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New mHealth App Certification – The Next CCHIT Like Mistake

Posted on January 17, 2012 I Written By

John Lynn is the Founder of the blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of and John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

I first heard about the new Secure, Branded App Store for Hospitals and Healthcare called Happtique in early December on Techcrunch. At its core, I think it’s an interesting idea to try and filter through what the article claims are “23,000 mobile health apps available for iOS and Android.” Helping physicians and hospital administrators filter through these apps could be valuable. Plus, most hospital administrators would love a way to have a phone that was limited on which apps it could download.

Well, it seems that the company has shifted gears a little bit. As Brian Dolan from Mobi Health News reported, Happtique is taking the first steps to setting up a certification for mobile health apps.

Happtique, a healthcare-focused appstore, announced plans to create a certification program that will help the medical community determine which of the tens of thousands of health-related mobile apps are clinically appropriate and technically sound. The company has tapped a multi-disciplinary team to develop the “bona fide mHealth app certification program” within the next six months. The program is open to all developers and will be funded by developer application fees.

It will certify apps intended to be used by both medical professionals and patients.

While I think that providing some way for people to filter through the large number of mobile apps, I think certification is a terrible way to go about it. Many people know I’ve written many an article about CCHIT pre-EHR incentive money and how screwed up the CCHIT EHR certification was for the industry. I think it’s just as bad news for Happtique to create a certification for the mobile health industry.

Turns out that Happtique seems to have agreed with this idea back in October 2010 where they said in a MobiHealthNews interview, “We are not in the business of opining whether an app is ‘good’ or ‘bad’ though. That’s not our role. Apple doesn’t do that and others don’t either. If the FDA indicates that an app is a medical device and needs to be regulated, well, that’s a different situation and we can take it out of the store.” Seems they’ve seen a different business opportunity.

They have a couple recognizable names on their board to create their certification including Howard Luks and Dave deBrokart (better known as e-Patient Dave), but I believe they’re going to find that it’s an impossible task. First, because they won’t have the breadth of knowledge needed to create certification requirements for every type of mHealth app. Second, what value will the certification really provide? Third, how do you make the certification broad enough to apply to all 20,000+ apps while still providing meaning to those using a very specific mHealth app? Plus, I’m sure there are many other issues I haven’t thought of yet.

The problem with these certification ideas is that they start with great intentions, but always end up bad.

Lessons Learned from FDA Cleared Mobile Health Devices

Posted on May 6, 2011 I Written By

Like so many other things the government may start making life more difficult for mHealth companies in the future through regulations.  It really does not surprise me as they like to stick their nose in everything, but there are a few different perspectives at this point.  There is a great article by Brian Dolan at about FDA Cleared Mobile Health Devices.  I have included a few interesting parts of the article below.  It is clear that the FDA will change their involvement the question is now what impact they will have.

“We need to balance our desire for safety with rational risk tolerance and transparency,” the West Wireless Health Institute’s Chief Medical Officer Dr. Joseph Smith said during his presentation at the Institute’s Health Care Innovation day in Washington, DC last week. “And I think — I’ve not shared this with them — but I think we need to get the FDA out of the business of assuring absolute safety and into one of absolutely assuring transparency around risks and making sure decisions are well-informed as opposed to trying to protect all of us from the rare circumstances of failed technology.”At the event FDA officials confirmed that a draft guidance document focused on how the agency might regulate health apps would likely publish in the coming months. Officials acknowledged that apps included just a small sliver of the activity going on in mobile health, but it is a start. The FDA will seek commentary on the draft document from the industry during a 60 or 90 day period, officials said.

“Our intent was to support both patients and healthcare providers in the management of chronic disease,” Sysko said. “As we looked at the regulations as early as 2005 of the software that the FDA had published, it was really clear to us that we were an accessory to a medical device — an accessory to a blood glucose meter… We thought that there were sufficient guidelines from a software perspective to go ahead. Little did we know that it would be a long journey and there were many bumps along the way — many self-inflicted — but we felt that it was absolutely something we would have to do to bring our product to market.”