In 26 slides, Rock Health has neatly summarized for those unfamiliar with the FDA approval thickets (99% of us) on what is a regulated health tech product and is not. Instead of a MEGO (my eyes glaze over) experience (familiar to all those who’ve sledded through the FDA website), there are simple examples in how to determine what class your device falls into (I, II, III) and what you need to do to gain approval. It also clearly defines the substantial difference between 510(k) premarket submission and the far more complicated PMA premarket approval–and the fact that after approval, FDA will forever be in your life. It also notes that other approvals such as FCC may be required and many other tips on how to make the process easier and less garment-rending for your organization. Features comments from Chris Bergstrom of WellDoc and Geoff Clapp, who co-founded Health Hero which is now Bosch Health Buddy. SlideShare link
Don’t be an apphole
I’m not just posting a link to this article because I wish I had coined the headline but it makes interesting reading in view of Peter Kruger’s Soapbox item Healthcare apps – welcome to the Piranha tank. The author of Don’t Be An Apphole is Kerri M Sparling, a blogger and speaker about diabetes. In the article Kerri makes some pertinent points about apps and describes her wishlist for the perfect diabetes app.
Is telehealth a busted flush? (UK)
Caroline Price, in an article in Pulse, one of the UK’s magazines for general practitioners “looks at telehealth’s uncertain future” in Analysis: Is telehealth a busted flush?. Free registration is required to access it but it may be worth doing as it is a fairly comprehensive round up of the mood of NHS GPs and commissioners in the wake of the recent Whole System Demonstrator (WSD) analyses. She has also included some figures she has rounded up from the 3ML pathfinder sites. “Pulse has also discovered that even the most enthusiastic CCGs are struggling to roll out the scheme. Of the seven pathfinder areas announced by Jeremy Hunt at an Age UK conference last November, two were unable to provide any figures for the number of patients benefiting from telehealth.”
Readers with access to the (‘private’) 3ML discussion group on LinkedIn will find a relevant, interesting discussion in progress. It was started by Chris Wright, the 3ML Programme Manager at the Department of Health: WSD data – help or hindrence? [sic]
Smart pill bottles 2.0
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/03/pill_bottle_small-4e1e1544a6de186dda09ddee4027d127.jpg” thumb_width=”150″ /]Back in 2009, this Editor was wowed by pill container-reminder Vitality GlowCaps, and has been cheered by its recent developments in developing a reminder pouch for non-pill medications. Now NYC-based startup AdhereTech adds to the med reminder picture through a specially designed compact bottle for pills or liquids that not only has lights, speakers and a built-in 45-day-long battery, but also is fully M2M–each bottle connects from anywhere via cellular 3G and LTE with no base station required. Thus the containers can be used by those ‘on the go’. Sensors in the containers also measure humidity and opening/closing–but what’s new here is providing a measurement of pills/liquids remaining in the bottle. This is done by measuring the capacitance, or stored charge, along the container walls, without actually touching the meds. Alerts are planned to be customizable in type and style (lights, chimes, emails, text). Testing is planned initially with Walter Reed Army Medical Center, Wake Forest University and University of Pennsylvania against standard containers on whether it increases adherence for a variety of disease conditions. The AdhereTech team is initially targeting use of the containers for specialty medications which require accurate dosing and where adherence is critical. Thanks to founders Josh Stein and Michael Morena for clarifications. This Pill Bottle Is a Smartphone Wannabe (Wired)
IBM, EME, UCLA fighting TBI
Another IBM-related item, this time on IBM using big data analytics software (but not Watson) developed in conjunction with Excel Medical Electronics (EME) used to alert for signs of dangerous brain pressure increases in traumatic brain injury patients. The UCLA Department of Neurosurgery will be analyzing real-time streams of vital signs collected from bedside monitors at the Ronald Reagan UCLA Medical Center ICU to spot subtle changes in the patient’s pulse, blood and intracranial pressure, heart activity and respiration. These changes can alert for dangerous high-risk increases in brain pressure. UCLA Relies on Breakthrough ‘Big Data’ Technology from IBM To Help Patients with Traumatic Brain Injuries (IBM release) Hat tip to Toni Bunting of TANN Ireland.
IBM discovers telecare as “Solutions for an Aging Population”
IBM, along with its ad agency Ogilvy, produced this four-minute, expensively produced ‘ad-doc’ (umentary) on the trial of (drum roll) a remote monitoring technology for elder care in Bolzano, Italy as part of their Smarter Cities initiative. Yes, it’s telecare, brushed up, dressed in blue and looking spanking new again! The story of Zita, a elderly woman and seamstress who lives in a lovely apartment in a hill town your Editor wouldn’t mind moving to, is the exemplar of both Italy’s growing aging population (23.5 percent are over 65) and how to accomodate both the older person living at home to ease the hard realities of aging cost impacts on local social services. IBM’s system and sensors (blue sensor box perched on the refrigerator at 2:34) appear to be unique in design. The rest will sound familiar. At about 3:00, “The sensor’s job is to recognize any abnormalities you can understand if someone could show signs of illness and eventually send an alarm to social services personnel.” Even the malapropism on the sensors recognizing abnormalities (see the web platform graphing at 3:14) and Nicola Palmarini of IBM’s remark “Preventing events means we avoid catastrophic events–dangerous for people…” were features/benefits your Editor worked with for QuietCare back in 2006-7. There’s nothing really new here except that IBM is trying what Care Innovations, HealthSense and GrandCare already have. But will IBM’s backing of telecare, which has been largely sidetracked to assisted living in the US and pushed to the side by consumer mobile health and apps, gain a new lease on life? Can we hope? Or are we back to the Same Old Struggle? Adweek article on IBM’s ad-doc.
[This video is no longer available on this site but may be findable via an internet search]Doctor, organize thy apps
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/03/Omnio-Home-31-229×300.jpg” thumb_width=”200″ /]You know there are a lot of physician-directed apps when a startup develops an app to organize apps. Omnio by Physicians Interactive promises to help the harried doc with an iPad identify the most relevant resources for the specialty and tag the most used everyday. They also plan to take a page from LinkedIn and design a home page with an activity wall. What is mystifying is that they do not have a native e-prescribing app yet, but a quick look at their website indicates that Physicians Interactive’s bread-‘n’-butter is advertiser-supported sampling and mobile media promotion/marketing. PI release. Virtual “black bag” iPad app to help healthcare professionals customize reference material, tools (MedCityNews)
Aging in America 2013: conference report
Joop Koopman, reporting for Bayard Presse, has generously shared with us (in English) his report on the annual conference of the American Society on Aging, which took place in Chicago 12-15 March. Commentary on presentations by Aging in Place Technology Watch’s Laurie Orlov, gerontologist Ken Dychtwald, Mary Furlong’s What’s Next Summit preceding ASA, AARP, Scott Collins of LinkageConnect, Caring.com and Louis Tenenbaum. Technologies: Care Innovations, GrandCare Systems and Philips. Communities: OnLok Lifeways, Avenidas (virtual). PDF (10 pages)
Joop Koopman is an experienced writer/journalist, with a background in Catholic media (as editor and publisher), baby boomer-oriented marketing, as well as public relations serving both commercial and non-profit clients and causes. He currently provides a stable of European magazines catering to the 50-plus audience with information on US marketing trends. He is fluent in Dutch and French.
Telehealth Soapbox: Healthcare apps – welcome to the Piranha tank
Peter Kruger, owner of the Steinkrug consultancy and founder of Alphadaugters explores the dilemma that faces developers of health-related software. This item is re-published, with kind permission, from the Alphadaughter’s blog.
‘Information wants to be free’ so stated Stewart Brand, founder of the Whole Earth Catalog, back in 1984. Over the next two decades, thanks to the Internet and personal computers, a significant amount of the world’s imprisoned information was liberated. Now something similar is about to happen to healthcare: or at least the part of healthcare that is digital. This has been bought home graphically by the recent collapse of yet another online healthcare service: the sleep coach company Zeo.
It perhaps no coincidence that some healthcare IT companies are struggling just we see the release of a new generation of mobile technology. The Samsung Galaxy S4 has, as standard, a number of features mobile health companies previously had to build into their proprietary platforms. It will not be long before Samsung’s eye tracking feature appears in mhealth applications running on the Galaxy and other consumer mobile handsets. (Already Fujitsu has announced software that can check a person’s pulse rate through a tablet or smartphone camera.) Any company that has waited until their customers pressed for Apple and Android versions of their mhealth service has probably left it too late. And for those who have already ditched their proprietary platforms in favour of consumer mobile devices; (more…)
Wessex HIEC collaborate and ‘After Ruby’ telehealth and telecare education and training materials (UK)
We have reported previously on the development of support for people involved in telecare and telehealth in the south of England, via the Southampton University-based Wessex Health Innovation and Education Cluster (HIEC). They have now set up a system for online information sharing and collaboration part of which is a section for people interested in telehealth and telecare. Sign up in the top left hand corner. See also their videos recording the experiences of patients and their carers, here.
In addition, they have posted some videos from a recent training day run by Paul Rice and David Barrett who are marketing the training under the name ‘After Ruby’. Introduction and link to them here.
NHS funding – the bleak future
For anyone hoping to sell services to the NHS over the next decade, the content in this slideshow by Anita Charlesworth, Chief Economist of the Nuffield Trust is gloomy reading. Much as it is a pain using presentation software for this type of material, do pick your way through it. You might wish to have a strong drink to hand when you get to the ‘remaining gap’ on slide 9.
Anita Charlesworth: The Funding Outlook for Health Care Heads-up thanks, Roy Lilley’s newsletter.
Depression warning for heart failure patients
GP Online picks up on an American study (links to original) – the implication is that early identification of the onset of depression in people with heart failure could reduce a considerable number of early deaths. Depression warning for heart failure patients. Surely it shouldn’t be too difficult to get self-reported mood trends into electronic medical records and to flag up negative changes in a timely manner. It may be more cost effective than other forms of remote symptom monitoring…
UPDATE Tuesday 26 March: There may be a connection to social isolation – also associated with depression. Social isolation ‘increases death risk in older people’ BBC item.
‘Leading the charge in wireless health’–to where?
CNN’s visit to Quantified Selfing Land (though not said) is travelogued in a ‘What’s Next’ blog on innovation, with a piece on and by USC’s Center for Body Computing head Leslie Saxon, MD. What is so surprising to this Editor is that the video piece (note: may not be viewable from all countries) is so theoretical and future-oriented. Even though real companies and tech are here–AliveCor’s always smart and dapper Dr. David Albert, Sonny Vu’s Misfit Shine, UnderArmour athletic wear, Zephyr–the glossy way it’s presented is that it’s ‘swell stuff that will transform the future.’ Have our ‘grizzled veteran’ readers heard this song before, let’s say about 2006?
What is more disturbing is how dismissive Dr. Saxon’s article is of evident skepticism and of her own colleagues who are, after all, going to be part of and help drive this change. She dismisses medicine as “working from a 2,000 year old paternalistic doctor-patient model” as if nothing has happened in the past few years. Oddly she juxtaposes a 2007 conference with last week’s Congressional hearings leading with “The reactions interested me because, in my experience, where there is anger, there is also fear and irrationality.” Aside from being an extreme and disparaging view of her colleagues’ (and users) motives (and perhaps some bad editing), it simply wasn’t there in the hearings. Based on reports extensively compiled here, it was exactly the opposite–acceptance. (more…)
Quantified Selfing: security and statistics
It was inevitable, but now there’s concern about your QS data’s security and hacking. With healthcare organizations having security breaches rather routinely (wander over to the Privacy Rights Clearinghouse), the Federal Government routinely fighting off ‘denial of service’ assaults and Facebook, Apple, Twitter and Dropbox joining the hacked club, how long will it be before a fitness or telehealth company is breached? Or hospitals/providers which use insecure messaging, Skype and data files? Or those 600-odd practice EHRs? From the article, Avi Rubin, the director of the Health and Medical Security Lab at Johns Hopkins University: “Any system that consists in large part of software is hackable. At some point, someone will hack a major repository of healthcare data. And it won’t be pretty.” World’s Health Data Patiently Awaits Inevitable Hack (Wired) Hat tip to David Albert, MD via Twitter
QSers also assume that tracking devices are accurate. What happens when it’s two different devices, different totals? Doesn’t matter much with pedometers, but blood glucose is a different matter. Scientific American takes on ‘informed interpretation’ of data and the sticky issue of whether a monitoring regime does more good than harm. Writer Hilda Bastian: “Human health isn’t about simple mechanics and tinkering with a few measurable levels….There is, though, potential for harm, including unnecessary and pointless anxiety. There’s value, too, in contemplating the meaning of where we’re going with this, and the consequences of adults focusing so much on our selves in this particular way.” “Every Breath You Take, Every Move You Make…” How Much Monitoring Is Too Much? Hat tips to Carolyn Thomas, The Ethical Nag / Heart Sisters and TTA Soapboxer, and George Margelis, via Twitter.
Losing ground: Alzheimer’s as a leading cause of death
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/03/Alz-bar-graph.png” thumb_width=”200″ /]This short bar chart (Change in Number of Deaths between 2000 and 2010) tells a story that your Editor did not realize. Alzheimer’s disease currently is the 6th leading cause of death in the United States overall–and where the opposite of progress has been made. Part of this could be better diagnosis, but in large part it is the aging population.
For those innovating health tech, there’s a big job to be done here: not a cure, but to support those with Alzheimer’s and vascular dementias in everyday quality of life (brain fitness, mental stimulation, activities of daily living/ADLs); to aid their caregivers in caring for them, as well as their own quality of life; and geriatric professionals in lengthening time at home and creating stimulating communities, not ‘memory care floors’. Not perhaps as fun as a fitness app, but potentially more rewarding and disruptive to the current distressing model. Graph courtesy of the Alzheimer’s Association (US)
The further adventures of the Ozcan cellphone microscope
Can your phone do this? (Armed With Science) discusses how the US Army Edgewood Chemical Biological Center (ECBC) is developing cellphone-based wide-field fluorescent imaging for pathogen detection in the field, but also mentions partnering with a team at UCLA as the developers of the clip-on microscope and a small firm called Holomic LLC for a second add-on for assay purposes. Both devices sounded familiar to this Editor, and it turns out that Dr. Ayodgan Ozcan is the common denominator–and head of the team–on both (Holomic is his spinoff commercialization company). The microscope is the LUCAS [covered since its debut in May 2010] and the assay is likely the iTube [TTA 13 Dec]. Interesting that the Army not only is pushing this forward, but also the partnership.
Most Recent Comments