Xcertia takes another pass at app certification, but will it fly? (US)

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2015/12/alp-mountains-peaks-in-winter.jpg” thumb_width=”150″ /]An app developer and a healthcare/digital health innovation lab get into the certification game. Can they fly over the treacherous peaks this time? Social Wellth made good on their promise (or threat?) to get into the app vetting business this past week through announcing a partnership with Columbia University-based HITLAB at the HITLAB Summit this week to develop a certification organization known as Xcertia. Last year, Social Wellth acquired the remains of Happtique from GNYHA Ventures [TTA 12 Dec 14]. The Xcertia principles center around privacy, security, operability and content–as Happtique’s did. The intent is to not only develop a program to certify apps based on established standards, but also form a Signature Steering Committee to ensure they maintain “their definitive set of criteria for evaluating mobile health apps.” MedCityNews, release

Possible conflict of interest. It all sounds positive, but the head of Xcertia, David Vinson, is also the CEO of Social Wellth, which despite its nonprofit-ish name makes its living by developing consumer apps and “dashboards” for insurance companies, a task grandly called (from their press release) “the curation of digital health experiences by leveraging mobile health technologies that allow for integration and aggregation of all digital assets.” Social Wellth also makes quite a bit of hay on its website about app curation for its clients. (more…)

When disruptive healthcare tech disrupts the wrong things, including safety

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2014/04/Thomas.jpg” thumb_width=”150″ /]Last week’s Health 2.0 conference was (of course) a three-ring circus of new technology and its corollary, a lot of hype. An astute writer new to this Editor, Michael Millenson, draws together the key points of two prominent, but not hyped speakers there: Robert Wachter, MD and Michael Blum, MD, both practicing in University of California San Francisco’s (UCSF) medical center. Dr Wachter, chief of the Division of Hospital Medicine, has been profiled in these pages earlier this year in a review of an excerpt from his book, The Digital Doctor: Hope, Hype and Harm at the Dawn of Medicine’s Computer Age. There he wrote about the example of Pablo Garcia, nearly dying from over-prescribed doses of an antibiotic that a chain of errors in their EHR started. Dr Blum is Director of UCSF’s Center for Digital Health Innovation. But their points are on the same track: “the danger of disruptive technology that disrupts the wrong things: upsets checks and balances that keep patients safe, makes working conditions more stressful and simply doesn’t play well with others.” His conclusions are on the money: #1, it’s not the technology but the adaptive change that front and back line clinicians will need to make; #2, entrepreneurs with whiz-bang tech that zips data to the clinician without fitting it into a care process are doomed to fail; #3 some kind of curation is needed. But whether that will be Care Innovations’ Validation Institute or Social Wellth (which purchased the late Happtique from GNYHA) is another story. Key for Health IT Entrepreneurs: Don’t Disrupt the Wrong Thing (Forbes)

‘Separating the wheat from the chaff’ in medical apps daunting: JAMA

Medical apps may not be strangers to doctors’ offices anymore but they also realize that apps are difficult to recommend responsibly to patients or even to find, because there is no real guidance or validation. This current article in JAMA online confirms the perception and the need for care integration that both Editors Charles especially and Donna have pointed out lo these many years. However this Editor is quite disillusioned at the attempts to date to ‘curate’ apps with the Happtique failure and the relatively low profile to date of IMS Health’s AppScript and professional review site iMedical Apps and the stated intentions of SocialWellth which purchased Happtique. The reality is that the numbers are against it–IMS Health in their study estimated 40,000 medical apps–in 2013. For apps that want to take the high road, it’s economically difficult, but could be rewarding in the long term. The WellDoc BlueStar diabetes tracking and management support app did with FDA clearance and prescription-only use, but few so far can see a revenue model there. Also MedCityNews.

Intended use determines degree of health app regulation–and also how you communicate your attributes and performance claims. Bradley Merrill Thompson, who performs an invaluable service by advising our field on regulation, compliance and interacting with FDA, demonstrates how a developer can determine where the intended use of an app might fall (more…)

Looking back over Telehealth & Telecare Aware’s predictions for 2014, part II

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2015/01/magic-8-ball.jpg” thumb_width=”150″ /]Editor Charles has treated you to a look back on his 2014 predictions, daring Editor Donna to look back on hers. Were they ‘Decidedly so’, ‘Yes’, ‘Reply hazy, try again’ or ‘My sources say no’? Read on…

On New Year’s Day 2014, it looked like “the year of reckoning for the ‘better mousetraps’”? But the reckoning wasn’t quite as dramatic as this Editor thought.

We are whipping past the 2012-13 Peak of Inflated Expectations in health tech, diving into the Trough of Disillusionment in 2014.

There surely were companies which turned up ‘Insolvent with a great idea’ in Joe Hage’s (LinkedIn’s huge Medical Devices Group) terms, but it was more a year of Big Ideas Going Sideways than Crash and Burns.

Some formerly Great Ideas may have a future, just not the one originally envisioned. (more…)

ATA in the accreditation arena for online patient visits

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2014/12/ata-seal-of-accreditation.png” thumb_width=”150″ /]The American Telemedicine Association (ATA) has joined the gold rush of accreditation, in this case for online ‘virtual’ visits between doctor and patient only. US providers (only) can apply to ATA’s Accreditation Program for Online Patient Consultations through a multi-step process for vetting up to three years.

  • First round application clears a company for eligibility. Through 28 Feb 2015, it is also open to ATA members only: Institutional Members, Sustaining President’s Circle and President’s Circle. On 1 March it will open to all companies in the US. Canada accreditation will start at a date to be announced in 2015.
  • Once eligible, the second round application contains ATA Administrative Rules & Terms, Standards and Guidance, Application Form, Program Overview and Fee Schedule. Fees are annual, based on the numbers of providers of online, real-time patient consults in all service lines, which presumably means areas such as primary care, behavioral, pediatric etc.
  • The company provides an application and supporting documentation. ATA then conducts a survey to review the documentation, online resources and demonstration of online services. During the process, ATA says it will notify about areas which are not compliant and organizations will have the opportunity to “provide a plan of corrective action and present corrective materials to show compliance before a final decision regarding accreditation is rendered.”
  • The accreditation is valid for three years, contingent on submitting an Annual Accreditation Report at the beginning of year 2 and 3 of its accreditation cycle.

Of interest to your Editors and readers is how this accreditation was developed.  (more…)

Journal starts peer review process–at a price–for mHealth apps

If the rosy future of mHealth apps [study here] is to be achieved, some form of validation and review is needed, but is ‘pay to play’ the way to go?. The Journal of Medical Internet Research has come up with a peer review process which gives, in the words of mHealthNews, “developers a chance to have their products evaluated by “medical and mHealth experts from the JMIR peer-reviewer database (possibly complemented by consumers/patient experts) for a cool $2,500 per app.”  Aside from the price, (more…)

Certifying medical apps (contd.)

No sooner had I given my keyboard the final tap to publish the conclusions of my work yesterday on medical apps than the first item hit my inbox that suggest that certification is a flawed proposition.

The suggestion of this iMedicalApps article is that the Happtique saga has shown certification to be impossible. Instead it is suggested that people make up their own minds based on peer review on sites (you’ve guessed it) such as theirs, and a greater understanding of apps.  The key paragraph for me is (more…)

Driving up medical app usage in the UK – part II

Introduction

This series of posts covers some work I have been doing over the past three months: attempting to answer the question of how best to improve the perception by clinicians and patients of the efficacy of health-related apps. This work has been done for the i-Focus project, part of the Technology Strategy Board’s dallas programme.

Part I attempted to summarise the EU regulations covering health-related apps. The point was made that any health-related app must comply with data protection and consumer protection requirements, irrespective of whether the risk level is sufficient for it to be classified as a ‘medical device’. Where an app is classified as a ‘medical device’ it also has to be classified so that the appropriate adjudication work can be determined for it to receive a CE mark (Class I, lowest risk, requires least investigation; Class III, highest risk, requires greatest investigation).

This post summarises the principal findings from discussions with a very wide range of potential stakeholders, (more…)

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

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

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…)

Is the ‘last mile’ of app certification efficacy metrics?

News and announcements around app certification definitely were hot topics in the past week or so, but are they more heat than light? Do these certifications adequately address efficacy? Stephanie Baum, in her follow-up to the Happtique kerfuffle in MedCityNews, opens up the discussion with the proposition: “It seems like there needs to be some way to prove that apps actually help people.” Bradley Merrill Thompson of Epstein Becker & Green points out “It’s certainly useful to know that an app works from a software perspective reliably, but it is even more valuable to know that the app can actually improve health.” While Happtique certification standards have a gap here, this Editor would point out that they were evolved nearly two years ago when the reporting/analysis needed for this was largely not available. Newer programs such as Johns Hopkins’ mHealth Evidence and the new IMS Health AppScript [TTA 15 Dec] can dip into the ‘big data’ pool far more effectively. Will Happtique be able to address this, or leave the ‘last mile’ to others? And what is the real and quantifiable demand for app certification anyway? Health app prescribing by physicians is a question mark in this Editor’s observation; the larger market may be health plans and programs such as Partners HealthCare’s Wellocracy, Cigna’s GoYou  and Aetna’s CarePass.

IMS Health enters health app ranking, prescribing

Global healthcare informatics provider IMS Health during mHealth Summit announced its entry into mHealth prescribing and evaluation with AppScript. They also are getting into the development standards business with AppNucleus, a hosting platform that from the description, will guide developers in designing secure, HIPAA and HITECH Act compliant apps using IMS Health information and data analytics. AppScript uses a proprietary methodology called AppScore to classify and evaluate apps based on functionality, peer and patient reviews, certifications, and their potential to improve outcomes and lower the cost of care. According to Information Week Healthcare, AppScore includes 25 criteria developed by IMS and its physician advisors (more…)

Happtique halts app certification on data security concerns

Health app industry self-policing and ‘trusted sourcing’ credibility at stake?

Updated below. Last week, after Happtique announced its ‘Inaugural Class’ of 19 certified apps [TTA 2 Dec]–certified on their standards of operability, privacy, security and content–a young HIT software developer, Harold Smith III, discovered some major security flaws in two of them: MyNetDiary’s Diabetes Tracker and TactioHealth5. User names and passwords were stored in plain text files–not encrypted–and Mr. Smith then subjected them to a ‘man in the middle attack’ (MITM) which he explains as “…where a nefarious source intercepts your communication from the App to the server. They decrypt the SSL connection, pull out your data, and send the data on to the server.” Both failed. Worse, the ePHI (ePersonal Health Information) of both were not sent in a secured way and not stored in secure, encrypted files. After advising both companies of the problems (including one of these companies in person at the mHealth Summit), as well as Happtique, and receiving no satisfactory response after days passed, Mr. Smith went public Tuesday and Wednesday on his blog mHealth and Mobile Development. Both articles deserve careful reading. Our readers with software development background will appreciate 1) his meticulousness and 2) his ire not only at Happtique but their validator, Intertek, at the poor technical quality of their vetting; the non-techies like your Editor will appreciate the clarity of his writing.

Small blog, big impact today. Happtique has suspended its certification program (website notice) and on its website now has revised certification standards. Regarding the credibility of Mr. Smith, (more…)

Happtique certifies 19 health apps

Happtique, which started in 2011 as a health app certifier and curator, then ‘pivoted’ to what they term a “virtual marketplace and distribution platform” (?) after a major management change this spring, has mystifyingly announced the ‘Inaugural Class of 2013’ of 19 certified health apps. These presumably passed certification guidelines finalized in September 2012. But the bare list of apps and links leads this Editor to more questions. Is this meant for the clinical market as part of their mRx program? Consumer market? And how will they find out? While the apps range from the obscure (Amazing Abs) to the expected (MyNetDiary’s Diabetes Tracker) to the well-known from major names (GreatCall’s UrgentCare, which counts as two on the list), it’s hard not to feel a certain sense of underwhelm at this news: 19 out of nearly 30,000 counted by iMedical Apps [TTA 23 July] and even against the 200 listed in MyHealthApps [TTA 26 Nov]. MedCityNews’ light and oddly edited article only adds to the mystery. And Mobihealthnews reveals that the 10 companies listed paid for certification of their apps, which is not surprising, but if more than a nominal amount (application fee) very well takes away from the impression of objective certification. 

Ed. Note: Over the past three days this Editor has contacted Happtique to confirm the application fee and to generally comment on the program. As of this writing (Thursday 8:30pm NY time), no reply has been received. However, a FierceMobileHealthcare interview with then-CEO Ben Chodor gave a range of $2500-3000 to certify an app for two years, with a 30 day turnaround time.

Launches: MyHealthApps directory, mobile mental health app in Cambridgeshire

MyHealthApps launches; Sun Network launches Crisis Card app for Cambridgeshire residents

Last year at this time, the PatientView patient research firm published The European Directory of Health Apps 2012-2013 with about 200 entries. Alex Wyke from PatientView has been kind enough to follow up and let us know as a comment on the original article [TTA 15 Nov 2012] that it has been expanded and relaunched as MyHealthApps. The site has grown to 307 apps selected by over 450 patient groups and with ‘heart’ ratings on a five-point system. While not comprehensive yet, notably it is now a truly international website with mirror sites in 48 languages from Albanian to Welsh, including four varieties of English (!) There are also submission links for patient groups and developers. PatientView developed this with support from: GSK, Janssen, Novo Nordisk, O2/Telefonica Europe, Vodafone Foundation, NHS England’s Library of Health Apps, UK government body KTN CONNECT and the European Commission’s Directorate General for Communications Networks, Content and Technology (DG CONNECT). The patient group review and backing (more…)

The lack of evidence in health IT and patient engagement

In health economist/consultant Jane Sarasohn-Kahn’s lengthy analysis of the IMS Research report, Patient Apps for Improved Healthcare: From Novelty to Mainstream, ‘mainstream’ does not necessarily mean that apps deliver value–in health outcomes, health support or behavior change–which is why doctors have largely ignored them. For the 43,000+ ‘health apps’ so categorized in the Apple iTunes store, only 23,000 met IMS’ criteria of a ‘genuine health app.’ Few apps manage chronic disease for the highest health spenders or assist seniors, amazingly 5 apps =15 percent of all downloads with most apps having less than 500 downloads. Most apps provide information only and only 20 percent capture/track user data. Not dissimilar to the Manhattan Research smartphone study [TTA 30 Oct], the bulk of apps address behavioral health, eyes and hearing, endocrine and nutrition, heart/circulatory, musculoskeletal, and cancer. In IMS’ view, (more…)