement, research lead, Dr. Gadi Segal, head of internal medicine at Sheba, shared, “Today’s widely used rule-based systems for prevention of medication risks, including prescription errors and adverse drug events, are unsuccessful and associated with a substantial false alert burden. These alerts are ignored in nearly 95% of cases. Our study demonstrates that MedAware’s patient safety platform, which leverages a probabilistic, machine-learning approach based on outlier detection can significantly minimize such risk.”

 

 

HHS Awards $107 Million to Health Centers

The U.S. Department of Health and Human Services has announced plans to award nearly $107 million to over 1,300 health centers across all 50 states, territories, and the District of Columbia.The Quality Improvement award seeks to “ recognize the nation’s health centers – funded by the Health Resources and Services Administration – that have demonstrated excellence in areas such as behavioral health, diabetes prevention and management, and heart health.” The new funding comes after the HHS has announced plans to award nearly $400 million to combat the nation’s opioid epidemic crisis. Health Resources and Services Administration acting administrator Tom Engels shared in a statement: “Today we are recognizing nearly all Health Resources and Services Administration-funded health centers for their continued improvements on clinical quality measures and supporting them to continue as quality leaders nationwide in the years to come.”

 

 

New App Uses Gamification to Help Manage Asthma

A new app developed by health tech startup MySpira uses gamification and augmented reality functionality, release by Google (ARCore) and Apple (ARKit), to provide children with asthma tools to improve training and awareness of correct inhaler techniques. Developed by UK-based Orbital Media together with the University of Suffolk through a Knowledge Transfer Partnership, the app was partly funded by Innovate UK and the Arts and Humanities Research Council. In response to a limited study completed by the startup, MySpira medical advisor, Dr. Simon Rudland commented: “The initial results of this research are extremely promising, improving both technique and compliance. Not only does this lead to better health long-term, but if adopted nationwide, could dramatically reduce the number of emergency cases, resulting in fewer hospitalisations. We are looking at integrating this app into our existing asthma support services in the future.”

 

 

Left-Pocket/Right-Pocket: The Systemic Challenge Facing Health Tech Disruption

 

By Alfred Poor, The Health Tech Futurist

 

In the past decade, health technology has raced ahead at an unprecedented pace. We are seeing new tools that help diagnose and treat a wide range of illness and chronic disease sooner and more effectively. Telemedicine brings healthcare services to those who need it but who have difficulty getting to a hospital or other clinical setting. Remote patient monitoring can detect problems before they become emergencies requiring an ambulance ride and an expensive hospital readmission.

 

New wearables make it possible to automatically maintain a diabetic patient’s blood glucose levels within a much tighter range, greatly reducing the chance of expensive and life-changing secondary complications such as blindness or the loss of a limb. Smart implants can monitor important biometrics such as glucose levels without the frequent need for invasive finger sticks to draw blood. Innovation is not limited to diabetes. Exoskeletons and smart prosthetics can reduce healthcare costs while delivering a better quality of life. The list of disruptive innovations is nearly endless. But almost all of them share a common challenge; I call it the “Left-Pocket/Right-Pocket Problem.” A 2009 program in Camden, New Jersey, serves as a poster child demonstration of this situation. According to one government report, about half of all Medicare expenditures are spent on just five percent of the eligible beneficiaries. In Camden, a consortium of city hospitals pooled their data and discovered that one percent of the patients visiting the hospitals were responsible for $46 million in treatment costs over a five-year period.

 

A pilot program put together a team that targeted just 35 of these “frequent flyer” patients who racked up an average $1.2 million in hospital charges per month. Social workers coordinated their healthcare and other aspects of their lives, such as getting into drug treatment programs. They provided housing for the homeless patients and saw that they ate balanced meals every day. The result? The average monthly hospital costs were cut in half to $531,000. The cost of the program for a year was about $300,000. That amounts to a 20:1 return on investment. Here’s the problem; I don’t know of many hospital emergency departments that have line items in their budgets that cover apartment rent and social workers for homeless patients. The expenses come out of the left pocket, but the savings go into the right pocket. (Or to be more accurate, the “savings” mean that less money is taken out of the right pocket.) This is the challenge for disruptive health tech. It’s not enough to solve a problem; there must be a sustainable business model that pays for the new technology so that its development and production are sustainable.

 

Diabetes costs more than $300 billion each year in the U.S. alone, including both healthcare costs and reduced productivity. Imagine if a closed-loop wearable system could cut those costs by just one third, by eliminating many of the instances of costly complications. $100 billion is enough to pay more than $3,000 per year to each person with diabetes in the U.S. That would be more then enough to pay for a closed-loop insulin pump system for each patient. Similar cases can be made for other chronic diseases and ways that wearable health tech devices can provide a significant return on investment: COPD, heart failure, various forms of vision impairment, and more.

 

The problem is that we don’t have a closed-loop financial system to support these innovations. The savings – or reduced costs – benefit one entity’s budget while the cost of such programs might have to come from some other source.

 

We are seeing some signs of hope, however. For example, the Veterans Administration is a much more self-contained entity than some other healthcare organizations. The VA has been able to undertake some landmark projects in telehealth, especially in the areas of mental health treatment. The result has been greatly improved outcomes at much lower costs.

 

Businesses are another example of where health tech disruption is gaining traction. Employee fitness incentive programs have been proven over and over to have a real and significant return on investment that can transfer directly to a company’s bottom line. In addition to controlling healthcare costs (either direct costs or insurance premiums), these programs have been shown to reduce absenteeism, increase productivity, foster employee engagement, and improve employee retention. These gains can add millions of dollars to a business balance sheet every year.

 

While it’s important to build a better mousetrap, the world won’t beat a path to your door if you don’t have a way to pay for it. Health tech businesses must do more than just show that their products and services will save money; they must also show how the money can move through the system to cover the costs of the devices in the first place.

 

 

Author bio: Alfred Poor, the Health Tech Futurist, believes that innovative health tech will save healthcare in the U.S. and worldwide by lowering costs and improving outcomes. He is a full-time technology speaker and writer, and is the Editor of Health Tech Insider, an industry website and newsletter that covers wearable and mobile devices for health and medical applications.

 

 

 

Left-Pocket/Right-Pocket: The Systemic Challenge Facing Health Tech Disruption
MedTech Insider: U.K. Reroutes $300 million Towards New AI Lab

MedTech Insider: U.K. Reroutes $300 million Towards New AI Lab

 

U.K. Reroutes $300 million Towards New AI Lab

The United Kingdom has announced plans to invest £250M (~$300M) in public funds towards the National Health Service (NHS) to develop an artificial intelligence laboratory. The Lab will be charged with the responsibility of expanding the use of AI within the NHS as it oversees the digitization efforts of the NHSX. The Lab will serve as “an interface for academic and industry experts, including potentially startups, encouraging research and collaboration with NHS entities (and data) — to drive health-related AI innovation and the uptake of AI-driven healthcare within the NHS.” In a press release, the Department of Health and Social Care claimed that the lab will “bring together the industry’s best academics, specialists and technology companies to work on some of the biggest challenges in health and care, including earlier cancer detection, new dementia treatments and more personalized care.”

 

Pillpack Faces Rising Opposition Against CVS and Walgreens

The struggle between Amazon’s Pillpack–an emerging e-prescription service– and pharmacy powerhouses CVS and Walgreen has continued to escalate. Most recently, PillPack has experienced an increasing number of denied transfer requests from the two pharmacies. While CVS and Walgreens claim that the company is not receiving proper consent from patients, PillPack argues that the pharmacies are improperly refusing to honor legitimate requests. In a statement to CNBC, PillPack spokeswoman Jacquelyn Miller shared: “While incumbent pharmacies may be disappointed in the loss of business, it is unacceptable to make unsubstantiated allegations about PillPack’s practices while simultaneously creating systemic barriers that make it harder for a customer to switch pharmacies.” Walgreens, CVS, as well as the National Community Pharmacists Association (a co-owner of PillPack rival, Surescripts) have all previously voiced concerns over PillPack’s alleged practices, with a Walgreens spokesperson commenting: “We’ve communicated our concerns directly to PillPack. We respect our patients’ privacy rights, and strongly believe that patients are entitled to, and benefit from a personal and trusted relationship with their pharmacist.”

 

Cerner & Duke Collaborate On CVD Patient Data

Duke Clinical Research Institute (DCRI) is partnering with health IT company, Cerner on a pilot project to analyze de-identified patient data to determine the most effective treatment options for chronic cardiovascular disease. Duke researchers will utilize Cerner technology, named the Cerner Learning Health Network, to analyze de-identified patient data from the University of Missouri Health Care and Ascension Seton in collaboration with Dell Medical School at the University of Texas. In a released statement, Ann Marie Novar, the principal investigator for the research project explained: “Current models for clinical research and registries that rely on mostly manual chart abstraction are too expensive, too slow and too small to continue. We have to figure out better ways to leverage existing electronic resources to transform how we do clinical research.” Once completed, the research will be published and sponsored by Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson.

 

CMS Proposal May Allow Physicians More Freedom To Use Remote Patient Monitoring

The Centers for Medicare & Medicaid Services has  announced two proposed changes to the 2020 Physician Fee Schedule which may provide more room for practitioners to more easily receive reimbursement from remote patient monitoring. The proposed amendments amend CPT code 99457, which was first introduced last year in order to cover “remote physiologic monitoring treatment management services, 20 minutes or more of clinical staff/physician/other qualified healthcare professional time in a calendar month requiring interactive communication with the patient/caregiver during the month.” The new proposals would alter this code to cover additional time spent on care. In a blog, Nathaniel Lacktman, a partner in the Foley & Lardner law firm and chair of its national Telemedicine & Digital Health Industry Team shared: “Changing the RPM rules to expressly allow incident to billing of CPT code 99457 under general supervision greatly expands the potential operations and business models associated with RPM services, thereby allowing more patients to enjoy the quality-improving benefits of remote patient monitoring.”

 

 

MedTech Insider: Convincing Boards To Make Cybersecurity A Priority

Convincing Boards To Make Cybersecurity A Priority

Due to sensitive and valuable data gathered by healthcare providers, medical organization are among the most likely and vulnerable targets for cybercrime. Read More

MedTech Insider: Convincing Boards To Make Cybersecurity A Priority

4 Ways AI Transforms Mental Health Care

“Good morning. How are you feeling today?” asks Youper, an AI-powered emotional health assistant app. Like a growing number of health tech services, the app seeks to address the growing rates of stress, anxiety, depression, and similar mental health issues. The AI company belongs to an industry both ripe for change and burgeoning with innovation: mental health tech.

Read More

4 Ways AI Transforms Mental Health Care