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FDA Moving Forward with New Regulatory Approach to Digital Health

June 16, 2017
by Heather Landi
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The U.S. Food and Drug Administration (FDA) is moving forward on a broad initiative focused on fostering new innovation in digital health, and one major part of this initiative will be a Digital Health Innovation Plan outlining how devices will be regulated, according to FDA Commissioner Scott Gottlieb, writing in a blog post.

In the blog post, published Thursday, Gottlieb wrote that the Digital Health Innovation Plan will include a “novel, post-market approach to how we intend to regulate these digital medical devices” that will provide digital medical device developers and health IT startups clarity on the regulations. “To encourage innovation, FDA should carry out its mission to protect and promote the public health through policies that are clear enough for developers to apply them on their own, without having to seek out, on a case-by-case basis, FDA’s position on every individual technological change or iterative software development,” Gottlieb wrote.

Further, the FDA will take steps to advance the goals of the 21st Century Cures Act, he said. The Act revised FDA’s governing statute to, among other things, make clear that certain digital health technologies—such as clinical administrative support software and mobile apps that are intended only for maintaining or encouraging a healthy lifestyle—generally fall outside the scope of FDA regulation.

“Such technologies tend to pose low risk to patients but can provide great value to the health care system. FDA, led by the FDA’s Center for Devices and Radiological Health (CDRH), is working to implement the digital health provisions of the 21st Century Cures Act and, in the coming months, will be publishing guidance to further clarify what falls outside the scope of FDA regulation and to explain how the new statutory provisions affect pre-existing FDA policies,” Gottlieb wrote

The FDA also plans to provide guidance to clarify its position on products that contain multiple software functions, where some fall outside the scope of FDA regulation, but others do not. In addition, FDA will provide new guidance on other technologies that, although not addressed in the 21st Century Cures Act, present low enough risks that FDA does not intend to subject them to certain pre-market regulatory requirements, Gottlieb stated. “Greater certainty regarding what types of digital health technology is subject to regulation and regarding FDA’s compliance policies will not only help foster innovation, but also will help the agency to devote more resources to higher risk priorities,” he wrote.

What’s more, the FDA also will initiate a pilot program exploring the creation of a third-party certification program under which lower risk digital health products could be marketed without FDA premarket review and higher risk products could be marketed with a streamlined FDA premarket review.

“Certification could be used to assess, for example, whether a company consistently and reliably engages in high quality software design and testing (validation) and ongoing maintenance of its software products. Employing a unique pre-certification program for software as a medical device (SaMD) could reduce the time and cost of market entry for digital health technologies,” Gottlieb wrote.

Further, he stated, “This will be the cornerstone to a more efficient, risk-based regulatory framework for overseeing these medical technologies.”

The FDA also wants to explore leveraging the post-market collection of real-world data, which developers could use to support new and evolving product functions. Developers of digital health tools could leverage real-world data gathered through the National Evaluation System for health Technology (NEST) to expedite market entry and subsequent expansion of indications more efficiently, Gottlieb said.

He described NEST as a “federated virtual system for evidence generation composed of strategic alliances among data sources including registries, electronic health records, payer claims, and other sources.”

The Medical Device Innovation Consortium (MDIC), a public-private partnership, is serving as an independent coordinating center that operates NEST. In the coming weeks, MDIC will announce the establishment of a Governing Committee for the NEST Coordinating Center comprised of stakeholder representatives of the ecosystem, such as patients, health care professionals, health care organizations, payers, industry, and government, he stated. Further, he wrote that although FDA does not own or operate NEST, the agency has been establishing strategic alliances among data sources to accelerate NEST’s launch with the initial version of a fully operational system anticipated by the end of 2019.

“Applying this firm-based approach, rather than the traditional product-based approach, combined with leveraging real-world evidence, would create market incentives for greater investment in and growth of the digital health technology industry. Such processes could enable developers to deploy new or updated software more rapidly and would help FDA to better focus our resources,” Gottlieb wrote.

The health IT community generally seems to support the direction that the FDA is taking. Eric Topol, M.D., a cardiologist, geneticist, digital health researcher, and director of the Scripps Translational Science Institute, tweeted “Really good to see FDA, Gottlieb prioritizing digital health to catalyze medicine’s future.”

 

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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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