That other three-letter agency, the Federal Communications Commission (FCC), which has shown a distinctly competitive face versus the FDA on Federal healthcare tech policy over the past three years and more, has formed–drum roll–a task force to examine adoption of wireless technologies by health care organizations. Connect2HealthFCC will “identify regulatory barriers and incentives to expand the use of wireless health technologies; and strengthen partnerships with stakeholders in the telehealth and mobile health industries.” If this an accurate statement of the task force’s purpose, the parade not only has gone by, but it’s also three counties away. Yet going back in our files, this Editor notes that the FCC has vigorously fenced not only with the FDA, but also with HHS, NIH, NIST and Congress for its place in the Federal HIT regulatory firmament. With issues such as ‘net neutrality’, wireless bandwidth and rural broadband, the FCC has a heaping healthcare helping on its plate just in assuring national access and removing conflicts in frequency demands by devices. However, the task force is headed by Michele Ellison, lately the FCC’s top regulatory enforcer with, as The Hill notes, 6,000 actions under her belt. In Foggy Bottom, things are never what they seem. iHealthBeat
Wearables solving real ‘jobs to be done’
- The OrCam computer-assisted vision device (above) for those with low vision, which interprets nearby visual inputs, including letters, faces, objects, products, places, bus numbers, and traffic lights–and describes them to the wearer through a bone-conduction device heard by the user only. From Israel and available only in the US at present, the initial pricing is around $2,500.
- Physician, surgical and law enforcement decision support may be the best use of Google Glass–not exactly the ‘hipster on the L train’ picture promoted by Google.
- Emotiv’s mind-controlled wheelchair, which is controlled by a headset (EPOC) capable of picking up electrical signals.
- For autistic children and adults, Neumitra and Affectiva are both bands that measure and alert for physiological stress that may lead to inappropriate wandering or acting-out.
- Red-green color blindness affects 1 in 12 men and 1 in 200 women. It can be dangerous–think of traffic lights and wiring–and EnChroma’s correcting set of glasses is a simple, useful solution. Reportedly there is a 30 percent improvement in color identification and a 70 percent improvement in color discrimination. The pricing is fairly standard at $375-460.
NY-based accelerator, pilot programs up
Pilot Health Tech NYC 2014 is again providing $1 million in funding from a variety of partners for 10 or more pilot projects centered in New York City. Its purpose is to match early-stage health technology companies with healthcare organizations such as hospitals, employers, payers and pharma companies. Supported by NYC Economic Development Corporation (NYCEDC) and Health 2.0, the application deadline is past but for those which have applied, the matchmaking sessions are on 11-12 March with a deadline for joint applications 23 May and Pilot Day 25 June. Website.
Still open is the New York Digital Health Accelerator (NYDHA) program sponsored by the New York eHealth Collaborative (NYeC) and the Partnership Fund for New York City. Applications are due 11 April which will fund up to 10 early and ‘growth-stage’ companies with $100,000 plus entry into a mentorship program with thirteen New York metro healthcare providers. Funding is being provided by several investors, Genentech, Merck, Pfizer and Infor. Website, release.
Crime-sensing hair clip points to ‘fashionable safety’
Mobile in healthcare: HIMSS Analytics infographic
You can read the full 3rd Annual HIMSS Analytics Mobile Survey of 170 health IT and clinical staff or treat yourself to the highlights in this infographic. It summarizes key findings such as 59 percent have a mobile technology plan and 29 percent are developing a mobile technology plan; 62 percent indicated that they offer patients access to at least one of the mobile tools identified in the research, including patient portals, telehealth services and remote monitoring devices; only 22 percent indicated that three-quarters of the data captured by mobile devices was integrated into the organization’s EMR. Developed by HIT Consultant.
Nintendo’s next move: entertaining healthcare
Nintendo, which has sold 100 million Wii consoles but is facing a shrinking market and increased competition in video gaming both from established companies like Sony and mobile gaming providers, has announced its intention to shift the notion of ‘entertainment’ into ‘quality of life’ (QOL) and health. This will be set up as a separate new business area. CEO Satoru Iwata said that Nintendo wants to “create an environment in which more people are conscious about their health and in turn expand Nintendo’s overall user base.” Although this sounds terribly vague, this Editor recalled that the Wii console had a brief vogue a few years ago in senior communities for fitness and that Editor Emeritus Steve had written about its use in rehabilitation and telehealth as far back as April 2008! (Additional articles here) One wonders what corporate imperatives discouraged the initial exploration of Wii for health. Now the field is thick with competitors from fitness bands (Jawbone, Fitbit, Misfit) to smartphones to Samsung’s new iterations of the Gear watch. Venture Beat.
Could virtual reality in games like Wii be useful therapy in relieving the phantom limb pain (PLP) from amputation? A recent Swedish study published in Frontiers in Neuroscience (abstract) indicate that it might. Researchers Max Ortiz Catalan and his colleagues developed an augmented reality therapy where muscle signals from the amputated arm activated a virtual arm that performed virtual tasks, and relieved the pain in a subject who had painful PLP for 48 years. “The patient reported that his pain gradually reduced, and he experienced pain-free periods over the course of his virtual reality treatments. He said his hand changed from feeling painfully clenched to feeling open and relaxed.” According to the article in Scientific American, the Swedish team has developed an at-home version if approved, and the technology may be adapted for other rehab such as post-stroke or spinal cord injury. Also FierceHealthIT.
VA, DoD aren’t collaborating on EHR: GAO
Your ‘Dog Bites Man’ item for the weekend (no, it’s not in reverse!) is that the Government Accountability Office (GAO) has determined that Veterans Affairs (VA) and the Department of Defense (DoD) have not yet proved that their current two-system path, having rejected a single EHR, actually will be workable. In February 2013, both agencies abandoned a joint system after $1 billion in spend, and $4 billion in fixes/upgrades to their separate VistA and AHLTA systems. [TTA 15 Dec] By the two agencies going their separate ways, the GAO is mystified on what is going on with interoperability. The answer: not much. And as mentioned in our 15 December article, there was a 31 January deadline for an interoperability plan (or single system) to be implemented by 2016, mandated by the 2014 National Defense Authorization Act (NDAA). Obviously, this deadline has come and gone. FierceEMR article, GAO recommendation (full text PDF)
One way to overcome the interoperability problem and too much in the EHR? Get rid of those pesky backlogged patient records! The Daily Caller uncovered a VA whistleblower’s complaint to the VA’s Inspector General and their office of special counsel, plus Congress, that VA officials in Los Angeles intentionally canceled backlogged patient exam requests going back more than one year–and that the delay on exams went back 6-9 months. The deletions started in 2009. There is a wrongful dismissal (of said whistleblower) suit and other joy. Article, audio (02:21) Updates 3-4 March: according to Under Secretary for Health Robert Petzel, the Daily Caller report was ‘scurrilous’. He stated that about 300 records were closed but not deleted after administrative review, generally for old imaging requests, and there was no effort to delete records to boost performance. According to FierceHealthIT, the backlog is about 400,000. Also Military Times. According to EHR Intelligence, both DoD and the VA agree with the GAO recommendations; GAO will update its findings once the agencies have taken action. Also iHealthBeat.
Changes afoot at Aetna’s Healthagen?
Recent rumors predicted changes at Healthagen, the rebranded ‘Emerging Businesses’ unit of health payer giant Aetna, and that these would be apparent at HIMSS14. Mobihealthnews attempts to ‘Sovietologize’ Aetna chairman Mark Bertolini’s appearance (sponsored by Healthagen, not Aetna) and what products were included in the Healthagen (not Aetna) show floor display. First, the booth: only Accountable Care Solutions and health info exchange Medicity were featured. Former star iTriage (the original Healthagen product) was relegated to a distant booth. The much-touted CarePass consumer wellness platform? Absent. InvolveCare, the Healthagen caregiver app introduced last fall? Announced to be discontinued 28 April. In the true tradition of Sovietology, omissions are as apparent as inclusions. Second, the keynote: oddly, there are no content points cited from Mr. Bertolini’s speech in Mobihealthnews. We turn then to the Dan Munro in Forbes article, where Mr. Bertolini calls for the ‘creative destruction of healthcare’, a stock rallying point since 2009 (Yes, it doesn’t work. No, it’s not sustainable. It’s an iron triangle. Etc.) The bottom line was his announcing that Aetna’s business going forward would be ACOs and “driving a consumer healthcare experience.” Hopefully that will mean access and quality for the rest of us. Will Healthagen CEO Charles Saunders be part of leading the charge? Not a mention. One could say that the Magic 8 Ball says ‘cloudy’ for the present situation at Healthagen. Perhaps more changes will be revealed in coming weeks.
Verizon adds Telcare, Genesis to monitoring platform
Verizon received a second FDA clearance for its health management software platform, and added blood glucose management monitors Telcare and Genesis Health as part of it. The first clearance, according to Mobihealthnews, covered five telehealth devices from Ideal Life. Verizon’s intentions are to ‘white label’ market the system to providers who plan to use personally gathered telehealth as part of a patient management program in integrated delivery networks (IDNs), where it is currently in trial–plus health plans and self-insured employers. Verizon’s platform also has ‘gamified’ educational and motivational functions, including its own virtual currency for rewards. If this is proven in the US, will this be marketable in the UK and EU–and will Verizon go it alone or seek partners? Hat tip again on the story to reader Mike Short via Editor Charles.
It’s iAwards time again!
As the US East Coast faces low temps (down to 12 degrees again tonight) and another dumping of snow Monday, a small sign of spring, like flash-frozen daffodils and crocuses (crocii?), is the annual application call for the Triple Tree iAwards for Connected Health to be presented at the Wireless-Life Sciences Association (WLSA) 9th Annual Convergence Summit 14-16 May at the Omni in San Diego, California. Twelve finalists will be selected from applicants based on
criteria including the uniqueness of their solution; marketplace traction; clinical, operational or consumer relevance; size of addressable market and international presence across three categories:
- Operational Effectiveness: Solutions that address the financial, compliance or operational needs of a healthcare organization.
- Clinical Effectiveness: Solutions that address the care delivery and clinical effectiveness for a patient.
- Consumer Engagement: Solutions that empower consumers to make better healthcare decisions.
Finalists attend not only a dinner, but also for the first time this year a private business review session. Online applications can be accessed at the TripleTree and Wireless-Life Sciences Alliance websites along with a $195 fee. Registration for the conference is here. Hat tip to Editor Charles and reader Mike Short.
‘Grizzled pioneer’ VRI receives major investment from Pamlico Capital (US)
US telehealth monitoring and medical alert provider VRI (Valued Relationships, Inc.) of Franklin, Ohio earlier this month received a majority investment/recapitalization from Pamlico Capital, a Charlotte, North Carolina-based private equity firm. Terms of the transaction were not disclosed. Current lead executives CEO Chris Hendriksen and President Andy Schoonover will remain in active management and retain significant ownership in VRI, which they founded in 1989. Regarding the investment, Mr. Schoonover to this Editor stated that the funds will be used for expansion purposes. “It is another vote of confidence (alongside the Cardiocom acquisition) that telehealth is getting great results and is here to stay. The capital will support VRI’s growth objectives, particularly in executing a couple of large projects with health plans that VRI has booked for 2014, and the hiring of additional sales talent.”
Despite being in a rather ‘non-buzzy’ area of telehealth, the investment attracted the interest of some major players. VRI was assisted in evaluating its options by well-known digital health financial advisor Triple Tree; legal counsels were McDermott Will & Emery for VRI and Alston & Bird LLP for Pamlico. Pamlico specializes in the ‘middle market’ and has previously invested selectively in mid-sized healthcare providers such as Greenway (EHR), Healthcare First (home health software) and Physicians Endoscopy (surgical centers). Overall, and interestingly, this appears to be a positive, long-term vote for telehealth and medication monitoring, as well as for the viability of traditional medical alerts and some of the patient engagement/hospital readmission reduction models VRI has been developing with major payers such as Humana. Pamlico Capital release, Triple Tree release.
Is *less* regulation the answer for mHealth? (US)
What if the solution to the mHealth/digital health logjam of approvals at the US Food and Drug Administration (FDA) is to take clinical and health software completely out of their approval purview–and hand it to the National Institute of Standards and Technology (NIST), which is not a regulatory body but a standards-development organization. That is the solution proposed by the PROTECT Act of 2014 (Preventing Regulatory Overreach to Enhance Care Technology), proposed by Senators Angus King (I-Maine) and Deb Fischer (R-Nebraska). It’s put some of the better known organizations into a swivet, along with high profile attorney and mHealth legal expert Bradley Merrill Thompson with Epstein, Becker & Green. Possibly little to no regulation would be applied to EMRs, clinical support software and wearables/fitness apps–which is promptly being conflated by the usual suspects to heavy-duty equipment such as CT scanners. FDA also finalized its guidance last September on telehealth and telemedicine applications, which this would render irrelevant. The Washington betting is that this Senate bill will go exactly nowhere, but it’s indicative of the jockeying for position this Editor is seeing within the present government and now with advocates/lobbyists [TTA 13 Feb]. MedCityNews, FierceMobileHealthcare
Another ‘bionic pancreas’ in test
Another possible weapon against the Continuing Battle of Stalingrad faced by diabetics is in test in the Boston area. A system developed by associate professor of biomedical engineering at Boston University Dr. Edward Damiano (whose son has Type 1 diabetes), and assistant professor at Harvard Medical School Dr. Steven Russell has a sensor inserted under the skin that relays hormone level data to a monitoring device which sends data to an app on the user’s smartphone every five minutes. The app calculates required dosages of insulin or glucagon to maintain optimal blood sugar levels, and communicates the information to two corresponding hormone infusion pumps worn by the patient. Their target for FDA approval and rollout is 2017. Gizmag. Previously Editor Charles and this Editor have written about Diabetes Assistant and two other systems in clinical trials, which also are bringing this to a closer reality [TTA 20 Aug, 5 Aug]
Eric Dishman’s ‘view from the top’ on genomics
Eric Dishman of Intel’s Health & Life Sciences Group credits genomics with changing the course of treatment for his life-threatening cancer about two years ago. With new treatment based on his genomic sequencing, he became cancer-free in three months and eligible for a kidney transplant, which he received in early 2013 from, as it turned out, a fellow Intel-er [TTA 12 Apr]. His keynote at HIMSS14 was about what he calls ‘N=1″ personalized medicine, which is based on three Bs plus one: body, biology and behavior, plus beliefs. Dishman also recounted a story around the original Intel Health Guide of a woman caregiving for a mother with Alzheimer’s whose diabetes worsened because she could not make clinic visits; with the addition of remote monitoring to the care plan this was reversed. No mention of Care Innovations (the Intel-GE JV), but he presented the Sotera Wireless ViSi Mobile wireless patient monitor as an ‘ICU on a wrist’ (Intel is an investor). Neil Versel reports in MedCityNews.
More on the data analytics and integration behind genomics from an unexpected source–the chief medical officer of Northrop Grumman. If like Editor Donna, you had no idea that this company had a footprint in healthcare, prepare to be surprised. Thanks to our friends at HITECH Answers.
Samsung’s mHealthy S5, Gear–and potential
Samsung’s dual announcements in New York and at Barcelona’s annual GSMA Mobile World Congress (MWC) of the Galaxy S5 smartphone and the latest iterations of their smartwatch (left), the Gear 2/Neo, confirm what this Editor believes will be a major 2014 trend: the matter-of-fact integration of vital signs sensors into easy-to-adopt form factors. Reported by ZDNet:
- Galaxy S5: “It’s so small and unnoticeable, you would be forgiven for not giving it a second thought. Next to the flash is a heart-rate sensor that can — prepare yourself for a hearty dose of real-life sci-fi — see the blood pumping through your finger. It works when you gently push your finger over the flash on the rear of the handset. This ties in with the smartphone’s pre-installed health apps, such as the S Health, which includes a fitness tracker and pedometer.” The phone also connects to the Gear 2 software. (This is in addition to the fingerprint scanner.) Article
- Gear 2 and Gear 2 Neo specification: Bluetooth 4 low energy, Infrared, heart rate sensor, accelerometer, gyroscope Article
Easy to use tools for health–and fall detection–baked into a mainstream phone and a fairly attractive smartwatch. There’s plenty of health and safety functionality for all ages built into both. What’s the missing link? Here’s a thought. A manufacturer/wireless JV or subsidiary which targets the health monitoring potential of these devices to create a separate revenue stream. The ‘risk’ could be spread to resellers allowed to creatively adapt devices like the Gear for older adults in independent and assisted living environments, or for autistic/at-risk children. This is not an inconsistently supported AT&T ForHealth [TTA 5 Feb] or a failed Lifecomm [TTA 14 Oct 13], but an entirely different business model. Reader thoughts?
More on MWC: Washington Post
Update 28 February: The Galaxy S5’s heart rate sensor may make it a medical device in the eyes of South Korea’s health agency, forcing the phone to be regulated and reviewed in the ROK before its 11 April worldwide release. FierceMedicalDevices. Hat tip to @DrDave01 (Dr. David Albert of AliveCor) and David Doherty of @mhealthinsight via Twitter.
AliveCor links with Practice Fusion
Breathlessly noted in today’s mHealth blogosphere is AliveCor’s partnership announcement with EHR giant Practice Fusion to integrate their patient-generated ECG information. According to the release, the 100,000 physician base of Practice Fusion will have the option to import AliveCor ECG data into patient records. This is a major breakthrough for AliveCor, which just gained FDA over-the-counter clearance for its snap-on case [TTA 11 Feb]. The AliveECG app also enables physicians to obtain an expert review of the ECG data, annotate and electronically transfer this data into the EHR within seconds. Is this the confirmation that AliveCor is the ‘product of the year’ as the Forbes article puts it? Or just an indicator where mHealth with clinical quality could be going? (Let’s see if other EHRs like Athenahealth join the trend.) Release







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