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.
European Knowledge Tree Technology Group 2014 Conference (UK)
The European Knowledge Tree Technology Group (EKTG) has met periodically since the Ambient Assisted Living Forum in Odense in 2010. Recent meetings include sessions at AAL 2013 in Sweden. It is an ad hoc high level group drawn from across technology, finance, service, policy and innovation sectors. It has drilled into the barriers and drivers around mainstream market uptake of independent living services.
The Group will meet again in London on 24 & 25 March, 2014 at the London School of Economics to to consider a range of interconnected care-related topics:
- How does technology and care procurement take place?
- How do we educate the people who need it?
- Making the media work for you.
- How do we pay for what’s needed?
- What are the costs and systems of care?
- What can technology do for: Heart Disease, Mental Health, Sensory Deficits?
- How can we transfer technology from field to field, nano to macro technologies?
- Legal, ethical, and regulatory issues – do you meet them?
- Communicating in emergencies
- If the power goes off, do services work?
The Group aims to bring together key players from user groups, industry, finance, public and private stakeholders, policy makers (and, as they say in their blurb, YOU…). To join those key players, click here.
Digital Health and Care Alliance opens for business; free membership available (UK)
As the dallas programme approaches its halfway point, one of its four projects, i-focus, has formed an organisation to continue the promotion of interoperability across the health & care sector beyond the end of dallas. The Alliance, with the acronym DHACA, will help NHS organisations, local authorities and third-sector providers collaborate and share information about new digital services. This will significantly help members reduce costs, remove duplication of effort and improve support for independent living and self-management projects, resulting in much-improved patient outcomes. DHACA will operate across the full health and social care spectrum. Targeted at forward-thinking, engaged, health and care professionals as well as technology suppliers, DHACA will provide experienced assistance, trusted processes and in-depth knowledge to:
- Define and share best practice services, technologies and business models
- Define and share business requirements for future procurement and roadmapping
- Better use existing investments, assets and infrastructure
- Ensure quality, interoperability with other systems and future-proofing
Membership is currently free – more information and joining arrangements here. (Disclosure editor Charles Lowe has been recruited by ADI, as interim director of DHACA, to establish it – the medical apps work previously published on TTA will now be taken forwards in DHACA)
Samsung’s mHealthy S5, Gear–and potential
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/02/gear-2-neo-620×554.jpg” thumb_width=”150″ /]Is there an untapped mHealth business model here?
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
$3,300 annual savings from diabetes monitoring: study
A study published in this month’s Endocrinology (US) demonstrated a $3,300 per person annual reduction in employee healthcare costs in a trial of the Telcare mHealthmonitoring system in conjunction with ActiveCare data analytics used for an employee diabetes management program (N=143). The amount was the average decrease in 12 month claims between 2011 and 2012 for those who enrolled and used the program, versus those who enrolled but did not use the program demonstrated a $282 per person increase. Telcare press release, TouchEndocrinology.com (abstract/text) Hat tip to Editor Toni
New paper in the Practical aspects of Telehealth series
Establishing Telehealth in an institution, published this month in the Internal Medicine Journal, is the title of the fifth and latest in the Practical aspects of telehealth series of papers. According to the abstract the paper describes the development of a large teleoncology network over a vast geographical area in North Queensland, Australia.
The authors propose that the workforce, funding and infrastructure at rural sites, as well as the traditional mindset of healthcare professionals are key barriers to successful implementation of telehealth programmes. In the case of the Queensland teleoncology network, the rural hospital at Mt Isa, 900 km away from the central site, has been continually enhanced over a 5- to 6-year period. The success of the scheme is credited to these helping to overcome usual barriers.
Previous papers in this series are Practical aspects of telehealth: doctor patient relationship and communication, Practical aspects of telehealth: financial considerations (Journal in Internal Medicine), Practical aspects of telehealth: Are my patients suited to telehealth? and Practical aspects of telehealth: set-up and preparation for video consultations
National Health Summit Ireland–Special Report
Reader Andrew Macfarlane, Commercialisation & Centre Manager, CASALA at The Netwell Centre of the Dundalk Institute of Technology, stepped forward to report on this past Wednesday’s Summit. (Please note the excellent cross-references for those who may not be familiar with Ireland-specific programs.) Many thanks Andrew from Editors Toni and Donna!
From an Industrial Age to Information Age Healthcare – National Health Summit, Ireland
The 10th National Health Summit, which took place in Dublin, Ireland, saw a good attendance and an impressive range of speakers. The event is primarily targeted at decision-makers involved in leading and managing the delivery of healthcare services in Ireland.
The morning session outlined the changing landscapes of healthcare delivery both in an Irish and International context. Next up, separate tracks covering Health Insurance (as the Irish government seeks to introduce Universal Health Insurance), Hospital Management & Digital Healthcare (the primary topic covered by this post). The final session covered helping patients stay healthy at home and an insightful panel discussion on reform of the health service.
Tony O’Brien, Director General of the Health Services Executive (HSE) provided the opening address, entitled “Choices for our health service”. The HSE is a large organisation of over 100,000 people, whose job is to run all of the public health services in Ireland. He highlighted that like most health care systems, they are facing rising demand and costs (current budget €13.6bn), and that at the same time has endured significant health budget cuts, 26% since 2008, with €600+m planned savings in 2014. The annual National Service Plan sets out key priorities.
Key takeaway from a digital health point of view is the policy aim of A New Model of Care Treatment at the Lowest Level of Complexity that is Safe, Timely, Efficient and as Close to Home As Possible. The HSE envisages transforming from an industrial age healthcare to information age healthcare, with cost-effective use of ICT. Challenging perhaps with a historical under-investment in ICT at 0.85% of budget vs EU average of 2-3%, a number of speakers referenced the “Ghost of PPARS” as reason for under investment.
Professor Aidan Halligan, Director of Education, University College London & Principal, NHS Staff College, England in a lively storytelling highlighted that the Cathedrals to Disease (more…)
The GET Project to grow EU startups/SMEs
Associated with the international Health 2.0 organization, the GET Project provides four services to promote the growth of eHealth start-ups and SMEs (small and medium enterprises) in four different phases: opportunity identification, business model definition, fundraising and internationalization. Health 2.0 is managing the “GET Funded” service, which provides SMEs looking for Series B or follow up investment (between € 0.5-2M) with training, resources and networking opportunities with VCs and investors at the European level. (Perhaps a way around the Series B crunch?) More information. Contact Pascal Lardier, International Director at Pascal@health2con.com. Editor Donna notes that the focus here does not appear to be UK, though one of the five Advisory Board members listed is from Scotland (and interestingly, two are from the US): Jan Rutherford, Partner, Scottish Equity Partners (SEP); Sandra Bates, Founder and CEO Innovation Partners; Dave Whitlinger, Executive Director, New York eHealth Collaborative (NYeC); Ron Michael Liebkind, Founder and CMO, Laastari Retail Clinics; Rajendre Khargi, Chair, OneWorld International Foundation.
Telefónica buys strategic stake in Saluspot
Telefónica Digital today announced a strategic agreement with and a financial stake in information/medical community website Saluspot to extend the latter’s content and network in Spain and Latin America. Saluspot is an interesting cross between health information (WebMD) and physician locators (in the US, ZocDoc and Vitals) in that it provides free, anonymous contact with registered (on their site) physicians via the website to answer consumer questions in areas where healthcare access is limited; through this matching it also provides visibility for doctors as well as a professional exchange and purchasing collective. The benefit for Saluspot is to increase their coverage beyond Spain and Chile, and for Telefónica to add health tech services in major markets such as Brazil, where they acquired chronic care management company Axismed last year. Telefónica’s eHealth reach, according to the release, is over two million eHealth service customers in Latin America and its media networks include Eleven Paths, giffgaff, Media Networks Latin America and Terra.
Tunstall welcomes you to ‘my world’
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/02/Tunstall-tab.jpg” thumb_width=”150″ /]Tunstall unveiled its tablet-based integrated system for supported housing at this week’s Housing LIN Extra Care Housing Annual Conference in London. ‘my world’ groups applications for residents in an easy-to-use way for communication (email/messages), scheduling care visits, booking meals, home maintenance, finding out about community events, weather and the like. These features are all somewhat reminiscent of other systems such as GrandCare and the original concept behind Waldo Health. It appears to this Editor that Tunstall has designed my world/my clinic as Tunstall’s World–a fully proprietary ecosystem, as seen in their model installation with Herefordshire Housing. The release notes that it is integrated with Tunstall’s ‘my clinic‘ multi-user telehealth system and the Communicall Vi reporting system, as well as Contour Homes. Certainly when a system is complex, having it ‘closed’ is assurance that everything works together. But is a closed system the best quality, most economic and effective arrangement for individual, a community’s or a council’s needs? Press release, brochure
Telehealth for Parkinson’s, autism, Alzheimer’s (podcast)
For your weekend listening, Neil Versel’s interview with Ray Dorsey, MD, co-director of the Center for Human Experimental Therapeutics at the University of Rochester, where he discusses use of off-the-shelf telehealth for primarily Parkinson’s disease but also for autism and Alzheimer’s. Article with podcast link (just under 18 minutes.)
Apple patents health monitoring headphones with ‘head gesture’ control
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/02/apple-patent-earphones.jpg” thumb_width=”150″ /]Another reminder of Apple’s growing interest in the health monitoring and fitness space is the news that the company has just been granted a patent for a “Sports monitoring system for headphones, earbuds and/or headsets” (U.S. Patent No. 8,655,004). The biometric headphone system can sense a number of metrics including temperature, heart rate and perspiration levels. It also contains ‘head gesture’ control which could allow users to change music tracks and adjust volume by tilting or rotating their head. Read more in Apple Insider.
Related TTA posts: Sensor-based monitoring coming to an iPhone near you? / Wearable technology – so much choice, so much data to sell? / Turn up, tune in but don’t drop out with health monitoring earphones
Aerotel’s HeartView ECG goes mobile and personal
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/02/aerotel-heartview-p128-mobile-feb14.jpg” thumb_width=”150″ /]For those attending GSMA Mobile World Congress in Barcelona next week and interested in how a more traditional telehealth provider incorporates mobile technology, stroll over to the Israeli Pavilion (Hall 5, Booth #5C81) to see Aerotel‘s new (debuted at Medica Dusseldorf last November) HeartView P12/8 Mobile, an extension of their existing 12-lead ECG line that incorporates a 3G module for patient data transmission to either a call center or to a physician’s email. Aerotel claims that it is the smallest and most accurate 12-lead mobile monitor on the market. We thank Boaz Babai of ARPU~UP, Aerotel’s marketing agency, for the heads-up–but it would have been helpful to have a link to the (nonexistent?) product web page. Release (finance.yahoo.com).
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