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Tip for digital health start-ups: To navigate regulatory gray areas, “engage early and engage often” with the FDA

FDA’s enforcement discretion for digital health is more ambiguous than ever in 2021 (MobiHealthNews):

The digital health ecosystem has swelled to encompass a broad range of products over the years.

On one end of the spectrum is software-as-medical-devices (SaMD) and prescription digital therapeutics, product categories for which a comprehensive regulatory strategy and engagement with the FDA are mandatory. On the other are wellness apps and other low-risk digital tools that likely spend more time worrying about oversight from the Federal Trade Commission than the health regulator.

However, a growing number of companies are finding themselves in a gray area of enforcement discretion, a term the FDA uses for lower-risk products that meet the definition of a medical device, but do not require regulatory submission, review and authorization before heading to market … Early-stage companies that haven’t yet internalized these concepts of documentation and transparency should take an “engage early and

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Four trends accelerating mental health innovation in the COVID/ post-COVID era

The money behind mental health: How the pandemic increased innovation, investment in behavioral health care (Fierce Healthcare):

Earlier this month, Modern Health marked a milestone few companies ever reach: unicorn status.

With the help of its latest $74 million funding round, the startup, which serves as a mental health benefits platform for employers, topped a $1 billion valuation.

… And while Modern Health was already attracting plenty of interest before the pandemic, CEO Alyson Watson said her company is among those in the behavioral health space that have seen what can only be described as a seismic shift across the industry in the wake of COVID-19. In the first half of 2020 alone, digital behavioral health startups scored $588 million, roughly the annual funding for this segment in any previous year, Rock Health wrote in a report last year … That’s translating to some real changes in the industry, including

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Innovation in COVID times: Otsuka and Click Therapeutics announce fully virtual clinical trial, leveraging Verily’s Project Baseline

Otsuka launches pivotal trial of digital therapeutics for depression (MedCity News):

Otsuka Pharmaceutical is launching a virtual study to see if digital therapeutics can reduce depression symptoms.

It’s the next step in a partnership between the Tokyo-based drugmaker and Click Therapeutics, a digital health startup that is developing programs for smoking cessation, depression and insomnia.

They plan to enroll up to 540 patients in a randomized, controlled trial that will test the digital therapeutic’s efficacy in patients that are taking antidepressants. The remote trial will be conducted using Verily’s Project Baseline platform…

“Specifically, in mental health, we do think that digital therapeutics will provide additional benefits for patients and that’s the reason why we are not only interested in one intervention but also obviously are committed to broaden this with other approaches that are meant to improve the life of patients,” (Otsuka Chief Medical Officer Christoph) Koenen said. “We do

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On Brain Awareness Week, mental health innovation, tDCS, biofeedback, psychedelics, and more

Welcome to a new edition of SharpBrains’ e‑newsletter, starting with some ideas to get in the mood for Brain Awareness Week next month (March 15–21st). May BAW 2021 be a hundred times more upbeat than last year’s…

#1. Seven brain teasers and a neuroplasticity podcast to celebrate Brain Awareness Week 2021

#2. Imagine what this capability may mean just a few years from now. Should/ will Google alert Gmail users about their (future) cognitive status? Study: Artificial intelligence program identifies linguistic markers that predict, with 70% accuracy, who gets Alzheimer’s Disease years later

#3. Similar to what happened to Thync back in 2016, Halo Neuroscience struggled to commercialize tDCS as a non-medical device and the technology is being repurposed for clinical use. Neuromodulation developer Halo Neuroscience closes its doors; Flow Neuroscience acquires assets

#4. Here you have a couple recent meta-analyses suggesting a growing adoption in the near future of web-based, … Read the rest

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Happify Health raises $73M to deepen partnerships with pharmaceutical companies and insurance payers

Happify Health raises $73M to expand its digital therapeutic care delivery capabilities (MobiHealth News):

Founded in 2012, Happify is best known for digital programs that provided automated self-guided support across various areas of mental health and wellness, such as stress management for employees or health plan members. Should the user need additional support, the platform can also facilitate a referral to third-party coaching, therapy, telemedicine or other available resources.

In more recent years the platform has expanded to address more than a dozen other chronic conditions, such as heart health and psoriasis, that can overlap with mental health conditions…

“Today, our platform covers more than 20 million lives, with more than 5 million individuals having received care through our platform,” said Tomer Ben-Kiki, cofounder and CEO of Happify, in a statement.

“We are also working with five leading pharmaceutical partners on digital therapeutic solutions and four out of the five

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How Pixar’s “Soul” met the Science of Awe

Five years ago, I (Dacher) received a call from Pixar writer and director Pete Docter to talk about his new film. The last time I said yes to such a request, I served as a scientific consultant for his film Inside Out. So, I was intrigued.

Before my visit, Pete offered a brief sketch of the film. The main character, Joe, is a middle-aged jazz pianist in a rut as a middle school band teacher in Queens. Just before his breakthrough show with a famous quartet, he falls into a manhole and dies, entering into another realm of consciousness. There he encounters “The Great Beyond”—but escapes to a pre-life realm, the “Great Before,” where he befriends a cynical “new soul” named 22. The story is about their respective quests: for 22 to find her reason for living, and for Joe to get back to life in his body for a … Read the rest

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Consumer Reports finds unclear, questionable privacy practices and policies among popular mental health apps

Mental Health Apps Aren’t All As Private As You May Think (Consumer Reports):

Type “mental health” or a condition such as anxiety or depression into an app store search bar, and you can end up scrolling through endless screens of options. As a recent Consumer Reports investigation has found, these apps take widely varied approaches to helping people handle psychological challenges—and they are just as varied in how they handle the privacy of their users.

… Researchers in Consumer Reports’ Digital Lab evaluated seven of the most popular options, representing a range of approaches, to gain more insight into what happens to your personal information when you start using a mental health app.

The apps we chose were 7 Cups, BetterHelp, MindDoc (formerly known as Moodpath), Sanity & Self, Talkspace, Wysa, and Youper. We left out popular alternatives such as Headspace, which is pitched as a meditation app, although the

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Blue Note Therapeutics raises $26M to help treat cancer-related distress via cognitive behavioral stress management (CBSM)

Blue Note Therapeutics Raises $26.25 Million in Series A Financing (press release):

Blue Note Therapeutics, Inc., today announced the closing of a Series A financing round of $26.25 million. Proceeds will allow the company to scale the organization and fund near-term clinical trials of its lead prescription digital therapeutic (PDT), which will potentially improve the treatment of cancer. The capital will also support the development of Blue Note’s pipeline assets. The Series A financing was led by JAZZ Venture Partners and joined by Summer VC.

Blue Note Therapeutics is dedicated to serving patients suffering from cancer-related distress. Working closely with leading cancer research centers and patient communities, Blue Note is developing clinically validated medical devices designed to improve overall cancer outcomes. These products will help address the specific psychosocial needs of oncology patients and may reduce comorbidities such as anxiety, depression, and fear of cancer recurrence…In 2020, Blue Note launched

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How Wonder and Awe help us transcend self, regulate stress, and improve well-being

What is awe?

We have all experienced it, even if we didn’t know what to call it. Whether we’re overlooking a beautiful view after a challenging hike or watching a new leaf grow on the plant we’ve been nurturing in lockdown, the feeling we get in that moment—amazed, inspired, transported—is what researchers call awe.

In his new book, Awestruck, psychologist Jonah Paquette explains the process underlying the experience of awe and uncovers both its complexity and its value to our well-being. Walking readers through various scientific findings, he shows that awe helps improve our relationships, decrease our stress, and make us happier. By illustrating awe’s many benefits, Paquette gives us a reason to seek more awe experiences in our lives—and then shows us how to do it.

How we experience awe

An awe experience, as Paquette defines it, involves two primary components: encountering “vastness” and experiencing transcendence. Vastness happens when … Read the rest

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