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Presented by Listen Carefully: The collision of health care and technology. | | | | | |  | | By Adriel Bettelheim | Presented by Listen Carefully | You know the pandemic’s gone on too long when we have to think about Covid-inspired health gifts for a second holiday season. But amid the gloom, there’s also hope for a more normal 2022 — and new apps and other digital tools to keep us healthier. We asked leaders in the health and tech field what they're buying for friends, family and themselves this season. Christina Farr, principal investor and health tech lead at OMERS Ventures: “I'm eyeing a few things I want to try. The Eight Sleep [smart mattress] is at the top of my list — you can change the temperature around your side of the bed, which is amazing because I like things a lot warmer than my partner. And I'm keen to see how my sleep gets affected by things like booze, exercise, stress, the time I eat, etc.” Nicholas Genes, director of informatics for the emergency department at NYU Langone Health: "Is sleep cooling a fad? We all could probably improve the quality of our sleep quality by sticking to a schedule, putting down our phones before bed, etc. — but it’s so much more tempting to imagine we’ll always wake up feeling refreshed after investing several hundred dollars on a gadget ... An affordable whole-body experience is the bFan, which circulates room air under your covers and can fit most any bed ... Eight Sleep's Pod Pro can be programmed to adjust the mattress topper temperature throughout the night, via app. More affordable, and perhaps just as effective, is a cooling pillow — a lot of pillows use fancy synthetic materials but the Leesa Hybrid offers a removable gel insert to absorb heat." Jason Helgerson, founder and CEO of Helgerson Solutions Group: “Bring on the metaverse! I fear another lockdown is coming and last year’s Peloton won’t be enough to save me from social isolation.” Joel White, executive director of the Health Innovation Alliance: “I got two new iPads for my sons with the condition they use them for educational programming for a set amount of time each week. Covid has taken its toll on tolerance for screen endurance, but iPads and other tablets are useful educational devices, even in a world of distance learning. Last year, I got my mom a remote monitoring device as she got Covid and almost died and had a related fall and couldn’t get to the phone. For me, I used a telehealth app to do routine care appointments, and we just gave my son a Binax at-home test.” Andrew Tomlinson, director of federal affairs at CHIME: “I’m a big Peloton guy and runner. With in-person races back next year, I’m planning to do my first marathon, and running is chockful of running gadgets. I’m a running shoe addict, so I’ve been intrigued about buying some of these advanced engineered shoes like the Puma Deviate Nitro Elites that Molly Seidel wore when she won her bronze medal. Instagram also appears to think I need a Theragun, and, let me tell you, nothing makes you want something like a good targeted ad featuring a Peloton instructor, Formula 1 driver or pro golfer. Do I need one? Probably not. Do I think I need one now? Absolutely.” John Nosta, founder of NOSTALAB and health tech expert: “For most of us, there's nothing better than a good night's sleep. Sleep provides a key window for recovery — from the complexities of memory transfer and storage to simple healing and recovery. But sleep can provide us with critical information and act as a surrogate to health issues; sleep data (quality, heart rate, respiration) can be a ‘check engine light’ for existing and emerging conditions. My favorites are the Apple Watch and Oura ring. Various apps like AutoSleep can dimensionalize the data to provide a robust sleep profile.” Welcome back to Future Pulse, where we explore the convergence of health care and technology. Share your news and feedback: @dariustahir, @ali_lev, @abettel, @samsabin923 , @_BenLeonard_. | | | | A message from Listen Carefully: Proposed regulations for a new category of over-the-counter hearing aids are under review. These devices are intended for individuals with perceived mild to moderate hearing loss. Unfortunately, the FDA proposal allows for devices with enough power to assist even those with severe to profound hearing loss. This is dangerous for patients and increases the chance of further damage to their hearing. While expanding access is crucial, these regulations must protect patient safety above all else. | | | | | | Len Ramirez @lenKPIX “Elizabeth Holmes on cross examination is being asked about @JohnCarreyrou article in the Wall Street Journal. She said she ‘mishandled the entire process’ and called it a ‘disaster.’ She also said she was trying to protect ‘trade secrets.’” BOOM TIMES FOR VIRTUAL CARE GADGETS: Americans’ increased acceptance of virtual health monitoring will drive sales of health apps and wearable devices in the next few years, according to projections from Deloitte. Some 320 million wellness and health gadgets — including smartwatches, fitness trackers and other wearable sensors — will be shipped globally in 2022, up from 265 million this year, the consultancy said. By 2024, the total should hit 440 million — a 66 percent increase from this year. | 
AP Photo | Paul Silverglate, Deloitte vice chair and U.S. tech sector leader, points to the pandemic accelerating a shift to virtual care. “It's getting woven into a broader collection of well-being and health care,” he said. Yet privacy concerns and physician skepticism could still dampen expectations, including some providers who don’t trust the accuracy of the data from wearables or can’t access the information. Deloitte also projects nearly $500 million in worldwide spending on mental health apps in 2022, using a “conservative” 20 percent growth rate. The apps took off in response to pandemic stressors, spurring broader demand for virtual mental health care. OMICRON PUTS FACEBOOK VAX MISINFO BACK IN SPOTLIGHT: D.C. Attorney General Karl Racine is kicking his investigation into Covid misinformation on Facebook up a notch, POLITICO'S Alexandra S. Levine writes. As part of the probe, which is examining whether Facebook’s claims about its handling of coronavirus vaccine misinformation have violated consumer protection laws, Racine subpoenaed the company for relevant records. But his office said Tuesday that because the tech giant won’t turn over ample details on the misleading material and efforts to combat it, the AG had escalated his fight — now asking the court to enforce the subpoena. Facebook has “for months … refused and actively ignored our attempts to find out what actions it is taking” to address the spread of Covid vaccine misinformation on the platform, said Abbie McDonough, a spokesperson for Racine’s office. Facebook spokesperson Andy Stone said that “we are cooperating with Attorney General Racine, have offered to meet with him and his staff, and are producing documents, in accordance with our terms and applicable federal law.” 23andME HIRES CHIEF SCIENTIFIC OFFICER: The ancestry company known for spit tests and questionnaires has hired a new executive focusing on scientific research. Chief Scientific Officer Joseph Arron comes from biotech giant Genentech and has a background that syncs with the firm’s emerging focus on drug discovery. 23andME hopes its access to customers’ genetic information, correlated with self-reported answers about their health, will give them clues that can be used to find new treatments. As of this spring, according to regulatory filings, it had identified 40 drug candidates. Of course, that’s a long way to actually finding a pill that can ward off disease. Until then, we’ll focus on whether cilantro tastes like soap — a trait that’s genetically determined. | | | |   | | | | | | BOOSTER OUTLOOK RISES ON OMICRON SPREAD: We’ve written before about the booster market and the potential windfall from making Covid shots to bump up people’s antibody counts to buffer against emerging Covid-19 strains. Now, the arrival of the Omicron variant is changing the calculus in a positive way for makers of mRNA vaccines and some antibody therapies. Morgan Stanley estimates Omicron could generate an additional $20 billion to $50 billion in 2022 revenues, mostly for Pfizer-BioNTech and Moderna, whose shots are likely to be preferred for their quick turnarounds from factory to market. Both companies would need new emergency authorizations from the Food and Drug Administration, but Morgan Stanley notes the needed studies could be completed rapidly, allowing the companies to produce in excess of 6 billion boosters next year. | 
Justin Sullivan/Getty Images | On the flip side, Omicron and its many mutations should reduce the number of effective antibody treatments. Based on available data, that could be bad for Eli Lilly and Regeneron, whose therapies won’t be significantly effective against Omicron, Morgan Stanley says. The analysts also predict Merck and Pfizer will sell all the experimental Covid-19 pills they can make, pending FDA approval. | | | APP TO LIMB: HOLD THAT POSE: It seems like just about everyone blew out their knee at some point trying to WOFH (Work Out From Home). I was among them, and that, combined with pre-pandemic aches that flare up now and then, meant that I have become quite the connoisseur of remote and app-based physical therapy. The experience has been mixed. And had I been “exercise naiïve” — i.e., had I not already experienced both rehabilitative medicine and various kinds of recreational fitness, I am not sure how much I would have gained from it. As clinics closed early in the pandemic, PT by telemedicine was my only option. But remote sessions are intrinsically limited; no hands-on modalities, no in-person equipment. Nor could my PT see me perfectly as I moved from one exercise to the next, constantly adjusting my phone camera angle. And there were a few tech meltdowns, meaning my health plan thought I had a full session, but maybe I had only half. But overall, I got better, though I think I would have healed faster with in-person care. One tool that helped — with both remote and in-person PT— was an app with videos of the exercises my therapist prescribed. I’m terrible at remembering exercises, and the stick-figure drawings PTs have given me are … stick figures. A mini-movie lets me do the routine with more precision and confidence. But I could still talk to my PT, and she could modify the exercises. Later, when another injury flared up, my health insurer gave me an at-home PT program. This wasn’t telemedicine; it was me, alone, following directions on a computer screen. I had one initial 15–20 minute video consult with a human PT; after that, I could enter questions in a chat box, and complete feedback surveys but not get real-time response. On the plus side, I controlled the schedule, and I didn’t have to drive, Metro, park, etc. It made me exercise s-l-o-w-l-y, which is safer, harder, and, for me, more effective. But it was set up, ridiculously, to do only one side of the body. If I tried to go back and do the second leg, the app went kerflooey. And the routine was too easy for several weeks. I could tell the computer, “I don’t like this exercise, take it away.” I couldn’t say, “I don’t like this exercise in exactly this form, but if we tinker it would be really good for me.” It took a month for it to get more challenging. By then, I had changed jobs and lost access. I did like a few of the exercises — but being me, I couldn’t exactly remember them. In short, these apps have potential, but in an ideal world, they’d have a bigger Real-Person component. As we emerge from the pandemic, we’re going to have more hybrid work for our brains. Maybe we’ll need hybrid PT for our brawn. Joanne Kenen is the Commonwealth Fund Journalist in Residence at Johns Hopkins School of Public Health and a Politico contributing editor.
| | | The New York Times goes inside the CDC’s new forecasting and modeling unit. Psychedelic telehealth is here: What can go wrong, asks Vice. And venture capitalist Christina Farr explores why every digital health startup is also a clinic.
| | | | A message from Listen Carefully: Over-the-counter (OTC) hearing aid legislation was first introduced in 2017; since then, misinformation has been leading consumers to believe inexpensive consumer electronic devices are a quick fix to hearing loss. They are not. A hearing aid is not a consumer electronics device; they are medical devices and should be regulated as such.
To properly protect patients and provide adequate help for mild-to-moderate hearing loss, FDA’s OTC hearing aid regulations should allow:
· A max output of 110 decibel, and
· A max gain of 25 decibel.
Currently, the proposal has an upper limit output of 120 decibel (equivalent to a chain saw) and no limit on max gain. This could cause more harm than help. We encourage Americans to submit comments to these proposed regulations and hope that the FDA will Listen Carefully and put patient safety first. | | | | | | | Follow us | | | | |  |
