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.
The Vital Moto Mod measures five vital signs–heart rate, respiratory rate, blood oxygen saturation (SpO2), non-contact core body temperature, and systolic/diastolic blood pressure–through primarily a finger cuff and sensors. For BP, the cuff uses sensors and a novel inflatable bladder. Vital USA claims that running through all five readings takes between two to three minutes. The results download to the HIPAA-compliant Vital app which will be available through the Google App Store. The app also guides the user through how to take one or more of the vital signs. The Vital Moto Mod is not yet FDA cleared or CE Marked.
As CNet remarked, the mod is huge and not exactly something you slip into your back pocket. They didn’t have the opportunity to check it for accuracy against other standard medical devices. It will be available after April 8 for $395 (£290).
One questionable aspect of the website is the consistent usage and demonstration of ‘vital signs monitoring’ and confirmation of its accuracy when in the FAQs, under “Is the product FDA approved”, it states that “this is a health and general wellness product. The Vital Moto Mod is not a medical device and therefore not currently regulated by the FDA.”
However, announced on the 24th was their partnership with Partners Connected Health of Boston to validate the readings in a clinical trial that will compare the Vital Moto Mod to predicate medical devices, which is preliminary to FDA approval. Release
It appears that the US company, HQ’d in Boca Raton, FL, has an Irish parent, ARC Connected Health.An earlier, less clunky entrant, which this Editor first saw at Connected Health 2015 is the Sensogram SensoSCAN finger cover monitor which is a 4-in-1, measuring blood pressure, heart rate, blood oxygen saturation (SPO2), and respiration rate (but not temperature). Measurements are viewable on a screen readout. It is currently available for $499 through their website and is in the process of FDA clearance. In development is the VitalBand, which adds fall detection, medication reminders, goal notifications, and pre-programmed contacts to the SensoSCAN’s four vital signs. Data is stored on both devices and uploaded to their app via Bluetooth.
This Editor is impressed with the idea of consumers not having to work with multiple devices but sees two definite drawbacks: size of the Vital Moto Mod and the cost of both up to $499. They are most useful to those who have to monitor multiple vitals for chronic conditions, yet they are both, at this time, stand-alone, not reimbursable, and not integrated with any major telehealth system. It’s yet to be seen if they will be accepted by telehealth companies (which kit their tablets or hubs with multiple devices), payers, and patients.
Rounding up the roundups in health tech and digital health for 2017; looking forward to 2018’s Nitty-Gritty
2017’s digital health M&A is well-covered by Jonah Comstock’s Mobihealthnews overview. In this aggregation, the M&A trends to be seen are 1) merging of services that are rather alike (e.g. two diabetes app/education or telehealth/telemedicine providers) to buy market share, 2) services that complement each other by being similar but with strengths in different markets or broaden capabilities (Teladoc and Best Doctors, GlobalMed and TreatMD), 3) fill a gap in a portfolio (Philips‘ various acquisitions), or 4) payers trying yet again to cement themselves into digital health, which has had a checkered record indeed. This consolidation is to be expected in a fluid and relatively early stage environment.
In this roundup, we miss the telecom moves of prior years, most of which have misfired. WebMD, once an acquirer, once on the ropes, is being acquired into a fully corporate info provider structure with its pending acquisition by KKR’s Internet Brands, an information SaaS/web hoster in multiple verticals. This points to the commodification of healthcare information.
Love that canary! We have a paradigm breaker in the pending CVS-Aetna merger into the very structure of how healthcare can be made more convenient, delivered, billed, and paid for–if it is approved and not challenged, which is a very real possibility. Over the next two years, if this works, look for supermarkets to get into the healthcare business. Payers, drug stores, and retailers have few places to go. The worldwide wild card: Walgreens Boots. Start with our article here and move to our previous articles linked at the end.
US telehealth and telemedicine’s march towards reimbursement and parity payment continues. See our article on the CCHP roundup and policy paper (for the most stalwart of wonks only). Another major change in the US is payment for more services under Medicare, issued in early November by the Centers for Medicare and Medicaid Services (CMS) in its Final Rule for the 2018 Medicare Physician Fee Schedule. This also increases payment to nearly $60 per month for remote patient monitoring, which will help struggling RPM providers. Not quite a stride, but less of a stumble for the Grizzled Survivors. MedCityNews
In the UK, our friends at The King’s Fund have rounded up their most popular content of 2017 here. Newer models of telehealth and telemedicine such as Babylon Health and PushDoctor continue to struggle to find a place in the national structure. (Babylon’s challenge to the CQC was dropped before Christmas at their cost of £11,000 in High Court costs.) Judging from our Tender Alerts, compared to the US, telecare integration into housing is far ahead for those most in need especially in support at home. Yet there are glaring disparities due to funding–witness the national scandal of NHS Kernow withdrawing telehealth from local residents earlier this year [TTA coverage here]. This Editor is pleased to report that as of 5 December, NHS Kernow’s Governing Body has approved plans to retain and reconfigure Telehealth services, working in partnership with the provider Cornwall Partnership NHS Foundation Trust (CFT). Their notice is here.
More UK roundups are available on Digital Health News: 2017 review, most read stories, and cybersecurity predictions for 2018. David Doherty’s compiled a group of the major international health tech events for 2018 over at 3G Doctor. Which reminds this Editor to tell him to list #MedMo18 November 29-30 in NYC and that he might want to consider updating the name to 5G Doctor to mark the transition over to 5G wireless service advancing in 2018.
Data breaches continue to be a worry. The Protenus/DataBreaches.net roundup for November continues the breach a day trend. The largest breach they detected was of over 16,000 patient records at the Hackensack Sleep and Pulmonary Center in New Jersey. The monthly total was almost 84,000 records, a low compared to the prior few months, but there may be some reporting shifting into December. Protenus blog, MedCityNews
And perhaps there’s a future for wearables, in the watch form. The Apple Watch’s disconnecting from the phone (and the slowness of older models) has led to companies like AliveCor’s KardiaBand EKG (ECG) providing add-ons to the watch. Apple is trying to develop its own non-invasive blood glucose monitor, with Alphabet’s (Google) Verily Study Watch in test having sensors that can collect data on heart rate, gait and skin temperature. More here from CNBC on Big Tech and healthcare, Apple’s wearables.
Telehealth saves lives, as an Australian nurse at an isolated Coral Bay clinic found out. He hooked himself up to the ECG machine and dialed into the Emergency Telehealth Service (ETS). With assistance from volunteers, he was able to medicate himself with clotbusters until the Royal Flying Doctor Service transferred him to a Perth hospital. Now if he had a KardiaBand….WAToday.com.au Hat tip to Mike Clark
This Editor’s parting words for 2017 will be right down to the Real Nitty-Gritty, so read on!: (more…)
The NHS announced at the top of this month that it would test Babylon Health‘s ‘chatbot’ app for the next six months to 1.2 million people in north London. During the call to the 111 medical hotline number, they will be prompted to try the app, which invites the user to text their symptoms. The app decides through the series of texts, through artificial intelligence, in minutes how urgent the situation is and will recommend action to the patient up to an appointment with their GP, or if acute to go to Accident & Emergency (US=emergency room or department) if the situation warrants. It will launch this month in NHS services covering Barnet, Camden, Enfield, Haringey, and Islington, London. TechCrunch.
The NHS’ reasons for “digitising” services through a pilot like Babylon’s app is to save money by reducing unnecessary doctor appointments and pressure on A&Es. It provides a quick diagnosis that usually directs the patient to self-care until the health situation resolves. If not resolved or obviously acute, it will direct to a GP or A&E. The numbers are fairly convincing: £45 for the visit to a GP, £13 to a nurse and £0 for the app use. According to The Telegraph, the trial is facing opposition by groups like Patient Concern, the British Medical Association’s GP committee, and Action Against Medical Accidents. There is little mention of wrong diagnoses here (see below). The NHS’ app track record, however, has not been good–the NHS Choices misstep on applying urgency classifications to a ‘symptom checker’ app–and there have been incidents on 111 response.
Babylon’s founder Ali Barsa, of course, is bullish on his app and what it can do. (more…)
Betas, ‘moving fast and breaking things’ don’t work in our territory. That is the POV of Vic Gundotra, the CEO of AliveCor, which has successfully introduced and marketed its smartphone snap-on ECG globally. Witness the up vote from the NHS on technology (Daily Mirror), while the American Medical Association (AMA) in the US wants better vetting of both clinical and DTC health tech and refers to much of it as ‘quackery’ (Forbes). According to Mr Gundotra, who was in engineering at Google and Microsoft prior to AliveCor, “Healthcare is not a market that can be hacked.” and “When a product directly relates to human health, following regulatory requirements needs to be a core part of the strategy from day one. What has been seen as a burden needs to be seen as a benefit. It’s time that we stop viewing regulatory bodies as obstacles and start viewing them as valuable partners. This is a mindset that should be adopted across a company’s entire team — from board to CEO to VC to developer.” And the incompatible expectation of Silicon Valley VCs, “18 months tapping our feet, then exit” as well. Recode
This has proved to be a great week for digital health credibility.
Firstly Sleepio picked up two honours – one was scoring the highest mark on the first Ranked Health output. The second was getting the American College of Physicians to come out and say that CBT-I should be the treatment of choice for insomnia (above hypnotics).
Meanwhile a study has shown that “A Smart Phone-based ECG Recorder Is Non-inferior to an Ambulatory Event Monitor for Diagnosis of Palpitations”. In layman’s language, the Alivecor/Kardia smartphone peripheral and app are as good as the awkward to wear & cumbersome Holter monitor.
Well done both!
Those who have heard Dr Sophie Bostok, the indefatigable Sleepio Sleep Evangelist, explain (more…)
AliveCor have today announced the Kardia Band which replaces the ordinary strap on an Apple Watch. Touch the band with your other hand and it records a one-lead ECG (EKG=US) that communicates with the Watch app, Kardia by AliveCor. The Atrial Fibrillation (AF) Detector then uses an algorithm to instantly detect and inform the wearer of the presence of AF, the most common cardiac arrhythmia and a leading cause of stroke. Other ‘detectors’ look at the ECG to determine normal heart rate and rhythm or if you should retake an ECG so physicians receive only the highest quality recordings.
Users can also record voice memos on their Apple Watch to accompany each ECG that give doctors and caregivers a clearer picture of what was happening at the time of the recording — describing symptoms such as palpitations or external factors like caffeine intake. Kardia also integrates seamlessly with Apple’s Health app to include ECG data with steps and calorie intake to provide richer, personal analysis over time.
A short note at the end indicates that the FDA-cleared AliveCor Mobile ECG, best known for snapping on to an iPhone but works on Android smartphones as well, has been rebranded as Kardia Mobile to establish a product family.
In the US, the Kardia Band is pending 510k clearance and is not currently for sale. Plans for the UK have not been formally announced but anticipated soon. AliveCor release.
- In communication, internet non-usage among 75+ has declined to 50 percent over the past 15 years.
- The tablet form factor is losing ground as smartphones get bigger. Older adults and smartphones are beginning to ‘get along’ partly as they grow larger, but also that feature and simple phones are becoming less available.
- Also losing ground is senior housing–residents are delaying entry to assisted living until they are mid 80s and frailer. Savings and debt in the boomer group is low and high, respectively.
- Investors are caring more about home care, with large investments ($80 million) in three regional home care worker startups: Honor (San Francisco), Home Hero (Los Angeles), and Hometeam (New York/New Jersey), caregiving apps and chronic care management (CareSync, with an $18 million raise).
- Dementia care support tools are (finally) developing into its own category.
Surprising conclusions: PERS alerting stays strong, but changes to be mobile-enabled and more cosmetic; a lot of convergence of categories and forms; and the term ‘health tech’ will replace ‘digital health’. Oh my!
Trying at least temporarily to distract this editor’s attention from his recent unfortunate experience with Jawbone technology, here are some interesting app and wearables snippets received over the summer.
We begin with news of the first CE certified mole checking app, SkinVision which rates moles using a simple traffic light system (using a red, orange or green risk rating). The app lets users store photos in multiple folders so they can track different moles over time. It aims to detect changing moles (color, size, symmetry etc.) that are a clear sign that something is wrong and that the person should visit a doctor immediately.
This contrasts with the findings of a paper published in June examining 46 insulin calculator apps, 45 of which were found to contain material problems, resulting in the conclusion that :”The majority of insulin dose calculator apps provide no protection against, and may actively contribute to, incorrect or inappropriate dose recommendations that put current users at risk of both catastrophic overdose and more subtle harms resulting from suboptimal glucose control.”, which to say the least of matters is worrying. (more…)
The Royal College of Physicians has just published app guidance that, according to EHI “doctors should only use medical apps with an official CE mark”. EHI goes on to clarify that the guidance “applies to medical apps that can be classed as medical devices, which are bound by EU law to carry the mark.”
The Digital Health & Care Alliance (DHACA), of which this reviewer is Managing Director, is extremely concerned that this advice may seriously impact on the beneficial use of medical apps in the UK as it places the onus of deciding whether an app is a medical device on individual clinicians, a decision that at times even experienced MHRA personnel can equivocate on.
- Samsung and Partners HealthCare announced a direct-to-mobile partnership to develop chronic care management mobile software that monitors vital signs such as blood pressure, blood glucose and weight, as well as delivers mobile patient engagement, medication adherence and wellness self-management. Clinical trial is scheduled for June. Partners has always been a pioneer in the mHealth area, but playing with Samsung, Partners is flying at a slightly higher level than with Wellocracy and certainly the late Healthrageous. Partners release, Mobihealthnews (more…)
The Future of Medicine Is in Your Smartphone sounds like a preface to his latest book, ‘The Patient Will See You Now’, but it is quite consistent with Dr Topol’s talks of late [TTA 5 Dec]. The article is at once optimistic–yes, we love the picture–yet somewhat unreal. When we walk around and kick the tires…
First, it flies in the face of the increasing control of healthcare providers by government as to outcomes and the shift for good or ill to ‘outcomes-based medicine’. Second, ‘doctorless patients’ may need fewer services, not more, and why should these individuals, who represent the high-info elite at least initially, be penalized by having to pay the extremely high premiums dictated by government-approved health insurance (in the US, ACA-compliant insurance a/k/a Obamacare)–or face the US tax penalties for not enrolling in same? Third, those liberating mass market smartwatches and fitness trackers aren’t clinical quality yet–fine directionally, but real clinical diagnosis (more…)
Looking back over our predictions made on 31st December last year, it’s hard to quibble with any, and worth hanging on to those that didn’t come good this year.
Our first was
Security and data privacy issues will become a serious mHealth issue in 2014; developers failing to take great care over security and privacy issues will risk very adverse publicity and worse.
Job done: that certainly proved correct, with many being exposed as either selling or potentially selling private information. Clinicians were not immune from privacy invasion either. Here is a US summary of the issues. Attention was drawn to an EU Article 29 data protection opinion (actually published in 2013) that sought to clarify the legal framework applicable to the processing of personal data in the development, distribution and usage of apps on smart devices, and the obligations to take adequate security measures. Many apps got hacked too, including FDA-approved ones. There were also items, such as this one, demonstrating how complex the law is in this area in the US. In the EU, the arrival of the Data Protection Regulation in 2015 (now some say 2016) will undoubtedly improve data privacy significantly, though the failure to treat data used for health purposes differently from (more…)
One of the surprises for this Editor, and for others attending the mHealth Summit, was to see the sizable presence of Qualcomm Life on both the exposition floor and during the sessions. From a near-nil presence at ATA 2014 and gone dark on news, the floodlights snapped on last week with new partners and a new emphasis: coordination of chronic and transitional (hospital to home) care management (CCM/TCM).
On the show floor, the spotlight was on the partner companies which mixed the established with (mostly) the early and mid-stage. Readers will recognize names such as AliveCor, Telcare, OMRON, Nonin and Airstrip; not so well known are Vaica, Orion Health, Monitored Therapeutics, IMPak Health, Vital Connect, Care Connectors, toSense (CoVa), Dexcom, InteliChart, TruClinic, ForaCare, VOXX, vitaphone (outside of Europe), Propeller Health and Noom Health (a NYeC Digital Health Accelerator 2014 graduate). The partners occupy different parts of the management continuum, integrating communications, record sharing, population health management, sensor-based monitoring, traditional and non-traditional vital signs monitoring, medication management, behavioral change methodologies and PHRs. The 2net Hub is still present for data transmission, sharing and storage, but more prominent is Qualcomm Life’s HealthyCircles platform which provides the clinical management ‘glue’: secure communications, record sharing and care team coordination. HealthyCircles was purchased in mid-2013. Founder James Mault, MD, FACS joined Qualcomm Life as VP/Chief Medical Officer.
We had some post-mHealth Summit reflection time by telephone this Wednesday while Dr Mault was in Boston. (more…)
mHealth Summit this year had an abundance of digital health company news announcements, not only from the conference but also timed to coincide with the heightened interest around it. Your Editor looks over the most interesting of them, briefly. Thanks to Ashley Gold of Politico’s Morning eHealth (@ashleygold, daily reports archived here), Stephanie Baum of MedCityNews (@stephlbaum) and Anne Zieger of Healthcare Dive for their coverage and their company in the press room!
Partners HealthCare researches, Validic expands, AliveCor and Omron ally, Happtique sells out, Doctor on Demand is telemental, Orange goes dental, VA Innovation Rocks
- Partners HealthCare/Center for Connected Health’s cHealth Compass will use panel and other research to help companies, device manufacturers, startups and investors determine what end users–consumer and provider–want out of personal health tech. Focus groups, interviews and usability testing will help to determine product design, evaluation, assess applications and feasibility as well as interim/final product testing. Partners is already organizing in Massachusetts a 2,000-patient database which rewards participants $50 on registration and $110 annually to be in a monthly survey panel. cHealth Compass website, BetaBoston (Boston Globe)
- Health data connector/aggregator Validic demonstrates the attractiveness of Anything Big Data on with new clients including the Everyday Health consumer/professional website and the adidas Group’s sport and fitness apps. Recently they added WebMD, Pfizer, University of Pittsburgh Medical Center (UPMC), NexJ Health and MedHost to their client list. The company claims that their ‘ecosystem’–probably the most popular buzzword at this year’s conference–of healthcare companies and tech developers now reaches over 100 million people with devices such as Omron, Alere, Qardio, Telcare, Jawbone and Withings. Release
- AliveCor accentuates the retail with Omron. AliveCor, which developed the first FDA-cleared ECG for smartphones and gained clearance for an atrial fibrillation algorithm in August, is collaborating with Japanese device manufacturer Omron on developing its retail presence. Omron’s devices are available in major drugstores such as Walgreens, RiteAid and Walmart so certainly AliveCor is due to benefit. AliveCor is also part of a revived QualcommLife (more on this in an upcoming article) Release, Mobihealthnews (Your Editor had the pleasure of meeting at last AliveCor’s CMO and founder Dr. Dave Albert.)
- Happtique sold to SocialWellth. Last year’s floor talk was about Happtique’s first class of certified apps and a security expert’s untimely discovery of major flaws (more…)
The New York eHealth Collaborative’s fourth annual Digital Health Conference is increasingly notable for combining both local concerns (NYeC is one of the key coordinators of health IT for the state) and nationally significant content. A major focus of the individual sessions was data in all flavors: big, international, private, shared and ethically used. Another was using this data in coordinating care and empowering patients. Your Editor will focus on this as reflected in sessions she attended, along with thoughts by our two guest contributors, in Part 2 of this roundup.The NYeC Conference was unique in presenting two divergent views of ‘Future IT’ and how it will affect healthcare delivery. One is a heady, optimistic one of powerful patients taking control of their healthcare, personalized ‘democratized medicine” and innovative, genetically-powered ‘on demand medicine’. The other is a future of top-down, regulated, cost-controlled, analyzed and constrained healthcare from top to bottom, with emphasis on standardizing procedures for doctors and hospitals, plus patient compliance.
First to Dr Topol in Monday’s keynote. The good side of people ‘wired’ to their phones is that it is symptomatic, not of Short Attention Span Theatre, but of Moore’s Law–the time technology is now taking for adoption by at least 25 percent of the US population is declining by about 50 percent. That means comfort with the eight drivers he itemizes for democratizing medicine and empowering the patient: sensors, labs, imaging, physical examination, records, costs, meds and ‘Uber Doc’.