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Tag: FDA

F.D.A. Authorizes E-Cigarettes to Stay on U.S. Market for the First Time

Article Excerpt: The Food and Drug Administration for the first time on Tuesday authorized an electronic cigarette to be sold in the United States, a significant turn in one of the most contentious public health debates in decades. In greenlighting a device and tobacco-flavored cartridges marketed by R.J. Reynolds under the brand name Vuse, the agency signaled that it believed that the help certain vaping devices offer smokers to quit traditional cigarettes is more significant than the risks of ensnaring a new generation.

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Article Source: The New York Times


The FDA Should Better Regulate Medical Algorithms

Article Excerpt: Medical algorithms are used across the health care spectrum to diagnose disease, offer prognosis, monitor patients’ health and assist with administrative tasks such as scheduling patients. But recent news in the U.S. is filled with stories of these technologies running amok. From sexual trauma victims being unfairly labeled as “high-risk” by substance-abuse-scoring algorithms to diagnostic algorithms failing to detect sepsis cases in more than 100 health systems nationwide to clinical decision support (CDS) software systematically discriminating against millions of Black patients by discouraging necessary referrals to complex care—this problem abounds.

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Article Source: Scientific American


Addiction Therapy at the Touch of a Button

Article Excerpt: There’s seemingly an app for everything these days, including hacking the mental elements of drug addiction. “We can’t be available to our patients 24-7,” said Bruce Goldman, senior director of behavioral health at Zucker Hillside Hospital on Long Island, “the app is.” The hospital began prescribing reSET-O as part of a pandemic pilot program, now the app is a standard care option… “These digital treatments can provide care that is sometimes as good as or better than clinician delivered therapy,” said Dr. Lisa Marsch, a researcher with Dartmouth College’s Geisel School of Medicine.

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Article Source: WWNY TV (Also posted in WCAX, Dartmouth Geisel School of Medicine News, and many others)


Study: Chatbots Could Help People with Substance Use Disorder Avoid Relapse

Article Excerpt: A digital chatbot could be one way to help individuals with substance abuse disorder, according to a new study published in Drug and Alcohol Dependence. The study, which was conducted during the COVID-19 pandemic, found that individuals with SUD using the chatbot Woebot significantly reduced their substance use occasions more than individuals on the waitlist, who did not receive the intervention. The bulk of participants in the test group also said that they would recommend the intervention.

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Article Source: MobiHealthNews


HIMSSCast: Are Digital Therapeutics the Future of Mental Health?

Article Excerpt: For a long time, the standard of care in mental and behavioral health has been some combination of pharmaceuticals and talk therapy. But with FDA-cleared, rigorously vetted digital health apps, there’s a new piece of the puzzle, and it has the potential to combine the advantages of therapy with the scalability of drugs.

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Article Source: MobiHealthNews


Can An App Be Medicine? These Companies Think So

Article Excerpt: There are signs that CMS (Center for Medicaid and Medicare Services) may be embracing digital therapeutics soon. In January, CMS finalized a rule called the Medicare Coverage of Innovative Technology (MCIT), which would make technologies with a breakthrough status from the Food and Drug Administration eligible for reimbursement under Medicare for four years… In addition to MCIT, a bill introduced last year may create a stronger pathway to reimbursement for digital therapeutics. The Prescription Digital Therapeutics to Support Recovery Act would ensure Medicare and Medicaid cover prescription digital therapeutics that render behavioral health services, including programs that address mental health disorders and substance abuse. If it is eventually passed, this bill would create a benefit category for digital therapeutics…

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Article Source: Fast Company


Issues in Regulating DTx

Article Excerpt: Access to evidence-based psychotherapies remains limited by time constraints, affordability, stigma, and other factors. Digital therapeutics (DTx) represent a valuable addition to psychiatrists’ toolkits. But before they recommend DTx, psychiatrists should consider how these programs are being evaluated by regulators and delivered to patients. Although existing DTx target a range of physical illnesses, those targeting mental health issues have received more funding in 2020 and 2021 than all other types. This development will have a direct impact on the practice of psychiatry. The scope of this impact depends in large part on how regulatory oversight evolves, since regulation determines: which types of DTx are subject to oversight; whether a particular DTx is available via prescription or over the counter (OTC), and the required level of adjunctive care associated with it; and the evidence required for commercialization and reimbursement.

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Article Source: Psychiatric Times


Integrating Digital Therapeutics Into Care of Serious Mental Illness

Article Excerpt: Digital health technologies designed for serious mental illness (SMI) have the potential to close mental health treatment gaps. Upwards of 85% of individuals with SMI now use mobile phones as part of their daily routines, and over 60% own smartphones. A significant number of those with SMI have expressed interest in learning to use mobile applications to manage their moods, monitor mental health symptoms, and receive digital treatments.

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Article Source: Psychiatric Times


Digital Therapeutics Extend Their Reach in Neurology

Article Excerpt: In recent years, a new genre of medical intervention has started to emerge — digital therapeutics. In the wake of promising results in a number of conditions, one high-profile approval by the US Food and Drug Administration (FDA), and several ongoing clinical studies, neurologists (and other doctors) may soon be prescribing video games alongside conventional therapies for several conditions.

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Article Source: Medscape