With data breaches on the rise, the FTC is looking to make health apps more accountable for telling patients when their data has been exposed.
The FTC released a new statement specifying that all health apps that capture sensitive patient information notify users, the commission itself and in some cases the media when a security breach has compromised identifiable health data. If the company fails to do so it could face a fine of $43,792 per day of violation. [Read more…] about The Federal Trade Commission (FTC) hardens data security rules for health apps and devices
Study backs benefit of insomnia DTx Sleepio on mental health (pharmaphorum):
The study – published in the journal Behaviour Research and Therapy – tested the Sleepio app developed by digital health specialist Big Health as an add-on to standard NHS care for anxiety and depression under the improving access to psychological therapies (IAPT) policy.
Patients who signed up to use Sleepio – a six-week digital cognitive behavioural therapy (CBT) course – achieved significantly better improvement in symptoms compared to controls, with an IAPT recovery rate of nearly 65% versus 58% in the control group. [Read more…] about Study: Self-guided sleep app Sleepio, combined with standard care for depression and anxiety, delivers better outcomes than standard care alone
Welcome to a new edition of SharpBrains’ e‑newsletter, featuring ten timely resources and research findings for lifelong brain and mental fitness.
#1. Let’s start with a fascinating story and study 🙂
Study with 330 centenarians finds that cognitive decline is not inevitable … (Henne Holstege, PhD, assistant professor at Amsterdam University Medical Center) said her interest in researching aging and cognitive health was inspired by the “fascinating” story of Hendrikje van Andel Schipper, who died at age 115 in 2005 “completely cognitively healthy.”
#2. Neuroscientist Lisa Genova, author of the beautiful novel Still Alice, releases non-fiction book on Memory: “It is sobering to realize that three out of four prisoners who are later exonerated through DNA evidence were initially convicted on the basis of eyewitness testimony. “You can be 100 percent confident in your vivid memory,” Genova writes, “and still be 100 percent wrong” … Genova assures her readers that only two per cent of Alzheimer’s cases are of the strictly inherited, early-onset kind. For most of us, our chances of developing the disease are highly amenable to interventions…”
#3. Timely tips for the weekend: Shape your environment, shape your mind
- Surround yourself with nature
- Create opportunities for awe
- Clear the clutter
#4. “For a mission to succeed, high mental and cognitive function would be absolutely critical; astronauts would be called on to perform demanding tasks in a demanding environment. Losing 20 IQ points halfway to Mars is not an option … Stress—an emotional or mental state resulting from tense or overwhelming circumstances—and the body’s response to it, which involves multiple systems, from metabolism to muscles to memory—may be the chief challenge that astronauts face.” Next in NASA’s path to Mars: Overcoming astronauts’ cognitive and mental health challenges
#5. Study: Depression affects visual perception … making it more accurate (based on a cool optical illusion)
#6. It’s good to have more tools in the neuro toolkit…assuming we use them wisely: Emerging applications of transcranial Direct Current Stimulation (tDCS): e‑sports skills training, cognitive enhancement in older adults
#8. Mental Health in the Digital Age: From digital therapeutics to personalized mental health solutions: Pear Therapeutics expands platform via partnerships with Empatica, etectRx, KeyWise, and Winterlight
#9. The award was won last year by Indian village teacher Ranjitsinh Disale; who will be next? Final day to nominate teachers for the $1M Global Teacher Prize 2021
#10. And last, but certainly not least, let’s welcome Mental Health Month (May) by appreciating our beautiful brains
Wishing you a mentally healthy and cognitively stimulating month of May,
The SharpBrains Team
Welcome to a new edition of SharpBrains’ e‑newsletter, this time featuring eleven timely resources and research findings for lifelong brain health and mental well-being.
#1. “Awe is the feeling we experience when encountering vast things that we don’t understand. Around the world and in culturally varying ways, studies show, we experience awe in response to others’ kindness and courage, nature, music, religious or spiritual practice, the visual and dramatic arts, and epiphany … It leads us to share, collaborate, and wonder. In experiences of awe, people often speak as if they have found their soul.”
Sometimes it IS awesome to learn how the sausage was made: How Pixar’s “Soul” met the Science of Awe
#2. Here are six suggestions to incorporate awe into daily routines and improve mental well-being, based on the new book Awestruck: Linger, Slow down, Appreciate your senses, Unplug, Awe walks, Awe journaling.
#3. Speaking of Awe and Wonder, why not take a few minutes to appreciate our most precious natural resource via these
five brain teasers?
A few wonderful news for many with unmet mental/ brain health needs:
#4. Prediction: In just a few years we’ll look back at today and wonder, why didn’t we all, of all ages, access biofeedback tools and games designed to measure and retrain heart rate variability? Growing research supports Heart Rate Variability (HRV) biofeedback training to lower stress and anxiety, increase sports performance
#5. Blue Note Therapeutics raises $26M to help treat cancer-related distress via cognitive behavioral stress management (CBSM): “Nearly half of all cancer patients experience psychosocial distress, anxiety, or depression. If left untreated, these feelings can lower a cancer survivors’ quality of life and may negatively affect survival.”
#6. AppliedVR raises $29M to help make virtual reality the standard of care for treating chronic pain: “Chronic pain is one of the most common medical conditions in the world, yet it still is incredibly debilitating to patients, costly to the system and complex to treat. While our mission has always been to demonstrate that VR can be a powerful analgesic in any setting, the COVID-19 pandemic has created a surge in demand for digital medicines like VR that can be delivered safely to patients in their own homes” — Matthew Stoudt, co-founder and CEO of AppliedVR
#7. Happify Health raises $73M to deepen partnerships with pharmaceutical companies and insurance payers: “We are also working with five leading pharmaceutical partners on digital therapeutic solutions and four out of the five national payers to help support their members’ mental health and chronic illness needs. We look forward to reaching an even bigger audience with the support of our new partners.” — Tomer Ben-Kiki, cofounder and CEO of Happify
This growing number and range of innovative digital health tools demands more and better research, smarter regulations, and more transparent privacy policies:
#8. Consumer Reports finds unclear, questionable privacy practices and policies among popular mental health apps. “In general, these mental health services acted like many other apps you might download. For instance, we spotted apps sharing unique IDs associated with individual smartphones that tech companies often use to track what people do across lots of apps. The information can be combined with other data for targeted advertising. Many apps do that, but should mental health apps act the same way? At a minimum, Consumer Reports’ privacy experts think, users should be given a clearer explanation of what’s going on.”
#9. Tip for digital health start-ups: To navigate regulatory gray areas, “engage early and engage often” with the FDA. Important advice as “…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”
#10. Innovation in COVID times: Otsuka and Click Therapeutics announce fully virtual clinical trial, leveraging Verily’s Project Baseline: “We do believe that the treatment landscape in mental disease is going to evolve in a way where obviously pharmacotherapy will always play a role, but we do think digital therapeutics can play an additional role, and to some extent, substitute as well as augment pharmacological intervention.” — Otsuka Chief Medical Officer Christoph Koenen
#11. Finally, much of the opportunity around applied neuroscience and neuroplasticity relies not on tools but on mindsets, as discussed in this fantastic interview (To prevent “cognitive entrenchment,” think like a scientist and be wrong often):
“JS: You write that being wrong is tied to a more joyful life. Why is that?
AG: I had noticed Danny Kahneman [the Nobel prize–winning behavioral economist] just lights up with joy when he finds out that one of his hypotheses is false … In some ways, the joy of being wrong is the freedom to keep learning. If you can embrace the joy of being wrong, then you get to anchor your identity more in being someone who’s eager to discover new things, than someone who already knows everything or is expected to know everything.”
Wishing you a healthy and stimulating month of April,
The SharpBrains Team
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. [Read more…] about Tip for digital health start-ups: To navigate regulatory gray areas, “engage early and engage often” with the FDA
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. [Read more…] about Innovation in COVID times: Otsuka and Click Therapeutics announce fully virtual clinical trial, leveraging Verily’s Project Baseline