Happy Holidays and a most Festive Season!

The Editors of TTA wish our Readers and Friends, as well as their families, the best for this festive season! Hanukkah has passed, but we have a Merry Christmas to come. (And don’t forget Boxing Day!)

Even if you do not celebrate Christmas, these words of Charles Dickens speak to us all:

“I will honour Christmas in my heart, and try to keep it all the year. I will live in the Past, the Present, and the Future. The Spirits of all Three shall strive within me. I will not shut out the lessons that they teach!”
― A Christmas Carol

The next Alert will be on Friday, 4 January, and resume on Thursdays the following week.

Our best wishes for a happy, healthy, and prosperous New Year!

Ultrasound to break up brain amyloid plaques moving to human trials in 2019

Somewhat outside of telecare, but inside our concern with the health of older people, is the exciting news of a novel ultrasound treatment to break up the amyloid plaques in the brain that may be the cause of many dementias and Alzheimer’s Disease. Initially developed at the University of Queensland in 2015, the original objective was to open the blood-brain barrier to facilitate antibody treatment for dementia. Researchers found that in tests on mice, the ultrasound ablation cleared the plaques without any further drugs. Later tests found that the treatment clears both “toxic proteins and restores memory function safely in several different rodent models, including an older mouse model designed to resemble human brains of 80 to 90 years old.” 

Australian government funding is key in helping accelerate development. The first stage in human trials is a phase 1 safety trial, kicking off later in 2019. 

While at least a decade in the future if all goes well in clinical trials, one of the researchers, Jürgen Götz, is thinking larger, towards future personal ultrasound devices which could be used for personal treatment or prevention. New Atlas

An earlier study referenced in MedPageToday summarized results and concerns with a Canadian study. 

News roundup: CVS-Aetna still on hold, blockchainers Change acquires PokitDoc, Teladoc’s COO resigns under insider cloud, Clapp joins Cricket

Federal Judge Richard Leon of the Washington, DC District Court is taking a consideration break on the integration of CVS and Aetna, after holding it up on 3 December. The Department of Justice (DOJ) originally recommended that the merger was legal under anti-trust law after Aetna divested its prescription drug plan to WellCare and both companies’ settlements with several states. Judge Leon, reviewing under the Tunney Act requirement that the merger meet the public interest, is waiting for the DOJ to respond to further steps that CVS has taken to keep the companies separate. According to Seeking Alpha, CVS will take “constructive measures on pricing and sensitive information” and that an outside monitor would be brought in to monitor the companies commitments. Hartford Courant

Health IT software company Change Healthcare acquired assets of San Mateo-based PokitDoc, a healthcare API and blockchain developer. PokitDoc has developed blockchain transaction networks for EHR and identity verification, automatic adjudication and smart contracts. Its APIs are used by Doctor on Demand, Zipnosis, PillPack, and available on Salesforce Health Cloud. Change’s own blockchain platform was developed in 2017. McKesson owns 70 percent of Change. PokitDoc had funding up to $55 million prior to purchase, the value of which was not disclosed. Mobihealthnews, Health Data Management

Teladoc cut loose its COO/CFO after insider trading and sexual misconduct allegations. Mark Hirschhorn resigned on 17 December from the telemedicine company after being instrumental in the company’s recent revenue and visit growth (albeit with a downward spiral on the share value). Mr. Hirschhorn was alleged to have not only have had a sexual relationship with a (much younger) subordinate while married, but also engaged in mutual insider trading…of Teladoc stock. The steamy details of the affair(s) and an equally seamy tale of a whistleblower’s fate are in the Southern Investigative Reporting Foundation’s ‘The Investigator’. For those more concerned about Teladoc’s financial future, a bullish analysis of their stock value and trends is over at Seeking Alpha. Adding to the fire: a class action lawsuit was also filed against Teladoc on behalf of the company’s shareholders, accusing the company of misleading or false statements. Also Mobihealthnews.

And it’s cheering to announce that a respected long-time telehealth executive has found a new perch. Geoff Clapp has joined Cricket Health, a provider of integrated technology around kidney health, as Chief Product Officer. Geoff is an authentic Grizzled Pioneer, having joined early telehealth RPM company HealthHero back in 1998, then their acquirer Bosch Healthcare. He was also founder of Better, which partnered with the Mayo Clinic on providing virtual care coordinators at popular prices for both consumers and health systems. Since then he has consulted for companies as diverse as Telcare (diabetes), Oration (sold to just-acquired PokitDoc), and in venture capital. Congratulations–and happy new year in the new job! Release

Kompaï robotics gets FABULOS in EU Horizon 2020 automated minibus competition

France’s Kompaï robotics, which Editor Steve first profiled in May 2011 (!), is still developing assistive robots for older adults, the disabled, and their caregivers. In another instance of technology integration and crossover into an area other than healthcare, they are a finalist in one of 5 consortia of 16 companies competing in the European FABULOS challenge to develop an automated minibus. Kompaï is partnering with Actia Automobile as the Kompai-Actia Consortium. Phase 1 of FABULOS starts 1 January with a feasibility study with conclusions for the start of prototype development. In autumn, the consortia will move to lab testing prototypes with real-world testing of the final three starting March 2020 in Estonia, Finland, Greece, the Netherlands, Norway, and Portugal. The R&D is being financed by the European Horizon 2020 Research and Innovation Programme with a total fund of over €5,5 million. FABULOS release.

VA expands telehealth services again with T-Mobile’s 70,000 lines

The US Department of Veterans Affairs and T-Mobile announced on Monday that T-Mobile would be adding 70,000 lines of wireless service to increase telehealth services in the VA network and expand services to veterans, especially those in rural areas. The expanding network will connect veterans at home and at VA facilities, such as community-based outpatient clinics (CBOCs), with VA clinicians within the VA network.

This adds to VA’s push this year to extend telehealth to distant veterans in rural areas through initiatives such as with T-Mobile and the Spok Health – Standard Communications partnership to expand the Spok Care Connect messaging service to more VA healthcare systems. The VHA (Veterans Health Administration) has long been the largest user of telehealth services in the US. Until recently, their emphasis has been on store-and-forward and clinic-based patient consults, but finally Home Telehealth (HT) is being supported. Reportedly, only 1 percent veterans used Home Telehealth, while 12 percent used other forms of telehealth [TTA 24 May]. Yet the VA was among the earliest users of remote patient monitoring/home telehealth, dating back to 2003 and even earlier, with companies such as Viterion and Cardiocom.

While most of the news about VA has been about their leadership changes and their difficulties around EHRs, their ‘Anywhere to Anywhere’ program was finalized in May. This allows VA practitioners to provide virtual care across state lines to veterans, regardless of local telehealth regulations.

T-Mobile is already the lead wireless provider to the VA. The 70K line addition is part of the carrier’s $993.5 million five year contract with the US Navy.  Business Wire, Mobihealthnews

Why they matter: the $225 million acquisition of Propeller Health; Hill-Rom’s integration of EarlySense’s bed monitor

It’s all about the integration of newer technology and partnerships into established, older tech–or furniture. In late 2014, a seven-year-old early-stage company from Wisconsin had a booth at the NYeC Digital Health Conference. Their digital, connected monitors attached to prescription inhalers and tracking app interested this Editor enough for her to discuss it with a telehealth company she consulted for at the time as a natural fit for their digital remote monitoring of COPD and asthmatic patients. The startup had a few major clients, mainly drug companies, and would have been boosted by Viterion’s VA business. (Editor note: it didn’t go anywhere)

Flash forward to November 2018, and after $70 million in funding and marketing in 16 countries, integration with nearly 90 percent of commercial inhalers, Propeller Health is being acquired by the much larger ResMed for $225 million, closing in March 2019. This is surprising as Propeller never exceeded $10 million in revenue (Research2Guidance).

Why it matters: Propeller brings to ResMed’s older respiratory technology not only new yet proven technology, but also established partnerships with pharma, healthcare, and payer organizations. They inhabit a huge and growing worldwide market. According to WHO, asthma affects 334 million people worldwide; COPD 250 million people. Digital solutions could be targeting as many as 270 million patients by 2023. Propeller also brings eight US FDA 510(k) clearances and CE markings. All of this makes this small digital medical company worth a serious multiple of revenue with the prestige of being a standalone unit within ResMed led by the co-founder. Read more about it from Research 2 Guidance’s “ten major reasons” why Propeller was worth it, Mobihealthnews, and MedCityNews.

An even smaller monitoring company, Early Sense, has made a significant lift (sic) in a partnership with leading hospital bed manufacturer Hill-Rom. Early Sense has been featured at many CES Unveileds (New York) as one of many Israeli companies with a growing US presence. While starting in the hospital area years ago with bed and chair sensors, within the past two years this Editor noted their move into consumer with an under-mattress sleep sensor unit that could track (via an app) your sleep, stress, heart rate, breathing–and fertility. Their clinical version tracks heart and respiratory rates, alerted for patient falls out of bed, and patient movement (or lack thereof) as an indicator of risk for pressure ulcers. Hill-Rom, which claims to be the world leader in hospital beds, is adding the Early Sense technology to its Centrella model to create a smart hospital bed–one that will monitor heart and respiratory rates over 100 times a minute. A 2015 study quoted in the release stated that mortality related to “code blue” events was reduced by 83 percent, cardiac arrests by 86 percent, and reported overall hospital length-of-stay was reduced by 9 percent ICU days by 45 percent.

Why it matters: Even hospital equipment has to differentiate versus competition, and one way is going digital RPM integrated into the bed itself. The least expensive way of doing so is to buy new technology and incorporate in your ‘traditional’ offering. For the smaller company, it is worth its weight in gold in publicity and the potential business through the giant company. ReleaseMedCityNews, Mobihealthnews

Just the Fax. Or Matt Hancock versus the Fax Machines (UK) (Updated)

Updated. Add fax machines to the Endangered Device list. The news that Health Secretary Matt Hancock has banned the NHS from purchasing new fax machines starting in January 2019, with a full phaseout of use by 31 March 2020, was this past weekend’s Big News in the UK health sector. This is to help force adoption of paperless methods such as apps and email, which is a noble intention indeed.

The remaining prevalence of fax machines in the NHS became a cause célèbre after the Royal College of Surgeons in July estimated that over 8,000 fax machines were still in use. The RCS takes credit for nudging trusts to ‘Ax The Fax’. Guardian

This Editor presumes that Secretary Hancock does not possess a printer, or find the need to print his records even for convenience–or posterity. (One wonders what he’s carrying in that folder or brief…) I also presume that he has never heard of electrical outages, data breaches, malware or ransomware which may make print records suddenly quite needed.

The Road to Perdition is Paved With Good Intentions. A wonderfully tart take on Mr. Hancock’s Fax Obsession is contained in Monday’s NHSManagers.net newsletter from Roy Lilley. He looks at why NHS offices and practices have stayed with fax machines–and the absurdity of such a ban when trusts and practices are attempting to squeeze every penny in a cash-strapped, failing environment:

  • It’s point to point and legally binding not only in medicine, but in law and finance–even in the US
  • They are on the desk, easy to use–requiring only plug in to power and a phone line, fax toner, and paper
  • They don’t need IT support
  • Compared to computers, printers, and internet service, they are wonderfully cheap

And paper-free isn’t a reality even in the US with EHR, tablets and smartphones widely used. Even HHS and CMS in the US require some paper records. Confidentiality and hacking–especially when tied to computer networks–are problems with fax, but the same can be said for computer networksOh, and if your systems are attacked by ransomware, it’s awfully handy to refer back to printed records and to be able to communicate outside of computer networks.

Mr. Lilley also points out that ‘No 18’, as he dubs the Secretary of State for Health, actually has no power to enforce his edict with trusts or GPs.

This Editor predicts a thriving market in used and bootleg fax machines–“check it out”, as the street hustlers say!

Other articles on this: Fortune, Forbes

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.

Unaliwear’s model/muse, Joan Hall, passes at 85

imageJoan Hall, the mother who inspired the creation of the stylish wearable PERS, Unaliwear’s Kanega watch, has died aged 85. Jean Anne Booth, Unaliwear’s CEO, founder, and Mrs. Hall’s daughter, wrote her memorable bio on the company’s website. 

Your Editor met Jean Anne in 2014 or 2015 at the mHealth Summit and in showing me the design, she explained that she wanted a wrist-worn emergency alert device/fall detection/assistant device that was stylishly designed to her mother’s exacting standards–and that didn’t require tethering to a smartphone. Mrs. Hall was also her chief style guide and model.

Joan Frances Goss Hall was an Auburn University graduate, professional model, and Army wife and mother who called Fort Sam Houston home. She opened and managed the gift shop at Fort Sam Houston, the well-regarded Army Medical Museum (AMEDD), created a memorial there, and consulted on clothing and props for the Vietnam War TV series, China Beach. For her extensive work, Lt. Gen. James Peake awarded Joan the Army’s highest civilian award, the Outstanding Civilian Service Medal, in 2000.

It strikes this Editor that through Mrs. Hall, we are reminded that this is not wholly a chilly business of seeking funding, avoiding data breaches, AI, sensors, and chips. There’s a human factor here that we are designing technology to help people.

There is much more, which you should read here

Our TTA team’s sympathy to Jean Anne and her family.

Will there ever be a medical ‘tricorder’?

ZDNet teases us that ‘the race is on’, but is it? It’s a great clickbait headline, but the substance of the article illustrates the distance between today’s tech reality versus the picture of Star Trek’s Bones pointing a Tricorder at a patient and immediately pronouncing that your malady was Sakuro’s Disease or some strange Vulcan malady.

Was it that long ago that the Scanadu Scout was the odds-on bet to be the Tricorder? The hype began in 2012 [TTA 23 May 2013] with Indiegogo funding, competing for the XPRIZE, and breathless pronouncements at nearly every healthcare conference. By 2016, it missed the Qualcomm Tricorder XPRIZE finals (with Northern Ireland’s Intelesens), bricked all sold units to date to comply with FDA regulations on investigational devices, and with Chinese money in hand, moved into other testing devices. Those looking for Scanadu today will be disappointed as their website is unreachable. The DeBrowers and medical director Alan Greene, all of whom were fêted on the healthcare scene, are engaged over at Doc.ai with a new mission of decentralizing precision medicine onto the blockchain using AI, using your medical data gathered on an app (of course).

Google X was up next as Scanadu was fading. There were various devices they were hyping and testing as Google’s life sciences skunk works morphed into Verily, but to date they have all petered out, with some questions raised about people and project churn at the Alphabet unit [TTA 6 April 2016] .

Basil Leaf Technologies (as Final Frontier Medical Devices) wound up winning last year’s final Qualcomm XPRIZE with DxtER, which could diagnose and interpret a defined set of 13 health conditions to various degrees, while continuously monitoring five vital health metrics, using a mix of sensors and an AI-powered diagnostic engine. What they are planning to market first is not DxtER, but a single-disease device to monitor congestive cardiac failure (CCF) since FDA approval for DxtER “would take aeons to be approved.”

Urine tests are also a ‘wet’ way into a tricorder state, with both Basil Leaf and the University of Glasgow working on devices which could quickly scan for metabolites in urine that indicate particular diseases.

QuantuMDx’s Q-POC, from Newcastle UK, is expected to launch in 2019 with handheld diagnostics for bacterial and viral infections. In addition to quick diagnostics for outbreaks in less developed countries, they are also developing diagnostics to prescribe the right antibiotic the first time. This is critical in treatment superbugs such as MRSA and MSSA, as well as more garden variety infections which can go wrong quickly. TTA profiled their crowdfunding launch in 2014.

The ZDNet article wraps up with a bit of romance about how a tricorder is needed for Mars, but down here on Earth, the reality is that a tricorder will likely be a combination of devices and analytics, stitched together by machine learning and AI.

CVS-Aetna merger closes, but hardly ‘rubber stamped’ in Federal court

The deal is done, but expect unhappy holidays. As expected, the $69 million CVS-Aetna merger closed the week after Thanksgiving, on Wednesday 26 November, and are proceeding with their integration. Later that week, a Federal judge in the Washington, DC District Court complained at a hearing that both companies had treated him as a “rubber stamp” for the agreement. He was “less convinced” than the Department of Justice that the merger was legal under US anti-trust law. Yesterday (Tuesday 3 Dec), Judge Richard Leon ordered both companies and the DOJ to file briefs by 14 December “to show why their integration should not be halted while he considers whether or not to approve the consent decree reached in October,” according to Reuters.

This is despite various pounds of flesh:

  • The Department of Justice imposing the condition that Aetna sell its Medicare Part D drug plan business to far smaller WellCare Health Plans
  • New York State’s Department of Financial Services extracting concessions around their concerns: acquisition costs will not be passed onto consumers through increased premium rates or to affiliated insurers; maintaining current products for three years; privacy controls; cybersecurity compliance. Oh yes, a small $40 million commitment to support health insurance education and enrollment. (Healthcare Finance 26 Nov)
  •  But New York is a piker in its demands compared to California. The Department of Managed Health Care Director approved the merger based upon:
    • Minimal increases in premiums–and no increase due to acquisition costs
    • Investing $240 million in the state healthcare delivery system, including $166 million for state healthcare infrastructure and employment; $22.8 million to increase the number of healthcare providers in underrepresented areas like Fresno and Walnut Creek by funding scholarships and loan repayment programs; and $22.5 million to support joint ventures and accountable care organizations (ACOs) in value-based care (Healthcare Finance 15 Nov)

A CVS spokesman said in an email after the hearing: “CVS Health and Aetna are one company, and our focus is on transforming the consumer health experience.” (CNBC)  That transformation according to CVS president Larry Merlo involves expanding healthcare services beyond their present clinics to managing high-risk, chronic conditions, and transitions in care. Aetna’s expertise will be invaluable here as well as in an rumored expansion to urgent care (Seeking Alpha). All to out-maneuver Amazon, of course, which is promoting (on TV) PillPack and has applied for additional pharmacy licenses to ship drugs to customers in Washington, New Mexico and Indiana from their Phoenix facility (Healthcare Finance).

It appears that Judge Leon has his own serious reading of the 1974 Tunney Act, which requires a Federal court to ensure the agreement is in the public interest, despite the states and the DOJ.