December 08-11, 2023

MedTech Impact 2023

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News & Insights


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
MedTech Insider: Mayo Clinic and Cerner Partner

MedTech Insider: Mayo Clinic and Cerner Partner


ONC Awards The Sequoia Project with  Responsibilities for TEFCA

The Office of the National Coordinator for Health IT (ONC) has awarded the Sequoia Project with a cooperative agreement to serve as the recognized coordinating entity (RCE) for the Trusted Exchange Framework and Common Agreement (TEFCA). The Sequoia Project–a non-profit that advocate for nationwide health information exchange–will now be responsible for developing, implementing, and maintaining the common agreement portion of TEFCA which will create the baseline for technical and legal requirements for health information networks to share electronic health information. In a released statement, Mariann Yeager, CEO of the Sequoia Project explained: “We have learned through our own operations that seamless nationwide sharing of health information is most readily enabled through trust agreements, consistent policy and technical requirements, and appropriate, balanced governance to provide assurance of trust and interoperability. We look forward to working alongside ONC as the Recognized Coordinating Entity.”



Goshen Health Implements Secure Text Messaging Between Patients and Providers

Clinicians at Goshen Health in Indiana have begun utilizing a secure messaging platform to connect patients and providers in real time through one-to-one and group chat text messages. Initially in search of a platform through which nurses and physicians could communicate, Goshen Health completed an extensive vetting process before selecting DrFirst Backline Communication. The application supports document attachments, photos, audio files, and video. In an interview with Healthcare IT News, Dr. David C. Koronkiewicz, of Goshen’s Center for Orthopedics and Sports Medicine shared: “Improving communication using secure messaging has been shown to improve efficiency and both physician and nursing satisfaction. Ultimately, our patients will benefit with more timely and effective communication.” Dr. David C. Koronkiewicz, Goshen Health Center for Orthopedics and Sports Medicine. In a report completed following the implementation of the platform, patients around the perioperative period resulted in 83% of users being very or extremely satisfied with the ability to communicate directly with their surgeons.



Center for Medical Interoperability Releases New Verification Program

The Center for Medical Interoperability has released a new C4MI Verified program, designed with recommendations made the National Academy of Medicine and to be conducted “through partnerships with medical device vendors and its member health care organizations. The program will be combined with supporting specifications to improve and expedite the development of interoperable medical technology. In a public statement, Dean Harrison, chairman of the Centers Board, shared: “The program will enable healthcare organizations to have confidence that the solutions they purchase will be interoperable.Both buyers and suppliers of healthcare technology stand to benefit when the marketplace shifts to support products and solutions that better serve the needs of patients and providers.”.



Mayo Clinic, Cerner, and Oxford Partner In New London Clinic

Mayo Clinic, Oxford, and medical technology company Cerner have partnered together to open a new 27,000-square-foot clinic in London. Built in collaboration with Oxford University Clinic and Oxford University Hospitals NHS Foundation Trust, the clinic will be the first in Britain to provide pharmacogenomic testing that predicts how certain medications will be metabolized by a patient’s body. The clinic will utilize Cerner Millennium as its foundational electronic health record platform,  in order to provide coordinated care and aid providers in delivering proactive health management. Ben Hume, the health clinic’s manager expressed his thoughts in a public statement:”At Mayo Clinic Healthcare in partnership with Oxford University Clinic we are dedicated to providing the highest quality service to clients looking to take a proactive approach to their health. The management and security of all medical records was therefore a crucial consideration when we chose to adopt the Cerner Millennium technology.”



MedTech Insider: MIT Develops Robotic Thread Designed To Travel Through Brain’s Blood Vessels


MIT Develops Robotic Thread Designed To Travel Through Brain’s Blood Vessels

Engineers from the Massachusetts Institute of Technology have developed a “magnetically steerable” robotic thread  that can “actively glide through narrow, winding pathways such as the labrynthine vasculature of the brain.” The engineers believe that the robotic thread will soon be capable of pairing with existing endovascular technologies, allowing clinicians to remotely guide the thread through patients’ brain vessels to treat blockages and lesions that can cause aneurysms and strokes. In a statement on the research completed on the thread-like technology, Kyujin Cho, professor of mechanical engineering at Seoul National University shared: “One of the challenges in surgery has been to be able to navigate through complicated blood vessels in the brain, which has a very small diameter, where commercial catheters can’t reach. This research has shown potential to overcome this challenge and enable surgical procedures in the brain without open surgery.”



Advent Health Launches AI- Powered Clinical Command Center

Clinical health system, Advent Health has opened 12,000 square-foot AI clinical command center to ensure efficient patient care across it’s nine hospitals. Built in partnership with GE Healthcare, the center will utilize artificial intelligence to inform and guide decisions across a number of departments and areas including  patient transfers between units and facilities, dispatch of ambulances and helicopters, and prioritizations of placement across the hospital’s multiple locations. Considered to be the largest hospital mission center of its kind, the center will operate 24 hours a day and will feature 60 monitors displaying real-time data including patient-status, ambulance status, and more.



Figures Reveals Healthcare Sector Most Vulnerable to Data Breaches

A recent Freedom of Information (FOI) request from data security solutions firm Egress reveals that organizations within the healthcare industry are the most likely to fall victim to a personal data breach, with 18% of all breaches coming from the healthcare sector. The data further demonstrated that more than 60% of personal data breaches reported to the Information Commissioner’s Office this year were caused by human error. In a statement, CEO of Egress, Tony Pepper explained: “The healthcare sector persistently tops the list when analysing the sectors affected by data breaches. This is very concerning, especially given the nature of the data. Why this particular industry continues to suffer from internal breaches is worrying and the sector must quickly take action to identify how it can work towards mitigating the insider threat.”



Apple Health Records Joins Several Allscripts Platforms

Apple Health Records has integrated with a number of Allscripts EHR platforms, enabling iPhone users to assemble their personal health information across numerous difference organizations. Providers and patients documenting patient data with Allscripts’ Sunrise, TouchWorks EHR, and Professional EHR products will be given access to Apple’s platform. Patient’s will be able to view and share medication history, test results, procedures, immunizations, and various other medical data. In a released statement, Allscripts CEO Paul M. Black shared: “With Health Records on iPhone, patients can become more active members of their own care team. Health Records on iPhone empowers individuals to direct how their own health data is stored and used. We are proud to offer this and other FHIR-connected applications for our clients and their patients.”



MedTech Insider: MIT Develops Robotic Thread Designed To Travel Through Brain’s Blood Vessels
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: CashMD Launches Price Transparency Platform

MedTech Insider: CashMD Launches Price Transparency Platform



New Study Offers Insight on VR Pain Management Outcomes

A recently published clinical study completed at Cedars-Sinai is providing a glimpse at the real-world outcomes of inpatient VR patient management. The research demonstrates that therapeutic virtual reality may not merely be an effective approach for hospital inpatient experiencing pain, but may retain its impact when provided over multiple days under real-world circumstances. In the study’s conclusion, the researchers wrote: “We found that on-demand use of VR in a diverse group of hospitalized patients was well tolerated and resulted in statistically significant improvements in pain versus a control group exposed to an in-room ‘health and wellness’ television channel. These results build upon earlier studies and further indicate that VR is an effective adjunct therapy to complement traditional pain management protocols in hospitalized patients.” Read More

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: U.K. Reroutes $300 million Towards New AI Lab
This Week: Telehealth Innovation Bill Returns to Capitol Hill

This Week: Telehealth Innovation Bill Returns to Capitol Hill

CMS Launches New Physician Focused Claims Data Project

The Centers for Medicare & Medicaid Services has announced the launch of a new pilot program aimed at providing healthcare providers with direct access to patient claims data. Using application programming interfaces through the Medicare Blue Button program, the program is designed to allow practitioners with deeper insight into patients’ history, providing data access to previous diagnoses, medication lists, and more to provide a more full picture of a patient’s medical history. The pilot has launched on the program website, where clinicians may request access to the pilot. CMS will begin the program with a select group in August, and then expand to a growing number of providers. In a statement, CMS Administrator Seema Verma noted: “Technology, coupled with open data sharing, is how we will improve value, control costs and keep patients healthy while ensuring a solvent Medicare program for generations to come.


Kaiser Permanente Appoints First Chief Digital Officer

Kaiser Permanente has appointed Prat Vemana as its first Chief Digital Officer for Kaiser Foundation Health Plan and Hospitals. Vemana will be responsible for the strategy, development, and execution of the company’s digital vision in partnership with the internal health plan, hospital, and medical group teams. As the former Chief of Product for Home Depot, the move marks the continued trend of medical organizations looking outside of healthcare for technology expertise. In a released statement, Kaiser Permanente Chairman and CEO Bernard J. Tyson shared: “We’ve made tremendous investments in building our digital platforms and creating greater access for our members. Now we are taking it to the next level by focusing on digital experiences that change the way transactions and services are delivered.”


Researchers develop wearable device that could administer medication to prevent overdoes deaths

Researchers from Purdue University are developing a wearable sensor capable of detecting when a user’s heart rate decreases to trigger the administration of Narcan–an antidote used for opioid overdoses. Still in the proof-of-concept stage, the wearable sensor is made up of a battery, RF control, and induction device. In a video describing the developing technology, Hyowon Lee, an Assistant Professor of Biomedical Engineering at Purdue, explained: “A lot of time patients who overdoes are found alone and are incapacitated to inject the life-saving drug themselves. We are trying to come up with a closed loop solution that can automatically deliver an antidote.” The opioid crisis remains as a major public health crisis within the U.S., with over 70,237 overdose deaths in 2017 alone.


Telehealth Innovation Bill Returns to Capitol Hill for Third Attempt

The Telehealth Innovation and Improvement Act  is headed back to congress after failed attempts in 2015 and 2017. The bill seeks to provide incentive for more healthcare providers to launch telehealth programs through reimbursements via the Department of Health and Human Services’ Center for Medicare and Medicaid Innovation (CMI). Additionally, the bill would have the CMI evaluate telehealth models for cost, effectiveness, and improvement in quality of care “without increasing the costs of delivery.” In a press release, U.S. Representative John Curtis (R-UT) who introduced the bill with co-sponsor Joe Neguse (D-CO) stated: “Telehealth innovation is critical to expanding cost-effective healthcare access in a state like Utah, where care is often unavailable or difficult to access for rural communities. […] Technology provides great potential to enhance connectivity between healthcare professionals and their patients and I’m pleased to work with willing partners on both sides of the aisle to find healthcare solutions for rural communities across Utah and around the country.”

MedTech Insider: FDA Releases Mid-Year Pre-Cert Update


FDA Releases Mid-Year Pre-Cert Update

The Federal Drug Administration has released a mid-year update on its digital health pre-certification pilot program. Currently, the original 9 companies allowed are enrolled within the new Working Model format, meaning that additional companies seeking approval on new products will no go through the new Pre-Cert pathway in addition to the traditional review process. Unlike previous FDA regulatory processes, the Pre-Cert program will provide approval focus on companies and developers as opposed to individual products. As part of the program, the FDA will complete retrospective testing in which the agency developed a mock excellence appraisal summary based upon the pilot participant site visits and public comments. Reviewers additionally completed a mock assessment to determine if a regulatory decision could be made on the excellence appraisal summary. In the update, the agency remarked that, “The test achieved its objectives in identifying the feasibility of the Streamlined Review package along with the Excellence Appraisal summary to be sufficient to conduct a premarket review of SaMD [software as a medical device].”  If finalized, the Pre-Cert program could drastically alter the way digital health companies interact with the FDA.  


Healthcare Industry Experiences Unprecedented Rates in Data Breaches

For the ninth consecutive year, the healthcare industry has experienced the highest cost of  data breaches. According to recent findings from the “Cost of a Data Breach Report” completed by IBM Security and Ponem Institute, the rise in data breaches have cost organizations nearly $6.3 million on average, more than 60 percent higher than any other industry. In a comment to Healthcare IT news, Chief Technology Officer and Global Remediate Lead at IBM X-Force IRIS explained the vulnerability of patient data: “Unlike passwords that can be changed or credit cards that can be reset with an expiration date, health data lasts forever and can be used for numerous malicious activities such as identity theft, insurance and health care fraud, and more.” Scott, as well as other security experts, shared that one critical area of improvement for healthcare organizations would be the adoption of security automation tools.


Tension Rises Between Amazon’s Pill Pack and Surescripts

A year after acquiring the online pharmacy company PillPack for $753 million, Amazon is involved in a tense battle with incumbent industry player Surescipts over access to patient data. PillPack’s current online pharmacy service depends on comprehensive patient medications lists provided indirectly from Surescripts in order to inform patients on health and safety risks, and help them keep up with refills. PillPack now says that access to this vital patient data will soon be cut off: “While we’re not surprised when powerful incumbents try to undermine these efforts, we are confident that our collaborative approach to bring customers more choice, more convenience, and improved quality will ultimately prevail.” Amazon is now considering legal action again the CVS owned company. The conflict follows a recent lawsuit filed by the FTC alleging that Surescripts is “illegally monopolizing the e-prescribing market.”


CVS Health Launch Social Care Network

CVS Health will be launches a social care network platform aimed at addressed social determinants of health as insurers develop strategies to integrate beyond doctor’s offices and into communities in order to reduce medical costs. CVS and its Aetna health insurance will reportedly partner with Unite Us, a “social care coordination platform.” The social care platform comes alongside an wide host of initiatives intended to address various social determinants of health in order to cut health care costs including a $40 million investments from CVS and Aetna in affordable housing. In a released statement, Taylor Justice, Co-Founder and President of Unite Us, remarked: “Our mission is to connect individuals and families across the United States to the services they need through collaboration with local service providers, shared infrastructure, and an inclusive approach for those in need.”



MedTech Insider:  FDA Releases Mid-Year Pre-Cert Update