If you–like most rational people–have some confusion in deciphering the current FDA state of affairs as it applies to mHealth, this summary from major law firm Foley & Lardner will be helpful. Written by special counsel for healthcare/mobile health Monica R. Chmielewski, it defines in few words FDA’s classifications, which mHealth technologies are, and which are not, subject to FDA oversight. In particular, MDDS (medical device data systems) were recently downgraded from Class III (the greatest oversight with pre-market approval) to Class I. FDA has also recently finalized recommendations in a guidance document for medical device manufactures for managing cybersecurity risks. mHealth Technology – Development in an Uncertain Regulatory Climate (Health Care Law Today)
A Canadian view of ‘Healthcare Systems of the Future’
Do we wait for the interconnected, seamless future of consumer-driven healthcare, or work with what we have now? Michael Smit of Canadian virtual consult provider Medeo argues for the latter: “The component pieces for a connected healthcare system exist today. We simply haven’t connected them yet.” He argues that Medeo’s Equinoxe platform, because it uses simple PC equipment, retains patient records securely and creates a health record, is a step more advanced than what Canada has seen in fixed telemedicine settings. Mr Smit also draws a picture of health management, the “3 D’s”–Data, Device, and Decision, integration with telehealth and the increasingly mobile-driven patient group, advocating that the health record should not have to be actively managed by the patient, but be a byproduct of cumulative patient interactions with the healthcare system. The Catalysts Of Virtual Care
Now a (virus) killer robot
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/11/Xenex-robot.jpg” thumb_width=”150″ /]And it’s not a computer virus, either. The US Air Force’s 633rd Medical Group (MDG), based at Langley Air Force Base, Virginia has adopted Saul The Virus Killer Robot. Developed by Xenex Healthcare Services, it zaps viruses human cleaners can’t reach or disinfect. According to the article, Saul sweeps the room with “pulses of high-intensity, high-energy ultraviolet rays 25,000 times brighter than florescent lights to split open bacterial cell walls and kill dangerous pathogens commonly found in hospitals”. The pulses are verified in killing 22 microorganisms including single strand ribonucleic acid (RNA), like that of a virus similar to Ebola, at a range of two meters out in any direction, within five minutes, and at an efficiency rate of 99.9 percent. A useful fighter against more common and nasty MRSA, C.diff and other hospital-borne infections. Armed With Science
Australia’s med device ‘Fast Track’ changes–webinar
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/11/Australia-flag.jpg” thumb_width=”150″ /]For over a decade, the Australian Therapeutic Goods Administration (TGA) has had a ‘fast track’ expedited review program in place for medical device importers–including mobile health–with existing CE Marks. Now this program, after a long campaign, will be extended to Australian manufacturers–and there are other changes. Arthur Brandwood, who spearheaded this effort, will be conducting a free webinar on Tuesday 18 November, noon Eastern Time (US). It will cover Australia’s aggressive deregulatory agenda, their tax incentive (43.5 percent for R&D expenditure), the simple process for regulation of clinical trials and TGA’s web based submission process for device approvals. (more…)
Short Tuesday takes
Alere, Optum, Wyss, Proteus, Soreon Research, Baywater Healthcare
Alere Health to be acquired by Optum. Alere is selling its condition, wellness and case management group for $600 million to the health services subsidiary of UnitedHealth Group. The surprise is that Alere Health, which presently serves 22 million patients in 29 states, includes two service lines considered hot: analytics and connected health. Alere Connect, the former MedApps, is included in this sale. Alere (the parent company) will be concentrating on rapid diagnostics. Alere Health release, fact sheet….Vibrating insoles may help to guide the balance-impaired, eventually. Research on stochastic resonance as an aid to balance and gait has been researched for nearly ten years–our earliest article on it was written by former EIC Steve in 2006. The current study tested ‘white noise’ to help lower the level of buzzing needed to generate stimulus in the feet. Conducted by the Institute for Aging Research (IFAR) at Hebrew SeniorLife, Beth Israel Deaconess Medical Center, the Wyss Institute for Biologically Inspired Engineering at Harvard University, Harvard Medical School, and Merck Sharpe and Dohme (MSD) Consumer Care. (more…)
Philips finally gets to GoSafe
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/11/img-gosafe-button.jpg” thumb_width=”160″ /]At long last… the Philips Lifeline GoSafe mobile PERS with fall detection and GPS, announced with fanfare at International CES 2013 and delayed well over 18 months from its original debut date, has quietly entered the market. The chunky and somewhat ‘cartoon alien’-ish pendant, while connected in-home to a conventional base station communicator, also uses GPS, ‘intelligent tracking’ to determine the user’s last known location, Wi-Fi, audio beaconing and voice response via cellular to alert for assistance. Pricing has settled at $149 for the device and a $54.95 monthly subscription. GoSafe joins the Philips Lifeline mPERS smartphone app introduced in August [TTA 28 Aug] and Lifeline with AutoAlert extensively debated here. No indication of distribution outside the US. PRNewswire release, Lifeline website, Mobihealthnews.
Tunstall Americas finds a Mountain Home
Gold in dem der hills? Tunstall Americas, Tunstall Healthcare Group’s US subsidiary, on Monday announced the acquisition of Mountain Home Medical, a Denver, Colorado-based telehealth provider of medical alarm and medication manager systems for the home market. In its announcement, Tunstall Americas gave the reason as “The acquisition demonstrates Tunstall’s commitment to expand its service footprint across the United States through acquiring or partnering with highly regarded regional, state, and local providers… ” Mountain Home is certainly the latter with business only in the state’s 53 counties, serving Medicaid eligible and private pay customers. Industry estimates put their subscriber base at under 5,000 customers.
A change in US strategy? Unlike Tunstall in the UK and Europe, the Americas subsidiary has maintained a low profile since the 2011 acquisition of AMAC, which at time of sale (more…)
The sun is in his heaven and all’s well with the world?
It’s tempting to think that nothing much has changed in the world of telehealth & telecare recently. For example the quality of healthcare PR looks to be unchanged, if the recent announcement by Telehealth Sensors is anything to go by. They claim to have developed an incontinence sensor that is “a revolutionary advancement in the home healthcare and post-acute care monitoring market.” Careful reading suggests this “revolutionary advancement” is based on the property of water, apparently only recently recognised by Telehealth Sensors, that it conducts electricity (especially if its impure) – so advanced in fact that such sensors with a rather longer lifetime than the 30 days claimed by Telehealth Sensors, have (more…)
Tunstall Healthcare asks lenders for covenant extension
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/07/Big-T-thumb-480×294-55535.gif” thumb_width=”175″ /]Breaking News. A report in S&P Capital IQ LCD (McGraw-Hill Financial) published Thursday (subscription required), states that Tunstall Healthcare Group has asked its lenders to extend for one year the step-down provisions in its loan covenants, from this December to December 2015. ‘Step-down’ is the process whereby a company begins to de-leverage over time by reducing the ratio of debt to earnings before interest, taxes, depreciation and amortization–EBITDA) and thereby add value to the company for its lenders. Responses are due by mid-November.
The extension request indicates that the decline in UK and US revenues evident in our July report on their FY 2013 results continue, as do the perils of leveraged debt. (more…)
Google X developing nanoparticle/sensor diagnostic
The research skunkworks of Google, Google X, is investigating combining nanoparticles introduced to the bloodstream via a pill, with a wrist-worn sensor that would detect where the nanoparticles attach. They could attach to cancer cells, fatty plaques in blood vessels, or analyze the chemical composition of blood to detect imbalances. The wrist-worn sensor (which looks awfully like a smartwatch) would upload the readings of the nanoparticles via light and radio waves one or more times a day. By going public at this stage, the intent of Google X is to license out the technology for further development and to find partners. The BBC News Technology article has an unfortunate headline not backed up in the article: Google is developing cancer and heart attack detector
Hospitals snooping on your shopping and eating
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/10/Doctor-Big-Brother.jpg” thumb_width=”150″ /]Another charming use for Big Bad Data. Hospitals are investigating whether available data on patients–prospective and current–on shopping patterns and other purchase behavior such as gym memberships can be used to predict patient risk of disease. Leading the way is Carolinas HealthCare System, which operates the largest group of medical centers in North and South Carolina. With more than 900 care centers including nursing homes, they have 2 million patients to analyze for risk, using data points such as purchases a patient has made using a credit card or store loyalty card, to create predictive models on patient risk and eventually to reach out to patients. Of course this data crunching has a purpose, and that is to meet quality metrics imposed by HHS and CMS. The goal would be to change the risk curve (more…)
Journal starts peer review process–at a price–for mHealth apps
If the rosy future of mHealth apps [study here] is to be achieved, some form of validation and review is needed, but is ‘pay to play’ the way to go?. The Journal of Medical Internet Research has come up with a peer review process which gives, in the words of mHealthNews, “developers a chance to have their products evaluated by “medical and mHealth experts from the JMIR peer-reviewer database (possibly complemented by consumers/patient experts) for a cool $2,500 per app.” Aside from the price, (more…)
Is ‘relationship medicine’ enough to kickstart telemedicine?
Investor Todd Hixon (New Atlantic Ventures) opines in Forbes about the ‘new paradigm’ of relationship medicine, with the primary care doctor at its center and responsible for the patient’s long-term health quality. He admits that the concept, in some respects, resembles the 1950s days of the local GP who knew everything about everybody, but where he posits the telemedicine ‘inflection point’ is the ability to create a link between the doctor and patient that is efficient as well as effective via virtual video consults, email, text and phone. He then jumps to the notion (more…)
Free research report on the state of mHealth apps
research2guidance has published the 2014 (fourth) edition of mHealth App Developer Economics with an in-depth market analysis on the current status and future impact of mHealth app publishing. Some findings of the global study:
- Revenue achieved $2.4 billion in 2013 and projected to be $26 billion by 2017, derived primarily on a subscription model from services.
- Surprisingly, mHealth app publishers and “wannabes’ (planning to release soon) by the numbers target chronically ill patients (31 percent) with the top being diabetes and obesity, with the greatest potential cost benefit on nonadherence and hospital readmission–then health and fitness (28 percent). The B2B market presently is composed primarily of physicians, targeted by 14 percent of app developers, but the five year outlook is that physicians and hospitals will develop into the primary distribution channel. (more…)
Digital health accelerators, anatomized (US)
A phenomenon in both the US and the UK is the digital health accelerator that ‘enrolls’ promising startups and nurtures their entrepreneurial founders with business coaching and limited funding. In the UK, accelerators cluster around universities such as Sheffield, Edinburgh, Ulster, Bristol and Bath. In the US, startup accelerators clustered bicoastally–Boston/New York-Silicon Valley/San Diego–and were dominated by Blueprint Health, StartUp Health and later Rock Health. In the past three years, they have dispersed to places like Minneapolis, Dallas, Phoenix and Philadelphia. Lisa Suennen, no stranger to the scene as a managing partner of advisory service Venture Valkyrie, has written ‘Survival of the Fittest: Health Care Accelerators Evolve Toward Specialization’, published by the California Health Care Foundation. She notes that accelerators, once meant for entrepreneurs/developers to help them bridge the gap from the kitchen table (more…)
Friday’s Alert: Telehealth and Telecare Aware Updated
Owing to an elusive problem on our server our adoption of a new alerts emailing system is still not complete, so we are unable to send out the usual alerts email today (see apology above). We appreciate your patience. In the interim, please spread the word by tweeting this post. Thank you.
Today’s alert is brought to you by:
2014 Digital Health Conference | November 17-18, New York, NY
Join the NY eHealth Collaborative at the Digital Health Conference
10% registration discount with Code TTA. www.digitalhealthconference.com
Five new articles including further commentary on the TSA chair selection and a look at the worldwide black market in medical ID theft
TSA chair selection critiqued
(Paul Harper’s article in Roy Lilley’s newsletter reviewed)
Health apps presently of little use, says Australian telehealth expert
(CE Dr George Margelis debunks current state of the art)
Panasonic enters telehealth, debuts On4Today
(USA unit goes social, plus pilots a TV telehealth interface)
The sheer screaming attractiveness of medical ID theft
(Harry Lime would find this new black market more lucrative than stealing off Army trucks)
Roundup: data breaches ’round the world
(Hungary’s CEU takes a long hard look at it, and even FDA is vulnerable)
Earlier this week:
Home telehealth projected to outpace ‘telehospital’ by 2019 (Pick your forecast!)
Telehealth for Motor Neurone Disease (Sheffield Institute trial patient monitoring report)
Last week in TTA:
Ebola and health tech: where it can help, where it failed
Life expectancy up, but so is death from falls (US)
Google testing telemedicine program via Helpouts
12 percent of US veterans now using VA telehealth services
Faux Glass: not just a knockoff, but a sendup
TSA appoints new chair (Heraclitus’ comment a must-read)
Telemedicine getting out of the waiting room–perhaps
Three seminars on negotiating IP licensing, IT procurement and services (US)
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