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12/20/2022

Bill Could Pave the Way for Prescription Digital Therapeutics Reimbursement

Article Excerpt: New legislation would allow for reimbursement of prescribed digital therapeutics under Medicare, which proponents argue could increase access to these emerging treatments. Still, others say it’s new technology, and the wrong reimbursement model could tamper innovation and increase patient costs. The Access to Prescription Digital Therapeutics Act of 2022, introduced in the U.S. Senate in March, aims to amend the Social Security Act to provide Medicare coverage and reimbursement for prescription digital therapeutics.

Full Article: https://tinyurl.com/464yhtr7

Article Source: MobiHealthNews

Posted in: Regulation & Policy // Tagged: ; ; ; ;
11/10/2022

Digital Therapeutics Summit Held at Dartmouth

Article Excerpt: Nearly 175 people representing the digital health and pharmaceutical industries, health care systems, clinicians, scientists, investors, Dartmouth students and faculty, and government officials representing the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) gathered on Dartmouth’s campus November 2 for daylong discussions centered on digital therapeutics. Hosted by Geisel School of Medicine’s Center for Technology and Behavioral Health (CTBH) and Dartmouth’s Magnuson Center for Entrepreneurship, the program provided an overview of the science and clinical practice of digital therapeutics, the current and anticipated paths to their global deployment, and a vision for the future. This is the first time these groups have come together in conversations hosted by an academic institution about the digital health landscape and may well be viewed as a seminal moment in the rapidly developing field.

Full Article: https://tinyurl.com/2fnhbyxa

Article Source: Dartmouth Geisel School of Medicine News

Posted in: Dissemination & Implementation // Tagged: ; ; ; ; ; ; ; ; ; ;
08/02/2022

How Much Are Patients Actually Using Mental Health Apps? Research on Engagement Is Elusive

Article Excerpt: As companies selling health care apps struggle to prove to a skeptical system that they really deliver results, we’re about to start hearing a lot more about “engagement.” A new paper scrutinizing six clinical trials supporting four mental health apps cleared by the Food and Drug Administration argues there’s an urgent need to close the “gap between intention and real-world efficacy for digital therapeutics” — specifically, the dearth of data on how much people actually use digital treatments.

Full Article: https://tinyurl.com/nxu5kryh

Article Source: STAT News

Posted in: Methodologies & Analytics // Tagged: ; ; ; ; ;
08/01/2022

Digital Therapeutic Improves Symptoms of Insomnia, Anxiety, Depression for 6 Months

Article Excerpt: Data from a real-world study revealed that treatment with prescription digital therapeutic Somryst achieved reductions in symptoms of insomnia, anxiety and depression, per a late-breaking poster at the SLEEP meeting.Somryst is the only FDA-authorized prescription digital therapeutic for the treatment of chronic insomnia, manufacturer Pear Therapeutics stated in a related press release. “Chronic insomnia is often associated with depression and anxiety so it’s important to evaluate the impact of insomnia treatment on such psychiatric comorbidities,” Yuri Maricich, MD, MBA, Pear Therapeutics chief medical officer and head of development, said in the release.

Full Article: https://tinyurl.com/3drnwpnx

Article Source: Healio

Posted in: Emerging Technologies // Tagged: ; ; ; ; ; ; ;
07/12/2022

Digital Therapeutic for Substance Use Disorder Drives Down Care Utilization, Cost

Article Excerpt: Digital therapeutics firm Pear Therapeutics has released new data showing its prescription substance use disorder (SUD) therapy reduces hospitalizations and lowers healthcare costs for patients. The data will be published in the journal Advances in Therapy, but the findings are currently available online as a pre-print. The treatment is called reSET. The app is built around cognitive behavioral therapy (CBT) utilizing the community reinforcement approach (CRA), the company said. It includes a 12-week course of therapy, in which patients are incentivized for completing lessons and abstaining from drug use. The app also includes fluency training designed to reinforce the lesson content. Previous studies have shown the therapy can be effective at improving rates of abstinence and treatment retention when coupled with usual treatments. In the new report, investigators wanted to know how such improvements might translate into changes in healthcare resource utilization and costs.

Full Article: https://tinyurl.com/ybezxs3e

Article Source: Managed Healthcare Executive

Posted in: Emerging Technologies // Tagged: ; ; ; ; ; ; ;
05/23/2022

Wysa Receives FDA Breakthrough Designation for CBT Tool

Article Excerpt: Wysa, an artificial intelligence (AI) based digital companion for behavioural health, has been granted Breakthrough Device Designation by the Food and Drug Administration (FDA) for its AI-based digital mental health conversational agent for patients 18 years and older with a diagnosis of chronic musculoskeletal pain (defined as pain lasting longer than three months) and depression and anxiety. The device delivers cognitive behavioural therapy (CBT) via a smartphone-based conversational agent to reduce the symptoms of depression and anxiety, reduce pain interference, and improve physical function.

Full Article: https://tinyurl.com/2kz3nvsk

Article Source: Med-Tech Innovation News

Posted in: Emerging Technologies // Tagged: ; ; ; ; ; ; ; ; ;
05/02/2022

Does Online Opioid Treatment Work?

Article Excerpt: While Covid-19’s death toll grabbed the spotlight these past two years, another epidemic continued marching grimly onward in America: deaths from opioid overdose. A record 68,630 individuals died from opioid overdoses in 2020, partly as a result of the isolation and social distancing forced by the pandemic; early data suggest that death rates in many states were even worse in the first half of 2021. But the coronavirus pandemic may also have had a paradoxical benefit for those addicted to opioids: Because Covid-19 made in-person health care unsafe, US telehealth regulations were relaxed so that more services — including addiction treatment — could be provided online. As a result, people with opioid use disorder are accessing medication and support across the country in greater numbers than ever before. While it’s too soon to know for sure whether this helps more people kick their addiction, early signs are promising.

Full Article: https://tinyurl.com/ae7ytv7v

Article Source: Knowable Magazine

Posted in: Emerging Technologies // Tagged: ; ; ; ; ; ; ;
04/26/2022

Can Virtual Reality Help Ease Chronic Pain?

Article Excerpt: Chronic pain is generally defined as pain that has lasted three months or longer. It is one of the leading causes of long-term disability in the world. By some measures, 50 million Americans live with chronic pain, in part because the power of medicine to relieve pain remains woefully inadequate. As Daniel Clauw, who runs the Chronic Pain and Fatigue Research Center at the University of Michigan, put it in a 2019 lecture, there isn’t “any drug in any chronic-pain state that works in better than one out of three people.” He went on to say that nonpharmacological therapy should instead be “front and center in managing chronic pain — rather than opioids, or for that matter, any of our drugs.”Virtual reality is emerging as an unlikely tool for solving this intractable problem. The V.R. segment in health care alone, which according to some estimates is already valued at billions of dollars, is expected to grow by multiples of that in the next few years, with researchers seeing potential for it to help with everything from anxiety and depression to rehabilitation after strokes to surgeons strategizing where they will cut and stitch. In November, the Food and Drug Administration gave authorization for the first V.R. product to be marketed for the treatment of chronic pain.

Full Article: https://tinyurl.com/3wkx6p8z

Article Source: The New York Times Magazine

Posted in: Emerging Technologies // Tagged: ; ; ; ; ;
02/28/2022

Digital Therapeutics Should Be Regulated With Gold-Standard Evidence

Article Excerpt: There is enormous growth in the digital health sector, illustrated by huge capital investment, and a massive proliferation of mental and behavioral health apps and associated marketing claims. We are particularly concerned about one component of this sector, namely “software as a medical device”, which the Food and Drug Administration (FDA) defines as “software intended to be used for one or more medical purposes,….without being part of a hardware medical device,” and where the purpose is “treatment or alleviation of disease.” This new approach to treatment, increasingly referred to as digital therapeutics (DTx), has the potential to transform mental health care. The global DTx market was valued at more than $3.5 billion in 2020 and is projected to reach $23.5 billion by 2030. According to industry reporting, the largest number of DTx programs today are related to mental health, and most FDA submissions for DTx use cognitive behavioral therapy to promote behavior change in conditions ranging from insomnia to substance use disorder. The opportunity for innovation is clear. However, there are challenges that must be addressed.

Full Article: https://tinyurl.com/2myajfns

Article Source: Health Affairs

Posted in: Regulation & Policy // Tagged: ; ; ; ; ; ; ; ; ; ;