This Week in MedTech

This Week in MedTech

- March 22, 2019

This week’s digital health news

Whistleblowers Claim CHS Made False Meaningful Use Claims
Numerous whistleblowers claim that health organization, Community Health Systems submitted hundreds of millions of dollars in false claims to the Department of Health and Human Services “for federal incentive payments through CMS’ Promoting Interoperability Program for EHRs.” The lawsuit alleges that CHS received over $450 million in incentive payments between 2012 and 2015. The Centers for Medicare and Medicaid Services currently distributes incentive payments to healthcare providers that implement and use EHRs to improve care coordination. Plaintiffs allege that “some of the defects in the software, including an inability to calculate weight-based dosing accurately, exposed patients to mistakes that were easily missed in institutional settings and potentially catastrophic.” Recently released court documents state that the plaintiffs seek to recover damages and civil penalties through the False Claims Act.

Congressional Telehealth Caucus Seeks Input from Industry Stakeholders
The Congressional Telehealth Caucus issued a letter Thursday morning requesting “suggestions, recommendations, or relevant experiences” to be submitted as the group drafts comprehensive telehealth legislation for the 116th Congress. First launched in 2017, the caucus has since drafted a number of telehealth bills. In the letter, the caucus writes: “We look to build on these successes during the 116th Congress, [and seek] recommendations on policy areas most likely to prompt Congressional action, including ideas that are fiscally responsible and able to generate bipartisan support.” Recommendations must be sent to Telehealth.rfi@mail.house.gov by April 1.

FDA Grants Approval to VR Care Management Platform
The US Food and Drug Administration has given approval to to EYE-SYNC, a mobile health platform that uses virtual reality technology to improve care management for those suffering from concussions. Developed by SyncThink, the device uses a VR headset with infrared cameras and an app to help clinicians evaluate impairments and monitor recovery. According to the company, the technology is already being utilized by Massachusetts General Hospital, Stanford Children’s Health, and the NBA’s Gold State Warriors. Approval for the device ran through the FDA’s Breakthrough Device Program intended to provide a streamlined approval pathway for medical devices and products that provide useful treatments or diagnoses for life-threatening or debilitating conditions.

 

White House Releases Report on HealthTech For Aging Population
The White House Task Force on Research and Development for Technology to Support Aging Adults recently published a report on “emerging technologies to support an aging population.” The report focuses on the need to develop creative strategies to address the significant shift in the U.S.’ increasingly aging population. The task force notes: “The number of Americans aged 65 or older is growing rapidly — increasing by 40 percent between 2000 and 2016 to approximately 50 million people, over 15 percent of the total population — and is expected to grow to nearly a quarter of the population by 2060.” The report highlights the growing demand for medical technologies developed for seniors. The task force asserts that it is “critical that the federal government proactively develop strategies, tools, and recommendations to enable older Americans to live healthy, independent lives for as long as possible.”

Homeland Security Warns Against Medtronic Defibrillators
Homeland Security has released a warning on various critical flaws found in Medtronic defibrillators. The department warns that the small cardio-defibrillators, which use radio communications, are susceptible to interception. Homeland Security gave the warning a 9.3 out of 10 rating level, stating that interception of the device requires “low skill level.” In an interview with TechCrunch, Peter Morgan– the founder of Clever Security who found and reported the bug to Medtronic in January– stated: “It is possible with this attack to cause harm to a patient, either by erasing the firmware that is giving necessary therapy to the patient’s heart, or by directly invoking shock related commands on the defibrillator. Since this protocol is unauthenticated, the ICD cannot discern if communications its receiving are coming from a trusted Medtronic device or an attacker.”

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