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10/28/2023

Updates in Federal Legislation Addressing Digital Therapeutics, Access to Care

Article Excerpt: Health care legislation has been on hold at the federal level following Kevin McCarthy’s (R-CA) removal as Speaker of the House. Although legislation cannot currently pass through Congress, important actions around digital therapeutics, access to care, and health care disparities are still important to highlight. In a session at AMCP Nexus 2023, Jennifer Mathieu, MA, senior vice president of professional and government affairs at the Academy of Managed Care Pharmacy, and Geni Tunstall, JD, director of regulatory affairs at AMCP, discussed federal legislative and regulatory updates that are on the horizon.

Full Article: https://tinyurl.com/5bt7ktce

Article Source: AJMC (Also in Pharmacy Times).

Posted in: Regulation & Policy, Uncategorized // Tagged: ; ; ; ; ; ;
10/15/2023

FDA Forms New Digital Health Advisory Committee to Cover Growing Role of Tech

Article Excerpt: From time to time, the FDA convenes an outside group of experts to weigh in on an experimental drug or medical device, or to offer insight on a scientific matter that raises questions. The FDA has 49 committees and panels oriented around various therapeutic areas and modalities. As regulatory submissions increasingly include digital components, the agency wants to ensure it is adequately informed about these technologies. It’s adding a digital health advisory committee charged with providing that perspective.

Full Article: https://tinyurl.com/4ysra39t

Article Source: MedCityNews

Posted in: Regulation & Policy // Tagged: ; ; ; ; ; ; ;
08/22/2023

Researchers Developing Mixed Reality Naloxone Training to Combat Opioid Overdose Deaths

Article Excerpt: OSF Healthcare (OSF), a not-for-profit healthcare organization, has announced this week a new partnership with Illinois State University (ISU) and Southern Illinois University Carbondale (SIU) to utilize mixed-reality technology to create an immersive training program designed to help combat opioid overdose deaths. The partnership is based on the development of an Illinois Innovation Network-funded education project called Virtual Reality Embedded Naloxone Training (VENT). The work centers around the development of mixed-use or augmented reality (AR) education for an immersive, engaging approach to train people on how to administer naloxone — which serves as a safe and effective antidote for suspected opioid overdoses. OSF noted that the U.S. Food and Drug Administration (FDA) made naloxone nasal spray available over the counter in March as part of a strategy that includes harm reduction through innovation and education.

Full Article: https://tinyurl.com/39b2rhn4

Article Source: Auganix

Posted in: Emerging Technologies // Tagged: ; ; ; ; ;
07/21/2023

FDA Clears Prescription Digital Behavioral Therapeutic for Type 2 Diabetes

Article Excerpt: The Food and Drug Administration (FDA) has cleared AspyreRx™, a prescription digital behavioral therapeutic device for adults with type 2 diabetes.The device is intended to provide cognitive behavioral therapy (CBT), as an adjunct to standard of care, to patients aged 18 years and older with type 2 diabetes under the care of a health care provider. Prescribed in 90-day increments, the digital therapeutic delivers CBT through a mobile application in a weekly, step-by-step process to help patients improve glycemic control.

Full Article: https://tinyurl.com/hx63366n

Article Source: Psychiatry Advisor

Posted in: Emerging Technologies, Regulation & Policy // Tagged: ; ; ; ; ; ;
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: ; ; ; ; ; ; ;