PARO therapy robot tested, cleared by NHS for — hygiene

click to enlargePARO, the therapeutic robot seal developed in Japan by Professor Takanori Shibata for socialization use with geriatric dementia patients, is moving closer to being approved for use in the UK. It passed a cleaning and hygiene test conducted over nine months by Dr. Kathy Martyn, principal lecturer in the University’s School of Health Sciences, on a 10-bed dementia ward run by Sussex Partnership NHS Foundation Trust. The findings were that PARO was safe within the hospital setting for an acute care dementia unit.

TTA Editors have been covering PARO since 2010 (!) and despite the qualms in certain quarters [TTA 22 June 2010 ], unsurprisingly (to this Editor) the research has shown that it lowers stress and anxiety, promotes social interaction, facilitates emotional expression, and improves mood and speech fluency. Digital Health News (Picture from Toronto Star)

The Theranos Story, ch. 47: the post-mortem, blaming–and ghost chasing–begin

click to enlargeNow that Elizabeth Holmes is the former CEO of Theranos, many of the publications who huzzahed their ‘revolutionary’ blood testing system three short years ago are publishing their post-mortem analyses, often of how the wool was pulled over their eyes.

Jenny Gold from Kaiser Health News and NPR has a short ‘alarming’ tale of her press visit in November 2014 to a Theranos testing site at a Palo Alto Walgreens for an NPR feature. At Walgreens, she spoke with patients on the record and was invited to witness their blood draw–not the finger prick Theranos (and Walgreens) promoted, but a standard volume blood draw. After multiple and telling upset reactions from her company press handlers, including demanding Ms. Gold erase her audio recording (!) and accusing her of harassment, alarms went off at the Walgreens store for a non-existent fire. She was baited with an interview with Ms. Holmes–which never happened–and wound up with a corporate attorney instead who made unsupported statements. Ms. Gold canceled her story, which if she tracked the bad smell would have been likely the first press shot across the bow. What this post-mortem tells us is the extent of the coverup and the sheer (and unethical) fawning flackery that appeared in places like the New Yorker, Forbes, Inc., and Fortune.  NPR

The FT further digs into our gullibility, our wanting to believe that someone in a black turtleneck could put the Big Labs out of business,  how we in the press hungered for a new and female Steve Jobs to shake up the status quo. Andrew Hill: “Trouble often hits, though, when leaders stick to their story after it has diverged from reality, swerving into embellishment, mythmaking and, in Ms Holmes’s case, apparently fraud.”

But we were no smarter than those who gave Ms. Holmes and Mr. Ramesh ‘Sunny’ Balwani $700 million in Mad Money. (more…)

Contact lenses as a drug delivery system take home MIT Sloan Healthcare prize

This Editor has been covering contact lenses in health tech since at least 2013–contact lenses that detect glucose for diabetics (Google/Novartis/Alcon), eye pressure (Sensimed), and even detect multiple diseases (Oregon State University). None to date have made it into commercial release.

Here’s another try, this time from this year’s winner of the MIT Sloan Healthcare Innovation Prize competition. Theraoptix won the $25,000 grand prize, sponsored by Optum. The lenses are designed to deliver eye medication on a time release basis using a thin polymer film formed into a tiny circular strip sandwiched into the lens material. They can be worn for up to two weeks to slowly but constantly deliver drugs in the treatment of diseases like glaucoma or after surgery. It can also deliver drugs effectively for back of the eye treatment of macular degeneration, diabetic retinopathy, retinal vein occlusion, and similar diseases that today require in-office injections.

Theraoptix was developed by Lokendra Bengani Ph.D. of the Schepens Eye Research Institute of the Massachusetts Eye and Ear Infirmary. It was based on core technology by ophthalmologist Joseph B. Ciolino MD, who is Dr. Bengani’s mentor. We wrote about Dr. Ciolino’s research previously [TTA 7 Sept 16] including a look back at contact lens research. There were seven other finalists, of which the most interesting to this Editor was Kinematics shoe insole sensors for gait detection analysis (and fall prevention).  MIT News

The Theranos Story, ch. 46: “F for Fake.” SEC’s fraud charges force Elizabeth Holmes out (finally).

click to enlargeOur New Year’s 2018 prediction (after December’s $100 million loan from Fortress Investment Group): “Ms. Holmes will be removed and replaced, then the company will be reorganized and/or renamed.”

Fortress did not have to wait long or get their hands dirty. Today, the Securities and Exchange Commission (SEC) charged both founder and now former CEO Elizabeth Holmes and past CEO/president Ramesh ‘Sunny’ Balwani with securities fraud. While Mr. Balwani will fight the charges, Ms. Holmes escaped trading her black turtleneck for an orange jumpsuit by agreeing to pay a penalty of $500,000 to the SEC, give back 18.9 million shares to the company, give up her uniquely Silicon Valley perk of super-voting equity rights, and is now barred from serving as a public company director or officer for 10 years. From the Theranos release: “As part of the settlement, neither the Company nor Ms. Holmes admitted or denied any wrongdoing.”

This penalty may seem puny in the light of other securities fraud cases, but it appears that Ms. Holmes took little salary out of the company, with most of her long-gone billions in presently worthless remaining stock. 

The exact meaning of fraud, as determined by the SEC in cases like these, is not casual. We can say that we never believed the Edison or miniLabs would work despite the press hype. We can observe that patients and doctors were misled in test results, resulting in major human cost (our Ch. 22).  The fraud here is directly tied to representations made to investors that enabled Theranos’ massive funding, in multiple rounds, of over $700 million between 2013 to 2015. These misleading representations included demonstrations, reports on the functioning of its analyzers, inflating its relationships such as with the DOD, and its regulatory status with the FDA.

It also does not matter that all the funds were privately raised. The SEC in its statement firmly stated that it will treat private equity as it does public when it comes to investments (pay attention, health tech companies): (more…)

Blockchains, EHRs, roadblocks and baby steps

TTA founder and former editor Steve Hards crawls out of his retirement tent to squint at the misty landscape of blockchain technology.

In a recent dream I was observing an auditorium full of people chanting “Blockchain! Blockchain! Blockchain!” and yes, mantra-like, blockchain is now popping up all the time in health technology articles and presentations.

It has taken a while to get to this stage. It was January 2016 when Editor-in-Chief Donna first mentioned blockchain. Since then there appears to have been more talk than action.

A year ago, in February 2017, health IT guru Brian Ahier was able to say in a comment here “Blockchain of course, is going to sneak up on a lot of people…”

Where we have seen developments occurring is in the trickle of ‘coins’ or ‘tokens’ in health-related Initial Coin Offerings (ICOs) of dubious investment worthiness. I may rant about those in a follow-up article if anyone is interested. (Let me know in a comment.)

The terminology is still in its ‘shakedown phase’ (see this great terminology rant) and, because of the publicity around Bitcoin, which is on a blockchain, the distinction between blockchains and distributed ledger databases is blurred. There are technical differences: blockchains are a sub-set of distributed ledgers (Wikipedia), which is the term I’ll generally use in this article.

Distributed ledgers and EHRs

What are the implications of distributed ledgers for the biggest databases in healthcare, electronic health records (EHRs)?

The two principal characteristics that differentiate distributed ledgers from the databases with which we are familiar are that they are more robust and, potentially, more private. Some even claim to be quantum computing hack proof although we will have to wait for hackers with quantum computers to test that.

Traditional databases are formed from one large or several linked entities that have a centralised control from where performance, data integrity and security are monitored and managed. There are human and technological factors that introduce weaknesses to all such systems, as the number of data breaches reported here over the years testify.


MediBioSense partners with MRIGlobal for Department of Defense health monitoring system

Doncaster, UK-based MediBioSense Ltd. [TTA 23 Jan, 17 Feb] is partnering with Kansas City’s MRIGlobal to develop a wireless health monitoring system for the US Department of Defense Combating Terrorism Technical Support Office (CTTSO). The limited information in the release indicates that the joint project will provide technology integration and development services for CTTSO. The system “will provide medical grade health monitoring data and allow for real-time decisions to protect health.”

MediBioSense is the developer of the monitoring platform for and global distributor of the VitalPatch, originally developed by VitalConnect. MRIGlobal is a contract research organization for government, academia, and industry that works in the areas of national security, defense, health, and energy. In health, they develop solutions in in vitro diagnostics, infectious diseases, and ‘global biological engagement.’

CTTSO’s website description: “Identify and develop capabilities to combat terrorism and irregular adversaries and to deliver these capabilities to DoD components and interagency partners through rapid research and development, advanced studies and technical innovation, and provision of support to U.S. military operations.”

Which makes this new development quite interesting in what the VitalPatch may be detecting–and possibly a little hush-hush!

A tipping point in consumer acceptance of health apps, AI, and virtual care? Accenture thinks so.

Accenture’s 2018 Consumer Survey on Digital Health indicates that the tipping point may be here, sort of. Some key findings:

  • Consumers had high rates of favorable acceptance and likeliness to use AI-enabled clinical services: home-based diagnostics (66 percent of respondents), virtual health assistants (61 percent), and virtual nurses to monitor health conditions, medications and vital signs at home (55 percent), which may be good news for the future of telehealth services.
  • The 2,301 respondents already are using mobile and tablet health apps (48 percent). 44 percent are using patient portals for to fetch their health records, primarily to get information on lab and blood-test results (67 percent), to view physician notes regarding medical visits (55 percent), and their prescription history (41 percent).
  • Wearables are being used by 33 percent and favorably viewed by over 70 percent as beneficial in understanding their health condition (75 percent), engaging with their health (73 percent), and monitoring the health of a loved one (73 percent). 

Virtual care seems to be leading the way over wearables and remote patient monitoring–and after-hours care, patient follow-up, and patient education are leading virtual care.

  • 25 percent had received virtual care services in the previous year, up from 21 percent in last year’s survey. 16 percent are taking part in remote health consultations, compared with 12 percent in 2016. 14 percent are participating in remote monitoring, up from 9 percent in 2016.
  • 47 percent state that given a choice, they would prefer a more immediate virtual medical appointment over a delayed in-person appointment.
  • For after-hours care, 73 percent said they would use virtual care for after-hours (nights and weekend) appointments.
  • 71 percent said they would use virtual care for taking a class on a specific medical condition. 65 percent would use virtual care for a follow-up appointment after an in-person visit.
  • Most respondents said they would also use virtual care for a range of additional services, including discussing specific health concerns with medical professionals (73 percent), in-home follow-up after a hospital stay (62 percent), participating in a family member’s medical appointment (59 percent), and being examined for a non-emergency condition (57 percent).

Accenture release and report.

Is Uber fit to deliver healthcare transport? Healthcare organizations may want to check.

Healthcare-related organizations have codes of conduct pertaining to suppliers. Does Uber meet compliance standards? As we reported a few days ago in our article on the burgeoning area of non-emergency medical transport (NEMT) [TTA 9 Mar], Uber Health’s debut with a reputed 100 healthcare organizations has led this Editor to a further examination of Uber, the organization. Uber has had a hard time staying out of the headlines–and the courts–in the past two years, in matters which might give healthcare partners pause.

  • On 21 Nov, Uber reported that the personal data of 57 million users, including 600,000 US drivers, were breached and stolen in October 2016–a full year prior. Not only was the breach announcement delayed by over a year, but also in that year it was made to go away by Uber’s paying off the hacker. Reuters on 6 December: “A 20-year-old Florida man was responsible for the large data breach at Uber Technologies Inc [UBER.UL] last year and was paid by Uber to destroy the data through a so-called “bug bounty” program normally used to identify small code vulnerabilities, three people familiar with the events have told Reuters.” The payment was an extraordinary $100,000. “The sources said then-CEO Travis Kalanick was aware of the breach and bug bounty payment in November of last year.” The Reuters article goes further into the mechanism of the hack. It eventually led to the resignation of their chief security officer, former Facebook/eBay/PayPal security head Joe Sullivan, who ‘investigated’ it using encrypted, disappearing messaging apps. Atlantic.
  • CEO and co-founder Travis Kalanick was forced to resign last June after losing the confidence of the company’s investors, in contrails of financial mismanagement, sexual harassment, driver harassment, and ‘bro culture’. This included legal action over Uber’s 2016 acquisition of self-driving truck startup Otto, started by former Googlers who may or may not have lifted proprietary tech from Google before ankling. These are lavishly outlined in Bloomberg and in an over-the-top article in Engadget (with the usual slams at libertarianism). Mr. Kalanick remains on the board and is now a private investor.
  • The plain fact is that Uber is still burning through funds (2017: $1bn) after raising $21.1bn and its valuation has suffered. The new CEO Dara Khosrowshahi, who earlier righted travel site Expedia, has a tough pull with investors such as SoftBank and Saudi Arabia’s Public Investment Fund. Also Mashable.

Healthcare and NEMT, as noted in our earlier article, are a strong source of potential steady revenue through reimbursement in Medicare Advantage and state Medicaid programs, which is why both Uber and Lyft are targeting it. The benefits for all sides–patients, practices, these companies, sub-contractors, and drivers–can be substantial and positive in this social determinant of health (SDOH).  

Healthcare organizations, especially payers, have strict codes of compliance not only for employees and business practices but also for their suppliers’ practices. Payers in Medicare Advantage and Medicaid are Federal and state contractors. While Uber under its new CEO has shown contriteness in acknowledging an organization in need of righting its moral compass (CNBC), there remains the track record and the aftermath. Both deserve a closer look and review.

Lyft and Uber’s big tech twists on a Social Determinant of Health–medical-related transportation

Social determinants of health (SDOH), that widely-discussed concept often dismissed as the turf of social workers and small do-good companies such as Healthify, are receiving a substantial boost from two profit-oriented, on-demand transportation companies: Uber and Lyft. Several years ago, smaller companies such as Circulation and Veyo [TTA 21 Feb, 26 Apr 17] entered the non-emergency medical transportation (NEMT) field with their on-demand services. These proved to be valuable links in the continuum of care–valuable in helping patients make their appointments, at generally a lower cost than Access-a-Ride or taxis, while collecting a wealth of data on usage.

Uber and Lyft’s recent announcements take the NEMT concept further with integration into discharge planning, chronic care management in practices, and EHRs while keeping it simple for patients and caregivers.

  • The launch of Uber Health, targeted to healthcare organizations (and just in time for HIMSS). The ride booking for both patients and caregivers uses a HIPAA-compliant dashboard for the health manager to book the ride, and text messaging to the patient for confirmations and pickup. Over 100 healthcare organizations are piloting the service. MedCityNews
  • Lyft Business inked a deal with Allscripts to integrate booking transportation into appointment setting. The Allscripts EHR is in 45,000 physician practices and 2,500 hospitals (which doesn’t include newly-acquired Practice Fusion’s 30,000 small ambulatory sites). Besides its own driver base, Lyft also has used its Concierge API to facilitate partnerships with NEMT brokers working with providers such as Circulation, National MedTrans (the NEMT provider for Anthem’s CareMore Health Plan HMO), and American Medical Response for drivers and more specialized vehicles. Hitch Health works with Lyft and independently integrates into Epic and Athenahealth. MedCityNews, POLITICO Morning eHealth (scroll down).

But does providing transport for appointments save money? The logic behind it is that missed appointments can exacerbate existing conditions; a direct example is dialysis, where missing an appointment could result in a hospital admission. Another area is patient avoidance of making appointments. The CareMore Health Plan study reduced waiting times and ride cost, increasing patient satisfaction–great for HEDIS and ACO quality scores, but the longer-term cost saving is still to be determined.

Another attraction for Lyft and Uber: steady revenue. In Medicare Advantage, 70 percent of members are covered and all state Medicaid programs reimburse their members for qualifying transportation.

What if you crossed Alexa with a robotic healthcare manager?

click to enlargeYou might have a tabletop ‘companion robot’ that’s called, interestingly, Pillo. It doesn’t look like something on a bed, nor does it ambulate, but more like a souped-up pastel colored Alexa with Eyes. Debuting at HIMSS 2018 this week, what is non-Alexa-like about it is that is a voice-responsive Wi-Fi/Bluetooth-connected healthcare manager, interacting with the user on Alexa-type requests but in the main managing (nudging?) their care plan, reminding them of medical appointments, delivering patient education, and dispensing their pre-loaded medications in a cup . Pillo claims to use AI algorithms to manage care, proactively engage with patients, and recognize users via voice and facial recognition. Orbita is supplying the platform for the voice assistant technology.

Pillo appears to be targeted to users with chronic conditions who need assistance in care management and with a connecting mobile app to family caregivers and clinicians. There’s no mention of a tracking platform nor connectivity with medical devices such as glucose meters or blood pressure cuffs. According to Forbes, it will ship in 4th Quarter, no pricing mentioned. Pillo raised $1.5 million in a venture round last August from BioAdvance (Crunchbase) with additional funding from Stanley Ventures, Hikma Ventures (the venture arm of Hikma Pharmaceuticals) and Thompson Family Foundation for a total of $4m (Forbes). It’s hard to tell if this will appeal to or be subsidized by pharma, payers, or Medicare primary care providers such as ACOs because the release is rather opaque on specifics.

CVS sets it up for Aetna with $40 billion in the third-largest bond sale ever

Obviously, CVS is confident of an approved merger and that it will work. CVS issued $40bn of investment-grade debt today (6 March) to finance the purchase of Aetna, according to sources talking to Bloomberg. The attraction was premium interest and other incentives, up to 1.95 percentage points above Treasuries in the 30-year portion of the nine-part offering. This serves to refinance a bridge loan of $49bn from 20 investors that was taken in December to initially finance the $67.5 bn acquisition. 

By Bloomberg’s calculation, the bond sale ranked only behind $40bn +blockbusters from Verizon (2013) and AB InBev (2016). Analysts and portfolio managers cheered at the terms. It’s expected to close by second half 2018. No word yet from DOJ, however, which asked for additional information on 1 Feb which further extends their waiting period. Mutual shareholder meetings are still scheduled for 20 March [TTA 2 Feb].

Another positive investor take is over at Seeking Alpha, citing excellent fundamentals, a diverse revenue stream, and innovation in “management’s commitment to evolve the company for the future” as well as “trying to revolutionize the doctor-patient-pharmacy relationship, and using its convenience store appeal to support it.” But we knew that already! The article goes on to extrapolate on the Amazon Effect and where CVS, with a bit of tweaking (healthier food choices with pre-made options in stores, much as many Duane Reade/Walgreens have in NYC), could steal a march. (Our prior coverage and mentions are here.)

E-skin? Bionic skin? No matter the name, the ‘ultimate wearable’ for monitoring is advancing.

‘Bionic skin’ as the ultimate wearable has been taking several dimensions. TTA Editors have previously reported on tattoo-like stretchy sensors applied to the skin for monitoring vital signs from a variety of academic and commercial developers. Here are two new advances of interest for those who follow the progress of wearables:

  • click to enlargeFrom University of Tokyo’s Graduate School of Engineering, a team led by Professor Takao Someya has developed an e-skin (left) that can measure vital signs and basic images, send them to clinicians, and–in what may be a first–display them on the surface in real time. This feature is useful for anyone, but especially for those who have difficulty communicating information due to speech or cognitive impairments. According to EurekaAlert, it combines a flexible, deformable display with a lightweight sensor composed of a breathable nanomesh electrode and wireless communication module. Developed in conjunction with Dai Nippon Printing (DNP), it is a 16 x 24 array of micro LEDs and stretchable wiring mounted on a rubber sheet. In its test form, it communicated temperature, pressure, myoelectricity (the electrical properties of muscle), and recorded an ECG. DNP expects to commercialize it in three years and improving its coverage for larger surfaces. It lasts about one week without creating irritation, another major factor in skin sensors. Video on EurekaAlert. Also Engadget. A paper on this research was delivered at AAAS last week
  • More information on Prof. Someya’s research is available in this IEEE Spectrum article, largely about the challenges of e-skin flexibility for use in patches and in prosthetics. Their research is utilizing TFTs (thin film transistors) and plastic skin one-tenth the thickness of common plastic wrap as the most sensitive and adaptable technologies.
  • University of Colorado Boulder has developed a monitoring e-skin that self-heals if damaged, which may extend e-skin life and usability. It uses a polymer (polyimine) laced with silver nanoparticles which can be repaired by easily available ethanol compounds and is fully recyclable with another solution that separates out the silver. The test patch conducts temperature and pressure. This looks thicker than plastic wrap, however. Engadget

Health tech for stroke prevention and rehab from Kardia Mobile, Watch BP, Northwestern U (UK/US)

click to enlargeIs stroke avoidable? We know it is an expensive medical event at $20-23,000 for hospitalization alone (NIH), which does not count rehabilitation or the devastation to individuals and their families, including loss of ability and work. NHS England is testing two devices, the Kardia Mobile and Watch BP, with an eye to preventing stroke in those vulnerable to it. 6,000 devices are being distributed to GP practices in England in a program through 15 NHS and care innovation bodies known as Academic Health Science Networks (AHSNs). The Alivecor‘s Kardia Mobile is a smartphone add-on clip that captures a medical-grade ECG in 30 seconds, stores, and sends readings to physicians. The application to stroke is primarily in atrial fibrillation (AF) and irregular heart rhythms, which according to statistics, more than 420,000 people across England have. Watch BP is a blood pressure cuff device which is also equipped with an AF detection system. The goal of the project is to identify 130,000 new cases of AF over two years, to prevent at least 3,650 strokes and potentially save 900 lives. Savings to NHS are being estimated at £81 million annually. Digital Health News

Post-stroke rehabilitation treatment is also being boosted by a new device developed at Northwestern University and being tested at the Shirley Ryan AbilityLab, a Chicago research hospital. It is a Band-Aid® like device which can be applied to key areas such as the throat (left above, credit AbilityLab), chest, or limbs to send back information to doctors on how a patient in treatment post-discharge, especially at home, progresses. The sensors and platform measure heart activity, muscle movement, sleep quality, swallowing ability, and patterns of speech. Especially revolutionary is the monitoring of speech communication and swallowing, which are often impaired in stroke patients but hard to track once the patient is out of a facility. The team’s research was presented last week at the American Association for the Advancement of Science (AAAS) annual meeting. New Atlas. Hat tip to Toni Bunting.

UK roundup: CCIO Simon Eccles warns against ‘shiny objects’, NHS Liverpool CCG award to Docobo, 87% concerned with NHS info security

click to enlargeNHS Digital CCIO doesn’t like ‘shiny objects’. Dr. Simon Eccles used his first NHS Digital board meeting as national CCIO to encourage delivering the current agenda first and not getting distracted by the ‘shiny objects’ of new innovations which also divert funding. “It is our collective challenge to make sure that doesn’t happen to things that are valued by the NHS – to do what we said we’d do and not be too distracted by new and shiny things.” This seems to be at odds with non-executive director Daniel Benton, who “suggested that NHS Digital needed to become more flexible as an organisation so that it was in a better position to roll with the punches in future.” Digital Health News

Docobo announced their win of the NHS Liverpool Clinical Commissioning Group‘s scale up of telehealth as part of the Healthy Liverpool program. The three to five-year contract has a maximum value of £11.5 million. The current Mi Programme (More Independent) partly funded by the Innovate UK dallas initiative and using Philips equipment is at 900 patients with 5,300 total patients since 2013. The plan is to scale up the program to 4-5,000 patients a year and support new clinical pathways and conditions including lung conditions, heart failure, and diabetes. Docobo’s platform is Doc@Home which uses patient information from the CarePortal device or their own digital devices. Docobo release. NHS Innovation Accelerator, Digital Health News

A survey of 500 British adults conducted by UK IT VAR Proband found that perceptions of public sector information security are poor. 87 percent were concerned about the security of their information with the NHS. Of that 87 percent, 34 percent were ‘very concerned’ about their cybersecurity. Taking this with a grain of salt, 80 percent distrusted security at the Driver and Vehicle Licensing Agency (DVLA) and 78 percent on data held by the police. The General Data Protection Regulation (GDPR) can’t come too soon [TTA 17 Feb] — but are you ready? More in Proband’s Online Security Audit (PDF).

Telehealth policy and reimbursement changes summarized by Center for Connected Health Policy (US)

A significant barrier to the adoption of telehealth (defined here as video consults, store and forward imaging, and remote patient monitoring) is the issue of reimbursement gaps. Basic Medicare (the Federal program for those over 65) pays for video and store and forward only under certain conditions (primarily under rural telehealth programs) but does pay for RPM as part of chronic care management (albeit under a maze of codes and procedures). Medicaid (the state low-income insurance program) is far more lenient, and private pay in states varies widely, with 36 states having some form of parity payment legislation. However, Medicare is planning expansion beyond what is covered in private plans (Medicare Advantage) by 2020. Some Federal programs such as the advanced Next Generation ACO program and the bundled payment Comprehensive Care for Joint Replacement model have telehealth waivers.

The always-helpful Center for Connected Health Policy (CCHP) has published a five-page guide to where these programs stand. Becker’s Hospital Review. CCHP PDF