December 08-11, 2023

MedTech Impact 2023

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Category: News

Justice Department Proposes Telemedicine Medication Rule

Justice Department Proposes Telemedicine Medication Rule

Ransomware Attack Freezes EHR Data at 112 Nursing Homes

Virtual Care Provider Inc., a digital health company that provides cloud hosting and IT services to care facilities across the nations has been hit by a ransomware encryption attack, locking access to patient data at 110 nursing homes. The impacted services include billing systems, email, phone service, EHRs and medication administration data, potentially putting the lives of thousands of patients in risk. The hackers have demanded $14 million in bitcoin for a decryption key. The company estimates that 20% of its servers were impacted by the attack, including around 800,000 computers across 45 states.

U.S. Veterans  Experience Significant Increase In Telemedicine Use

The United States Department of Veterans Affairs has announced a 17% percent jump in telemedicine use amongst veterans within the past year alone, with more than 2.6 million telehealth care services delivered. The announcement follows the completion of the first full fiscal year of the department’s  Anywhere to Anywhere program–an initiative which enables VA health care teams to treat veteran regardless of location, including across state lines. Officials noted that “approximately two-thirds of the 294,000 VA Video Connect appointments in FY 2019 were for tele-mental health visits,” and include critical care services such as suicide prevention. In a statement, VA Secretary Robert Wilkie shared: “We want every Veteran to have a choice to schedule an in-person, telephone or video visit with their providers depending on their preferences for health care delivery.”


Amazon Launches Medication Adherence Feature

In a continued move into the digital health scene, Amazon has launched a new medication adherence feature to it’s popular voice-activated device, Alexa. The new feature allows users to link pharmacy prescriptions, review prescription information, and receive reminders. The feature has been developed in collaboration with Omnicell, a tech-based medication management company. The feature will first be made available to Giant Eagle Pharmacy customers, and likely to more pharmacies throughout next year. Amazon noted that the feature would use “multiple layers of verification” to ensure user information is efficiently protected.


Justice Department Proposes Telemedicine Medication Rule

The Justice Department has proposed a new rule to create a special registration process for providers looking to utilize telehealth services to “prescribe controlled substances.”  Previously, the “Special Registration to Engage in the Practice of Telemedicine” within the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, required providers to conduct an in-person examination before prescribing controlled substances online, except when practicing telemedicine. The guidelines for the practice of telemedicine are through which providers practicing telemedicine can meet the in-person requirement includes a special registration given by the DEA, which up until now was never created. The move has been pushed for and supported by various telemedicine organizations including the  Center for Telehealth & e-Health Law and the American Telemedicine Association.



Apple Launches New Medical Research Feature and More

Apple Launches New Medical Research Feature

Apple has launched a new medical research feature available to iOS users to sign up for one or more of the company’s three ongoing studies. Following the Apple Heart Study completed with Stanford University in 2018, the company’s new app will allow users to sign up and take part in three studies focused on heart health and movement, hearing loss, and women’s health. The study’s will be lengthy and comprehensive, with the women’s health study running for a decade or more. All the studies have been submitted to and approved by institutional review boards and include consent forms to comply with privacy laws. The tech company has partnered with various prestigious health organizations including the World Health Organization, the American Heart Association, and Harvard University among others.


New X-Ray Technology Poses Groundbreaking Clinical Potential

Researchers from the University of Maryland are testing a new method of X-Ray imaging which utilizes color to identify microfractures in bones. The lab developed nanoparticles, or “GPS particles” which navigate and attach to microfractures during the imaging process. The development of spectral CT imaging technology has many potential applications, for the fields of radiology and cardiology especially, as the researchers explained: “Regular CT does not have a soft-tissue contrast. It cannot tell you where your blood vessels are. Spectral CT can help solve that problem.” The technology will be prepared to begin further human testing as early as 2020.


Google Unveils New Clinical Documentation Tool

Following recent reports of patient-data controversy, Google has provided a look at a new clinical documentation tool similar to an EHR system. The tool includes an integrated charting system and aims to make it easier for practitioners to search for a variety of metrics and such as vitals, labs, medications, both handwritten and typed notes and more.  Dr. Alvin Rajkomar, a product manager at Google and practicing physician explained: “Clicking on any value will start a deeper exploration showing recent and historical trends both graphically and with tables. Doctors can query the entire chart with their own words and typos.” Currently in its pilot phase, the technology is available to Ascension, a healthy system currently caught in the patient-privacy controversy over the two companies joint partnership, Project Nightingale.


Mayo Clinic Research Analyzes Link Between Burnout and EHR Use

A new study published in the Mayo Clinical Proceedings takes a look at the relationship between physician burnout and EHR use. The researchers polled 5,000 practitioners across all specialties in 2017 and 2018 and found that “the usability of current EHR systems received a grade of F by physician users when evaluated using a standardized metric of technology usability,” and further that “a strong dose-response relationship between EHR usability and the odds of burnout was observed.” Alongside issues with usability, physicians cited administrative burdens such as prior authorization, regulatory concerns, documentation requirements, malpractice concerns and the rise of consumerism as links to EHR caused burnout. The findings, not unlike those before, pose the potential for EHR developers and regulators to invest in making the necessary steps to address this technology-related burnout in practitioners.



Apple Launches New Medical Research Feature and More
Medtech Insider: Google Patient Data Project Under Federal Investigation

Medtech Insider: Google Patient Data Project Under Federal Investigation


Google Patient Data Project Under Federal Investigation

Shortly after the Wall Street Journal published an article detailing Google’s acquirement and storage of identifiable medical data U.S. regulators announced plans to investigate the company. The initial Wall Street Journal report uncovered a partnership with the healthcare system, Ascension, that gave Google access to tens of millions of patients’ names, health histories, date of birth, lab results, diagnoses and hospitalization records without the consent of doctors or patients. Project Nightingale, as the secret transfer partnership is called, was being used to design new AI-powered software. The Office for Civil Rights in the Department of Health and Human Services has announced plans to immediately begin investigations on the violation of HIPPA law.


Machine Learning Helps Predict Risk of HF in Diabetes Patients

Research from Brigham and Women’s Hospital and UT Southwestern Medical center has produced a new machine learning algorithm that predicts the risk of heart failure hospitalizations for type 2 diabetes patients. Utilizing data from nearly 9,000 patients in the ACCORD Trial, the researchers developed a model that can identify patterns within 147 different demographic, clinical, and biological predictors. In a statement, Ambarish Pandey, MD, MSCS, a preventive cardiologist at UT Southwestern and the senior author of this study shared: “This risk tool is an important step in the right direction to promote prevention of heart failure in patients with type 2 diabetes. It can be readily used as part of clinical care of patients with type 2 diabetes and integrated with the electronic medical records to inform physicians about the risk of heart failure in their patients and guide use of effective preventive strategies.”


Sheba Medical Center Moves to Become First Fully VR-based Hospital

Israel-based Sheba Medical Center has announced plans to incorporate virtual reality throughout all of its hospital departments.The hospital has partnered with XRHealth technology–a technology company specializing in extended reality and therapeutic application. Eyal Zimlichman, M.D., Sheba’s chief medical and chief innovation officer explained the hospital decision in a released statement: “We’ve identified medical virtualization as one of the technologies that will transform healthcare. Within this realm, we aim to be a leader in developing new health services based on VR.” In recent years the VR healthcare industry has experienced a considerable surge, with current estimates illustrating a potential for the global VR healthcare market to reach $3.8 billion by 2020.


Study Demonstrates Value of mHealth in Medication Adherence

A new study completed by researchers from John Hopkins University School of Medicine demonstrates the capability of digital therapeutics to dramatically increase long-term medication adherence. In an analysis of 288 patients being treated at 18 clinicas within the U.S., researchers utilized a digital therapeutic program designed to help patients with Hepatitis C. The platform included an ingestible sensor and wearable patch, and showed a 99% sustained virologic response rate after 10 weeks. The overall median was 95% compared to other medication adherence programs which typically result in less than 60%. The platform monitors physiologic signs and relays information to providers. Bradley Crotty MD, MPH, an internist utilizing the platform at the Froedtert & Medical College of Wisconsin (MCW) health network and an assistant professor of Medicine at MCW shared that program allows provider to “better partner with patients by understanding how they’re doing between appointments and increasingly help personalize and optimize their regimen more quickly.”



Medtech Insider: $4 Billion in Healthcare Data Breaches for 2019


$4 Billion in Healthcare Data Breaches for 2019

Findings reported by Healthcare Finance provide a broad and detailed understanding of the financial toll data breaches have caused healthcare organizations. Since Q3 of 2016, more than 93% of healthcare organizations have experienced a data breach, with 57% experiencing more than 5 data breaches within that time frame. According to 90% of hospital representatives, IT security budget have remained level since 2016. Further, the organization reported that while cybersecurity spending has increased to about 6% of the total annual IT spend, physician organizations have reported a decrease in expenses allocated for cybersecurity, with less than 1% of their total budgets. Overall, data breaches are expected to cost the healthcare industry $4 billion by the years end, with costs projected to rise in 2020.


Clinical Trial Uses In-Brain Chip to Fight Opioid Addiction

Researchers from the West Virginia University Rockefeller Neuroscience Institute (RNI) and West Virginia University Medicine (WVU) have begun a new clinical trial that uses brain-embedded technology to potentially curb opioid addiction in cases that have resisted other methods of treatment. A team of neurosurgeons from the universities implanted a “deep brain simulation” (DBS) devices into the brain of a 33 year old man.The device has a minitature electrodes attached to specific parts of the brain associated with addiction and self control behaviors. Alongside the potential for curbing addiction impulses, the device will provide researchers with data regarding real-time cravings within addiction patients.


Apple Completes VA Health Records Rolloout

On Wednesday, Apple and the VA announced the completion of the Apple Health Records rollout to U.S. veterans. Within the Health Records feature, veterans will have access to an aggregated record of allergies, immunizations, lab results, procedures, and other health information. In a released statement, VA Secretary Robert Wilkie shared: “We have delivered veterans an innovative new way to easily and securely access their health information. Veterans deserve access to their health data at any time and in one place, and with Health Records on the Health app, VA has pushed the Veterans experience forward.” The tech rollout includes 1,243 facilities across all 50 states, Cuba, Guam, Philippines, Puerto Rico, and US Virgin Islands.


New “Intelligent” Metamaterial Could Transform MRIs

Researchers from Boston University have developed a new, affordable “intelligent” metamaterial that has the potential to change the MRI process into one “faster, safer, and more accessible.” When placed beside the body that is the target of a scan, the metamaterial selectively boosts the low energy emissions by the patient’s body, increasing SNR “by 10-fold” and improving MRI imaging at a low cost. One of the researchers noted: “Shortening MRI examinations is paramount to maximizing the capacity. Not to mention revenue, as well as the overall patient experience of this powerful imaging technology.” With the support of the National Institute of Biomedical Imaging and Bioengineering, the researchers estimate the metamaterial should cost less than $100 to construct.



Medtech Insider: $4 Billion in Healthcare Data Breaches for 2019

MedTech Insider: Health Organizations Push Back Against Apple Health Records


Health Organizations Push Back Against Apple Health Records

Leading health organizations are pushing back against new federal rules allowing providers to share medical records to third-party apps. Organizations such as the American Medical Association and the American College of Obstetricians and Gynecologists have warned regulators that those who authorize consumer apps to retrieve their medical records could be vulnerable to serious data abuses. Under the new rules, federal privacy protections–which regulate how health providers and insurers utilize and share medical records, will no longer apply after a patient transfers their data to a consumer app. In a statement, Dr. Jesse M. Ehrenfeld, an anesthesiologist who is the chair of the American Medical Association’s board argued: “Patients simply may not realize that their genetic, reproductive health, substance abuse disorder, mental health information can be used in ways that could ultimately limit their access to health insurance, life insurance or even be disclosed to their employers. Patient privacy can’t be retrieved once it’s lost.” Additional proposed rules by the Centers for Medicare and Medicaid Services would require Medicare and Medicaid plans, and plans participating in the federal health insurance marketplace, to adopt A.P.I.s so patients can utilize third-party apps to get their insurance claims and benefits information. Health providers and health record vendors will have two years to comply with the A.P.I. requirements.  Providers accused of “information blocking” could be subject to federal investigation. The regulations are expected to become final this year.


First Health Tech Pacifier Measures Glucose in Newborns

Researchers from University of California, San Diego and University of Alcalá in Spain have developed a new pacifier with a built-in biosensor capable of measuring glucose concentrations in a newborn’s saliva in real-time. The pacifier utilizes a thin channel to pull saliva into a detector in which the glucose-oxidase enzyme reacts with the glucose in the saliva, then a Prussian Blue electrode transducer strip is used to detect the reaction. Finally, “The strength of the electric current produced by the strip is indicative of the amount of glucose in the sample, and this measure is transmitted wirelessly to a smartphone or other device.” Currently, identifying type 1 diabetes within infants requires accessing interstitial fluid within the child’s skin. Further, diagnostic technologies capable of detecting the disease are typically only available within hospitals, leading to high rates of undetected conditions early in a child’s development. Published in the journal Analytical Chemistry, the study poses potential for significant improvement in post-birth diagnosis type 1 diabetes and other conditions.



Health Start-Up Babylon Receives Additional $550 Million Investment

U.K. based health technology start-up Babylon has raised an additional $550 million investment  from Saudia Arabia’s sovereign wealth fund.Following the investment round which also included an  investments from German re-insurer ERGO Fund and an undisclosed U.S. Health insurer, the company has announced it is now worth $2 billion dollars. The company has gained recognition for it’s work with the United Kingdom’s Nations Health Service–building a platform that allows patients to book consultations with a doctor over video using a smartphone. Additionally, the startup has created an AI system which can receive data about the symptoms experienced by a user, and then compare the information to a database of known conditions and illness to find possible matches and identify a possible course of action and related risk factors. In a statement, Dr Ali Parsa, founder and CEO of Babylon shared: “We have seen significant demand from partners across the US and Asia. While the burden of healthcare is global, the solutions have to be localised to meet the specific needs and culture of each country.  This investment will allow us to maximise the number of lives we touch across the world.”


New Cranial Navigation System Wins Clearance in  Europe

Toronto based health tech company, ClaroNav has received regulatory approval in Europe  for it’s new Navient Cranial Navigation System. The product is designed to help streamline neurosurgical navigation through a more intuitive and space-efficient approach than operating room traditional models. The device can be used in open or percutaneous procedures to ” help locate surgical targets within the brain and wherever stereotactic neurosurgery is used.” The technology does not require mounting or spherical markers and there are no cables to connect/disconnect. According to ClaroNav “A sensor mounted above the monitor pulls out and is pointed at the surgical scene, and then pre-calibrated navigation probes are used to help accurately identify relevant anatomy. All of the instruments are steam sterilizable and there are no disposables that need to be stocked and then disposed of after each procedure.” The system has been indicated for use in any cranial interventions in which the use of sterotactic surgery may be appropriate. The CE Mark approval enables the product to be available for commercial sale throughout Europe.



MedTech Insider: Health Organizations Push Back Against Apple Health Records
Medtech Insider: Cerner Partners with Amazon on New Cognitive Health Platform

Medtech Insider: Cerner Partners with Amazon on New Cognitive Health Platform


Cerner Partners with Amazon on New Cognitive Health Platform

Health software company, Cerner is partnering with Amazon Web Services to develop a new cloud-based health platform. The platform will utilize artificial intelligence to provide predictive insights for health care decision makers. According to a Cerner press release, the platform, named Project Apollo,will serve to bring a more cognitive approach to practicing medicine. During a company conference, the company’s Chairman and CEO Brent Shafer predicted that “Health care will change more in the next five years than it has in the past 30,” and further shared: “Cerner’s technology, and collaborative programs, along with the most respected providers, will lead a wave of disruptive innovation focused on making health care better.”


UnitedHealthcare Launches New On-Demand Telemedicine App

Major healthcare organization UnitedHealthcare has developed a new app that allows members to access virtual visits on-demand. The app will be available to over 27 million employer plan members 24/7 and will additionally allow users to track benefits and compare pricing. In a statement to Fierce Healthcare, Pat Keran–Vice President of Product Innovation for the company–shared the ultimate goal is to develop a “one-stop-shop” dashboard for patients that integrates wellness programs, claims data, and remote patient monitoring. “From a technical standpoint, we’re really modified and molded the back end to really help us modify and improve the application. […] We could really make this more of a comprehensive dashboard for members who want to engage with their healthcare all in one spot,” Keran shared.


Livongo Health Gains Federal Employee Contract

Livongo Health, a quickly growing digital health care company focused on diabetes care management, recently signed a contract to provide those covered by the Federal Employees Health Benefits Program with connected health services. The company will provide digital health services for Blue Cross Blue Shield-based members diagnosed with type 1 or type 2 diabetes. In a press release, Livongo CEO Zane Burke shared: “This is Livongo’s largest agreement to provide diabetes services in our history and is another great example of the market’s excitement about our Applied Health Signals platform .” The company is is expected to serve around 25,000 included members in 2020 and 45,000 in 2021.


Omada Health Adds to $73 Million Funding Round

Emerging health tech start up Omada Health has added on to a $73 million funding round with a new “strategic investment” from Intermountain Ventures for an undisclosed amount. The digital chronic disease management company has products which help manage hypertension, Type 2 diabetes, and mental health conditions, among other medical needs. In a statement to MobiHealthNews, CEO Sean Duffy shared: “We’ll leverage this investment to accelerate the expansion of the company’s integrated digital care program, as well as deepen our collaborations with Intermountain, aiming to bring patients the very best in digital care.” The additional funding round leaves Omada total funding for the year above $200 million.




MedTech Insider: Microsoft Issues Urgent Windows Patch To Address Security Issues

MedTech Insider: Microsoft Issues Urgent Windows Patch To Address Security Issues


Microsoft Issues Urgent Windows Patch To Address Security Issues

Microsoft is calling on Windows users to install and “emergency” out of band security patch to address critical vulnerabilities in its softwareThe advisory warns of major security flaws in some versions of Internet Explorer which could allow an attacker to remotely take over an affected system. As the most vulnerable industry, health care organizations are being urged to act quickly in response to these developments. Numerous cybersecurity experts are calling on Healthcare CIOs and security officials to address any “out-of-band patch.” Clyde Hewitt, executive advisor of cybersecurity firm CynergisTek shared: “In this instance, it means an active exploitation has been found that impacts up to 7% of all browsers including versions of Internet Explorer 9, 10, and 11.” The U.S. Homeland Security has issued an advisory warning urging all affected users to install the patches as soon as possible to avoid ransomware attack.


Hava Health Prepares Vaporizer For Smoking Cessation

Tech startup Hava Health is developing an e-product to help users stop smoking. Following the surge in vaping lung cases in recent weeks, Hava Health is positioning itself as an alternative to help users quit nicotine addiction and ultimately vaping use. The startup has already raised a small seed round from prominent venture capital investor including Global Founders Capital, Make in LA, Backstage Capital, Quake Capital, Next Fab, and Ben Franklin Technology Partners.  Unlike other vaping products, the company explain that the tech is designed to not merely serve as an alternative to traditional cigarette, but as a means to quit smoking completely. Co-founder Josh Israel explains: “We started this because [co-found Devin Serago’s] grandmother died from lung cancer and his little brother expressed frustration that he couldn’t quit using the vaporizers and was smoking more than he would have if he had used a regular cigarette.” The company is in the process of applying for approval from the U.S. Food and Drug Administration to be classified as a smoking cessation treatment. 


FDA Releases Revised Guidance On Digital Health Software

The U.S. Food and Drug Administration has released two guidance documents regarding the regulation of various kinds of digital health software. The first outlines categories of clinical decision support (CDS) products that would or would not require direct regulatory oversight from the agency. Notably, this guidance added a risk-based categorization approach for determining the enforcement over these tools. The second describes kinds of software products that will no longer fall within the agency’s definition of a medical device including software for health care facility administration, electronic paper records, and apps designed to encourage health and wellness-which the agency noted “pose a low risk to patients, but can provide great value to consumers and the healthcare system,” and thus “generally fall outside the scope of the FDA’s regulation.”


Amazon Launches Pilot Virtual Medical Service 

Amazon has announced the launch of a new virtual health clinic with in-home visits and follow ups. Currently, the virtual health service benefit is available to employees and their families within the Seattle region. Named Amazon Care, the pilot includes a combination of telemedicine and in-person services. Amongst numerous capabilities and options, employees will be able to text a nurse on any health topic, arrange for a nurse visit at home, and select prescription delivery from a care courier. Amazon officials have shared that the service will  be able to address “urgent issues like colds, allergies, infections, minor injuries, preventative health consults, vaccines, lab work, sexual health services like contraception and sexually transmitted infection (STI) testing and general health questions.” 



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, 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, 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 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