TTA’s New Year Surprises: AliveCor wins ITC round v Apple, Amazon-One Medical Oregon OK, telehealth expansion done for 2 years, NHS advances effective stroke diagnosis, recovery by 48%, Allscripts now Veradigm, more!

 

 

Weekly Alert

Two surprises not under the Christmas tree or New Year’s hat. The ITC upheld AliveCor patents and damages versus Apple, pending their PTAB appeal, and Amazon got its first state approval for One Medical. As expected, telehealth’s national Medicare reimbursement was extended for two years, setting policy for health plans. And NHS advanced rapid stroke diagnosis with Brainomix trial in 22 hospital trust trial, tripling near-full recoveries to 48%.

Weekend news roundup: GE Healthcare spins off, adds CTO; Allscripts now Veradigm; NHS Brainomix AI stroke trial success; Withings home urine scanner; Careficient buys Net Health EMR; CommonSpirit’s class action suit on data breach
Amazon-One Medical gains conditional OK in Oregon–a preview of coming scrutiny?
(What happens at the big state and Fed level?)
Telehealth extensions signed into US law with Federal FY 2023 omnibus bill (Major breakthrough to widen nationally reimbursed telehealth)
Split decision! ITC rules that Apple violated AliveCor patents; enforcement held for PTAB appeal (David v Goliath continues!)

A potpourri of news wraps 2022, starting with confirming how telehealth can stand on its own even in specialty care visits and its continued strength in mental health. In the US, most telehealth expansion is confirmed for two years. But as predicted, DEA is going hard after ADHD misprescribing — a unicorn may lose its horn as a result. Oracle is erasing Cerner’s home town presence as Epic stomps a patent troll. And beware of DDoS–it may distract from more nefarious cybercrimes.

We wish our Readers all the happiness of the season, as we look forward to the start of the New Year. We’ll be back with new articles after 2 January. 

We wish our Readers a happy, healthy holiday season and New Year!
News roundup: DDoS attacks may be ‘smokescreen’, DEA slams Truepill with ‘show cause’, telehealth claims stabilize at 5.4%, Epic squashes patent troll, Cerner meeting exits KC, MedOrbis, Kahun partner on AI intake (From cybercrime to Cerner, c-c-c-changes roll)
Telehealth two-year extensions included in US Federal ‘omnibus’ budget bill (Tucked into a Moby Dick-sized whale of a bill)
Few specialty telehealth visits require in-person follow up within 90 days: Epic Research study 2020-2022 (Findings, though, may be pandemically skewed)

It’s a week of contrasts as the holiday season starts. There are ‘green shoots’ in startups and fundings, yet so many organizations have run into the red, with a high human cost. A literal bright spot–a lighting system that can detect and report falls. And the Holmes Defense Team files an appeal for a new trial that may delay her delivery to Club Fed for a long time. (Hoping the Feds will forget?)

Rounding up fundings and startups: Override(ing) pain; brainy Synchron and In-Med Prognostics; Click off migraine; Cardiosense and CHF detection (A touch of seasonal cheer)
Smart lighting that detects and reports falls in older adults–and more–debuts in UK and Ireland (Lighting up fall detection is a big step forward)
10 reasons for a new trial? Elizabeth Holmes’ legal team files appeal, delay in prison start (updated) (Foot dragging strategy continues as financial penalty to be decided)
Mid-week roundup: Wisconsin’s Marshfield Clinic zeros out telehealth staff; Komodo Health lays off 9%; epharmacy Medly’s Ch. 11, PharmEasy layoffs; OneStudyTeam releases 25% (Coal in too many stockings)

Windups as the holidays and year-end loom. AliveCor loses its David vs Goliath patent battle with Apple, with consequences to come. The Theranos drama nears its end with Balwani’s sentence. But in new developments, robotics for care support and care becomes part of…energy management? And can VIMPRO help NHS manage its patient population crush?

Theranos’ Balwani gets an unlucky 13 year sentence, restitution to come (No tears, no dramatic statements, little media scrum, and a lighter sentence than expected)
AliveCor loses Patent Office ruling with Apple; three patents invalidated (This one isn’t over–the stakes are high)
News (and robot) roundup: ElliQ companion robot upgrades, named to 2022 TIME list; Robin the Robot introduced for older adult care; Utilita acquires Canary Care (UK) (Robots advance, interesting integration of care with energy management)
Perspectives: Could the telehealth VIMPRO model save the NHS from drowning in demand? (A smarter approach advocated in managing patient populations )
Optum Labs creates and funds digital health research hub at Cornell Tech NYC (Reviving NYC in digital health, or gathering ideas for Optum to develop elsewhere?)

Something a bit different this week with two maximum roundups. athenahealth may IPO–again. Amwell may bolster telemental health with Talkspace. Cerebral and former CEO dueling in court. Taking bets on where Theranos’ Elizabeth Holmes will spend her sentence–and when. Plus…year-end buys and fundings. 

Who’s buying, selling, funding wrapup: athenahealth IPO deux?, NextGen EHR buys reseller TSI for $68M, Cloudwave buys Sensato; fundings for Lumen, UpStream, Aide Health
“Big Story” update: where Elizabeth Holmes will spend 11 years, Cerebral sues former CEO Robertson, Amwell buying Talkspace? 

As usual in the rollup to (US) Thanksgiving, it was a light news week. Our two roundups include Babylon Health’s encouraging Q3 results, DOJ’s appealing to block the UHG-Change buy–already closed (!)–an senior exec move from Walmart Health to JPM, and digital health/health tech funding yellow flagged to 2025 by Very Important Investors.

Mid-week news briefs: House members’ ‘grave concerns’ on two deaths tied to Oracle Cerner VA rollout; care.ai’s $27M funding; Clear Arch’s new mobile RPM platform; digital health investment in rough times
News roundup: Babylon Health Q3 revenue up 3.9x; surprise–DOJ to appeal UHG-Change buy approval; Walmart loses senior health exec Pegus to JPM

Legal matters led this week, with Friday’s sentencing of Elizabeth Holmes to over 11 years in Federal prison and Cerebral’s ex-CEO fishing for evidence to use in legal actions. Amazon unveiled Clinic, a low-budget messaging platform for common condition diagnosis. Women’s health Maven rounded up $90M but Sema4 exited that testing field, losing 500. 

Breaking–The Theranos denouement: Elizabeth Holmes sentenced to 11.25 years with an investor loss of ~$121 million (Loss to be finalized at later date, sentence to start 27 Apr 2023)
Ousted Cerebral CEO may sue company, accuses management of scapegoating on Schedule 2 prescribing (Set up for legal action–or more settlement to go away)
The Theranos denouement: ‘Humble, hardworking’ Elizabeth Holmes sentencing Friday; prosecution and defense paint different pictures (updated)
News briefs: ResMed-Verily’s Primasun sleep solution; Maven Clinic’s $90M Series E; Mount Sinai genomics spinoff Sema4 lays off additional 500, exits women’s health
Yes, Virginia, there is an Amazon Clinic, after all; non-face-to-face consults for common conditions (Amazon’s Chevrolet–or Yugo–entry?)

 

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Telehealth & Telecare Aware: covering the news on latest developments in telecare, telehealth, telemedicine, and health tech, worldwide–thoughtfully and from the view of fellow professionals

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Donna Cusano, Editor In Chief
donna.cusano@telecareaware.com

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Split decision! ITC rules that Apple violated AliveCor patents; enforcement held for PTAB appeal

David v. Goliath slugfest continues. The International Trade Commission (ITC) confirmed its Initial Determination [TTA 28 June] that Apple Watches infringed AliveCor patents on ECG readings. This Final Determination counters the US Patent and Trademark Office’s Patent Trial and Appeal Board’s (PTAB) December ruling that found not only in favor of Apple’s patents but also invalidating AliveCor’s three patents in question [TTA 8 Dec].  

The ITC’s findings come under a 60-day presidential review from 22 December. The penalty on Apple comes under a Limited Exclusion Order (LEO), a cease and desist order. It sets a bond in the amount of $2 per unit of infringing Apple Watches imported or sold during this review period. However, enforcement of the ruling will be delayed until the review of AliveCor’s appeal of the PTAB ruling wends its way through that process in the Northern District of California, which is expected to take place in early 2024, a year from now.

A running dispute since 2020. Once upon a time, AliveCor and Apple worked together to give ECG functionality to the Apple Watch. This ended after the Apple Watch 4 incorporated ECG readings. This resulted in court actions related to patents starting in early 2021 [TTA 29 Apr 21, 9 July 21]. Apple is now up to the Watch 8, incorporating more and more cardiac and health monitoring features. AliveCor has also moved on with financing with a GE Healthcare-backed Series F this past August, the KardiaMobile 6L, and the KardiaMobile Card. As of today, it has over 170 patents.

As this Editor remarked in December, going after a rival’s patents is an often necessary but risky business that can backfire. Right now, David has moved Goliath to a draw now, with further matchups this year into next. AliveCor release, Mobihealthnews      Hat tip to Dr. Dave Albert, founder and Reader.

AliveCor loses Patent Office ruling with Apple; three patents invalidated

Apple prevails in the patent infringement suit by AliveCor–and got three AliveCor heart monitoring patents invalidated as ‘unpatentable’. In the duel of patent infringement claims dating back to May 2021 between AliveCor and Apple, the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) not only ruled that Apple did not infringe on AliveCor’s patents, but also threw out the AliveCor patents that were the basis for the infringement. AliveCor had sued Apple for patent infringement on their ECG technology in three US patents: No. 10,595,731 (“the ’731 patent”); No. 10,638,941 (“the ’941 patent”); and No. 9,572,499 (“the ’499 patent”) in their Apple Watches 4, 5, and 6. [TTA 29 Apr 21, 9 July 21

The term ‘unpatentable’ is used when the PTAB deems the patent, even when granted in the past, too obvious or too general. When the PTAB finds that, they throw out the patent and it is no longer valid.

Apple of course crowed that they developed their own patents fully on their own, and not from the time when AliveCor’s ECG monitoring was incorporated into earlier Apple Watches. Apple is up to the Series 8. AliveCor has already announced it will appeal and await the pending ruling from the International Trade Commission (ITC) to block the import of Apple Watches. The ITC’s initial determination in June was positive [TTA 28 June] and AliveCor of course is ‘cautiously optimistic’ on the Final Determination due in a few days (12 December). With the PTAB’s finding, it is far less likely that the ITC will impose an import block when AliveCor’s patents have been invalidated.  9to5Mac, Mobihealthnews

AliveCor has moved forward with its KardiaMobile series, including a credit card-sized device (left), and has enjoyed substantial investment, with an August Series F (amount undisclosed) round led by GE Healthcare. 

Patent invalidation is a danger in any patent infringement lawsuit. In 2015, Bosch Healthcare, which had bought HealthHero, an early RPM platform marketed as Health Buddy, and ViTelNet, was a serial patent challenger. They went after Philips, Viterion (while owned by Bayer), both to a draw, and won against a slew of barely-out-of-the-cradle companies forgotten by nearly all of us such as Alere Health, MedApps, Waldo Health, and Express MD Solutions. Then they sued Cardiocom in 2012 with the same expectation. Except that a year later, Cardiocom was acquired by Medtronic. Deep-pocketed Medtronic fought back hard–and by 2015, the PTAB invalidated most of Bosch’s key patents. Bosch withdrew from the US market abruptly in 2015. TTA 19 June 20157 September 2015 primarily about the ongoing Teladoc-Amwell dustups

Given their funding and device development, AliveCor will likely not face Bosch’s fate, but such invalidations have consequences yet to be determined and litigated. 

US International Trade Commission initial determination: Apple infringed AliveCor’s patents (updated)

If affirmed, a David versus Goliath win. AliveCor, the developer of the KardiaMobile ECG devices, announced late today that Administrative Law Judge (ALJ) Cameron Elliot of the US International Trade Commission (ITC) issued an Initial Determination that Apple infringed certain AliveCor technology patents. If affirmed by the full ITC in a Final Determination by 26 October (!), it could lead to an exclusion order barring the importation of certain Apple devices infringing on AliveCor patents from the US.

The initial complaint was filed in May 2021 [TTA 29 April] concerning Apple’s infringement in the Apple Watch 4, 5, and 6 of three AliveCor ECG technology US patents: No. 10,595,731 (“the ’731 patent”); No. 10,638,941 (“the ’941 patent”); and No. 9,572,499 (“the ’499 patent”). Last February, AliveCor successfully moved with the ITC to have the investigation terminated on certain claims on the three patents, but a considerable number remained. This is what ITC terms an “unfair import” or Section 337 investigation. These regard intellectual property rights, including “allegations of patent infringement and trademark infringement by imported goods.”

Updated for links: AliveCor press release, ITC Public Notice which details what parts of what patents have been infringed. Both the 731 and the 941 patents have been found to be infringed under Section 337. The 499 patent has not been violated. This Editor will assume we have to wait till October for any exclusion orders.

AliveCor releases KardiaMobile ECG in the convenient credit card size

AliveCor, the parent company of KardiaMobile mobile ECG devices, is releasing for sale the KardiaMobile Card, a credit card-sized single-lead ECG. It was FDA cleared in November. It’s mighty for its size, detecting six of the most common arrhythmias: atrial fibrillation, bradycardia, tachycardia, PVCs, sinus rhythm with SVE, and sinus rhythm with wide QRS. The pricing is $149 and includes the $99 annual KardiaCare subscription, which renews after the first year. 

In a price and product comparison, the standard KardiaMobile single lead, which is a strip with two press sensors, remains on sale for $169 and the 6L, which has a slightly bulkier sensor but is clinically equivalent to a six-lead ECG, is $239. KardiaCare includes advanced determinations, cardiologist reviews, heart health reports, and more. Owners of older smartphones should review compatibility before buying, however. Release, Mobihealthnews

As of 1 February, there is no update on AliveCor’s legal actions against Apple on patent infringement in the Apple Watch: April’s patent infringement complaint filed with the US International Trade Commission (ITC) [TTA 29 Apr 21] and their late May Federal antitrust suit in the Northern District of California [TTA 9 July 21].

Is healthcare too much for Big Tech’s Google and Apple? Look at the track record. And David Feinberg’s $34M Cerner package.

With Google scattering Google Health to the four winds of the organization--the heck with what employees recruited for Health think of being reorg’d to, say, Maps or YouTube and falling through the corporate rabbit hole–more detail has leaked of Apple’s struggles. This time, on the scaleback list (a/k/a chopping block) is Health Habit. It’s an app in the Apple Store that connects users with AC Wellness, a doctor’s group in Cupertino, California. The ‘eligible participants’ are restricted to Apple employees. From the app site, they can check weight, nutrition, blood pressure, and schedule wellness checks. It seems to be the typical ‘skunk works’ project that’s not ready for prime time, but its public fate seems to be poorly timed and simultaneously, overblown because they are–well–Apple

Bottom line, is healthcare once again proving rather resistant to being leveraged by technological solutions? Those of us who go back to the Stone Age of health tech, or those of us who joined in the Iron and Bronze Ages, remember when you couldn’t get into a conference cocktail party without a “wellness” app. (You say you’re in behavioral and remote patient monitoring for older adults? Oh, look! A squirrel!)

Microsoft was going to dominate consumer health with their HealthVault for personal health records (PHRs). We know how that turned out–dead apps, Fitbit an also-ran bought, Pebble and Misfit going to the drawer of failed toys, Jawbone t-boning plus Intel and Basis written off in 2017, and HealthVault unlamentedly put out with the trash at the end of 2019. Oh yes, there was an earlier Google Health for PHRs, which died with a whimper back in 2012 or so.

The press releases crow about Big Tech’s mastery of complexity, yet going off on their own without partners–or even with partners–never seems to work. In the industry, it makes for a few good articles and the usual rocket launching at places like Forbes, but the pros tend to treat it with a shrug and pull out a competitive plan. Glen Tullman, founder of Livongo who will never have to worry about paying for chateaubriand for two for the next billion years or so, stated the obvious when he said that patients cared about the overall experience, not the tech.

Speaking of experience, Amazon Care promises the best for its employees and enterprise accounts–a one-minute telehealth connection, a mobile clinician if needed within the hour, and drugs at the door in two hours. All with direct pay. This has met with skepticism from telehealth giants like Teladoc and Amwell with established corporate bases. There’s also CVS Health and Walgreens. The Editor has opined that care isn’t Amazon’s game at all–it’s accumulating and owning national healthcare data on Amazon Care and Pharmacy users that is far more valuable than whatever is spent on providing care and services [TTA 16 June]. Will Amazon really be able to pull it off?

Paddy Padmanabhan, the author of Healthcare Digital Transformation, lists a few more reasons It’s Too Hard For Big Tech In Healthcare in his HealthcareITNews article here….

  • Healthcare is a part-time job for Big Tech
  • Big tech firms want to solve the healthcare problem by themselves
  • Selling technology is not the same as selling healthcare services

…but holds out some hope that the initial success of “digital-first and virtual-first providers of healthcare emerging as challengers” will point the way for them.

And speaking of Google Health and former employees, Cerner’s necessary SEC disclosure today of new CEO and president David Feinberg, MD’s compensation package was sure to create some talk in Googleville among his now-scattered team. $34.5 million over the next 15 months is structured as follows:

  • $900,000 base salary
  • a target cash bonus of $1.35 million
  • a one-time cash bonus of $375,000 stock
  • $13.5 million in Cerner’s restricted shares for 2022
  • $3.375 million in stock shares for the fourth quarter of 2021
  • a new hire award of $15 million in restricted stock shares to offset his equity loss with Google. 

Whew! Becker’s HealthIT

News roundup: AliveCor’s latest FDA clearance plus antitrust vs. Apple, VRI on the market, Walgreens’ ‘tech-enabled future’ indefinite plus VillageMD status, monthly telehealth usage drops 12.5%

AliveCor disclosed its latest FDA 510(k) clearance for the KardiaMobile 6L, for calculation of patients’ QTc interval by the patient remotely or in the office with a physician or other clinician. QTc interval is, for those of us who aren’t cardiologists, is the total time from ventricular depolarization to complete repolarization. If too long (prolongation) or too short (congenital short) for the heart rate, it can indicate a dangerous ventricular arrhythmia or atrial or ventricular fibrillation. The manual measurement takes 30 seconds. AliveCor also has clearance on software (InstantQT) that measures QT intervals quickly and accurately to detect potentially dangerous QT prolongations in patients. Prolongations can be triggered by medications including anti-arrythmia drugs, anti-fungals, antibiotics, and some psychiatric drugs. AliveCor release. In other recent news, in June they acquired CardioLabs, a monitoring and cardiac diagnostic service provider based in Tennessee, to expand their clinical servies. Release.  

And in David Sues Goliath–Again–News, AliveCor also filed, in that quiet week right before Memorial Day, a Federal antitrust suit in the Northern District of California. This lawsuit is over Apple’s exclusion of other heartrate analysis providers from the Apple Watch, harming AliveCor and consumers, and seeks damages plus an injunction to cease the exclusion. Release  This is in addition to their US International Trade Commission (ITC) complaint on infringement of AliveCor patents held for heart monitoring on the Apple Watch 4, 5, and 6. That seeks to bar importation of Apple Watches [TTA 29 Apr]. No update on that so far. 

‘Insider’ report: VRI on the market. PERS Insider, our newly discovered source for news about the emergency response device market, reported on 22 June that VRI, a PERS and remote patient monitoring provider, is up for sale. It has been majority-owned by Pamlico Capital, a private equity company, since 2014. VRI does not sell direct to consumer but concentrates on health insurance, government programs, and other B2B through its dealer network. No reasons for sale given, but with all things telehealth and most things remote healthtech fetching hefty sums post-pandemic, perhaps Pamlico senses a fortuitous time to test the waters for an exit. Article. (Subscribe here to their weekly free letter)

Walgreens Boots Alliance’s new CEO promises a ‘tech-enabled’ future for the chain, sans details. The incoming CEO, Rosalind Brewer, fresh from her COO position at Starbucks, on WBA’s Q3 earnings call mentioned a buildout of a “previously communicated tech-enabled healthcare initiative” but no further information, as still reviewing the company. Stefano Pessina has retired from the long-held CEO position, but retains the executive chair title in addition to being WBA’s largest individual shareholder. Forbes’ breathless report. More to the profit point, the latest on Walgreens and VillageMD’s full-service Village Medical practices at Walgreens locations: 29 new locations in Houston, Austin and El Paso, Texas this year, staying on track for 600 primary care practices in more than 30 markets over next four years. Business Wire

National telehealth usage dips to 4.9% of US claims in April, a 12.5% drop from March. Analyzing regional and national insurance claims data, non-profit health analytics company FAIR Health in its monthly report tracks telehealth receding as patients return to in-person care. Telehealth is now dominated by mental health procedure codes, accounting for 58.65% of diagnoses, with all other conditions at 3% or lower. Regionally, the Northeast is even higher at 64.2% and the Midwest above 69%. Monthly National report, Monthly Regional Tracker page

David sues Goliath: AliveCor claims patent infringement by Apple–ITC filing requests bar on Apple Watch US importation

Slingshot battle! AliveCor, developer of the Kardia Mobile electrocardiogram (ECG) and connected heart rhythm devices, filed a complaint with the US International Trade Commission (ITC) alleging Apple’s infringement of three AliveCor ECG technology patents for the Apple Watch 4, 5, and 6. The filing seeks to bar the importation of Apple Watches into the US and their sale.

According to AliveCor’s carefully worded release, their filing in the ITC “is one step, among others, AliveCor is taking to obtain relief for Apple’s intentional copying of AliveCor’s patented technology—including the ability to take an ECG reading on the Apple Watch, and to perform heartrate analysis—as well as Apple’s efforts to eliminate AliveCor as competition in the heartrate analysis market for the Apple Watch.”

This follows on the first shoe–AliveCor’s December lawsuit, filed in the US District Court for the Western District of Texas, alleging that the Apple Watch 4, 5, and 6 infringed on the same patents. The timing was interesting, as FDA cleared the latest update of the Apple Watch’s ECG monitoring at about the same time [TTA 10 Dec 2020]. In November, AliveCor cleared a Series E of $65 million.

The irony is that in 2017, the KardiaBand was the first FDA-cleared medical device accessory for Apple Watch. It was an ECG-reader that clipped onto the watch. AliveCor pulled it from the market after Apple introduced its own ECG feature in the Apple Watch 4.

AliveCor has their entire business riding on this. The mass-market Kardia Mobile, their six-lead medical-grade KardiaMobile 6L, and their KardiaCare platform with monitoring and evaluations are their business, unlike Apple for which ECG is only a feature.  Mobihealthnews, FierceHealthcare, MDDIOnline

Breaking: NHSX COVID contact tracing app exits stage left. Enter the Apple and Google dance team.

Breaking News: The NHS finally abandoned the NHSX-designed COVID contact tracing app in favor of the app based on the Apple and Google API.

The NHSX version had issues, seemingly intractable, on the BTE features on distancing and contact duration between devices, as well as the app being inaccurate on the iPhone.

The “Gapple” app is already in use in Italy, Switzerland, Denmark, Latvia, and Poland. As this Editor noted on Tuesday, Austria is in test, Germany just launched their ‘Corona Warning App’ and reported 6.5 million downloads in the first 24 hours. 

The BBC reported that the lead on the NHSX app, Matthew Gould and Geraint Lewis, are “stepping back” and former Apple executive Simon Thompson is joining NHSX to manage it

Depending on reports, the NHS either rejected the Gapple app in April or were working on it in tandem from May. More likely, they revived the latter with the NHSX problems. The Gapple version is decentralized in storing information about user contacts on individual phone handsets because of issues over user privacy, versus the NHSX centralized app.

According to the FT and TechCrunch, the government is de-emphasizing the utility of the app, and relying on its small army of contact tracers. 

But what about all those folks on the Isle of Wight?

More on this: Digitalhealth.net, TechCrunch, Financial Times     Hat tip to Steve Hards for alerting this Editor at the end of a busy day!

A short but canny look at consumer behavior as a driver of health technology

Whether the global ‘smart home healthcare’ market actually totals $30bn by 2023, as a Research and Markets study trumpets, is debatable, but one thing that this Editor agrees with is that successful home health devices need to take a chapter from Steve Jobs’ Apple and famed industrial designer Raymond Loewy’s playbooks (search our Loewy references here) and design for how the consumer lives and would use their product. It isn’t flashy design awards, but how that technology can not only fit into a person’s life but also be an asset that they’d miss if someone took it away–a point often forgotten in the rush of initial design, testing, and funding.

Writer Scott Thielman of Product Creation Studio, a Seattle-based industrial design and engineering firm, outlines four health tech products/services that represent technology that is intuitive, easy-to-use, accessible, and, I would add, have a little something extra that makes them indispensable.

  • Athelas, a next-generation immune monitoring device that resembles an Amazon Alexa in being a 3D black cylinder. Instead of playing music, it measures neutrophils, lymphocytes, platelets, white blood cells, morphology, and cell activation all within minutes from a test strip inserted in the cylinder. (Investigational device awaiting FDA review)
  • Rochester Institute of Technology (RIT)’s smart toilet seat (which Editor Charles punningly referred to here) was tested with heart failure patients. It measured nine clinically relevant features, including weight, single-lead ECG, systolic/diastolic blood pressure, blood oxygenation and localized pulse timing, and a ballistocardiogram (BCG) for measuring the mechanical forces associated with the cardiac cycle. Normally, the patient would have to use several devices for these measurements rather than taking a seat. Speaking of the seat, it is standard white and replaces the one in the bathroom. Results were published in JMIR mHealth and uHealth.
  • ResMed’s connection of its continuous positive air pressure (CPAP) sleep apnea treatment devices to the cloud before the patient uses them, plus their patient smartphone app helps them to claim that 84 percent of new users reach the necessary usage threshold for Medicare adherence in the first 90 days of treatment.
  • Clarify Medical’s build-in of user feedback for its home vitiligo and psoriasis treatment that goes direct to their in-house customer service also registers patient usage, needed fixes, and outreach to those who need additional coaching and training.
  • Livongo’s acquisition of myStrength’s behavioral health app [TTA 31 Jan] also points to the importance of consumer behavior in a somewhat different aspect–the 20 percent and more who are struggling with behavioral health issues along with one or more chronic conditions managed by Livongo for employers and health plans.

How to design home healthcare devices that people will use (Medical Design & Outsourcing)

 

News roundup: NeuroPace’s brain study, Welbeing’s Liverpool win, VA’s Apple talks, Medtronic’s diabetes move

imageNeuroPace, which developed an implanted brain-responsive neuromodulation system for patients with refractory and drug-resistant epilepsy, announced the result of their nine-year long-term treatment study.

  • Approximately 3 out of 4 patients responded to therapy, achieving at least 50% seizure reduction
  • 1 in 3 patients achieved at least 90% seizure reduction
  • 28% of patients experienced seizure-free periods of six months or longer; 18% experienced seizure-free periods of one year or longer
  • Median seizure reduction across all patients was 75% at 9 years
  • Quality of life improvements (including cognition) were sustained through 9 years, with no chronic stimulation-related side effects.

The study included 256 patients across 33 epilepsy centers with nearly 1,900 patient implant years of follow-up on the RNS System. Release.

Liverpool Mutual Homes (LMH) sheltered housing awarded its emergency alarm contract to Welbeing, a Doro Group company. Welbeing has added 1,200 LMH residents to their alarm services. Release (PDF)Hat tip to Welbeing’s Charlene Saunders.

It appears that the VA is talking with Apple about a mobile EHR. VA patients would be able to transfer their records to their iPhone — likely through Apple’s Health Records app. No time frame is mentioned and it’s hard to expect a quick turnaround given the VA’s stringent IT and security requirements. Another factor is that VA is making the long transition from VistA to Cerner’s MHS Genesis, bumpily. Mobihealthnews picking up a paywalled Wall Street Journal article.

Medtronic, otherwise known as the 9,000 lb Elephant that Sits Where It Wants, will acquire long-time diabetes partner Nutrino, an AI powered personalized nutrition platform. In June, Medtronic integrated Nutrino’s FoodPrint Report technology that connects meal and glucose variability into Medtronic’s iPro2 myLog app. Terms and timing were not disclosed. It fits in Medtronic’s recent strategy of smaller acquisitions and beefing up its diabetes business. Mobihealthnews.

Apple Watch, Zimmer Biomet in clinical trial for monitoring hip and knee replacements

imageZimmer Biomet, a musculoskeletal medical device company, is partnering with Apple to use the Apple Watch with an iPhone 6s and above in tracking the pre-surgery and post-operative recovery process for patients with hip and knee replacements. Zimmer is using the mymobility app developed with Apple to track patient-reported feedback, provide patient education and guidance, and share continuous health and activity sensor-based data with care teams. The aim is to improve the standard of care and patient outcomes after these surgeries.

The mymobility Clinical Study started on 15 October and may enroll up to 10,000 patients with 16 corresponding healthcare facilities including academic health systems, hospitals, and orthopedic surgery centers/practices. No length or end date for the study has been disclosed. 

A positive outcome leveraging patient engagement and providing continuous detailed clinical tracking data could have major significance. There are over 1 million hip and knee orthopedic replacements in the US annually, which is expected to increase to 3.5 million by 2035. The average cost of a hip or knee replacement is estimated at about $31,000, varying widely by region, based on a 2015 Blue Cross Blue Shield Association study. Post-surgery complications are common enough so that Medicare.gov tracks them through Hospital Compare.

According to Zimmer, “the mymobility app provides instruction and opportunities for enhanced engagement between the patient and healthcare provider. This mobile application is designed to work with the Apple Watch® wearable companion to remind patients to check their smartphone application daily, to read pre-planned and timed educational information, perform tasks, and complete assigned exercises; understanding their condition and care plan gives patients the ability to actively participate in optimizing their surgical outcome.” For the clinician, it is a communication tool between the patient and care team. “Surgeons use a clinician dashboard to monitor the threshold values and actively observe progress throughout each patient’s journey. Through the adoption of multifunctional sensor technology in the form of a wearable companion on the wrist, mymobility provides the potential to identify metrics that may permit further refinement of pre and postsurgical care.”

Healthcare Dive, Zimmer Biomet release, Zimmer mymobility study website

The Apple Watch, ECG and fall detection–a trend too far?

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2018/10/apple-watch-series-4-elektrokardiogram.jpg” thumb_width=”125″ /]Mid-September’s Apple Fans kvelled about the Apple Watch Series 4 debut. Much was made in the health tech press of Apple’s rapid FDA clearance and the symbolism of their further moves into medical devices with the Series 4 addition of a built-in atrial fibrillation-detecting algorithm and an ECG, along with fall detection via the new accelerometer and gyroscope.

This latter feature is significant to our Readers, but judging from Apple’s marketing and the press, hardly an appealing Unique Selling Proposition to the Apple FanBoys’n’Girls who tend to be about 35 or wannabe. The website touts the ECG as a performance feature, a ‘guardian and guru’ topping all the activity, working out, and kickboxing you’re doing. It positions the fall detection and Emergency SOS in the context of safety during or after hard working out or an accident. It then calls 911 (cellular), notifies your emergency contacts, sends your current location, and displays your Medical ID badge on the screen for emergency personnel, which may not endear its users to fire and police departments. 

Laurie Orlov in her latest Age In Place Tech article points out the disconnect between the fall risk population of those aged 70+ and the disabled versus the actual propensity (and fisc) to buy an Apple Gizmo at $400+. PewInternet’s survey found that 46 percent of those over 65 actually own a smartphone, though this Editor believes that 1) much less than 50 percent are Apple and 2) most smartphone features beyond the basic remain a mystery to many. (Where store helpers, children, and grandchildren come in!)

Selling to older adults is obviously not the way that Apple is going, but there may be a subset of ‘young affluent old’ who want to sport an Apple Watch and also cover themselves for their cardiac or fall risk. (Or have children who buy it.) This is likely a sliver of a subset of the mobile PERS market, which is surprisingly small–only 20 percent of the total PERS market. But monitoring centers–doubtful, despite it being lucrative for GreatCall.

The Theranos Story, ch. 51: how Holmes wasn’t Steve Jobs despite the turtlenecks–a compare and contrast

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/jacobs-well-texas-woe1.jpg” thumb_width=”150″ /]Did Elizabeth Holmes ‘misunderstand’ Steve Jobs’ methods or was there something more deliberate at work? This article by tech entrepreneur Derek Lidow in Forbes gives her the benefit of the doubt but is still damning. His points in summary are:

  • Holmes ran Theranos with zero knowledge of how to run an organization, and ran Theranos like a dictator. Hiring people with real expertise came late in the day, and most of them left once they realized her style. Jobs knew he couldn’t run a company, generally hired the right people to do so, and then let them run it.
  • Jobs teamed with a genius engineer named Steve Wozniak in Apple’s formative years, and the Woz guided Jobs as much as anyone at numerous critical stages. Woz was the balance to Jobs, the behind the scenes versus the on-stage. Holmes did not work with anyone in that way, which is atypical for startup founders. Her co-founder was unqualified, she didn’t listen to her staff as problems came up, and her board was a waste of titles and people who were either wholly capable in other fields or superannuated.
  • Holmes’ goal of mini-blood assays was impossible, and she was unlike other visionary founders to pivot to what was possible. Jobs tempered his vision by using methods and technologies which already existed to leverage Apple into what he envisioned. (Jobs also had his fair number of stumbles, such as the Newton tablet where the vision exceeded the available technology. It was also too advanced, violating the Raymond Loewy maxim of ‘most advanced yet acceptable’.)
  • Delighting the customer? Where Jobs excelled in this not only with end users but also with developer partners, Holmes failed and more. With deceptive blood testing, she hurt sick patients and doctors who depended on accuracy. The vision and her self-promotion were far more important. She wasn’t doing this for people–she was doing this for herself.
  • Holmes was over the top on compartmentalizing Theranos’ technical development, straight to failure. Teams on the same project didn’t share knowledge or fundamentally communicate with each other. This led to bad testing of only parts of the system, not the whole system. While Jobs kept a tight lock on exposing Apple developments until they were ready, department teams on a given project intensively shared information. 

Wearing the black turtleneck, being a young female, blond, and with enhanced blue pop-eyes akin to a Bug-Eyed Austin-Healey Sprite can get you noticed, but then you have to deliver the goods for that $900 million you raised. Holmes was inexperienced and psychologically ill-equipped to be a tech founder. This Editor also wondered if she (literally) garbed herself in Jobs’ exterior trappings to deceive and gull everyone from the mighty and rich to the ordinary and often sick. (And now she tells people she is a marytr akin to Saint Joan?)

The Theranos Effect, for which Holmes is responsible, will sadly continue to hurt not only early-stage healthcare innovators but also the few women among them. The Theranos Scandal: What Happens When You Misunderstand Steve Jobs

Apple’s patent on camera plus sensors for health measurements

9 to 5 Mac, the tip sheet for all things Apple, tracked down a patent granted to Apple (via Patently Apple) for computing health measurements using the iPhone. According to Apple in the patent, “electrical measurements may be used to measure heart function, compute an electrocardiogram, compute a galvanic skin response that may be indicative of emotional state and/or other physiological condition, and/or compute other health data such as body fat, or blood pressure.” It would use the front-facing camera, light sensor and proximity sensor to emit light that would be reflected back to the sensors. Additional sensors mounted in the same area would also generate additional health measurements such as body fat and EKG, which is already measured by the Kardia Mobile/Alivecor attachment. The camera and light sensor alone, based on the patent and the article, would measure oxygen saturation, pulse rate, perfusion index and a photoplethysmogram (which can monitor breathing rate and detect circulatory conditions like hypovolemia). Another demonstration of Apple’s keen interest in the health field, but what features will show up on real phones and apps–and when? 

Fitbit’s smartwatch on track; Intel exits the game

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2017/07/Fitbit-smartwatch.jpg” thumb_width=”200″ /]Fitbit’s ‘Project Higgs’ in-house designed smartwatch is, by all reports, on schedule to hit the market later this year in time for the holidays, at least in Wall Street’s expectations. To the FT (may be paywalled) CEO James Park reassured, “The product is on track to meet our expectations and the expectations that we’ve set for investors. It’s going to be, in my opinion, our best product yet.” It will be waterproof, a battery that lasts several days, have mobile payment capability (from the Coin acquisition), simple health tracking,  heart rate monitor, sleep tracking, stream music (Spotify and Pandora are rumored), and its own app store. It will be either Wi-Fi or smartphone connected. TechRadar’s agglomeration of rumors include pricing ($199 to $299 –about £231), swappable bands, a full-color screen with 1,000 nits of brightness, an aluminum body and built-in GPS. The most interesting part is the proprietary operating system which uses Javascript. Also Pocket-Lint articles 18 July and 19 July

Intel, however, is giving up the smartwatch and fitness tracking chase. In 2014 they acquired Basis in a well-publicized move and enlisted hip celebrities like 50 Cent to endorse their products versus the likes of Apple and Fitbit. In November about 80 percent of the group was let go, according to CNBC, and entirely eliminated this month. The New Technologies Group is now focusing on augmented reality. CNBC