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Category: Regulation & Policy

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.

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Article Source: Health Affairs


FDA Grants Breakthrough Therapy Designation to Device to Treat AML-Induced Depression

Article Excerpt: The FDA has granted a breakthrough device designation to BNT200, a digital therapeutic designed to treat anxiety and depressive symptoms in adults with acute myeloid leukemia (AML) currently hospitalized for a regimen of high-intensity induction chemotherapy, according to a press release by Blue Note Therapeutics. BNT200 is a software that is designed to treat the unique psychological stressors that create anxiety and depressive symptoms in adult patients with AML undergoing high-intensity induction chemotherapy. It is an on-demand digital therapeutic, with content synchronized with high-intensity chemotherapy treatment.

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Article Source: Targeted Oncology


Audio-Only Telehealth Now Approved Permanently for Mental Health/Substance Use Services

Article Excerpt: The Centers for Medicare and Medicaid Services (CMS) has expanded the definition of telehealth services that are permanently eligible for reimbursement under the Medicare program to include audio-only services for established patients with mental illness/substance use disorders (SUDs) who are unable or unwilling to use video technology… These services had been temporarily reimbursed as part of the government’s response to the COVID-19 public health emergency, beginning with the presidential emergency declaration in March 2020. In December 2020, Congress approved the Consolidated Appropriations Act (CAA) of 2021, a $1.4 trillion dollar package that—among many other provisions—permanently expanded mental health services provided via telehealth by easing geographic and site-of-service restrictions under the Medicare program. The rule is an enormous victory for patients and psychiatrists for which APA had advocated unceasingly for months.

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Article Source: Psychiatry Online


Hartford Retail Cannabis Forum Stirs Debate Over Economic Benefit, Public Health Risks

Article Excerpt: “There is a strong possibility that Hartford (Vermont) will ask its residents on (Town Meeting Day) of March 2022 if they want to opt in to allow cannabis sales in Hartford” (Hartford Selectboard Vice Chair Joe) Major said in introducing the topic at a town hall discussion Monday night at Hartford High School. The meeting, organized by the Selectboard and the Hartford Community Coalition, featured a panel of local experts on the issue so that voters “could make an informed decision before going into the voter booth,” Major said. The positives of allowing local cannabis sales, however, were challenged by professionals in the medical and social service fields, as well as some in the audience who cast a skeptical eye on industry-supplied data and a cautious approach. “When the (cannabis) industry is the one that’s telling you how it all works and promising you, that you’re going to make money as a town … and your property values are going to go up and you’re going to have high-paying jobs … you have to realize that’s all speculative,” said Alan Budney, a professor of psychiatry and biomedical data science at Dartmouth’s Geisel School of Medicine who researches cannabis use disorder.

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Article Source: Valley News


Pear Therapeutics Receives FDA Breakthrough Device Designation for Prescription Digital Therapeutic Candidate to Treat Alcohol Use Disorder

Article Excerpt: Pear Therapeutics, the leader in developing and commercializing software-based medicines called prescription digital therapeutics (PDTs), today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its reSET-A™ PDT product candidate designed for the treatment of alcohol use disorder (AUD). reSET-A potentially expands Pear’s addiction franchise, which includes FDA-authorized products to treat substance use disorder (SUD) and opioid use disorder (OUD). This is the second such Breakthrough Device Designation received by Pear, following the designation awarded for reSET-O®, the first ever for a PDT, which was for the treatment of OUD.

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Article Source: BioSpace


FDA Grants Breakthrough Designation to Magnus’ Neurostimulation Technology

Article Excerpt: The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Magnus Medical’s neurostimulation technology for the treatment of major depressive disorder (MDD). Developed based on the SAINT technology, the new, non-invasive Magnus System acts rapidly and is designed to treat MDD in people who have not sufficiently recovered after receiving antidepressant medication or other therapies… According to an investigational randomised controlled trial (RCT) published on the American Journal of Psychiatry website, the individually targeted neurostimulation technology relieved severe depression in 79% of people who received active treatment.

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Article Source: Medical Device Network


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


Biden Administration Seeks to Expand Telehealth in Rural America

Article Excerpt: The roughly 15 percent of the population living in rural America includes some of the oldest and sickest patients in the country — a disparity that has grown more stark during the coronavirus pandemic. The Biden administration is investing more in telemedicine, whose use has grown sharply during the pandemic, as a way to improve their access to care. Last month, the Department of Health and Human Services announced that it was distributing nearly $20 million to strengthen telehealth services — usually medical appointments that take place by video or phone — in rural and underserved communities across the country. While the amount is relatively modest, it is part of a broader push to address the long-neglected health care infrastructure in those areas.

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Article Source: The New York Times