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New Health Affairs Study: Effectiveness of Digital Health Solutions Remains Unproven

January 7, 2019
by Mark Hagland, Editor-in-Chief
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A review of the research around the new digital health solutions by a team of healthcare policy researchers finds those solutions’ effectiveness remains largely unevaluated

How effective are new digital health solutions—both consumer-facing and provider-facing—including “health care, health diagnostics, hospital, personal health, health insurance, analytics, big data, mobile apps, wearables, cloud data services, wellness, predictive analytics, mobile devices, data mining, biometrics, [and] home healthcare”—proving to be, in impacting health status? The reality is that even the serious study of such solutions remains in its infancy.

In that context, a group of healthcare policy researchers has just published an article in the January issue of Health Affairs. The researchers—Kyan Safavi, Simon C. Mathews, David W. Bates, E. Ray Dorsey, and Adam B. Cohen, have authored an article entitled “Top-Funded Digital health Companies And Their Impact On High-Burden, High-Cost Conditions,” in which they look at the extent to which other researchers have studied the effectiveness of all these solutions.

There is real collective potential in these solutions. As the authors point out, “Digital health companies hold promise to address major health care challenges, though little has been published on their impact. We identified the twenty top-funded private US-based digital health companies to analyze their products and services, related peer-reviewed evidence, and the potential for impact on patients with high-burden conditions. Data analytics (including artificial intelligence and big data) was the most common company type. Companies producing biosensors had the greatest funding. Publications were concentrated among a small number of companies. Healthy volunteers were most commonly studied. Few studies enrolled high-burden populations, and few measured their impact in terms of outcomes, cost, or access to care. These data suggest that leading digital health companies have not yet demonstrated substantial impact on disease burden or cost in the US health care system. Our findings indicate the importance of fostering an environment, with regard to policy and the consumer market, that encourages the development of evidence-based, high-impact products.”

What’s more, the authors note, “The necessary ingredients for the meaningful and widespread adoption of digital health technologies by patients and providers are falling into place: 70 percent of physicians report using mobile or smart devices as a part of their practice, and 80 percent of the US population has used at least one digital health application or technology.”

On the other hand, the task of analyzing the effectiveness of these digital solutions is a gargantuan one. As the authors point out, “[T]he digital health industry has become more crowded and diverse, as well as better funded. A 2016 study reported that 259,000 digital health apps were available for consumers. Global consumers are expected to spend $49 billion by 2020 on digital health solutions. A record number (296) of private digital health companies received venture funding in 2016, funding that totaled more than $4.2 billion that year and approached $6 billion the following year. As digital health companies have grown, digital technologies have attracted interest from US governmental bodies—as demonstrated by the Precision Medicine Initiative of the administration of President Barack Obama and the Digital Health Program of the Food and Drug Administration (FDA).”

So what have these researchers learned? While “Digital health products have the potential to help manage high-burden populations that account for the most morbidity, mortality, and cost in the US health care system,” they state bluntly that, “[A]mong a subset of leading private digital health companies in the U.S., we found relatively few studies published in the peer-reviewed literature. Most of those we found evaluated the product or service in healthy patients; high-burden populations were less commonly targeted. These results give reason to assume that digital health products and services from leading companies have had limited impact on disease burden and cost in the U.S. health care system in their current form and implementation.”

Indeed, the authors write, “We found no studies that evaluated effectiveness in terms of reducing cost or improving access to care. Furthermore, clinical effectiveness studies with a high level of evidence were uncommon (that is, there were few randomized controlled trials demonstrating clinical effectiveness). This may explain why the studies were largely published in lower-impact journals. Health care organizations attempting to identify which digital products to purchase might find such data essential,” they add.

As a result, they write, “We believe that the findings of this study indicate the importance of building an environment to encourage the digital health industry to build products and services that are impact focused and evidence based and that provide high value for patients and the health care system. Two areas that policy makers may address to foster such an environment are clarifying the regulatory requirements for such technologies and developing incentives that lead to a stronger customer market.”

Looking forward, the researchers note that, “To encourage innovation among companies aiming to solve critical challenges in the health care system, the FDA has created several guidance documents for app developers intended to clarify the scope of products requiring approval and the standards that these products must meet. FDA Commissioner Scott Gottlieb emphasized his hope that such clarity would help support the creation of digital technologies that, for example, empower patients to monitor and manage their chronic health conditions; enable better clinical decision making, diagnosis, and treatment; and help address public health crises.”

In addition, they note, “Another factor that may explain why the digital health companies in our study demonstrated little impact on key health care metrics or in high-burden patient populations might be the complex, challenging nature of the customer market for products with such characteristics. In contrast, wellness products that use direct-to-consumer approaches may present larger market opportunities.”

Ultimately, the authors write, “The value-based purchasing trend could encourage the market to produce more evidence-based, high-value digital health products. Value-based purchasing should incentivize providers to seek methods that improve outcomes and reduce costs. The Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 represents the strongest recent federal legislation to encourage a shift to value-based care.32 If value-based purchasing becomes the dominant model, digital health tools that have evidence-based value will be in demand. However, to expect value-based purchasing to drive digital health companies might not yet be realistic, because fee-for-service models continue to dominate patient care reimbursement.”  As a result, they state, “To incentivize the adoption of impact-focused products in the health care system, several approaches could serve as a bridge while value-based purchasing expands.”

Ultimately, the researchers conclude, “Digital health represents a new and expanding field with substantial promise to address major health care challenges in high-cost, high-burden patient populations. In this cross-sectional observational study of top-funded digital health companies, we found that few companies studied their products and services in high-cost, high-burden populations or measured their impact in terms of key health metrics such as outcomes, costs, or access. Most studies were of healthy patients, congruous with the direct-to-consumer approach that many digital health companies have taken to bring their products to market. These findings indicate the importance of building an environment to encourage the digital health industry to build products and services that are impact focused and evidence based and that provide value for high-cost, high-burden patients. Two areas in which policy makers could help foster such an environment are in clarifying the regulatory landscape around these products and incentivizing an impact-focused customer market.”



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Vanderbilt Transplant Center Launches Mobile App for Providers, Patients

January 22, 2019
by Rajiv Leventhal, Managing Editor
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The Vanderbilt Transplant Center is now giving patients and providers instant access to critical transplantation data—such as educational resources and donor information—on their smartphones and mobile devices.

According to the organization’s officials in a recent announcement, the app is designed to be a resource for transplant information at the Nashville-based Vanderbilt University Medical Center (VUMC) for both patients and providers.

“It helps patients find information about transplant programs as well as educational links about transplantation. Patients can customize what organ they are interested in learning more about, meet the transplant team and find provider locations. Living donor information is also available as well as a living donor referral form,” officials stated.

The Vanderbilt Transplant Center, Tennessee’s only full-service transplant center, provides chances for patients to participate in clinical trials and studies, as well as access to other specialists. Its transplant teams have performed more than 9,500 solid organ transplants since 1962, including all the major organs—heart, kidney, lung, liver and pancreas, according to its officials.

For providers, the app aims to offer improved access in the referring process for both adult and pediatric referrals through REDcap referral forms. The app gives referring physicians a secure process to contact the on-call VUMC transplant physicians to enable better communication, while also containing a direct link to call the VUMC Transfer Center for urgent transfers of patients to VUMC facilities. Providers also have access to outcome data, officials noted.

The Vanderbilt Transplant Center has debuted a new free app available for iOS and Android devices, available by searching “VUMC transplant” in the respective app store.

“Development of this app will allow patients unprecedented ability to connect with our system, schedule appointments and interact with our providers,” Seth Karp, M.D., H. William Scott Jr. professor and chair of the Department of Surgery and director of the Vanderbilt Transplant Center, said in a statement. “We have every expectation this service will increase our ability to reach patients and provide outstanding care.”

Edward Zavala, transplant center administrator, added, “The Vanderbilt Transplant app is a significant addition for our referring providers to access the transplant center. Additionally, the patient education component of the app provides patients ready access to transplant-specific education.”

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Report: At-Risk Medicare Seniors the Next Apple Watch Target?

January 18, 2019
by Rajiv Leventhal, Managing Editor
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Apple is engaging in discussions with multiple private Medicare insurers about subsidizing the cost of the Apple Watch for at-risk people over 65 years old, according to a CNBC report.

This week’s report, from health tech reporter Christina Farr, noted, “The insurers are exploring ways to subsidize the cost of the device for those who can't afford the $279 price tag, which is the starting cost of an older model.”

The latest version of the Apple Watch—the Series 4—was launched in September, and as officials of the tech giant stated at the time, brings “advanced activity and communications features, along with revolutionary health capabilities, including a new accelerometer and gyroscope, which are able to detect hard falls, and an electrical heart rate sensor that can take an electrocardiogram (ECG) using the new ECG app.” This version retails for at least $399.

According to the CNBC report, “Apple has paid a visit to several of the largest insurers in the market, as well as some smaller, venture-backed Medicare Advantage plans. The people declined to be named as the discussions are still private.”

The watch’s electrocardiogram function and fall detection capabilities particularly make it appealing and valuable for seniors; about 19 million seniors, and growing, are enrolled in a Medicare Advantage plan, which are private health plans that receive government payouts for providing services to seniors—about $10,000 per member, on average, Farr’s report noted.

According to Apple, the new Series 4 Apple Watch intermittently analyzes heart rhythms in the background and sends a notification if an irregular heart rhythm such as AFib is detected.  It can also alert the user if the heart rate exceeds or falls below a specified threshold.

And, the Apple Watch’s fall detection function utilizes a next-generation accelerometer and gyroscope, which measures up to 32 g-forces, along with custom algorithms to identify when hard falls occur, the company has stated.

To this end, data from health technology company HealthMine shows that 21 percent of Medicare Advantage beneficiaries use a fitness/activity/steps tracker; and 70 percent currently use digital tools, with a blood pressure monitor being used by 50 percent of beneficiaries.

In this realm, Apple is working with other major insurers as well. It was recently announced that UnitedHealthcare Motion, an employer-sponsored wellness program, is telling its participants they can get a free Apple Watch if they meet the insurer’s daily walking goals over a six-month period. For this initiative, program participants can use the Apple Watch to see how they are tracking against the program’s three daily goals—frequency, intensity, and tenacity—helping integrate physical activity and engagement with their health plan.

Industry observers have already begun to offer some reaction to CNBC’s story. In Farr’s report, Bob Sheehy, the CEO of Bright Health, an insurance start-up with a Medicare Advantage plan, and the former CEO of United Healthcare, spoke to the idea of seniors potentially avoiding expensive care visits by leveraging the device. “Avoiding one emergency room visit would more than pay for the device," said Sheehy.

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PerfectServe Acquisition of Telmediq Consolidates Secure Communication Platforms

January 17, 2019
by David Raths, Contributing Editor
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Combined companies have more than 500,000 clinical users across 250 hospitals, 27,000 physician practices and post-acute care organizations

PerfectServe, a provider of cloud-based clinical communication and collaboration solutions, has acquired competitor Telmediq, a secure communications platform provider for health settings.

Knoxville, Tenn.-based PerfectServe said it plans to support both solutions going forward, taking advantage of each platform’s cloud-based, service-oriented architecture to integrate complementary features.

Telmediq is deployed across 300 healthcare organizations and 80,000 users. It offers a call center solution, nurse mobility, advanced alert and alarm management capabilities, and mass notification functionality. Combined, PerfectServe and Telmediq have more than 500,000 clinical users across 250 hospital sites and 27,000 physician practices and post-acute care organizations. 

PerfectServe said the acquisition is an important step in its effort to build a care team collaboration platform that unifies the entire care team across the continuum, from inpatient, to outpatient, to patients at home. “Our vision is to build a platform that is separate from, transcends, and is fully integrated with the EHR and all other point-of-care technologies,” said Terry Edwards, president and CEO of PerfectServe, in a prepared statement. “The goal is to make it easy for clinicians to overcome persistent care coordination challenges that have existed in the industry for years.”

The Telmediq acquisition follows an investment last year in PerfectServe by private equity firm K1 Investment Management.



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