Soapbox: How healthcare disruption can be sidetracked

[grow_thumb image=”” thumb_width=”170″ /]Ron Hammerle’s comment on Disruptive innovation in healthcare hasn’t begun yet: Christensen (TTA 31 Mar), posted on LinkedIn’s Healthcare Innovation by Design group, made the excellent point that a potentially disruptive and decentralizing healthcare service–retail clinics–has been sidetracked, at least in the US, leaving an open question on their reason for being. This Editor thought it was worthy of a Soapbox. Mr. Hammerle knows of what he speaks because his Tampa, Florida-based company, Health Resources Ltd., works with retail and employer-based clinics to connect them via telemedicine/telehealth systems with medical centers.

When Clayton Christensen first anticipated that retail clinics would be disruptive to the established healthcare industry, their business model was potentially disruptive. What has subsequently happened, however, is a prime example of how potentially disruptive movements can be sidetracked.

After acquiring MinuteClinic and laying the foundation for taking retail clinics national, CVS Caremark chose to make deals with hospitals, which could easily afford to rent, open and operate such clinics without making money on the front end or facing real disruption. Retail clinics were a loss leader to hospitals in exchange for large, downstream revenues, and slightly-enhanced market share for the retailer’s pharmacy.

After CVS shocked Walgreens with one-two punches involving MinuteClinic and Caremark acquisitions, Walgreens came back with three counter-punches of its own:

1. They doubled the number of their clinics (to 700) in less than two years, thwarted AMA opposition, leapfrogged ahead of CVS in clinic count and totally changed the retail clinic model by setting up politically-invisible, broader service, make-your-profit-up-front, employer-based clinics. (more…)

PHI data: 361,000 examples that it’s more insecure than ever

We’ve been fairly consistent in our coverage of data breaches, including the regrettable fact that more digital data stored out there on EHRs and devices with low security means Happy Hacking (or Stealing) for Fun and Profit. [TTA 2 Apr] Here’s additional proof, including the first incident this Editor has seen of email phishing:

California, there they go: A theft of eight computers from Sutherland Healthcare Solutions’ medical billing and collections office compromised 338,700 patients’ personal health information (PHI), including SSIs. Sutherland provides services to the Los Angeles County Department of Health Services and Department of Public Health. Being California, three class action lawsuits have already been filed. Kaiser Permanente compromised 5,100 records at their Northern California Division of Research. According to iHealthBeat, it was on a laptop; Health Data Management reports it was on a server. The malware was lurking for 2 1/2 years (!) but it’s not determined whether the data was actually stolen. Phishing scam hits Catholic Health Initiatives, affects 12,000 in multiple states: What looked like an internal CHI email asking for patient information wasn’t– (more…)

“Wearing a fitness tracker…is so 2013”

So begins the article on a stick-on fitness tracker developed by engineers at the University of Illinois at Urbana-Champaign and Northwestern University. Certainly some impressive engineering on display.

Sadly no information is included in the article on how long the tracker stays stuck on, or minor issues like battery life or cost, so I’m not planning on giving up my Jawbone UP just yet. A most interesting development though – one feels it cannot be too long before it becomes implantable and the accelerometer doubles as a power source to top up the battery. Then it will be headline news.

More apparently will be revealed in this month’s issue of Science.

Meanwhile the Vandrico database now covers 195 wearables, a huge rise from the 118 when we first wrote about the database in mid February. Accelerometers are the most popular sensor.

Can the market cope with that level of choice…with Apple still, apparently, to come?

‘Blue Blazes’ indeed: Wal-Mart’s clinic in a back room

[grow_thumb image=”” thumb_width=”150″ /] The surprise here is not that Wal-Mart is teaming with Kaiser Permanente at two locations in California (Bakersfield, Palmdale) to trial a telemedicine/telehealth clinic. Nor is it that it’s confined to KP members and Wal-Mart employees–it is, after all, a pilot (albeit for two years). It’s that they’d let a photographer take a picture of the sheer crudity of the clinic setup (left, below, click to enlarge). It likely utilizes a disused storage area or back room, where the clinic, instead of soothing, clean white or blue, is institutional tan and crammed full of plug-ins–cameras, PC screens, equipment, exposed wires, plugs and outlets. Perfect for the claustrophobic! (s/o) The modish paint and signage at the entry area outside (see article photos) only serve to set up the potential user for disappointment. The question is, why didn’t they simply rent some ready-made kiosks from HealthSpot Station [TTA 29 Oct 13 + previous] or SoloHealth (already a Wal-Mart vendor)–or others? No wonder the nurse has to drag prospects off the floor. Truly a ‘What In Blue Blazes?’ moment that does not bode well for the success of this pilot–and a puzzle given the partners. Wal-Mart shoppers: The doctor will see you now (Bakersfield Californian)[grow_thumb image=”” thumb_width=”180″ /]


Medical Innovations Summit at the Royal Society of Medicine April 5 2014

The RSM held another of its innovation summits last Saturday. In addition to the 13 stimulating presentations, the morning was excellently hosted by past RSM President Robin Williamson whose stand-up comedy skills are surely a close match for his well-known surgical expertise.

The first presentation, from Big White Wall, an online provider of personalised mental health services, was begun by founder Jen Hyatt. She quoted hugely impressive statistics of how 95% of users report feeling better, 80% feel able to take control of their lives and 73% share their feelings for the first time when using the wall. She described how they use a ‘social media scraper’ and algorithms to assess people’s state of mind and suggest treatment plans. Dr Simon Wilson, Clinical director, said there was good evidence that online mental health therapy is as effective as face:face.  He went on to explain in more detail how the service was provided and what steps were taken when people posted genuinely concerning material. This is a superb innovation.

This was followed by Dr Farid Khan, CEO of PharmaKure, a company that looks for  (more…)

A ‘disruptive’ US primary care delivery app with UK roots

This past week, this Editor spoke with Jason Hwang, MD, one of the three co-authors of The Innovator’s Prescription and noted here recently [TTA 31 Mar]. Since leaving the executive director spot at Innosight Institute (now The Clayton Christensen Institute for Disruptive Innovation), he and a team have been developing a smartphone app, PolkaDoc, that may bring a little disruptive innovation to simple primary care. The intent is to make remote primary care for basic needs far more accessible to the general public 24/7, helping to alleviate the shortage (and workload) of US primary care physicians (GPs). The individual first installs the free app from Google Play or Apple’s App Store, answers a simple questionnaire, records a short video to confirm name and date of birth as a verifier/signature, and pays the exam fee via debit or credit card. A doctor then evaluates and prescribes, if appropriate, with prescription pickup at your local pharmacy. According to Dr. Hwang, the first use of this app will be for birth control, charging a modest $10 exam fee, exclusive of the prescription. Technically, the 24/7 coverage is achieved via asynchronous store and forward, which enables significant scalability; any participating physician may ‘see’ thousands of patients a day if desired. The app is fully HIPAA-compliant and on US-based secure servers. The ‘soft’ launch of the PolkaDoc service will start in about two to three weeks.

For our UK readers, this may sound like a variation on something familiar. The ur-model is ‘DrThom‘ acquired by Lloyds Pharmacy in 2011. The eponymous service was developed by one of the partners of PolkaDoc, UK-based OB/GYN Dr. Thom Van Every, to provide sexual health services first by mail and later online. In the UK, this was a premium service at £50. According to Dr. Hwang, the objective is to adapt for the US what has been successfully done in the UK, Australia and other countries, learning from the lessons of its predecessors. With the idea that “simple things are taken care of as simply as possible”, it also matches that concept with low price to be affordable for nearly all women.

My discussion with Dr. Hwang also ranged on the app’s potential use in other healthcare areas and plausible partnerships. More to come on this, certainly.

A small compendium of potentially useful info

In the process of looking for interesting items to highlight on Telehealth & Telecare Aware, occasionally we trip over info that, whilst not riveting in its own right, nevertheless may be of use to readers.  Here is a small selection of recent finds that we will add to – reader additions are most welcome too:

GP EU eHealth/telehealth penetration

The EU has recently published the results of a survey carried out last year on the penetration of eHealth & telehealth in GP surgeries across all EU countries (Croatia joined the EU during the survey) plus Iceland, Norway & Turkey. It comprises a very comprehensive executive summary, a full report, a series of individual country reports (44MB – beware) and a technical annex. Encouragingly it shows high adoption in the UK of EHRs though it’s no surprise the UK slips well down the ranks for things like telehealth adoption by GPs. (Giving extra weight to recent GPonline editorial calling for a change of culture by GPs regarding telehealth).

Reference to “N.H.S.” in the charts was (more…)

Police innovation fund – closing date 30th April 2014 (UK)

Of possible interest to readers is the offer of £50m of Home Office funding for the use of innovative technology to improve policing. Interest is indicated in everything from wearables, such as body-worn cameras, to shared digital infrastructure with other services, such as health. Bids need, obviously, to involve one or more police forces and be signed off by a Police & Crime Commissioner.

Read Damian Green’s speech introducing it. Further details, including the application process, are here.

Hat tip to Prof Mike Short.

Med-e-Tel 2014 Luxembourg

Next week’s Med-e-Tel (9-11 April) conference announced their final day of advance registration (today, 5 April) but if you are interested in going, please contact them directly for onsite information. The Journal of the International Society for Telemedicine and eHealth (ISfTeH), the publication of the main organizer of the conference, has published presentation abstracts in advance of the conference here. Conference website. ISfTeh April newsletter. New (7 April) overview press release. TTA is a past (and still listed as a) media sponsor of the event. If you are attending and 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.  

Scanadu hitting the tech ‘glitch’ wall?

[grow_thumb image=”” thumb_width=”150″ /]Tricorder XPrize-qualifying Scanadu, which eventually raised a stunning $1.6 million on Indiegogo [TTA 23 May 13], has stopped delivery of units to its early backers which started on 31 March. According to its blog late this week, their readings were not working as expected for temperature, there were inconsistencies in reading scans between the Scanadu device (categorized as ‘investigational’) and the app (via the smartphone), and the manufacturing tool to make the devices broke. Scanadu CEO Walter De Brouwer stated that “We hope that this (the delay) will not be more than 8-12 weeks.” The Scanadu Scout was also submitted for FDA clearance but requires usability studies to gain approval. In this Editor’s experience, all tech devices eventually hit the ‘glitch wall’, either at or near the outset or when the system scales up. Better to fix now than later, and kudos for their C-level for being forthcoming–because most are not. Also MedCityNews.

HHS draft report on health IT framework published

Another part of the 2012 FDA Safety and Innovation Act (FDASIA) clicked into place with the US Department of Health and Human Services (HHS) publishing a draft report proposing strategy and recommendations for what is rather grandly termed a “health IT framework”. Basically it defines more unified criteria, based on risk to the patient and function of what the device does, not the platform (mobile, software, etc.). It then separates products into three broad categories. Excerpted from the FDA release and the FDASIA Health IT Report:

  1.  Products with administrative health IT functions, which pose little or no risk to patient safety and as such require no additional oversight by FDA. Examples: billing software, inventory management.
  2. Products with health management health IT functions. Examples: software for health information and data management, knowledge management, EHRs, electronic access to clinical results and most clinical decision support software. This will be coordinated largely by HHS’s Office of the National Coordinator for Health IT (ONC) as part of their activities (including their current voluntary EHR certification program), but the private sector is also cited in establishing best practices.
  3. Products with medical device health IT functions, which potentially pose greater risks to patients if they do not perform as intended. Examples: computer-aided detection software, software for bedside monitor alarms and radiation treatment software. The draft report proposes that FDA continue regulating products in this last category. (Illustration on page 13 of report.)

The report also recommends the creation of a public-private entity under ONC, the Health IT Safety Center, which “would serve as a trusted convener of stakeholders and as a forum for the exchange of ideas and information focused on promoting health IT as an integral part of patient safety.” The private sector is duly noted as a ‘stakeholder’.

The report was developed by FDA “in consultation” with ONC and, not unexpectedly, the Federal Communications Commission (FCC). Another recommendation (page 28) is the establishment of a ‘tri-Agency memorandum of understanding (MOU)’ to further determine their working relationship in this area. There’s a 90 day comment period on the 34 page report, which is perfect for weekend reading (!) How this onion will eventually be peeled, rather than quartered, remains to be seen, as does anything emanating from Foggy Bottom.  FDA release. Report. FierceMobileHealthcare.

Update 8 April: A good summary of criticism and approval of the framework to date appears in iHealthBeat from the California Health Care Foundation. The two US Senators sponsoring the PROTECT Act [TTA 28 Feb, 6 Mar] stated there is still too much regulation of low-risk technologies, and Bradley Thompson of Epstein Becker/mHealth Regulatory Coalition believes the report is weak on the issues around clinical decision support software. With praise: HIMSS, Health IT Now Coalition and ACT, which claims to represent about 5,000 mobile application developers and IT firms, but has no locatable website.

Previously in TTA: FDA finally issues proposed rule simplifying medical device classification

Picture murky: 23andMe and the FDA

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)

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 AustraliaThe George Institute for Global Health Australia project page which extends the study to GP clinics

Mobile alerting trials for public emergencies (UK)

This service potentially will be used in the UK (as in other countries) to alert people in a particular area via their mobiles of an emergency and may give them appropriate instructions on what to do. The service does not require the government or anyone else to know individual mobile numbers – it works on all mobile devices within an area defined by the emergency.

Three trials were run last autumn, working with three of the UK’s biggest mobile network operators to test different technical approaches for such a system. Two different approaches were tested as part of the trials:

  • cell Broadcast service (CBS): the broadcast of a text-type message to all handsets in a defined area
  • location-based SMS messaging: all numbers in a specific location receive a traditional SMS message

Of the two, (more…)