2014: the year of reckoning for the ‘better mousetraps’

January 1, 2014 | by

Or, the Incredible Immutability of the Gartner Hype Cycle

From Editor Donna, her take on the ‘mega-trend’ of 2014

This Editor expected that her ‘trends for next year’ article would be filled with Sensors, Wearables, Glasses, Smartwatches, 3D Printing, Tablets and Other Whiz-Bang Gizmos, with splashes of color from Continuing Crises like Healthcare.gov in the US, the NHS’ 3million lives plus ‘whither UK telecare’, various Corporate ‘Oops-ses’, IP/Patent Trolls and Assaults on Privacy. While these will continue to spread like storm debris on the beach, providing continuing fodder for your Editors (and The Gimlet Eye) to pick through, speculate and opine on, what in my view rises above–or is under it all–for 2014?

We are whipping past the 2012-13 Peak of Inflated Expectations in health tech…

…diving into the Trough of Disillusionment in 2014. Crystallizing this certainty (more…)

Mainly mHealth: a few predictions for 2014, and some speculation

December 31, 2013 | by

Editor Charles on what to watch for in 2014

As we have covered previously (and here), there’s no shortage of forecasts that the mHealth market will continue to grow faster, or of penetrating comments like that that won Research2guidance a What in the Blue Blazes award that smartphone user penetration will be the main driver for the mobile health (mHealth) uptake. mHealth apps continue to proliferate – there’s even shortly to be a Pebble apps store. There are a few straws in the wind that not is all well though – for example, as we covered recently, Happtique ceased, at least temporarily, its apps approval process, citing security concerns.  Elsewhere Fierce Mobile described serious data privacy issues with the iPharmacy app, and the ICO recently produced security guidelines for app developers in the UK.  The EU is also strengthening data privacy, moving from individual country directives to a pan-EU regulation. This leads us to our first prediction (more…)

FDA tells 23andMe genomic test to stop marketing (US)

November 27, 2013 | by | 2 Comments

Quantified Selfers and the D3H (Digital Health Hypester Horde) are in a swivet. This past Friday, FDA slammed the door shut on the 23andMe Personal Genome Service (PGS) saliva test. This past summer, the company broadly marketed to US consumers, including a TV campaign [Charles Lowe, TTA 7 Aug]. The FDA cease-and-desist letter cites that 23andMe never provided requested data on their July and September 510(k) filings, which are now ‘considered withdrawn’, and cites that “after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions.” The danger is that people will make medical decisions based on the testing information and that the results produced may be faulty. It appears from FierceHealthcare that the kit has actually been marketed for five years. According to MedCityNews, it is backed by Google Ventures (the CEO/co-founder is the estranged wife of Google head Sergey Brin), New Enterprise Associates, MPM Capital and the Moscow billionaire Yuri Milner. A private citizen is petitioning the White House to overrule the FDA (as if that extra-legal move would be possible, but who knows with the influence of the Googlesphere?) and states that the agency ‘grossly overstates the risks’ (also MedCityNews). As of 2 Dec there are 3,306 signatures of the 100,000 needed; one suspects this administration has bigger slices of uncooked turkey on its plate such as Obamacare and a kind-of-achieved 30 Nov deadline on Healthcare.gov, which is now clearly seen as just one problem.

The 23andMe website is still fully up and still selling kits.

Editor Donna sorts through the noise for possible reasons why:  (more…)

Due diligence: the importance of the internal IP audit

November 4, 2013 | by

This is the fourth article of an occasional series on law and intellectual property (IP) as it affects software and systems used in health technology. The topic is the importance on implementing your own audit of your company’s IP and why you should enlist an outside company to do it. More than a list of your copyrights and patents, an independently conducted internal audit will prepare your company for the external due diligence expected when a bank wants to vet a loan or an investor knocks on the door–and it includes things like your website and IT. While Mr. Grossman is writing in the context of US law, our UK and international readers will find his pointers applicable both locally and in dealing with the US. What’s refreshing is his plain writing and lack of ‘legalese’. 

Mark Grossman, JD, has nearly 30 years’ experience in business law and began focusing his practice on technology over 20 years ago. He is an attorney with Tannenbaum Helpern Syracuse & Hirschtritt in New York City and has for ten years been listed in Best Lawyers in America. Mr. Grossman has been Special Counsel for the X-Prize Foundation and SME (subject matter expert) for Florida’s Internet Task Force. More information on Mr. Grossman here and at his blog.

INTELLECTUAL PROPERTY DUE DILIGENCE

Intellectual property may be among the most valuable assets your company owns. The problem with intellectual property (IP) is that by its nature its intangible. You can’t touch it or see it. So how do you know what you have and own?

The starting point is to look to any registrations you may have with the government. For example, you may have registered a copyright or trademark and have paperwork to prove it. However, the registrations are just the starting point. It turns out that getting a handle on your company’s IP assets can be a complex process.  (more…)

A highlight from ATA 2013 Fall Meeting: Psychiatric appointments as a ‘data-file’

October 29, 2013 | by

In a conversation at a recent Health 2.0 NYC event, this Editor asked Doug Naegele what was the most surprising topic at the recent American Telemedicine Association conference in Toronto. Doug has graciously contributed this short article. He is the founder of Infield Health, a firm dedicated to increasing health outcomes and reducing total cost of care by putting discharge instructions on mobile phones. 

At the ATA Fall Meeting in Toronto last month, Dr. Peter Yellowlees gave a presentation on his work at University of California-Davis around telepsychiatry. I was struck by a few of his discussion points:

1. It may be helpful to see psychiatric consults as ‘data files’ and not events that require mandatory real-time evaluation.
2. If we accept that these consults can be described as data files, then they can be forwarded to remote psychiatrists for viewing, evaluation, and treatment recommendations much in the same way radiological scans are remotely evaluated. (more…)

Is this Tunstall’s ‘taxgate’? Maybe not.

October 25, 2013 | by | 2 Comments
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/10/taxman_logo.jpg” thumb_width=”170″ /]On Monday, The Independent, one of the UK’s major national papers, turned its attention in a ‘Tax Special Investigation’ to nine healthcare companies which are using a corporation tax reducing scheme, the ‘Quoted Eurobond Exemption’, where they pay loan interest at high rates to their parent companies through a mechanism via the Channel Islands Stock Exchange, rather than their owners further investing by taking additional equity. (How it works–infographic from The Independent)

One of the companies the article focused on was Tunstall and its owners Charterhouse and Bridgepoint. Tunstall’s profits–like the other healthcare companies profiled, Partnerships In Care, Independent Clinical Services, Priory Group, Acorn Care, Lifeways, Healthcare At Home, Spire Healthcare and Care UK–come largely from the public sector and, by using this means to pay less tax, less money is recycled back to the Treasury. The article estimates the amount for each company which would have been paid had this tax exemption not been in place. This Editor notes that a number of the companies profiled have had significant inspection problems and numerous complaints–Tunstall is not one of them, but it is the second largest ‘tax avoider’ (after Spire) listed.

There seem to be three ways to regard this:
1) it’s a commendably clever contrivance
2) it’s a suspiciously shady stratagem
3) it’s a non-story because it is something imposed on Tunstall by its owners

Whatever it may be, we are left wondering if Tunstall’s customers benefit in any way from this tax saving. We will be interested in our readers’ views.

Independent article: Tax Special Investigation: Firms running NHS care services avoiding millions in tax It is equally popular with well known high street (US=Main Street) retailers and restaurant chains: Eurobonds scandal: The high street giants avoiding millions in tax    (more…)

Telehealth round-up: the good, the bad, and the future

October 20, 2013 | by | 2 Comments

Getting the bad news out of the way first, the seemingly-eternal researchers have thrown their grappling iron into the ancient store of data from the now-only-historically-relevant Whole System Demonstrator data pool and dragged out yet another unexploded bomb that they have then endeavoured to detonate, in the form of a short research article.

Thankfully the explosive has deteriorated with age so (more…)

Humana, Healthrageous and some object lessons

October 16, 2013 | by

The acquisition of the assets of Partners HealthCare spinoff Healthrageous by insurance and health service giant Humana is reverberating in the field in the US, particularly those in the buzziest digital health sectors. Some may look away, but a hard look provides some object lessons at the sheer unpredictability of the field for those who are innovating and attempting to shape consumer behavior and health. (Not behavioral health)

  • Healthrageous had an impressive lineage and credibility. Developed over three years at Partners HealthCare, it was spun off in 2010, PHC members on the board, leadership from well-known/regarded figures such as Rick Lee and Mary Beth Chalk–and enjoyed abundant, rapid startup funding–$12.5 million in two rounds, the last exactly one year ago, from equally impressive investors, reportedly $15 million total. No raiding the credit cards here.
  • It occupied what everyone for the past few years thought of as a sweet spot–personal health management targeted to employers/benefit managers along with health plans to lower costs that combined sensor-based telehealth data with individualized coaching and feedback–and data from a broad base of 10,000 users. (more…)

Non-functional Obamacare exchange websites? $500 million estimated to date. 2014? Priceless. (US)

October 11, 2013 | by

Updated/Revised for breaking news and analysis, 12-14 October (US). Much new information noted in dark blue. (Grab your tea or coffee…this is a long one as this story rolls on.)

The mainstream reports continue to build that both the Federal HealthCare.gov site, which provides health exchange enrollment for 36 states, and many of the state-run health insurance exchanges (14 plus District of Columbia) are a nightmare of programming glitches and simply don’t work. It is not the demand–which has been high but not unanticipatedly so with an initial 8 million hits–but more disturbingly, the programming appears to be is unsound.  “Computer experts” quoted by CBS This Morning are making statements like “It wasn’t designed well, it wasn’t implemented well, and it looks like nobody tested it,” going on to say ” It’s not even ready for beta testing for my book. I would be ashamed and embarrassed if my organization delivered something like that.” A more technical dissection of the site’s multiple system architecture problems is provided by Reuters here, with the best quote “The site basically DDOS’d itself,” he said. (DDOS–distributed denial of service, a hacking technique but here, the website overwhelmed itself!) 

Counting the cost

A rough calculation of the cost has been made on a tech website, Digital Trends. Andrew Couts (who is pro-Obamacare) ran some public numbers on the IT cost of setting up the Federal part of the exchanges and add in associated 2012-13 costs, and arrives at $500 million—not including the $2 billion to build out and operate the exchanges in 2014 (General Accounting Office). Larger numbers north of $600 million have been bandied about, but this Editor will go for now with Mr. Couts’ perhaps low estimate which has been supported by more mainstream reporting. (more…)

Data insecurity in Obamacare insurance exchanges (US)

October 8, 2013 | by | 2 Comments
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/10/keep-calm-and-enter-at-own-risk-3.png” thumb_width=”175″ /]The warning that should appear as the main page of 50 state health exchanges.

Subsumed under the ‘government shutdown’ (affecting in reality a distinct minority of Federal government employees) is the significant concern that the state-based online exchanges now selling individual insurance, effective 1 Jan 2014, much trumpeted under the Affordable Care Act and baked into it two years ago, already present significant vulnerabilities in securing the vital data of millions: Social Security number, date of birth, addresses, tax and earnings information. These state-based exchanges are also dependent on information from a Federal data ‘Hub’ which “acts as a conduit for exchanges to access the data from where they are originally stored.” (HHS Office of Inspector General report August 2013, page 2) If improperly secured, this opens up other Federal agencies to further upstream identity theft mayhem.

Already information is in the hands of thousands of call center staff and so-called ‘navigators’ who may or may not have gone through security verifications. Insurance customer information has already leaked outside of exchanges (see below). (more…)

Telehealth & IP Soapbox: Hacking through Patent Thickets

October 1, 2013 | by

Not only do company founders have to deal with patent trolls, but find their way through patent thickets. Patent thickets are overlapping patent rights through which developers must find a safe, defensible space for their technology. This article introduces this concept to our readers and outlines a strategy to deal with it–in early days, and not sticking one’s head in the sand as this Editor has encountered. What may surprise you in reading this excellent article is that the author, Dolly J. Krishnaswamy, is not an experienced litigator, but a law student at NYU while working as a Project Manager/Law Clerk, Goldstein Patent Law. She blends law, science, tech and journalism with her prior experience as a journalist for Science magazine, technology work in New York City and in the study of genetics while at Emory University. Enjoy the article.

Many of you are privy to the problem of excessive patents. You have all seen the articles about yet another cellphone company infringing on yet another patent, but what you’re left with are questions of what all this activity means and how to use that information to act in your best interest– whether you are the CEO of a company or the general counsel for one. At the 2013 ABA Annual Meeting held in San Francisco, legal experts tackled this problem, discussing the trends in patent litigation and some potential strategies for companies preparing to introduce products into heavily-patented market segments.

Generally speaking the use of patents can vary with some people using them for insurance and others using them strategically. From a business standpoint, how a company uses a patent depends on the industry that company is in. For example, in the medical technologies space, all the companies will have patents on their core technologies and be highly cognizant of the patents they have to deal with. With the record number of high patent filings, the continued state of high damages, and the fact that even smaller companies are beginning to see patent infringement lawsuits, it’s clear that patent strategy is a complex matter– further complicated by the presence of patent thickets. (more…)

Telecare Soapbox: Predicting the telequake

September 27, 2013 | by | 11 Comments
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/09/earthquake.jpg” thumb_width=”175″ /]Predicting earthquakes is notoriously unreliable but TTA’s ex-Editor in Chief Steve Hards says that one is on its way for the telecare and telehealth industry.

Earthquakes are hard to predict because, depending on the local geology and where you are in relation to the future epicentre, they vary in speed, intensity and effect. However, there are four generally recognised stages:

  1. a long period of between quakes when straining deep beneath the surface that goes unnoticed
  2. a build up of intense pressure along the fault which may be noticed as slippage
  3. the release of the pressure which causes the well-known effects of tremors, liquefaction and damage as the two sides of the fault realign
  4. the new resting position of the land each side of the fault

O2 and Bosch realising that systems which do not use smartphone-based technology are now dead in the water and therefore exiting from the UK telecare market was not the quake; they are just signs of stage two slippage. We will see more strains and cracks appear (more…)

Telehealth Soapbox: Medical device tax finally under fire; implications many (US)

September 26, 2013 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/09/gizmodo-the-top-10-rube-goldberg-machines-featured-on-film-rube-goldberg.jpg” thumb_width=”180″ /]A key part of the Rube Goldberg (or Heath Robinson)-esque funding of the Accountable Care Act (ACA, a/k/a Obamacare) is a punitive medical device tax of 2.3 percent levied on gross sales (not profits) of hip, knee, cardiac implants, many dental materials, diagnostics such as scanners, radiotherapy machines, catheters and more. Since it went into effect on 1 January, it has raised $1 billion according to the Medical Imaging & Technology Alliance, the Advanced Medical Technology Association and the Medical Device Manufacturers Association in July–for a program that does not start till 2014. According to The Hill, senior Senators Orrin Hatch, Barrasso and Hoeven are pushing for a repeal amendment to be attached to the stopgap spending bill. The reasons why the tax deserves to be tossed out on its ear are: (more…)

Is nothing private in your EHR? Another disturbing trend out of Swampland.

September 18, 2013 | by

According to a solicitation posted by the Department of Health and Human Services (HHS-Ed.) on Sept. 4, the CMS (Centers for Medicare and Medicaid Services) is commissioning the National Academy of Sciences (NAS) to study how best to add social and behavioral factors to electronic health record reporting.  Washington Free Beacon

So a non-profit online publication, which one would site on the conservative or libertarian side (part of the Center for American Freedom), breaks a huge story, way ahead of the mainstream media, which has major implications for privacy, data security, public health, how goes your doctor or hospital visit and the level of care you receive. Is this EHR TMI (too much information)? The Federal inclusion is being linked to Stage 3 of the Meaningful Use program and reimbursement under Medicare, Medicaid and the Children’s Hospital Insurance Program (CHIP). The NAS already is working on this with the Institute of Medicine to draft suggestions for collecting this behavioral data and identifying “core social and behavioral domains to be included in all EHRs.”

With linking the data to outside Nosey Parkers agencies such as public health entities, the possibilities for identified data becoming insecure or compromised increase dramatically. Will it be accessed (abused) by other entities involved in ACA such as the IRS, state Medicaid databases and Social Security? How much of this data will accidentially leak out in non-deidentified files? Will breaches of millions of non-encrypted records become the norm? Another important and oft-overlooked factor is the additional workload on already overworked hospital and clinical staff, who presently struggle to get comprehensive vital data correctly into multiple fields and screens on present EHRs–a major pain point among many speakers and participants at this past week’s iHT2 Health IT Summit. Finally, there’s the patient. He or she will be pressed to answer, due to penalties baked into the ARRA/HITECH MU3 incentives, the most personal questions about their life and behavior particularly if the diagnosis is one of what euphemistically was called a ‘social disease’. Having spoken this week to those in public health both at iHT2 and at Health 2.0 NYC, this Editor can see it as a deterrent to getting the care they need–or choosing evasion rather than truth with their doctor because there are no more confidences. Even the California Healthcare Foundation, hardly on the right wing, sounds an alarm in iHealthBeat.

Soapbox – what should a restructured 3millionlives do?

September 5, 2013 | by | 6 Comments

Times are tough for those who believe that technology can help improve the efficiency and effectiveness of healthcare delivery to improve patient outcomes. As pointed out by Richard Vize in the Guardian recently, telehealth has become the weapon of choice in the battle between GPs and the NHS, with publications such as Pulse and, most recently the HSJ, continuing to remind readers of the historic, and wholly-unrepresentative-of-telehealth cost effectiveness comparisons for the Whole System Demonstrator (WSD).

At the same time, the national Telehealth Forum’s survey of potential users indicated (more…)

The Internet.org initiative and the real meaning for health tech

September 3, 2013 | by

Internet.org — Every one of us. Everywhere. Connected.

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/02/gimlet-eye.jpg” thumb_width=”150″ /]Much has been made of the Internet.org alliance (release). The mission is to bring internet access to the two-thirds of the world who supposedly have none. It is led, very clearly, by Mark Zuckerberg, founder and CEO of Facebook. Judging from both the website and the release, partners Ericsson, MediaTek, Nokia (handset sale to Microsoft, see below), Opera (browser), Qualcomm and Samsung, no minor players, clearly take a secondary role.  The reason given is that internet access is growing at only 9 percent/year. Immediately the D3H tea-leaf readers were all over one seemingly offhand remark made by Mr. Zuckerberg to CNN (Eye emphasis):

“Here, we use Facebook to share news and catch up with our friends but there they are going to use it to decide what kind of government they want, get access to healthcare for the first time ever, connect with family hundreds of miles away they haven’t seen for decades. Getting access to the internet is a really big deal. I think we are going to be able to do it”

Really? The Gimlet Eye thought that mobile phone connectivity and simple apps on inexpensive phones were already spreading healthcare, banking and simple communications to people all over the world. Gosh, was the Eye blind on this?

Looking inside the Gift Horse’s Mouth, and examining cui bono, what may be really behind this seemingly altruistic effort could be…only business. (more…)