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…)

‘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…)

HIMSS’ last full day highlights company partnerships

[grow_thumb image=”http://telecareaware.com/wp-content/uploads/2015/04/himss_chicago_2015-588×337.jpg” thumb_width=”150″ /]It’s almost time to Say Goodbye to Sinatra’s ‘My Kind of Town’, but there’s still news: Samsung+Partners Healthcare, IMS Health, AliveCor, Interoperability≠Humana, Panasonic+Cisco

  • Samsung and Partners HealthCare announced a direct-to-mobile partnership to develop chronic care management mobile software that monitors vital signs such as blood pressure, blood glucose and weight, as well as delivers mobile patient engagement, medication adherence and wellness self-management. Clinical trial is scheduled for June. Partners has always been a pioneer in the mHealth area, but playing with Samsung, Partners is flying at a slightly higher level than with Wellocracy and certainly the late Healthrageous. Partners release, Mobihealthnews (more…)

Certifying health apps: is it at all possible?

This article in iMedicalApps takes a look back at the controversy that swirled around Happtique only four weeks ago–when Harold Smith III of Monckton Health and Fixmo went public on major data security flaws in two of their 19 certified apps–and moreover how Happtique did not respond to his concerns either in December or on the process in March [TTA 13 Dec]. It was the talk of the last big US gathering prior to International CES, the mHealth Summit.

Unfortunately, Satish Misra, MD, one of their editors, provides an argument best described as a ‘circular firing squad.’ Dr. Misra is absolutely correct on the enormity of curating and certifying tens of health/medical apps. But the point of the article seems to be that any kind of evaluation mechanism or certification is a fool’s errand.

The logic presented as this Editor interprets the article: Since Happtique’s certification process had standards which were complicated and arbitrary (plus, as it turned out, flawed), it proves that it’s useless to pursue standards and certification. In addition to being ‘resource intensive’ for reviewing tens of thousands of apps, standards cannot decide what app is the right choice, even if that was not the intent of the certification. So doctors and ‘end users’ have to become ‘app-literate’; hang the fact that the point of curation and certification is to do at least some of the heavy lifting (pre-screening) job for them beforehand! Back to the start: reading all the peer review stuff on thousands of medical apps, if it’s reviewed at all, as iMedicalApps does for some. (And will these reviews be 100% accurate? Will they subject every app to data security screening? What are their standards?) Back to Square One: DIY and Dodge City. Apps present too much (unpaid) work for docs to think about, patients use (then abandon) apps that can be privacy risks, because they don’t know any better and they aren’t white-hat hackers after all….

Remaining unconsidered by iMedicalApps is the plausibility of what Master Data Cruncher IMS Health is taking on with AppScript and AppNucleus [TTA 15 Dec]: a proprietary 25-point methodology (AppScore) that automates the classification and evaluation of health apps plus a hosting platform that uses IMS information to assist developers in creating secure, effective apps.

A far more detailed exploration of why at the very least an objective certification/evaluation process is needed is explored by Editor Charles in his continuing series Driving Up Medical App Usage in the UK, especially Part II (Part I here.) Watch for Part III shortly.

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…)