23andMe’s FDA coup hazardous to personal DNA data security?

March 5, 2015 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/03/DNA-do-not-access.jpg” thumb_width=”150″ /]Genetic test developer 23andMe’s wins with the FDA [TTA 20 Feb] served to clear the path for their current Bloom Syndrome and future kits as Class II devices. It’s long been believed that the company’s real diamond mine is in selling the DNA data gained through the kits, and with consent, to major pharma and medical companies. Proof: recent collaboration announcements with Genentech and Pfizer on genetic research. But how will this data be safeguarded? It may not be a significant concern now, but “Personal DNA information will become far more critical and more important to safeguard than the details of our life circumstances”. Hackermania’s Running Wild with AnthemHealth-sized data breaches (more…)

Veterans Affairs boosts telehealth, HIT in proposed 2016/2017 budgets

March 5, 2015 | by

The US Department of Veterans Affairs (VA), in its proposed 2016 budget released earlier this week, is increasing support for telehealth/mHealth along with programs that use these services–rural health and mental health. Telehealth’s VA budget from FY 2014 increased from $986 million to just below $1.1 billion in the current year. In FY 2016 (beginning 1 Oct), the VA is allocating $1.22 billion of a $56 billion budget, and in 2017 advance appropriations, $1.37 billion–a year-to-year increase of 11 percent and 12 percent respectively .

VA has the largest telehealth program in the US, divided into three main functional areas: (more…)

Keynote speakers at ATA 2015

March 4, 2015 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/02/ata-2015-300X145.jpg” thumb_width=”200″ /]There’s a diverse group of keynoters at this year’s American Telemedicine Association annual meeting in Los Angeles. They include Sanjay Gupta, MD, CNN’s Chief Medical Correspondent and a practicing neurosurgeon; Patrick Soon-Shiong, MD, founder/CEO of the Healthcare Transformation Institute and NantWorks; Yulun Wang, PhD, President of ATA and CEO of InTouch Health; Reed V. Tuckson, MD, ATA President-Elect, Managing Director of Tuckson Health Connections, former Chief of Medical Affairs at UnitedHealth Group and Senior Vice President for Professional Standards of the American Medical Association;LTG (Ret.) James Peake, MD, ATA Vice President, President of CGI Federal, former US Secretary of Veterans Affairs and Surgeon General of the US Army; and Ateev Mehrotra, MD, MPH, Associate Professor of Health Care Policy and Medicine, Department of Health Care Policy, Harvard Medical School. For more information on ATA 2015 and to register, click here. Telehealth & Telecare Aware is a media partner of ATA 2015.

Building from the bottom up: an approach to healthcare

March 3, 2015 | by

Reader and independent UK consultant Guy Dewsbury writes about an approach to health and social care delivery that gives staff more control, as well as accountability, and integrates mobile into not just tablets, but keeping care plans updated in real time.

Effectively it inverts the current care pathway, but potentially achieves a better quality of care, as frontline staff are not required to spend time updating records in an office because they are updated on the go.

and

Having a smartphone-based programme, in real time, allows the managers to be kept up-to-date on all their staff. The software could also help with reports and handovers ensuring the most up-to-date information on each person being cared for is available to the frontline staff coming on shift.

concluding

Empowering frontline staff with technology can mean more appropriate, timely care and a more resilient workforce who are happier as their worth is valued.

 

He’s been kind enough to give TTA readers access to his freshly published article in Care Management Matters.

Guy’s website here. Previously in TTA on the Dependability Assessment Tool for telecare.

Moving past the hype on mobile, wearables for consumer health

March 3, 2015 | by | 2 Comments
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2012/12/crystal-ball.jpg” thumb_width=”150″ /]Directionally positive, but still quite developmental in reality. The gold rush not quite begun.

In the past week or two, this Editor has been working her way through a stack of surveys and journal-published research, all heavily promoting the greater interest in and usage of consumer mobile health. Here we have Monique Levy of the well-regarded Manhattan Research finding in their surveys (via Mobihealthnews):

  • 86 percent of the general population is online for health
    • Half of those use mobile
    • Two-thirds use social media to seek health information
    • One-third communicate digitally with doctors
    • Three-quarters interact with online pharma resources
    • About 20 percent of patients say that mobile is essential for managing their care–increasing to 32 percent of people with diabetes, 39 percent for people with MS

Before the D3H (Digital Health Hypester Horde) crowd vaults over the moon, however, Ms Levy states that “What people mostly do on their smartphone is look for information.” She recommends optimizing websites (in this context, primarily pharma) for mobile search, and apps should address “real customer pain points or niche needs”, not just a cool tracking app.

Yes, but the D3H point out the fifth annual ‘Pulse of Online Health’ by Makovsky Health (healthcare PR agency) and Kelton (research), a survey of over 1,000 adults, headlining that almost two-thirds (66 percent)of Americans would use a mobile app to manage health-related issues, (more…)

Mole Detective still available on Google Play Store

February 28, 2015 | by

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…)

Telecare LIN Newsletter

February 27, 2015 | by

The Telecare LIN Newsletter for this month is out now and contains 44 pages of news, views [grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/02/ALIP.jpg” thumb_width=”150″ /]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.

‘Good’ dermatology consult app to launch 1 May

February 27, 2015 | by | 1 Comment

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…)

Action on bad apps in the US – not yet in the UK/EU

February 24, 2015 | by

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…)

Healbe GoBe sees daylight–but still can’t count calories

February 24, 2015 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/02/healbe-gobe-top-4-970×0.jpg” thumb_width=”150″ /]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 getting into the app store business (US)

February 24, 2015 | by

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.

American Telemedicine Association (ATA) 2015

February 23, 2015 | by

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. 

The NHS, tech, and the next 10 years – soapbox, event & call for posters

February 22, 2015 | by

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…)

23andMe finally gets a nod from FDA

February 20, 2015 | by

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?)

American Geriatrics Society: call for technology startups

February 20, 2015 | by

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 awards over $200k for heart failure telehealth

February 19, 2015 | by

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. [grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/02/HSHS.jpg” thumb_width=”150″ /]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…)