Issue 026. Get E&O weekly. | Subscribe
Digital health research from Brian Dolan.
Welcome to E&O.
Last week’s newsletter had a glass-is-half-full 56 percent open rate. Here’s what’s happening this week:
- Have you read that Google is acquiring Fitbit for $2.1 billion? More on that below. This has been the newsiest week of 2019, so I’ll try to keep these brief as this issue is now over-stuffed.
- Stat reports that later today President Trump is expected to nominate MD Anderson’s chief medical executive Stephen Hahn as the next FDA commissioner.
- A trio of Democrat Senators sent another letter to the FDA loaded with questions and concerns about the way Pre-Cert will work. Read the latest letter here. Their letter from October 2018 here. And the FDA’s June 2019 response to the first letter here.
- The Unbearable Lightness of De-identified Data: The concept of “de-identified patient data” eroded evermore this week as studies showed both MRI scans and gait data can be used to ID individuals.
- Rock Health and Stanford Medicine’s Center for Digital Health are out with their annual survey focused on consumer adoption of digital health.
- Bloomberg has the first (but still scant) details on what the JP Morgan-Amazon-Berkshire Hathaway creation Haven is up to: The JV is offering two health plans run by Aetna and Cigna to some JP Morgan Chase bank employees in Ohio and Arizona. The test run includes monetary incentives, no deductibles, and (sometimes) higher co-pays.
- Finally, have you read a16z’s new manifesto? From the same VC firm that brought you “Software is Eating the World”, comes “Biology is Eating the World”. (This metaphor gets grosser with each iteration. Are we up to a twice-eaten world now?)
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FDA puts AI/ML guidance on the backburner until 2021
In a surprising move, the FDA doesn’t plan to deliver additional guidance focused on AI and machine learning until 2021 — at the earliest. Its current list of fiscal year 2020 priorities, which actually takes the form of an A list and a B list, makes no mention of a final guidance for AI and ML.
You’ll remember that in April the FDA published a proposed framework for how it would regulate AI and machine learning in software as a medical device (SaMD). The agency asked for and received comments — 131 of them. So, that’s a wrap?
The FDA’s 2020 plans were posted two weeks ago for public comment, but have yet to receive any. Does the agency have its priorities right? Should AI and machine learning really be posteriorities?
FDA’s first official digital therapeutics meeting
If you are in the Digital Therapeutics Alliance, then this probably isn’t news to you: At the end of September, the FDA had its first official meeting focused on digital therapeutics, according to its public calendar. In attendance: the DTA’s Megan Coder, Akili Interactive’s Anil Jina, Pear Therapeutics’ Yuri Maricich, and Akin Gump’s Nate Brown. The FDA’s participants included Jeffrey Shuren, Bakul Patel, Owen Faris, Matthew Diamond, Elizabeth Hillebrenner, and Angela Krueger.
The agency’s calendar doesn’t offer any additional information, but the day before the meeting DTA’s Megan Coder tweeted a question about a potentially knotty issue that is not specific to DTx, but applies to any SaMD regulation:
“Digital health technologies absolutely rely on iterations to improve product quality, engagement, outcomes, etc. However, is there a term for iterations that move the product outside of its initial regulatory indication and clearance?”
Curious to see what comes out of these meetings with the FDA. Do digital therapeutics, which in the regulatory context might be best-defined as SaMDs that make treatment claims in their label, need regulatory clarity beyond the more general category of software as a medical device? Let me know if you have insights here and hit reply to this email with comments. I have some leads but hoping to flesh this out more before digging into it with a longer post.
Eli Lilly hiring for migraine digital therapeutic
Eli Lilly won an FDA OK for its migraine drug Reyvow two weeks back, and this week the pharma company posted an opening for a brand manager of digital products in its neuroscience group. The posting asks:
“Do you have a firm understanding of digital platforms/technologies and how they integrate into the end-user experience of a digital therapeutic product?”
Lilly’s Kirk Keaffaber, who is the company’s senior director and digital health leader in its biomedicines business unit, described the role on LinkedIn as “commercializing a digital health solution for patients with migraine.”
Pear, Ironwood to co-develop prescription digital therapeutics for GI patients
Fresh from its break-up with Sandoz, Pear Therapeutics announced this week a deal with Ironwood Pharmaceuticals to “explore developing [prescription digital therapeutics] for the treatment of patients with selected indications within the gastrointestinal (GI) space.” Pear noted that this deal was also an expansion beyond its existing portfolio of PDTs for brain-related conditions.
Ironwood has partnered with Allergan for most of the pharmaceuticals in its pipeline, so it will be interesting to see if whatever Pear co-develops with Ironwood goes to market with help from Allergan.
Ironwood currently has a drug in the market for irritable bowel syndrome with constipation (IBS-C) and others in its pipeline for the treatment of GERD, constipation in kids, as well as IBS with diarrhea (IBS-D).
AliveCor’s 2nd act: Powering health features in other companies’ wearable devices, starting with Xiaomi-backed Huami
In The AliveCor Report, I predicted that after Apple made its KardiaBand device redundant, AliveCor would make a push into partnerships with other wearable makers. This week, AliveCor announced a big partnership with Huami, a wearable maker partnered with and backed by China’s tech gargantuan Xiaomi.
I expect AliveCor will bring a feature similar to SmartRhythm, which it quietly shutdown before pulling its KardiaBand from the market entirely. Here’s how I described it in the report:
SmartRhythm: As part of its Kardia Band offering, AliveCor used the continuous heart rate monitoring function of the Apple Watch to create a new analysis feature called SmartRhythm in its Kardia app. The offering compared users’ heart rate data and activity data to what AliveCor’s neural network predicted the user’s heart data should look like. When it sensed something was off, SmartRhythm instructed the user to use Kardia Band to record their ECG. AliveCor discontinued SmartRhythm in mid-2019, but it is like to return on other platforms — possibly even Apple’s — in the future.
It’s clear now that a new and improved SmartRhythm will head to Huami devices before Apple’s. Given this week’s Google-Fitbit news, I imagine AliveCor is set to pay that group a visit to discuss competing with Apple, too.
MedRhythms begins RCT for digital therapeutic targeting post-stroke walking impairments
Digital therapeutics company MedRhythms began a five-site RCT to study its first product’s “impact on walking among a group of subjects who are stroke survivors with post-stroke walking impairments.” More details:
“MedRhythms’ clinical trial will be conducted at… the Shirley Ryan AbilityLab in Chicago, the Kessler Foundation in New Jersey, Mt. Sinai Hospital in New York, Spaulding Rehabilitation Hospital in Boston, and the Boston University Neuromotor Recovery Laboratory in Boston. This trial was launched following completion of a successful feasibility study in the target population, which was conducted at the Boston University Neuromotor Recovery Lab. The results of this feasibility study will be announced at the American Physical Therapy Association’s annual Combined Sections Meeting in February 2020 in Denver, Colorado.”
MedRhythms’ pipeline includes digital therapeutics for fall prevention, Parkinson’s and MS.
Round-up: Google’s $2.1 billion Fitbit acquisition
While it’s been rumored that Google might acquire Fitbit for the past month, the official word that the deal was on only came about a few hours ago. Here’s a compilation of early considerations from the first batch of reports on this multi-billion dollar deal:
Google is well aware that the deal will stoke privacy concerns: “We will never sell personal information to anyone. Fitbit health and wellness data will not be used for Google ads. And we will give Fitbit users the choice to review, move, or delete their data,” Rick Osterloh, Google’s SVP of Devices and Services wrote in a corporate blog post today.
The Washington Post points out this privacy issue could tank the deal. “Regulators could be particularly interested in privacy: Google collects a trove of data about the users of its services, ranging from search and email online to smartphones and smart-home devices. In doing so, the company often has found itself in the crosshairs of Congress and a slew of government agencies around the world for failing to protect that personal information.” The WaPo report notes the size of the break-up fee — $250 million — indicates that a break-up is likelier here than in a typical big M&A deal.
The Wall Street Journal says analysts think Fitbit could help Google get deeper into medicine: “Analysts have said the deal for Fitbit could allow Google to expand its reach into medical technology, an area where technology and health-care companies are competing to develop new ways for consumers to corral their digital health data.”
Google has not tipped its hand about what changes now: “Google also remains committed to Wear OS and our ecosystem partners, and we plan to work closely with Fitbit to combine the best of our respective smartwatch and fitness tracker platforms,” Osterloh wrote.
Remember, it was only this past January that Google spent $40 million on Fossil’s smartwatch IP.
Once Google owns Fitbit, two companies under the Alphabet umbrella will be among the nine participants in the FDA’s Pre-Certification pilot: Google/Fitbit and Verily. Does that mean anything for Google? For Pre-Cert? Room for one more now?
I shared this on Twitter already, but I found the least important detail about the Google-Fitbit deal: For M&A, companies typically create a new legal entity to handle the transition. Fitbit named this one Magnoliophyta Inc. Was that a nod to Fitbit’s very first device? Its only on-device feedback loop was a blue LED backlit flowering plant shape that grew as your step count grew. Magnoliophyta is another word for angiosperms, or flowering plants.
Odds and ends: Facebook, Pfizer, WellDoc, Propeller, Ginger, Withings, Onduo and more
Here’s a quick round-up of one-liners related to the companies noted above:
- Not too long after hiring former Google health strategist Roni Zeiger, Facebook is exploring ways it can help with preventive health in the US. It started with tools focused on heart disease, cancer, and the flu.
- Ginger acquired assets from now-mostly-defunct mental health startup Lantern earlier this year. It just added Lantern’s CCBT into the Ginger app starting with more than 80 interactive activity cards that help members manage stress and anxiety.
- As of October, Pfizer appears to be using the term “digital therapeutics” in job postings for its digital teams: “Digital Therapeutics are becoming increasingly important in the way health systems will manage patient conditions over the coming years.”
- Propeller added a feature that lets users of its connected inhaler devices “ring” the device from their smartphone if they’ve lost it.
- Onduo, Verily, and John Hancock announced a life insurance plan for people with diabetes that uses Onduo’s tech and coaching platform to help plan members save up to 25 percent on their premium.
- WellDoc inked a deal with Competitive Health to sell its digital diabetes assistant, BlueStar, to employers via Competitive’s channel.
- The New York Times revealed some growth metrics from menstrual tracking company Flo: “In September alone, more than 636,000 women completed the Flo health assessments, said the app’s developer, Flo Health. The app then recommended that 240,000 of those women, or about 38 percent, ask their doctors about the hormonal disorder.”
- Withings is now offering a B2B suite of devices and services called Med Pro Data aimed at managers of health coaching programs, researchers and medical institutions.
Quick links to E&O research reports
Previous newsletter editions are available on the E&O website so that newer subscribers can browse through past issues.
The links below aim to make it easier for paying subscribers to find the long-form research reports on the E&O site:
Adding one here next week! (Not a link yet)
The Pear Therapeutics Report (Subscribers-only Link)
The AliveCor Report (Subscribers-only Link)
Apple’s Healthcare Work Experience (Subscribers-only Link)
Approximating Livongo’s S-1 (Subscribers-only Link)
That’s quite enough already from Issue 026 of Exits & Outcomes. Next week: A new long-form research report.
