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Category: Regulation & Policy
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

09/14/2023

‘They Won’t Rip Telehealth Away’: Digital Behavioral Health Companies Prepare for Industry-Shaping DEA Decision

Article Excerpt: November is fast approaching, and with it comes the Drug Enforcement Administration’s (DEA) proposed rule on telehealth and controlled substance prescribing. After a six-month delay, the federal law enforcement and regulatory body will release regulations that will shape the future of telehealth within behavioral health in the post-COVID era. It also has the potential to redirect the evolution of telehealth in the behavioral health industry. Companies that exclusively or heavily focus on providing care via telehealth have had to prepare for the potential snapback to a regulatory environment where in-person exams were required before a telehealth provider could prescribe certain controlled substances.

Full Article: https://tinyurl.com/abd4vzmn

Article Source: Behavioral Health Business

08/17/2023

Dartmouth’s Latin American Community Explores Innovation

Article Excerpt: Over the past decade, Dartmouth has formed multiple partnerships in Latin America. The center that (Lisa) Marsch directs— the only National Institute on Drug Abuse-designated center of excellence in digital therapeutics—is collaborating with researchers, insurers, and patient advocacy groups in Latin America as well as government organizations, such as the Ministry of Health in Colombia and National Institute of Mental Health in Peru, to create a new mental health service delivery model for Latin America that will provide better evidence-based care.

Full Article: https://tinyurl.com/r9wpyxzz

Article Source: Dartmouth News

08/01/2023

Recreational Cannabis Has Arrived in Minnesota. What Are Its Health Benefits, Risks?

Article Excerpt: Despite its use in medicine, cannabis is a cause for concern for some clinicians, especially when they consider the developing brains of children and young adults. It is also an understudied substance, due in part to its federal classification as a Schedule 1 drug, limiting what we know, scientifically, about its potential benefits and harms on the human body. “Cannabis is not one drug,” said Jacob Borodovsky, a senior research scientist at the Geisel School of Medicine at Dartmouth. “The cannabis plant itself, we’ve identified over 150 cannabinoid compounds that are present in the cannabis plant. THC and CBD are just two of those 150 or more identified compounds.” So, what do we know about cannabis and its health impacts?

Full Article: https://tinyurl.com/2nu3xj5a

Article Source: Post Bulletin

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

07/14/2023

Does Artificial Intelligence Belong in Therapy?

Article Excerpt: For many, the nearest therapist these days isn’t someone sitting across from them in a room but a friendly face on the other side of a Zoom, or even a chat thread on a smartphone. In a quantum leap beyond those types of virtual encounters, increasingly, the entity offering mental health advice may not even be a human. Chat-based mental health services boomed during the pandemic, several of them using generative artificial intelligence chatbots to converse about mental health and offer virtual companionship. If that technology starts to make its way into professionally licensed mental health areas, Rep. Josh Cutler has filed legislation to make sure the usage is regulated and disclosed. And he had an unusual collaborator in that mission – his bill was co-written by the generative app ChatGPT.

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

Article Source: CommonWealth

07/12/2023

Making Digital Interventions Accessible and Affordable

Article Excerpt: As the nation grapples with soaring demand for mental health services amid a provider shortage, more psychologists are considering the benefits of digital therapeutics—evidence-based interventions available to patients on their mobile devices. These tools have the potential to help people struggling with substance use disorders, anxiety, insomnia, and other conditions. But there is a major hurdle blocking widespread access: Using digital therapeutics in practice is not usually covered by health insurance. The costs for the software alone can range from approximately $300 to $1,500 annually—fees that are out of reach for many patients.

Full Article: https://tinyurl.com/23dws648

Article Source: American Psychological Association

07/05/2023

Despite Room for Improvement, Telehealth Assists Incarcerated Patients

Article Excerpt: A report from the Bureau of Justice Assistance (BJA) described the various state-level efforts to expand access to telehealth that benefited justice-involved and incarcerated patients with substance use disorders (SUDs) throughout the pandemic, along with the lessons to guide future use. During the COVID-19 pandemic, people with SUDs experienced many adverse outcomes, including healthcare access barriers along with buying drugs off the street and using them alone… To address these issues, federal and state governments took action to remove telehealth access barriers and support those with SUDs.

Full Article: https://tinyurl.com/3pun4xcj

Article Source: mHealth Intelligence

06/26/2023

Close The Behavioral Health EMR Gap

Article Excerpt: There is increasing consensus that we must act to improve the nation’s behavioral health outcomes and capabilities. And the critical first step to fulfilling this goal is modernizing our behavioral health information technology infrastructure.

Full Article: https://tinyurl.com/yfupzd8b

Article Source: Health Affairs