Picture murky: 23andMe and the FDA

April 2, 2014 | by | 2 Comments

Genetic testing company 23andMe seems to be in no rush to resolve its differences with the FDA, and the digitalhealtherati a/k/a D3H (Digital Health Hypester Horde) are wondering why. In late November, 23andMe executives undoubtedly had a depressing Thanksgiving when the FDA ordered them to stop providing health reports (interpretation of genetic results) and marketing kits. Four months later, 23andMe continues to sell its kits for $99, providing only raw genetic data and ancestry reports–and according to its 31 March blog posting, will do so for the foreseeable future as they complete the regulatory review process. The blog quoted CEO and co-founder Anne Wojcicki, “My main priority is resolution with the FDA,” but actions speak louder than words–and the FDA isn’t talking. The FDA standard is still validation–the company has to analytically and clinically validate 23andMe for its intended uses, which is why the FDA took action against them in the first place.

  • Is the lack of urgency more about continuing to gather raw genetic and health data unimpeded? Ms Wojcicki had widely stated her real aim was to build a 25-million-strong database (Fast Company).
  • Is the real revenue stream of the company not the kits but in monetizing a massive database, selling it to researchers and others (Matthew Herper in Forbes)–the Google model which Ms Wojcicki is quite familiar with? Consider that there’s $126 million into the company, that is a lot of $99 kits.

Most companies in this situation would be imploding. This one is not. Interestingly. FierceMedicalDevices, The Verge

Previously in TTA: all you ever wanted to know about the 23andMe kerfuffle in FDA tells 23andMe genomic test to stop marketing (including this Editor’s analysis of their pre-FDA website with copy breathlessly expressing potentially life-saving or critical lifestyle changing claims, countered by legal ‘educational use’ boilerplate) and The inevitable: class action lawsuit against 23andMe (a check of the Ankcorn blog has no updates)

AliveCor community screening test finds atrial fibrillation in 1.5% (AUS)

April 2, 2014 | by | 2 Comments

A year-long pilot program in Australia to screen for for atrial fibrillation (AF) found new, previously undiagnosed AF in 1.5% of those tested. The SEARCH-AF study used the AliveCor Heart Monitor ECG  to test 1,000 customers 65 years and older through community screening in suburban Sydney pharmacies. Pharmacists used the AliveCor device, attached to an iPhone, to transmit 30-60 second ECG recordings to study cardiologists. If AF was suspected, the follow-up was a GP review and a 12-lead ECG performed. AF is the most common heart rhythm abnormality and puts an individual at five times the risk for stroke (National Stroke Association). Early diagnosis and treatment cost savings are straightforward: over $20,000 (~£12,400) for prevention of one stroke. (This Editor’s opinion–it’s an understatement.) Per the study summary:

The incremental cost-effectiveness ratio of extending iECG screening into the community, based on 55% warfarin prescription adherence, would be $AUD5,988 (€3,142; $USD4,066) per Quality Adjusted Life Year gained and $AUD30,481 (€15,993; $USD20,695) for preventing one stroke. (“Feasibility and cost effectiveness of stroke prevention through community screening for atrial fibrillation using iPhone ECG in pharmacies”, Thrombosis and Haemostasis, Ben Freedman, MD et al., 1 April online (subscription access required for full study)

15 new AF diagnoses per 1,000 may not sound high, but using the above estimate, this type of community screening using AliveCor or a similar device translates to a cost saving of over $310,425, assuming that all undiagnosed AF resulted in a stroke. Even if less, it is a nice return on investment, health and future outcomes. (This Editor invites more accurate cost analysis.) AliveCor release (San Francisco Business Times). Additional coverage CNet Australia. The George Institute for Global Health Australia project page which extends the study to GP clinics. 

Catching up with Medivizor

April 2, 2014 | by

This Editor had a quick catchup this week with Medivizor’s CEO and co-founder, Tal Givoly, at the introduction of Eco-Fusion (a personalized wellness/tech fusion service founded by Dr. Oren Fuerst, Medivizor executive chairman and co-founder; more on this when it goes to market). One of the better discoveries of our July 2013 CE Week NYC coverage and the H20NYC/Healthcare Pioneers evening [TTA 3 July], Medivizor’s USP is that it provides free, personalized, research-level information on serious or chronic health conditions based on specific user information. The user benefit is increasing pertinence to the specific condition and less time spent researching. Still in what they term a ‘public beta’, they have expanded (as promised) to cover 400 medical conditions in 10 domains, such as cancer, cardiovascular, infertility and diabetes, and are growing their community of users and forum interactions. Medivizor has also published a compendium of 10 of the most important breast cancer research papers published in 2013 into a free eBook. 

The role of spiritual care in PTSD and TBI

April 2, 2014 | by

Online ‘ChatWithAChaplain’ service also debuts

In our focus on technology, particularly on how it can assist in determining risk or helping patients to better manage the effects of PTSD and TBI, we neglect the critical role of personal spiritual care. In the military, the first line of this type of care are chaplains. This excellent 100 page handbook issued by the US Navy’s Chaplain Corps and their Bureau of Medicine and Surgery is a brief for chaplains explaining the medical and psychological nature of PTSD and TBI, how they can provide service members with culturally appropriate spiritual care, and how they integrate it with the mental health team’s work. For those outside the military working with approaches to these conditions, it is a wealth of medical and treatment information in one place–and will influence your thinking. It was co-authored by The Rev. George Handzo, VP for Pastoral Care Leadership and Practice at The HealthCare Chaplaincy Network, a nonprofit healthcare organization which helps people in distress from illness and suffering find comfort and meaning. HCCN is a leader  (more…)

How insecure can health data get? Very.

April 2, 2014 | by

Gigaom is one of our go-to sites for enthusiastic whiz-bang health gadget coverage (and more), but here’s the downside of all those devices: all that data. And it’s not only not secure, but also getting more insecure. Grégoire Ribordy of Swiss encryption company ID Quantique makes some key (and scary) points on the data breaches looming–and he doesn’t mention that block of Swiss cheese Healthcare.gov once:

  1. One-stop storage for your total health records and data, an idée fixe among government and single-payer theoreticians, just makes it one-stop-shopping for hackers.
  2. Richer health data means more to steal and exploit.  There’s also the illegal use of genetic information for employment discrimination–hard to enforce regulations, easy to misuse personal data.
  3. Biological crime isn’t just a future plot of ‘Law & Order.’ Criminals can target patients with specific conditions–or healthcare workers can make money on the side by supplying accident victim data to personal injury attorneys, as recently happened in NY. For prominent people, their sensitive health information can be leaked to the press for profit. (more…)

AKTIVE Conference 2014

April 1, 2014 | by

Technology, Care and Ageing: Enhancing Independence

8-9 April, University of Leeds, UK

Sponsored by AKTIVE, a project that started at the University of Leeds’ Centre for Care, Labour and Equalities (CIRCLE) in 2011, next week’s conference it is focused on understanding the impact telecare technology has on the everyday lives of older people who are prone to falls or who suffer from cognitive impairments (including dementia) and the people who support them to live at home. AKTIVE 2014 brings together researchers, industry, voluntary sector and local authorities interested in the role of telecare and other technologies in supporting older people at home. Our Contributing Editor Charles Lowe will be presenting on Wednesday the 9th, 11:15am – 12:30pm, on ‘How Activity of Daily Living (ADL) Monitoring is at last coming of age’ as part of a Forward Vision for Telecare. Full program. Information and registration (may still be available–we are checking)

Dermal patch senses, releases meds as needed

April 1, 2014 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/04/nnano.2014.38-f1.jpg” thumb_width=”175″ /]A research team from several institutions in South Korea and University of Texas, Austin have developed a dermal patch that not only delivers medication, but in the right dose and right time based upon muscle activity and body temperature. They developed a 2-inch rectangle made of stretchable nanomaterials containing heat-activated silica nanoparticles. The patch monitors muscle activity and body temperature, then releases a controlled dose of a drug. This would make it ideal for conditions such as Parkinson’s Disease where the drug should be timed when muscle tremors begin. At this point, there is no digital health/wireless component for recording, which is also needed. But given the long lead time–it won’t be ready for sale for five years. The Verge. Nature Nanotechnology (abstract only)

West Health busy on digital health investment, sale front

April 1, 2014 | by

The West Health Investment Fund, the for-profit which is part of the West Health combine, has invested further in Reflexion Health‘s Kinect-based physical therapy system [TTA 15 Jan 13] and sold off the Sense4Baby prenatal (fetal) monitor [TTA 8 Nov 10]. Both devices were spun out of the non-profit West Health Institute in 2012. Reflexion’s total from West Health Investment is $11.8 million between seed ($4.25 million) and now $7.5 million in Series A rounds. Their Vera physical therapy system uses interactive, video game style full-body exercises and instruction. It was originally piloted with the Naval Medical Center of San Diego and now is in test with Partners HealthCare in Boston and San Diego’s Rady Children’s Hospital. The Sense4Baby sale (undisclosed amount) was to AirStrip Technologies and covers the Sense4Baby assets (more…)

ATA 2014: TTA is now a media sponsor

March 31, 2014 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/03/ata-2014-square.jpg” thumb_width=”180″ /]This publication is rarely a media sponsor of conferences, by choice. When we are, it’s because the conference and the organization is significant to the progress of healthcare technology in remote monitoring and related areas. The American Telemedicine Association (ATA) is one of those special organizations in their long-standing advocacy of global telemedicine and telehealth. We are pleased to announce we are joining their distinguished roster of 2014 media partners.

The 2014 conference is being held in Baltimore, just north of Washington DC, from Saturday 17 May (pm) through Tuesday 20 May. There is a very full schedule of pre-meetings, local chapter/co-located meetings, multiple education tracks,and several keynote speakers. Highlights:

  • Industry executive sessions with major companies in telemedicine on Monday and Tuesday
  • Sunday, the ATA Telemedicine Venture Summit with law firm Jones Day has leading industry stakeholders and policy makers speaking, in addition to structured networking and matchmaking opportunities (more details, release)
  • The new Innovation Spotlight: Monday highlights interviews with telemedicine startups (release); Tuesday, ATA’s partnership with the XPrize Foundation (release).
  • For those who cannot attend onsite, there are virtual assets including ePosters and ATA TV.

More information and registration here. Twitter: @ ATA2014. ATA 2014 on Facebook here.

Editor’s Note: This Editor hopes to be able to attend the Monday sessions. Prior commitments prevent her from attending the other days. If you are interested in contributing coverage from one item to a day, please contact Editor Donna about arrangements. Our gentle requirements are that you send a timely report (within 72 hours) from this event. Our standard is that you can be selective and interesting rather than comprehensive. Of course you will receive writing credit, but other expenses will not be covered.  

Disruptive innovation in healthcare hasn’t begun yet: Christensen

March 31, 2014 | by | 6 Comments

Clayton Christensen, as many of our readers know, pioneered a theory of disruption in business models and a three-step cycle of innovation (empowering, sustaining and efficiency, now quite broken indeed). With two other writers, he applied these theories to healthcare in the 2009 book ‘The Innovator’s Prescription’ which this Editor heard co-author Jason Hwang, MD present in 2009 at the Connected Health Symposium and at a private meeting in 2011. One would think that we’d be well into disruption, which is part of the empowering innovation cycle and which the authors championed in the book as underway.

The surprise at the end of this Mobihealthnews article on his recent presentation at “Better Health” in Boston, a McKesson-sponsored meeting series, was not what constitutes disruption, but that it has not really started yet, four years later. This will be much to the surprise of many successful and unsuccessful companies (Misfit Shine, ZocDoc, Zeo, 23andMe) and health plans which have stoutly touted their products and services as The True Disruptors. Sorry, you may be only a part of the Big Shift: decentralization. Decentralization will push out parts of healthcare off the hospital (more…)

Redesigning PERS artistically in Glasgow

March 28, 2014 | by

Students at the Glasgow (Scotland) School of Arts are participating in a redesign of the traditional medical alarm (PERS)–the ubiquitous (among the old-old) neck or wrist-worn pendant. Sponsored by Chubb Community Care (part of Chubb Fire & Security in the UK, not the insurance company), the challenge is to design a pendant/watch from the user/carer/professional point of view on design and functionality. There are currently five groups competing for a £250 first prize plus second and third prizes. We understand from Chubb that the prizes will be awarded shortly and this Editor will bring you the results. How far afield will the teams will go? We hope as far as they can!  Chubb release

A snapshot of telehealth and telemedicine in rural America

March 28, 2014 | by

Telehealth and telemedicine (virtual consults) are moving forward in large and largely rural Nebraska and neighboring Iowa. The Nebraska Medical Center not only has an executive director for telehealth (not buried in an HIT department) but also no less than 13 initiatives in process from stroke to cancer care. Video networks connect rural hospitals with medical centers. The VA’s leadership in this geographic area has been crucial, with over 550 patients in home telehealth in Nebraska – Western Iowa and additional telemedicine programs for psychiatry, wound care, nutritional counseling and infectious diseases. Videoconferencing equipment in hospitals and public health centers, installed in a mid-2000s program, is being repurposed for video consults. Interestingly, its use in this region is not new. For 10 years, a University of Nebraska Medical Center (UNMC) psychiatry associate professor has been having routine video psychiatric consults with elderly nursing home patients. Telemedicine’s first use in Nebraska was also psychiatric–55 years ago–by a University of Nebraska Medical Center dean using undoubtedly black-and-white two-way video. Doctor’s home visit is back — kind of — as telehealth flourishes nationwide (?–Ed.), Omaha World-Herald

FDA finally issues proposed rule simplifying medical device classification

March 26, 2014 | by

The FDA has now published its proposed rule simplifying its medical device classifications as directed by the 2012 FDA Safety and Innovation Act (FDASIA). This permits reclassification by administrative order versus the rulemaking (notice and comment) process. (Presumably this rule, as part of the latter process, sets up the process for the former.)  In the US, the Food, Drug & Cosmetic Act (FDC Act), which FDASIA amends, has three classifications of devices from least restricted (Class I general controls) through premarket approval (Class III).  

As published yesterday in the Federal Register, the class definitions are being amended to balance the assurance of safety and effectiveness with “the level of regulation necessary to provide such assurance should be closely tailored to the risk presented by a type of device.” The long-awaited changes are seen as highly favorable for mobile health devices and apps which for the most part do not fit neatly into the present Class I-III structure.  (more…)

Biocompatible batteries for ‘sensors of the future’

March 26, 2014 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2014/03/Dissolving-Battery.jpg” thumb_width=”300″ /] Pointer to the Future. Implantable medical sensors and devices have a main drawback–their power source. Current batteries are bulky and must be manually removed. External power transference means fairly bulky outside and inside devices.

What if the sensor and batteries could simply dissolve harmlessly in the body when no longer needed?

Research from John Rogers at the University of Illinois at Urbana-Champaign and his team first led to biodegradable (in the body) electronics in 2012, and now dissolving batteries (above). (more…)

Pacifying baby, taking temperature

March 26, 2014 | by | 2 Comments

UK developer BlueMaestro has announced a temperature-sensing baby pacifier with the somewhat obvious name Pacifi. According to Mobihealthnews (but frustratingly not on their website), the pacifier sends temperature data via Bluetooth Smart to an iPhone or Android app. Parents can record medication dosing and reminders, track temperature and medication over time, and set up an alarm when baby runs a high predetermined temperature. It’s also dishwasher safe. Pacifi joins Raiing Wireless‘ body thermometer FDA cleared in 2012 (now iThermometer) and Kinsa’s plug-in smart thermometer which took a crowdsourcing approach to local public health. It is not cleared for sale yet in the UK or US, but was shown at last month’s Mobile World Congress Barcelona and the Smart UK Project in London. Unfortunately, it may be a while before Quantified Self Moms can put it on the list for their baby showers, along with the Owlet monitoring sock, Mimo onesie and iTeddy [TTA 10 Sept]. Related: MedCityNews compares Mimo to adult sleep monitor Lark, awarding the matchup to Mimo. The real matchup is Owlet versus Mimo (see this Editor’s comment). (Also see our comments here discussing the safety of RF monitoring around babies.)

NHS futures: Personalised and Preventative Care presentation

March 26, 2014 | by

Courtesy of Accenture, we now have (perhaps exclusively?) Aimie Chapple’s full presentation delivered at the NHS Futures Summit in November. The link is contained at the end of Editor Charles’ article on ‘NHS futures – more encouraging signs of change‘ which puts it into context and is definitely worth your reading time. Hat tip to Mark Radvanyi of Accenture for providing Personalised and Preventative Care: Technology Trends and Disruptors that will Shape the Healthcare Transformation.