ELabNYC Pitch Day

April 17, 2014 | by

10 April, Microsoft HQ, NYC

The Entrepreneurship Lab NYC (ELabNYC) presented its second annual class of companies to nearly 200 life science funders, foundations, pharmaceutical companies, healthcare organizations, universities and the occasional Editor. Of the cohort of 19 companies finishing the three-month program, 56% are now funded and 25% had first customer revenue by the end of the program. Each company pitched for five minutes on its concept, its current state of advancement (including pilots/customers), its team and a funding timeline. This Editor will concentrate on the five companies with a digital health component; she was intrigued by their diversity and focus on difficult problems of compliance and diagnosis, especially dementia and concussion. (more…)

eCaring gains Series A financing (US)

April 17, 2014 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/04/eCaring-Screenshot.jpg” thumb_width=”170″ /]Home care management/monitoring system eCaring (New York) this week secured $3.5 million in Series A funding, led by Ascent Biomedical Ventures. Private investor Stephen Jackson will be joining the eCaring board, as well as being on the board of client MJHS. Funding will go to product development, sales and marketing targeted to managed care plans, home health agencies, payers, hospitals and related entities. The CareTracker program is unique in that caregivers/aides with relatively low English language or computer literacy can, through icons, easily input both clinical and behavioral information on a home care patient which summarizes by patient and aggregates at the care manager level. There is also a CarePortrait feature that determines baseline norms for behavior such as activity and sleep. eCaring, with Pace University, was also one of 2013’s PILOT Health Tech NY/NYEDC/Health 2.0 winners for a project with the Henry Street Settlement. A big cheer for CEO/founder Robert Herzog who has been championing this aging services/aging in place technology for several years while QS apps and fitness trackers stole all the buzz at the cocktail parties and accelerators. Release, MedCityNews (photo)

Vision therapy app for amblyopia prescribed, reimbursed (DE)

April 17, 2014 | by

Amblyopia, also known as ‘lazy eye’, is a treatable vision processing disorder where vision in one eye decreases for no structural reason. It’s often seen in young children and is generally treated with a combination of patches (to block the stronger eye), eye exercises and glasses–on occasion, requiring surgery–in a process that can take up to two years. In a young child, that is a recipe for tedium. Caterna Vision Therapy, a spinoff from Technische Universität Dresden, has advanced the exercise portion to be child engaging and downloadable through the Apple App Store and Google Play to a PC or mobile device. Caterna claims the exercises also shorten length of treatment. The therapy is CE marked for Europe and in Germany is both prescribable and reimbursable through statutory provider Barmer Gek, fortunate as the cost is €980. It may presage more apps receiving similar treatment. Videos are available in English and German on their home page. Caterna hopes to expand their vision therapies into age-related macular degeneration (AMD) and eye-tracking.  eHealth Law and Policy

Two new health applications for Google Glass

April 12, 2014 | by

Beyond the surgical suite [TTA 24 Sept, 16 Nov], developers keep building platforms that enable telemedicine consults with Google Glass. An exciting one is Beam, developed by Remedy, which allows clinicians to securely share images, text, video and location through Glass. The consult can either be live streamed (synchronous) or store-and-forward (asynchronous) through Beam’s ‘expert interface’. Harvard and The University of Pennsylvania started pilots of Beam in March. The intriguing background is that one of the co-founders, Noor Siddiqui, is but 19–albeit one who has a Thiel Fellowship which gives young entrepreneurs the $100,000 opportunity to skip college and work on their project. Fast Company/Co.Exist, MedCityNews, press release via Telepresence Options. A bit more ‘out there’ is Personal Neuro Devices’ Introspect PND Wearable, a ‘passive brain monitor’ that based on the pictures, is an add-on to Glass that surrounds the head from back to front, with two sensors that extend between the ears and eyes. Ottawa, Canada-based PND claims it reads brain waves and the app then applies the changes to provide feedback, such as special content to modulate moods (their other business.) Release, PND page with video/pictures, ApplySci

US Army mCare app’s most-liked feature: appointment reminders

April 11, 2014 | by

A two-year study on the mCare mobile messaging app used to support ‘Wounded Warriors’, published in the June issue of Telemedicine and e-Health, found that the most popular use of this US Army-implemented program was the appointment reminders (85 percent). 70 percent continued app usage for six months, with the same percentage using it multiple times per week, making the app very ‘sticky’. Other features were wellness tips, care team reminders, care team messaging and announcements. Average participation was 48 weeks. ‘My Appointments’ was created about halfway through the study (January 2010) and other rolling changes were made. The regional US Army Community-Based Warrior Transition Units (CBWTU), which coordinate care for soldiers who receive outpatient care in civilian facilities due to distance from military facilities (and Guard/Reserve status), enrolled 497 veterans in five states who required at least six months of complex care. Satisfaction was high, with 78 percent of soldiers stating that mCare improved their experience in the transition unit, and half of the 75 care teams reporting that they saw an improvement in appointment attendance among patients using mCare.  The results are strong and mCare continues to be used by the Army. The study was headed by Col. Ronald K. Poropatich, MD, Deputy Director of the Telemedicine & Advanced Technology Research Center (TATRC).

Unlike most other research studies, this one had some unusual hurdles to overcome. There were significant changes in ownership of mCare’s contracting company during the main study period (May 2009-April 2011, with a follow on study completed December 2012). First developed by AllOne Mobile [TTA 20 Nov 2009] with security provided by partly-owned Diversinet, AllOne ‘zeroed out’ of business halfway through the study [TTA 20 April 2010], with Diversinet picking up the program after a legal wrangle. mCare was named one of the US Army’s ‘Greatest Inventions’ in September 2011. Diversinet itself, after a seemingly successful period having its MobiSecure platform adopted by AirStrip [TTA 24 Feb 2012], a five-year, $5 million Canadian distribution deal [TTA 14 Jan 2011] and continuing military contracts, could not pull itself into financial health and was acquired by ‘velocity of big’ IMS Health for a small $3.5 million last August. Additional study coverage in Mobihealthnews and iHealthBeat.

If you are having telehealth terminology turmoil

April 11, 2014 | by

…consider the US Government. A survey of 100 respondents across 26 Federal agencies participating in the Federal Telemedicine (FedTel) Working Group presented multiple definitions of telehealth in use by agencies. Combining iHealthBeat’s summary with some extra commentary in Becker’s:

The Agency for Health Research and Quality defines telehealth based on evolving technology and adopted definitions for telehealth that fit the technology being used;

CMS and the Office of the National Coordinator for Health IT (ONC) both define telehealth as the use of telecommunications and IT to provide access to diagnosis, health assessment, information and patient care;
The Health Resources and Services Administration defines telehealth as “the use of electronic information and telecommunications technologies to support long-distance” health care and lists some of the specific technology used to transmit data; and
The Indian Health Service uses specific health technologies in its definition, such as videoconferencing and remote patient monitoring. (Becker’s: the “telehealth toolkit encapsulates real-time videoconferencing, store-and-forward consultation, secure messaging, remote patient monitoring and mobile health services.”)

The report found that definitions also varied for health-related agencies outside of HHS. For example:
The National Institute of Standards and Technology (NIST) uses the American Telemedicine Association’s (ATA) definition;
The Department of Agriculture uses definitions of specific technology such as electronic health data and telecommunications; and
The Department of Veterans Affairs (VA) defines telemedicine as something that should be used “with the intent of providing the right care in the right place at the right time.”

One wonders if the FedTel members spend a good deal of governmental time defining their definitions and sorting through the variations. Which is why, for our readers in over 120 countries, your Editors try to stay away from the ‘inventive and idiosyncratic’ and mainly stick with the definitions you see in our right sidebar. Becker’s Hospital CIO. Full study published in Telemedicine and e-Health (May) courtesy of Becker’s.

First kick at World Cup will be by exoskeleton-equipped paraplegic

April 10, 2014 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/04/Exoskeleton_WEB.jpg” thumb_width=”170″ /]A Duke University team’s robotic exoskeleton will be worn by a Brazilian for the ceremonial first kick at the first World Cup match (Brazil-Croatia) in São Paulo in June. According to Mashable, the development of the lightweight alloy (though not in appearance from the video) body assistive ‘walking suit’ is by a multi-national team headed by Duke professor Miguel Nicolelis. The suit is connected to an electrode cap that uses brain waves to direct physical motion, enabling the wearer to ‘think and move’. Prof. Nicolelis has trained nine Brazilian paraplegics, ages 20-40 with different types of paralysis, to use the suits, and three will participate in the opening ceremonies. Guardian (also illustration) Duke University video (Mashable).

Stick on that comfy sensor patch

April 10, 2014 | by | 3 Comments
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/04/skinpatch-1-John-Rogers.jpg” thumb_width=”150″ /] From the head researcher (John Rogers at the University of Illinois at Urbana-Champaign) who brought you biodegradable implanted batteries and sensors [TTA 26 March], comes an almost tattoo-like stretchable sensor conforming to the skin which uses off-the-shelf, chip-based electronics for wireless monitoring. It is envisioned for wireless health tracking connecting to smartphones and computers, and for vital monitoring such as ECG and EEG testing, although this Editor would not use the term ‘clinical’ as Gizmodo has done (it is probably at the fairly sound level of an AliveCor.) However the article points out the advantages in long term use–adherence to skin is far more reliable, no dangling pendants or clunky bracelets, and it allows for multiple sensors to be worn comfortably. This type of patch would also be far kinder to the delicate skin of babies and the elderly. For them, it would make consistent long-term telehealth monitoring (e.g. blood pressure, ECG, O2, blood glucose) far easier over time. Perhaps the core of this is the PERS of the future with gait tracking and fall detection. Cost isn’t mentioned, but off the shelf elements undoubtedly are less expensive than custom/bespoke. Published in Science 4 April (abstract and summary; full text requires log in) Also see Editor Charles’ earlier take–maybe Mr. Rogers should speak to him!

Soapbox: How healthcare disruption can be sidetracked

April 10, 2014 | by | 3 Comments

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/04/Thomas.jpg” thumb_width=”170″ /]Ron Hammerle’s comment on Disruptive innovation in healthcare hasn’t begun yet: Christensen (TTA 31 Mar), posted on LinkedIn’s Healthcare Innovation by Design group, made the excellent point that a potentially disruptive and decentralizing healthcare service–retail clinics–has been sidetracked, at least in the US, leaving an open question on their reason for being. This Editor thought it was worthy of a Soapbox. Mr. Hammerle knows of what he speaks because his Tampa, Florida-based company, Health Resources Ltd., works with retail and employer-based clinics to connect them via telemedicine/telehealth systems with medical centers.

When Clayton Christensen first anticipated that retail clinics would be disruptive to the established healthcare industry, their business model was potentially disruptive. What has subsequently happened, however, is a prime example of how potentially disruptive movements can be sidetracked.

After acquiring MinuteClinic and laying the foundation for taking retail clinics national, CVS Caremark chose to make deals with hospitals, which could easily afford to rent, open and operate such clinics without making money on the front end or facing real disruption. Retail clinics were a loss leader to hospitals in exchange for large, downstream revenues, and slightly-enhanced market share for the retailer’s pharmacy.

After CVS shocked Walgreens with one-two punches involving MinuteClinic and Caremark acquisitions, Walgreens came back with three counter-punches of its own:

1. They doubled the number of their clinics (to 700) in less than two years, thwarted AMA opposition, leapfrogged ahead of CVS in clinic count and totally changed the retail clinic model by setting up politically-invisible, broader service, make-your-profit-up-front, employer-based clinics. (more…)

PHI data: 361,000 examples that it’s more insecure than ever

April 9, 2014 | by

We’ve been fairly consistent in our coverage of data breaches, including the regrettable fact that more digital data stored out there on EHRs and devices with low security means Happy Hacking (or Stealing) for Fun and Profit. [TTA 2 Apr] Here’s additional proof, including the first incident this Editor has seen of email phishing:

California, there they go: A theft of eight computers from Sutherland Healthcare Solutions’ medical billing and collections office compromised 338,700 patients’ personal health information (PHI), including SSIs. Sutherland provides services to the Los Angeles County Department of Health Services and Department of Public Health. Being California, three class action lawsuits have already been filed. Kaiser Permanente compromised 5,100 records at their Northern California Division of Research. According to iHealthBeat, it was on a laptop; Health Data Management reports it was on a server. The malware was lurking for 2 1/2 years (!) but it’s not determined whether the data was actually stolen. Phishing scam hits Catholic Health Initiatives, affects 12,000 in multiple states: What looked like an internal CHI email asking for patient information wasn’t– (more…)

‘Blue Blazes’ indeed: Wal-Mart’s clinic in a back room

April 7, 2014 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/10/blue-blazes.jpg” thumb_width=”150″ /] The surprise here is not that Wal-Mart is teaming with Kaiser Permanente at two locations in California (Bakersfield, Palmdale) to trial a telemedicine/telehealth clinic. Nor is it that it’s confined to KP members and Wal-Mart employees–it is, after all, a pilot (albeit for two years). It’s that they’d let a photographer take a picture of the sheer crudity of the clinic setup (left, below, click to enlarge). It likely utilizes a disused storage area or back room, where the clinic, instead of soothing, clean white or blue, is institutional tan and crammed full of plug-ins–cameras, PC screens, equipment, exposed wires, plugs and outlets. Perfect for the claustrophobic! (s/o) The modish paint and signage at the entry area outside (see article photos) only serve to set up the potential user for disappointment. The question is, why didn’t they simply rent some ready-made kiosks from HealthSpot Station [TTA 29 Oct 13 + previous] or SoloHealth (already a Wal-Mart vendor)–or others? No wonder the nurse has to drag prospects off the floor. Truly a ‘What In Blue Blazes?’ moment that does not bode well for the success of this pilot–and a puzzle given the partners. Wal-Mart shoppers: The doctor will see you now (Bakersfield Californian)[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/04/Wal-Mart-telemedicine.jpg” thumb_width=”180″ /]

 

A ‘disruptive’ US primary care delivery app with UK roots

April 7, 2014 | by

This past week, this Editor spoke with Jason Hwang, MD, one of the three co-authors of The Innovator’s Prescription and noted here recently [TTA 31 Mar]. Since leaving the executive director spot at Innosight Institute (now The Clayton Christensen Institute for Disruptive Innovation), he and a team have been developing a smartphone app, PolkaDoc, that may bring a little disruptive innovation to simple primary care. The intent is to make remote primary care for basic needs far more accessible to the general public 24/7, helping to alleviate the shortage (and workload) of US primary care physicians (GPs). The individual first installs the free app from Google Play or Apple’s App Store, answers a simple questionnaire, records a short video to confirm name and date of birth as a verifier/signature, and pays the exam fee via debit or credit card. A doctor then evaluates and prescribes, if appropriate, with prescription pickup at your local pharmacy. According to Dr. Hwang, the first use of this app will be for birth control, charging a modest $10 exam fee, exclusive of the prescription. Technically, the 24/7 coverage is achieved via asynchronous store and forward, which enables significant scalability; any participating physician may ‘see’ thousands of patients a day if desired. The app is fully HIPAA-compliant and on US-based secure servers. The ‘soft’ launch of the PolkaDoc service will start in about two to three weeks.

For our UK readers, this may sound like a variation on something familiar. The ur-model is ‘DrThom‘ acquired by Lloyds Pharmacy in 2011. The eponymous service was developed by one of the partners of PolkaDoc, UK-based OB/GYN Dr. Thom Van Every, to provide sexual health services first by mail and later online. In the UK, this was a premium service at £50. According to Dr. Hwang, the objective is to adapt for the US what has been successfully done in the UK, Australia and other countries, learning from the lessons of its predecessors. With the idea that “simple things are taken care of as simply as possible”, it also matches that concept with low price to be affordable for nearly all women.

My discussion with Dr. Hwang also ranged on the app’s potential use in other healthcare areas and plausible partnerships. More to come on this, certainly.

Med-e-Tel 2014 Luxembourg

April 5, 2014 | by

Next week’s Med-e-Tel (9-11 April) conference announced their final day of advance registration (today, 5 April) but if you are interested in going, please contact them directly for onsite information. The Journal of the International Society for Telemedicine and eHealth (ISfTeH), the publication of the main organizer of the conference, has published presentation abstracts in advance of the conference here. Conference website. ISfTeh April newsletter. New (7 April) overview press release. TTA is a past (and still listed as a) media sponsor of the event. If you are attending and interested in contributing coverage from one item to a day, please contact Editor Donna about arrangements. Our gentle requirements are that you send a timely report (within 72 hours) from this event. Our standard is that you can be selective and interesting rather than comprehensive. Of course you will receive writing credit, but other expenses will not be covered.  

Scanadu hitting the tech ‘glitch’ wall?

April 5, 2014 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/04/Blog-04-04.jpg” thumb_width=”150″ /]Tricorder XPrize-qualifying Scanadu, which eventually raised a stunning $1.6 million on Indiegogo [TTA 23 May 13], has stopped delivery of units to its early backers which started on 31 March. According to its blog late this week, their readings were not working as expected for temperature, there were inconsistencies in reading scans between the Scanadu device (categorized as ‘investigational’) and the app (via the smartphone), and the manufacturing tool to make the devices broke. Scanadu CEO Walter De Brouwer stated that “We hope that this (the delay) will not be more than 8-12 weeks.” The Scanadu Scout was also submitted for FDA clearance but requires usability studies to gain approval. In this Editor’s experience, all tech devices eventually hit the ‘glitch wall’, either at or near the outset or when the system scales up. Better to fix now than later, and kudos for their C-level for being forthcoming–because most are not. Also MedCityNews.

HHS draft report on health IT framework published

April 5, 2014 | by

Another part of the 2012 FDA Safety and Innovation Act (FDASIA) clicked into place with the US Department of Health and Human Services (HHS) publishing a draft report proposing strategy and recommendations for what is rather grandly termed a “health IT framework”. Basically it defines more unified criteria, based on risk to the patient and function of what the device does, not the platform (mobile, software, etc.). It then separates products into three broad categories. Excerpted from the FDA release and the FDASIA Health IT Report:

  1.  Products with administrative health IT functions, which pose little or no risk to patient safety and as such require no additional oversight by FDA. Examples: billing software, inventory management.
  2. Products with health management health IT functions. Examples: software for health information and data management, knowledge management, EHRs, electronic access to clinical results and most clinical decision support software. This will be coordinated largely by HHS’s Office of the National Coordinator for Health IT (ONC) as part of their activities (including their current voluntary EHR certification program), but the private sector is also cited in establishing best practices.
  3. Products with medical device health IT functions, which potentially pose greater risks to patients if they do not perform as intended. Examples: computer-aided detection software, software for bedside monitor alarms and radiation treatment software. The draft report proposes that FDA continue regulating products in this last category. (Illustration on page 13 of report.)

The report also recommends the creation of a public-private entity under ONC, the Health IT Safety Center, which “would serve as a trusted convener of stakeholders and as a forum for the exchange of ideas and information focused on promoting health IT as an integral part of patient safety.” The private sector is duly noted as a ‘stakeholder’.

The report was developed by FDA “in consultation” with ONC and, not unexpectedly, the Federal Communications Commission (FCC). Another recommendation (page 28) is the establishment of a ‘tri-Agency memorandum of understanding (MOU)’ to further determine their working relationship in this area. There’s a 90 day comment period on the 34 page report, which is perfect for weekend reading (!) How this onion will eventually be peeled, rather than quartered, remains to be seen, as does anything emanating from Foggy Bottom.  FDA release. Report. FierceMobileHealthcare.

Update 8 April: A good summary of criticism and approval of the framework to date appears in iHealthBeat from the California Health Care Foundation. The two US Senators sponsoring the PROTECT Act [TTA 28 Feb, 6 Mar] stated there is still too much regulation of low-risk technologies, and Bradley Thompson of Epstein Becker/mHealth Regulatory Coalition believes the report is weak on the issues around clinical decision support software. With praise: HIMSS, Health IT Now Coalition and ACT, which claims to represent about 5,000 mobile application developers and IT firms, but has no locatable website.

Previously in TTA: FDA finally issues proposed rule simplifying medical device classification

Picture murky: 23andMe and the FDA

April 2, 2014 | by | 2 Comments

Genetic testing company 23andMe seems to be in no rush to resolve its differences with the FDA, and the digitalhealtherati a/k/a D3H (Digital Health Hypester Horde) are wondering why. In late November, 23andMe executives undoubtedly had a depressing Thanksgiving when the FDA ordered them to stop providing health reports (interpretation of genetic results) and marketing kits. Four months later, 23andMe continues to sell its kits for $99, providing only raw genetic data and ancestry reports–and according to its 31 March blog posting, will do so for the foreseeable future as they complete the regulatory review process. The blog quoted CEO and co-founder Anne Wojcicki, “My main priority is resolution with the FDA,” but actions speak louder than words–and the FDA isn’t talking. The FDA standard is still validation–the company has to analytically and clinically validate 23andMe for its intended uses, which is why the FDA took action against them in the first place.

  • Is the lack of urgency more about continuing to gather raw genetic and health data unimpeded? Ms Wojcicki had widely stated her real aim was to build a 25-million-strong database (Fast Company).
  • Is the real revenue stream of the company not the kits but in monetizing a massive database, selling it to researchers and others (Matthew Herper in Forbes)–the Google model which Ms Wojcicki is quite familiar with? Consider that there’s $126 million into the company, that is a lot of $99 kits.

Most companies in this situation would be imploding. This one is not. Interestingly. FierceMedicalDevices, The Verge

Previously in TTA: all you ever wanted to know about the 23andMe kerfuffle in FDA tells 23andMe genomic test to stop marketing (including this Editor’s analysis of their pre-FDA website with copy breathlessly expressing potentially life-saving or critical lifestyle changing claims, countered by legal ‘educational use’ boilerplate) and The inevitable: class action lawsuit against 23andMe (a check of the Ankcorn blog has no updates)