Following on from our piece on the action taken by the FTC against two melanoma apps, it has been drawn to this editor’s attention that Mole Detective is still available, for £3.14/download, on the Google Play Store.
The relevant section of the FTC press release says:
Mole Detective Settlement and Lawsuit. Kristi Kimball and her company, New Consumer Solutions LLC, developed and first marketed Mole Detective in January 2012. U.K.-based Avrom “Avi” Lasarow and his company, L Health Ltd., took over marketing the app in August 2012. The marketers advertised the app primarily online, where it has sold in the Apple and Google app stores for as much as $4.99.
The settlement with Kimball and her company prohibits them from claiming that a device, such as an app, can detect or diagnose melanoma, unless the representation is truthful, not misleading, and supported by competent and reliable scientific evidence in the form of human clinical testing of the device. It also prohibits them from making any other misleading or unsubstantiated health claims about a product or service, and requires them to disgorge $3,930.
The agency will pursue a litigated judgment against non-settling defendants Lasarow and his company.
Especially as the organisation marketing the app is UK-based, (more…)
The Telecare LIN Newsletter for this month is out now and contains 44 pages of news, views and updates on various projects related to care for the elderly and telecare, mainly from the UK.
A short article in the NHS England website announcing a meeting in London in March entitled “Older People’s Care Summit” is highlighted and some of the statistics there caught my eye. It says that there are 3 million people over the age of 80 in the UK and by 2030 the number is expected to double with the figure reaching 8 million by 2050. I’ve worked with the demographic change graphs for some time now but this is a particularly stark statistic to bring home the need for new approaches to care for the elderly. (The summit still had spaces available if anyone is interested and registration is at this page).
There is a link to Roy Lilley’s new website “The Academy of Fabulous NHS Stuff” and pointers to some article on telemedicine in China.
On the technology side there is an item on mental health apps and a pointer to a good article on why Australia (could be any country really) isn’t further ahead than it is with Assistive Tech for the elderly living at home.
A good read to catch up on things you may have missed over the month.
Contrasting with Editor Charles’ ‘bad apps’ that made spurious claims on detecting dangerous melanomas is Pittsburgh-area Iagnosis’ ‘DermatologistsOnCall’ app set to launch 1 May on iOS and Android. This app is a virtual consult which will be available in 18 states. Currently it is available as an online service to Highmark commercial insurance members in Pennsylvania, West Virginia and Delaware, who provide a brief history, information on the condition and upload photos to a secure website. A board-certified dermatologist reviews, then provides a diagnosis, comprehensive treatment plan, prescriptions and if needed, an in-office referral for $45 (Highmark) and $59 (private). Present turnarounds average about 12 hours. To date they have raised an admittedly modest $2.8 million as part of a $7.25 million Series A preferred stock/debt conversion round, according to the Pittsburgh Business Times. Also MedCityNews and CrunchBase.
Tele-dermatology seems popular but funding remains modest, with Germany’s Klara (more…)
It is most encouraging to see that the FTC in the US has reached a settlement with two suppliers of “Melanoma Detection” apps: “In two separate cases, marketers of MelApp and Mole Detective have agreed to settlements that bar them from continuing to make such unsupported claims.” The FTC are pursuing actions against two other companies.
Echoing the requirements also of the EU’s Consumer Protection Directives as applied to health claims (notably the Misleading & Comparative Advertising Directive 2006/114EC), Jessica Rich, Director of the FTC’s Bureau of Consumer Protection said: “Truth in advertising laws apply in the mobile marketplace.” “App developers and marketers must have scientific evidence to support any health or disease claims that they make for their apps.”
Sadly, despite a number of exposures of ‘bad apps’ that we have previously covered, as yet no action (more…)
At CEWeek NYC last June, this Editor spent some time with Healbe’s co-founder, who demonstrated to me a prototype of the Healbe GoBe 100% Automatic Body Manager fitness tracker. I walked away underwhelmed at its performance and skeptical of its main claim to fame–automatic measurement of caloric intake via measuring blood glucose conversion to fluid in cells. This was reinforced by a trail of tech product reviewers digging into its development, the controversial science behind it and a growing rebellion on Indiegogo, where contributions exceeded $1 million. Then it took delays–first September, then November. Few in the industry believed it would ever ship.
However, it has, and at least one intensive review after a month of wear is in from Engadget. Topline: it’s not a scam (which will disappoint some) (more…)
Epic Systems, the #1 company in the hospital and large practice EHR business, is launching its own app store, reportedly within a few weeks. This opens up interesting possibilities not only for mHealth app developers–who need application standards and guidelines soon–but also for Epic’s reputation as a closed system that shies away from interoperability with other EHRs like Cerner, Meditech and McKesson–a serious wrinkle with their Department of Defense EHR joint bid with IBM to replace AHLTA. The HIT Consultant article quotes a leading Epic customer consultant on that the first apps will be clinical, then crossing over into consumer; the latter seems an obvious move with PHRs (personal health records) as part of Meaningful Use requirements.
2-5 May 2015, Los Angeles Convention Center, 1201 S Figueroa Street, Los Angeles, California
ATA’s annual meeting for 2015 connects like-minded telemedicine, telehealth, mHealth professionals and entrepreneurs from around the globe. With over 6,000 attendees, 13 educational tracks and the largest telemedicine trade show in the world, the ATA meeting is a premier forum to learn and network, featuring:
For more information and to register, see our special link here. Telehealth & Telecare Aware is pleased to be again an official media partner of this year’s ATA.
As a distraction from the things that, before the advent of handheld technology, little boys used to do in the school playground when this editor was young, once in a while we would engage in the pointless debate of what would happen if an irresistible force met an immovable object.
Those debates came to mind when Graham De’Ath kindly drew this editor’s attention to the recently published Labour Ten Year Plan for Health & Care. Now Telehealth & TelecareAware knows better than to indulge in politics, however the document was notable in that it did not make any significant reference either to the demographic reality of the next ten years, or the likely role of ‘technology’ in assisting with the resultant increase in care required (the word is mentioned just once, in the commitment to: “Set up a wide–ranging review of NICE which will look at reforming the NICE technology appraisal process…” [actually already underway by the NIB]). The Labour Party is far from being alone in this – readers with long memories will recall our amusement as the RCGP’s ten year forecast of the changes in GP practice where the biggest role technology was expected to play in 2022 was in remote delivery of test results.
The reality, TTA believes, will be very different: (more…)
Breaking news: Foot in door? Crack in the wall? This week’s Big News among the genomics enthusiasts among the healthdigerati is that 23andMe finally got one test through FDA, for Bloom Syndrome where the gene is carried by both parents, and now can freely sell the kits. Much is being made of wording in the press release from a major FDA executive as opening the door:
“The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information. Today’s authorization and accompanying classification, along with FDA’s intent to exempt these devices from FDA premarket review, supports innovation and will ultimately benefit consumers,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “These tests have the potential to provide people with information about possible mutations in their genes that could be passed on to their children.”
But far more of a startling admission by FDA is that 1) these genetic screening kits are now classified as Class II and 2) they intend to exempt them from the arduous pre-market review that is in Class III:
Along with this authorization, the FDA is also classifying carrier screening tests as class II. In addition, the FDA intends to exempt these devices from FDA premarket review. The agency plans to issue a notice that announces the intent to exempt these tests and that provides a 30-day period for public comment. This action creates the least burdensome regulatory path for autosomal recessive carrier screening tests with similar uses to enter the market.
There will be much more; this article by Chris Seper in MedCityNews is an excellent recap. Our articles previously in TTA.
Would one of our UK readers expand our knowledge on these kits’ regulatory status in the UK and EU? According to the MedCityNews article, the UK permits 23andMe’s genetic testing, but is vague on the details (CE approval?)
The American Geriatrics Society (AGS), the US association of physicians and other healthcare professionals who care for older adults, is inviting startup technology companies to a special exhibition area during their annual meeting 15-17 May in Washington DC (National Harbor). Along with a modestly priced display in the Technology Innovations Pavilion, 12 companies will also receive feedback and coaching sessions with geriatrics clinicians plus full conference access for two. Companies are selected on the basis of their application and the value of their technology to geriatric patients and caregivers. Applications are open until 15 March and apparently are not restricted to US companies. AGS page, application Hat tip to Wen Dombrowski, MD, of Resonate Health.
AstraZeneca Healthcare Foundation, the charitable arm of the UK based pharmaceutical company AstraZeneca, has awarded $205,564 to HSHS St. John’s Hospital in Illinois to support their Tele-Heart Pathway programme. The programme provides interventions to heart failure patients in their homes to support health management. With telemedicine and telehealth technology doctors monitor symptoms and help avoid complications at home after surgery, according to the hospital.
“We have seen a rapid evolution in the last few years of new devices and new ways of communicating with our patients,” said Mark Stampehl, MD and Medical Director of the heart failure programme at Prairie Heart Institute (PHI) at St. John’s Hospital, in an article entitled Telemedicine elevates care for heart patients published in the fall 2014 issue of the hospital’s quarterly magazine Healthy You. “Today, we are using tools to remotely monitor a patient’s condition and increase communication with other physicians to give patients access to specialty care from home.” (more…)
Medical students today enter their training oriented to technology, tablets in hand, but medical education usually does not integrate technology into practical use, particularly in the science-intensive first two years. Here are three med schools which are making an effort to do so:
- Hofstra-North Shore LIJ in Long Island, New York has new students spend their first eight weeks not in lecture classes but becoming certified emergency medical technicians (EMTs). This Editor guarantees they will have a greater appreciation for emergency medicine and patients needs after this.
- Penn State-Hershey, a major medical system in eastern central Pennsylvania, has their first-year students work as “patient navigators,” helping them and their families get through the medical system and learning about it, from the patient perspective, first-hand. The article doesn’t specify, but presumably they will learn something about how EHRs work (or not), PHRs and the pre/post-discharge process.
- NYU School of Medicine has a course using a database that tracks NY admission and charges. Students then analyze service and cost disparities. (Nice, but seems like a distraction to the basic crunch work.)
- Mayo Clinic is converting much of the traditional lecture material to electronic formats for its two medical schools for greater accessibility.
However, under the tent flap of improvements also comes sheer, screaming puzzlements (more…)
This Editor has been in Watch Overload (see Apple Watch
) for months, but this may be an exception. The UnaliWear Kanega
watch (in development) is for the sizable market of older adults who would wear a well-designed watch or band for safety assistance, but not one that screams Old Person With Plastic PERS, an objective shared with the latest edition of buddi
[TTA 16 Dec 14
]. Their prototype looks like a fairly techno steel watch, a little on the chunky side, but it packs in a lot: a 9-axis accelerometer for fall detection, a GPS locator, Bluetooth LE, cellular/Wi-Fi connectivity and a digital analog display with time and date. What’s unique: no buttons, smartphone or other tether. It works via speech recognition and ‘talks with’ the wearer (via mechanical voice, messaging on the display and a feed to a BLE hearing aid if worn.) (more…)
According to multiple press sources in the past 24 hours, the anxiously-awaited Apple Watch
is rumored to be having big trouble with its more advanced healthcare measuring features. We noted at the time “Haptic engine and heart rate monitor; 4 lenses. infrared, LED, photo sensors detect pulse.” plus daily activity [TTA 9 Sep
, 11 Sep
14]. Well, not quite. The Wall Street Journal
broke the news that it will not
debut in April including monitoring of “blood pressure, heart activity and stress levels” as originally planned because, simply, the watch did not measure them reliably and accurately (hairy, sweaty arms!), they were too complex or required regulatory approval (not so–see FDA and MDDS
Apple has relied on the Watch to defend its Still Most Innovative Company Post-Jobs turf, (more…)
Having met and been impressed at mHealth Summit by Health Wildcatters [TTA 26 Apr 13], a Dallas Texas-based healthcare accelerator, they are doing some smart marketing in sponsoring a series of local networking breakfasts called The Pulse to connect entrepreneurs, medical professionals, and other innovators from the thriving Dallas healthcare and business communities with healthcare startups. Their launch is Thursday 26 February from 7:30-9am. Coffee and continental breakfast is provided and the cost is an affordable $15. Reserve here. Hat tip to Hubert Zajicek of Health Wildcatters via Twitter
There’s plenty of telehealth
systems and apps that remind older adults of their meds, appointments and take their vital signs–but where are the ones that take care of the reality of ‘aging in place’: the loneliness of the man or woman who lives alone, how that person can communicate with family with their own lives 50 or 2,000 miles away, how family members can better oversee or coordinate her care? The problem hasn’t changed when first addressed over a decade ago by the earliest telecare systems. The technology, while more abundant, is largely uncoordinated, putting the burden on the caregiver. Laurie Orlov points out that ‘finding care is not the problem’ but that the care is at extremes: either too light (daily non-medical assistance) or a move to assisted living housing (average move-in now 80+). No company has truly organized a larger solution (more…)