A tricorder one step closer: Tyto Care gains FDA clearance for its digital stethoscope (US)

November 2, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/Mom_using_on_child_ear.jpg” thumb_width=”150″ /]Only a few years ago, the Star of the Future of Digital Health was the ‘tricorder’–that all-in-one vital signs device that Bones on Star Trek wielded with such élan (when he wasn’t uttering ‘He’s dead, Jim’). We haven’t heard much from Scanadu since early last year when it raised $35 million for its Series B and when it teamed with with Northern Ireland’s Intelesens as a finalist for the seemingly never-ending Qualcomm Tricorder XPRIZE. (Seven finalists are now in consumer testing with awards in early 2017.)

In the meantime, others have been proceeding in bringing their devices into reality far sooner, for real people with everyday health problems who want to examine a child, another family member or even themselves at home. One of these companies is Israel’s Tyto Care (picture above at left), which received FDA 510(k) Class II clearance for its digital stethoscope snap-on to the main device to monitor heart and lung sounds. The device also includes a digital imaging otoscope for ear exams, a throat scope, a skin camera and thermometer swipe. The Tyto home device includes video guidance instructions as part of the smartphone or tablet platform to enable a correct reading. It connects to an online platform to send the information, either in real time or store-and-forward, to a primary care physician the user selects. Tyto Care has been in investigational marketing in the US as well as Israel, bolstered by over $18 million in international investment. They are targeting home DTC as well as professional markets through practices, payers, virtual visit providers and possibly retail (one of their investors is Walgreens Boots). Release If you are attending MEDICA 2017 in Düsseldorf on 16 November, you can see Tyto Care demonstrated at the 5th Annual MEDICA App Competition.

Another all-in-one device is Las Vegas-based MedWand, which is still in pre-marketing. MedWand seems to feature clinic and ‘group’ packages as well as the individual device which includes a pulse oximeter. They received another round of undisclosed financing from Maxim Ventures, the venture arm for semi-conductor developer Maxim Integrated Products at end of September. Release.

Using telehealth to improve night-time ICU care

November 1, 2016 | by

Intensive Care Units treat the most sick people in a hospital and requires round-the-clock staffing by doctors and nurses. 24-hour staffing, however, means shift working and an inevitable night shift. To make it fair on all staff the shifts are usually rotated so any doctor or nurse would do a period on one shift and then move to the next shift.

It is not surprising that the more senior staff manage to have less night work than newer, less experienced ones. On the other hand night shifts may have attractions such as extra pay and this may be more important to the lower paid less experienced staff than to the higher paid senior ones. Also, the cost of staffing nights with less experienced staff may prove cheaper for the hospital. Nevertheless, the patients’ needs are no less important at night than during the day. Another aspect of night-time care is the possibility that a doctor or nurse may not be as alert at night as they would be in the day-time.

Looking at these downsides of night-time ICU care staffing, an hospital in the US has come up with a novel idea – move the doctors and nurses to a zone where it is day-time when it is night-time at the hospital and use telehealth to connect them. This is counter intuitive and has its own drawbacks.

Georgia’s largest healthcare provider Emory Healthcare is sending some ICU doctors and nurses to Sydney, Australia, for tours of six to nine weeks at a time, in a trial to staff ICU at night with health staff in a daylight zone using telehealth. The six month trial in collaboration with Philips and Australia’s Maquarie Health has been underway for 3 months.

The reason this is counter-intuitive is that telehealth was invented to overcome the problems associated with healthcare professionals and patients not being at the same location and here the two are being artificially removed to two ends of the world. While telehealth is a good solution to the diagnosis and treatment from afar, most professionals are likey to agree that it is inferior to being face to face with the patient. So it will be good to see the conclusions reached by this trial on how any drawbacks of distance balances out with having more alert doctors and nurses.

See also mHealth Intelligence article here.

Touch and feeling through a bionic prosthetic arm (DARPA-Univ. Pittsburgh)

November 1, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/11/bionic-arm.jpg” thumb_width=”200″ /]A robotic arm with a neural interface that allows the user to experience touch has been developed by the University of Pittsburgh and University of Pittsburgh Medical Center, funded by the Defense Advanced Research Projects Agency (DARPA).  The Revolutionizing Prosthetics program since 2006 has been developing advanced upper-limb prosthetics. Their first was the Gen-3 Arm System by DEKA Integrated Solutions Corporation, submitted for 510(k) in 2012. The subject for the test of the touch interface, Nathan, has been a quadriplegic from the chest down since 2004. He permitted four microelectrode arrays, each about half the size of a shirt button, to be placed in his brain: two in the motor cortex and two in the sensory cortex regions that correspond to feeling in his fingers and palm. Wires run from the arrays to the robotic arm, which has torque sensors that detect when pressure is applied to its fingers. These physical “sensations” are converted into electrical signals back to the arrays in Nathan’s brain so that he has the sensation of feeling and touch.  The sensation of touch in the bionic arm is near 100 percent natural and accurate. This research has great potential both for prosthetics and for other neurological conditions. Armed With Science.  Video

eTELEMED/MATH 2017: call for contributions deadline extended

November 1, 2016 | by

19-23 March 2017,  Nice, France

eTELEMED, the Ninth International Conference on eHealth, Telemedicine, and Social Medicine, and the co-located MATH (Mobile and Assistive Technology for Healthcare), are both calling for submissions of original scientific results. These contributions and presentations can take any one of these forms:

Contributions:
– regular papers [in the proceedings, digital library] – short papers (work in progress) [in the proceedings, digital library] – ideas: two pages [in the proceedings, digital library] – extended abstracts: two pages [in the proceedings, digital library] – posters: two pages [in the proceedings, digital library] – posters: slide only [slide-deck posted at www.iaria.org] – presentations: slide only [slide-deck posted at www.iaria.org] – demos: two pages [posted at www.iaria.org] – doctoral forum submissions: [in the proceedings, digital library]

Proposals for:
– mini symposia: see http://www.iaria.org/symposium.html
– workshops: see http://www.iaria.org/workshop.html
– tutorials: [slide-deck posed on www.iaria.org] – panels: [slide-deck posed on www.iaria.org]

Submission deadline is 19 November. The general information pages have more information on the conference tracks and topics. Links:  eTELEMED: General information, submission page; MATH: General information, submission page

Who’s hiring? Project manager-Simulation for Digital Health (SimDH) (UK)

October 31, 2016 | by

From the listing posted by London South Bank University, applications close 13 November:

South Bank University Enterprise Ltd, the enterprise company of London South Bank University, is looking for a Project Manager (PM) within its Research, Enterprise and Innovation Department (REI). REI activities cover a range of income generating activities and also support wider entrepreneurial activity and external engagement between business, staff and students.

The current post provides an exciting opportunity to join the newly developed Institute of Health and Wellbeing, an interdisciplinary and inter-professional centre of excellence working towards improving the health and wellbeing status of individuals, communities and regions. The Institute combines a number of expert disciplines across LSBU in a single unit, helping foster novel collaborations, partnerships and innovative research and enterprise activities. The focus of the Institute is to improve the health and wellbeing of populations through impactful interventions, research and policy guidance.

The PM will be responsible for the successful delivery of REI’s recently won European Regional Development Fund (ERDF) project, Simulation for Digital Health (SimDH). The role will require close working with Business Development Managers, academic Schools and external organisations to ensure projects are delivered to contract and achieve all desired objectives.

Complete information on the LSBU website.  SimDH website–this program is intended to assist health SMEs to develop and deliver novel products, processes or services. It will start in January but applications are being taken now here. Hat tip to reader Susanne Woodman

US: Telemedicine to be used during disasters

October 29, 2016 | by

The American Red Cross has entered into a partnership to pilot the use of telemedicine during periods of disasters in the US. During the pilot a nationwide network of physicians will be available for consultation via video calls.

Through this pilot collaboration, physicians working with Red Cross partner Teladoc will be available to people helped by the Red Cross whose access to health care providers has been limited or is unavailable after large-scale disasters. Teladoc’s virtual physician visit services will be made available via web, Teladoc’s mobile app and phone to address the primary health care needs of individuals affected by disasters.

Teladoc is reported to have donated remote medical care during the recent Hurricane Matthew. This partnership is positioned as an expansion of such disaster relief efforts rather than an expansion of its commercial activities.

Use of telemedicine in disaster relief has been implemented previously in the US by the Department of Veterans Affairs (VA). In 2014 the Office of Emergency Management of the VA awarded a contract to use the JEMS Technology disaster relief telehealth system. Going back much earlier, following the December 1988 earthquake in Armenia and the June 1989 gas explosion near Ufa, a satellite based audio, video and fax link, known as the Telemedicine Spacebridge, between four US and two Armenian and Russian medical centres,  permitted remote American consultants to assist Armenian and Russian physicians in the management of medical problems. Last year NATO tested use of telemedicine in disaster situations in a simulated disaster scenario in Ukraine.

Another system, Emergency Telehealth and Navigation, is deployed in Houston for helping with 911 calls. The Houston Fire Department has agreements with doctors so they have access to a doctor at any time to take calls from crew at emergency sites. They find that this avoids having to take some people to hospital when a doctor is able to determine that a condition is non-emergency where a paramedic may well have taken the patient to an Emergency Department.

The cybersecurity black hole–and bad flashback–that is the Internet of Things

October 29, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/10/blackhole_596.jpg” thumb_width=”150″ /]One week after the Dyn DDoS attack, the post-mortems get more alarming. Our Readers knew they were coming in 2014-2015 (our ‘Is IoT really necessary–and dangerous?)

IoT devices, and a lot of older networked medical devices, have been proven to be easy to hack, as even this non-ITer, non-codegeek realized then. But those in tech have been to this movie before–with Bluetooth circa 2002! Now shouldn’t designers have learned? From ZDNet:

“It’s almost like we’ve learned nothing from Bluetooth” says Justin Dolly, CISO at cybersecurity firm Malwarebytes.

“Seeing what these IoT vendors are doing, it just blows me away because they haven’t learned from history,” says Steve Manzuik, director of security research at Duo Security’s Duo Labs. “They’ve completely ignored everything that’s ever had bad vulnerabilities”.

Many of these devices, according to these experts, have default log in credentials, if they have them at all. IoT devices are also allegedly findable on a snoop site called Shodan. Reason why: the financial and market need to get products out fast and cheaply.

Over at data security company Varonis’ blog, with the great title in part, “Revenge of the Internet of Things”, another succinct and telling quote:

Once upon a time in early 2016, we were talking with pen tester Ken Munro about the security of IoT gadgetry — everything from wireless doorbells to coffee makers and other household appliances. I remember his answer when I asked about basic security in these devices. His reply: “You’re making a big step there, which is assuming that the manufacturer gave any thought to an attack from a hacker at all.”

Privacy by Design is not part of the vocabulary of the makers of these IoT gadgets

Varonis also gives a how-to on changing settings in your router so you don’t become a victim, and how to secure your gadgets.

Bottom line: when Hackermania is Running Wild, do you, or anyone, really need to be an early adopter of an internet- connected coffee maker or fridge? And if you need internet-connected home security, telemedicine virtual consults, telehealth/remote patient monitoring or telecare….best heed Varonis and secure it!

Earlier in TTA: Friday’s cyberattack is a shot-over-bow for healthcare 

Zimmer Biomet acquires telehealth company RespondWell

October 28, 2016 | by

Orthopedic device maker Zimmer Biomet today (27 Oct) announced the acquisition of St Louis-based telerehabilitation + telehealth company RespondWell. RespondWell provides several facets of post-surgical physical therapy: telerehabilitation with clinically prescribed exercise routines, virtual doctor-patient consults, tablet-based personalized care plan delivery and data collection/RPM, and ‘gamified’ patient engagement tools. Up to the acquisition, according to Xconomy, RespondWell had raised $2 million from investors and had been seeking another raise of $8 million. Zimmer’s purchase price was not disclosed, but the changeover was swift, with the RespondWell website already copyrighted and top-bar tagged with Zimmer’s information.

Based on the release, RespondWell will be integrated into Zimmer Biomet Signature Solutions, using the brands Therapy@Home and presumably their original Fitness@Home. RespondWell’s former CEO Ted Spooner has been named VP of Connected Health at Zimmer Biomet; in his interview with MedCityNews, he was pleased at the exit and the acquisition by a company which wants to scale his solution.

Signature Solutions was formed from related Zimmer programs a few months ago as essentially a specialized value-based care consultancy and service provider. The combination of the two–VBC consultancy integrating with a health tech service provider–appears to be a nascent trend–and perhaps finally a path for telehealth providers. Hat tip to reader David Lee Scher MD via Twitter

Care Innovations gets into the behavior change training business

October 28, 2016 | by | 3 Comments

An under-the-radar move by Intel-owned Care Innovations, which markets the Health Harmony telehealth and the QuietCare behavioral telemonitoring systems, is their entrance in the behavior change training business.

Care Innovations developed an accredited (CE eligible) training course for nurses to effect behavior change in patient beyond what may be a limited telehealth engagement. According to their release, the training will help them with coaching patients to increase their engagement with their health and identifying areas for improvement, along with the appropriate technology.

The three-hour course work, designed primarily for telehealth nurses but open to all, has three key learning sections:

  1. Six steps to take to achieve behavior change in healthcare
  2. Learning four coaching skills: crafting open-ended questions, sharing words of affirmation, demonstrating reflective listening and crafting summary statements
  3. Discussing the most common challenges associated with acting as the coach, which are avoidance, ambivalence, resistance and compliance.

There are three sessions before the end of the year, priced at a relatively modest below $300 rate, with group discounts. Information is on their website here.

It’s an interesting move in that the training seemingly is not exclusive to CI clients, although this Editor would expect that 1) it would fit best with CI’s system and 2) is a way of cultivating prospective clients in an academic, value-added way.

For CI, it is another association with the ‘intersection of behavior change and technology’ (more…)

The Theranos Story, ch. 22: the human cost of lab error (updated)

October 26, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/11/upside-down-duck.jpg” thumb_width=”150″ /]Save this one for the coffee or lunch break. What is the cost of a lab error on the human psyche? It can be mildly upsetting to you and your doctor, warning of a developing condition and some changes have to be made–or make for a very bad day/week/months. It can be falsely reassuring or simply confusing.

We know that in April, Theranos flunked a CMS review, and in May voided all test results from its proprietary Edison devices from 2014 and 2015, as well as some other tests it ran on conventional machines. The results were not only off, but way off, according to the WSJ. “Notes from the CMS inspection show that 834 out of 2,890 quality-control checks run on the Edison in October 2014, or 29%, exceeded the company’s threshold of two standard deviations from its average result. Standard deviation is a statistical measurement of variation. In addition, 80% of the 834 quality-control checks that raised a red flag under Theranos’s internal standards were more than three standard deviations from its average result, the inspection notes show.”

They also failed to notify patients for weeks or months, and often not until forced to. At least 10 lawsuits have been filed in Arizona and California. Some of the human stories of Theranos’ improbable lab results, which included tens of thousands of patients, with the cost of retesting, repeated doctor visits and agonizing suspense :

  • After five widely different Theranos blood coagulation tests in six weeks, a retired marketer living in Arizona and his doctor so distrusted the results that the latter recommended that he stop taking warfarin and switch to a milder medication. This patient found out only last Friday that Theranos had corrected a September 2015 test showing his blood taking more than six times longer than normal to clot. The other four tests showed the warfarin wasn’t thinning his blood enough. Contradictory results confusing both doctor and patient on treatment.
  • A thyroid cancer survivor got thyroxine results (T4) from three tests conducted in October 2014. The extremely high results could have indicated hyperthyroidism at the least, or a more serious condition. The results–false after retesting failed to confirm.
  • A breast cancer survivor had extremely high levels of estradiol, which could have been produced by a rare adrenal tumor that can secrete estradiol or an elevated risk of breast-cancer recurrence. Again, false results but found only after retesting.

The comments under the article are worth the long scroll. (They are running 98 percent in favor of Holmes for Prison 2017. Also there are a few shots at Walgreens’ role in legitimatizing Theranos by putting their centers in store; this embarrassing part of the story isn’t over, in this Editor’s opinion.) What is evident–fraud perpetrated on patients and doctors–and anyone who invested. David Boies, their legal supremo and board member, is gonna have a full docket between this and the various legal actions taken by the Alphabet Agencies.

Agony, Alarm and Anger for People Hurt by Theranos’s Botched Blood Tests. If the WSJ is paywalled, search under the headline text.

See here for the agony of TTA’s 21 previous Theranos chapters. We hope that John Carreyrou and the WSJ investigative team, which we’d assume includes Mr Weaver, this article’s author, are awarded the Pulitzer Prize.

MedStartr Momentum 2016–28-29 November (NYC)

October 26, 2016 | by

28-29 November 28
Gerald Lynch Theater (John Jay College-Lincoln Center), 524 West 59th Street, New York, NY

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/11/MedStartr_red_grey_sm.jpg” thumb_width=”150″ /]MedStartr Momentum is a conference with two full days focused on finding, partnering, piloting, and investing in the best new ideas in healthcare. With 9 Momentum talks, 7 discussion panels, 5 pitch contests with over $500,000 in prizes, and performances that will inspire, MedMo16 promises to be among the best events of the year for everyone involved in healthcare innovation. Speakers include John Nosta, Ben Chodor and from Northwell Health, Memorial Sloan-Kettering, NYU, Mount Sinai and Mad*Pow. It is also the kickoff for the MedStartr Venture Fund which adds to the crowdfunding impact of MedStartr–now up to 94 health projects. Find out more and register on the Momentum website. TTA is a supporter of MedStartr and Editor Donna is a MedMo16 event host. Hat tip to Alex Fair of MedMo16 and MedStartr.

The King’s Fund Digital Health Congress 2017–call for showcase projects (updated)

October 26, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2016/10/Kings-fund-call.jpg” thumb_width=”300″ /]Despite the colorful (and falling) leaves of autumn, The King’s Fund is looking forward to the Digital Health Congress on 11–12 Jul 2017. What’s up? First, they are looking for innovative digital health projects to feature. Contact Caroline at c.viac@kingsfund.org.uk for more information. The deadline to submit is Friday 9 December.

The 2017 Congress will focus on progress and improvements in:

1. enabling citizens to take an active role in their health and care
2. improving data sharing and interoperability across the health and social care economy
3. demonstrating the benefits and improving productivity
4. using technology and data to improve user experience and quality of care.

Editor Charles was, of course, first out of the gate earlier this month, and has informative guidelines on this here.

The King’s Fund’s event page is here; the Digital Health Congress fact sheet is here including information on sponsoring or exhibiting. To make the event more accessible, there are new reduced rates for groups and students, plus bursary spots available for patients and carers.  Hat tip to KF’s Claire Taylor for the information and the update. TTA will be a media partner of the Digital Health Congress 2017. Updates on Twitter @kfdigital17

Who’s getting what!

October 26, 2016 | by

Denny Hatch, the master direct mail copywriter and creative thinker, for decades had a private direct mail marketing newsletter called ‘Who’s Mailing What!’ This came to mind with some very big funding rounds in the past few weeks:

  • Omada Health’s Series C $48 million raise in September to boost validation, enhance its Prevention program and expand to state Medicaid for low-income patients. Current clients include Humana and Costco. Forbes attributed the size of the round to Omada’s approach in tying participant outcomes to over 50 percent of its compensation. MedCityNews.
  • Propeller Health‘s Series C of $21.5 million. This is a sensor on asthma meds such as inhalers that connects to an app. With 45 programs and clients like Dignity Health and Molina Healthcare, Propeller has been growing intensively since this Editor last saw them at the 2014 NYeC Digital Health Conference. Their total funding is now $45 million. TechCrunch.
    • And now that we mention it–don’t forget that TTA Readers receive a 10% registration discount on this year’s conference 6-7 December–use code TTA when registering. Click on the advert in the right sidebar to enter registration or view their event website.
  • Spain’s biotech sector got a boost when Ysios BioFund II Innvierte exceeded the initial fund target of €100 million (US$110 million), closing at €126.4 million (US$140 million). It recruited existing investors and multiple Spanish and European economic interest groups. With their Biofund I, Ysios has €191.4 million (US$220 million) in assets under management. MedCityNews
  • iRhythm closed its IPO on Tuesday with an over-allotment. Shares from last Thursday’s offering of 6.3 million shares at $17 on NASDAQ initially soared 65 percent to $28 before closing at $26.05. iRhythm’s Zio service is a cardiac monitor patch and long-term monitoring to determine whether a patient has an arrhythmia or atrial fibrillation. WSJ, Reuters
  • And before you have that AFib, if you are living in California, Heal can provide you with an in-person doctor house call from your smartphone for $99, which may be covered by a participating insurer. Series A round of $26.9 million. VentureBeat

‘Deconstructing the telehealth industry’ (Ziegler report, US)

October 26, 2016 | by

A recently published white paper from Ziegler, a specialty healthcare investment bank, that actually does what it says –deconstruct the US telehealth (and telemedicine) industry. It also constructs a framework of ‘who does what’. Good graphic and text (but not infographic, mercifully) detail on the shareholders, barriers, tailwinds and future state, plus financial/acquisition participants and a compact growth history. Article here on Benzinga, or go directly to Ziegler to download.

When is an app not an app? (When it’s a conundrum)

October 25, 2016 | by

It all started so simply. In DHACA under the leadership of Rob Turpin (BSI) we produced the definitive guide to app regulation in the UK. Sure it was 44 pages long (and will shortly need updating) however we all knew that an app was standalone software and that none other than MEDDEV 2.1/6, the ultimate definitive guide to when an app is a medical device defined software as:

…a set of instructions that processes input data and creates output data.

However doubts began to creep into this editor’s mind when he heard that app developers in the US were avoiding (US/FDA) medical device classification as that would rule them out as service providers, which can reduce future  reimbursement benefits – as we quoted Ralph-Gordon Jahns of research2guidance in 2014 “profitable developers… rely on service sales as their primary source of revenue.”

Things got more complicated when it emerged at the UK Health Show this autumn that PHE was considering listing digital GP services as (more…)

Friday’s cyberattack is a shot-over-bow for healthcare (updated)

October 25, 2016 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/03/26ED4A2300000578-3011302-_Computers_are_going_to_take_over_from_humans_no_question_he_add-a-28_1427302222202.jpg” thumb_width=”150″ /]Friday’s multiple distributed denial-of-service (DDoS) attacks on Dyn, the domain name system provider for hundreds of major websites, also hit close to home. Both Athenahealth and Allscripts went down briefly during the attack period. Athenahealth reported that only their patient-facing website was affected, not their EHRs, according to Modern Healthcare. However, a security expert from CynergisTek, CEO Mac McMillan, said that Athenahealth EHRs were affected, albeit only a few–all small hospitals.

A researcher/spokesman from Dyn had hours before the attack presented a talk on DDoS attacks at a meeting of the North American Network Operators Group (NANOG)

The culprit is a bit of malware called Mirai that targets IoT–Internet of Things–devices. It also took down the (Brian)KrebsOnSecurity.com blog which had been working with Dyn on information around DDoS attacks and some of those promoting ‘cures’. According to Krebs, the malware first looks through millions of poorly secured internet-connected devices (those innocent looking DVRs, smart home devices and even security devices that look out on your front door) and servers, then pounces via using botnets to convert a huge number of them to send tsunamis of traffic to the target to crash it. According to the Krebs website, it’s also entwined with extortion–read, ransomware demands. (Click ‘read more’ for additional analysis on the attack)

Here we have another warning for healthcare, if ransomware wasn’t enough. According to MH, “even for those hospitals with so-called “legacy” EHRs that run on the hospital’s own computers, an average of about 30 percent of their information technology infrastructure is hosted (more…)