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FDA Limitations Could Endanger Growth Of mHealth

Posted on December 28, 2015 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

mHealth technology has virtually unlimited potential. But until the FDA begins putting its stamp of approval on mHealth tools, many providers won’t take them seriously. And that could be a big problem for mHealth’s future.

Unfortunately, early signs seem to suggest that the FDA is in over its head when it comes to regulating mHealth. According to speakers at a recent FDA Law Institute conference, it could be years before the agency even has a solid idea of how to proceed, Bloomberg reports.

Jeffrey Shapiro, a member of the Washington, D.C. law firm of Hyman Phelps & McNamara P.C., told the conference the FDA just isn’t equipped to handle the flood of new mHealth approaches. “Experience has shown that the FDA’s almost 40-year-old regulatory framework is a bad fit for much of today’s health IT with its networked ecosystems, rapid iterative improvement, deep collaboration between providers and end-users and focus on clinical decision support rather than direct diagnosis or treatment,” he told the audience.

The FDA dismisses the notion that it’s not prepared to regulate mHealth technologies. Bakul Patel, the agency’s associate director for digital health, told Reuters that the agency is planning to fill three new senior health scientist positions focused on digital health soon. That’s an encouraging step, though given that there are more than 165,000 health apps on the market, probably an inadequate one.

Sure, few of those app developers will apply for FDA approval. And the agency only plans to demand approval for technologies that are designed to be used as an accessory to a regulated medical devices, or transform a mobile platform into a regulated medical device. mHealth devices it has already approved include Airstrip Remote Patient Monitoring, the AliveCor Heart Monitor for iPhone and McKesson Cardiology’s ECG Mobile.

On the other hand, if Shapiro is right, the FDA could become a bottleneck which could severely stunt the growth of the U.S. mHealth industry. If nothing else, mHealth developers who seek FDA approval could be faced with a particularly prolonged approval process. While vendors wait for approval, they can keep innovating, but if their proposed blockbuster product is in limbo, it won’t be easy for them to stay solvent.

Not only that, if the FDA doesn’t have the institutional experience to reasonably evaluate such technologies, the calls it makes as to what is safe and efficacious may be off base. After all, apps and remote monitoring tools don’t bear much resemblance to traditional medical devices.

In theory, upstart mHealth companies which don’t have the resources to go through the FDA approval process can just proceed with their rollout. After all, the agency’s guidelines for requiring its approval are reasonably narrow.

But in reality, it seems unlikely that providers will adopt mHealth devices and apps wholesale until they get the FDA stamp of approval.  Whether they geniunely consider non-approved devices to be too lightweight for use, or fear being sued for using questionable technology, providers seem unlikely to integrate mHealth technology into their daily practice without the agency’s green light.

Given these concerns, we’d best hope that the FDA doesn’t begin requiring its approval for EMRs. Or at the very least, we should be glad that it didn’t jump in early. Who knows where EMR infrastructure would be if vendors had had to play patty-cake with the FDA from day one?

Does adding all these EHR and other tech add or subtract to healthcare?

Posted on May 7, 2013 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.

Such a compelling and tough question to consider. Let me repeat it again so you can let it roll around in your mind for a minute:

Does adding all these EHR and other tech add or subtract to healthcare?

This was one of the off hand comments I heard someone make in their presentation at TEDMED and I think it’s a serious question that every EHR company and healthcare IT vendor should consider.

The simple answer to the question is that some companies add to healthcare and some take away from healthcare. That’s just the nature of markets. However, there’s a deeper part of the question which fundamentally asks if the shift to electronic is helping healthcare or hurting it.

As I’ve mentioned previously, at my core I believe that technology has an overall positive impact on any industry. In my heart I believe that technology has the potential to improve most things.

My fear with the above question is whether we’re implementing the right technology that will help us have a positive impact on healthcare or whether we’re currently implementing dated technology which will set us back for years to come.

I got in a heated discussion today on LinkedIn about the MUMPS database. A HUGE portion of healthcare is built on the back of MUMPS. Nothing against MUMPS (although it does sound like an STD), but is it going to be powerful enough to “add” to healthcare or will we reach a point that its limitations start subtracting from what could be possible?

I don’t necessarily want this post to become a MUMPS pros and cons post, but I think it’s a great illustration of why I’m reticent to say that the technology foundation that healthcare is building today is providing a platform for an amazing healthcare IT future.

On the other side of the spectrum is the plethora of smart phone apps and devices in healthcare. You can’t tell me that the Alivecor device or AirStrip’s work in the mobile field isn’t incredibly exciting. They’re leveraging the latest technology in a beautiful way.

One challenge we do face is the HUGE number of EMR companies and mobile health apps. With so many companies, we’re bound to have a healthcare software graveyard soon. Hopefully the companies we find in the graveyard are those who were subtracting from healthcare instead of adding to it. Unfortunately, that’s still just a hope and may not be the reality.

Many of our newer readers might not be familiar with my reference to Jabba the Hutt EHRs. The concept would seem to apply well to this post. For those not familiar with the concept, Jabba the Hutt was a really powerful individual, but it’s safe to say that he wasn’t very nimble. Does this sound a bit like some of the healthcare IT and EHR companies that dominate the market today?

Maybe I’m wrong, but the nimble innovative companies are the ones that usually add the most to healthcare versus subtracting. Luckily history is on my side. I’m just not sure we have enough Princess Leia companies that are in a position to wrap their chain around the neck of Jabba the Hutt companies.

I’ll let you decide which companies you believe add to healthcare and which ones subtract from healthcare. Although, I think we’d all benefit if every company focused on adding to healthcare.

Improving the EHR Interface and Topol Saves Patient’s Life on Flight Home

Posted on March 5, 2013 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.

As I thought through my day at HIMSS, a theme started to emerge from all the dozens of meetings I’ve already had at the show (with many more still to come). The theme I saw coming out was ways to improve the EHR interface. This is a much needed change in EHR’s, so it was interesting to see a whole series of companies working on ways to make the EHR interface better. Here are some of the highlights from companies I talked to at HIMSS.

SwiftKey – While the SwiftKey product can be used in the consumer space as well, it was interesting to see the technology applied to healthcare. SwiftKey is basically a replacement for your mobile device keyboard. In fact, I’d call SwiftKey a smart keyboard for your mobile device. What does it do to make your mobile device keyboard smart?

First, it offers word suggestions you can easily choose as you start to type. Most people are familiar with this base functionality because it exists in some form in most mobile keyboards (or at least it does on my Android). However, they’ve taken it a couple steps further. They actually use the context of what you’ve typed to predict what word you may want to type next. For example, if you type, “nausea and” then it predicts that you’ll want to type vomiting. If you type “urinary” then it will predict tract and then infection. Plus, they told me their algorithm will also learn your own colloquial habits. Kind of reminds me of Dragon voice recognition that learns your voice over time. SwiftKey learns your language habits over time.

I’m sure some of these predictive suggestions could lead to some hilarious ones, but it’s an interesting next step in the virtual keyboards we have on mobile devices. I’ll be interested to hear from doctors about what they think of the SwiftKey keyboard when it’s integrated with the various EHR iPad apps.

M*Modal and Intermountain – Thinking back on the demos and products I’ve seen at HIMSS 2013, I think that the app M*Modal has created for Intermountain might be the coolest I’ve seen so far. In this app, a doctor would say an order for a prescription, and the M*Modal technology would apply voice recognition and then parse the words into the appropriate CPOE order fields. It was pretty impressive to see it in action. Plus, the time difference between speaking the order and trying to manually select the various order fields on the mobile device was incredible.

I was a little disappointed it was only a demo system, but it sounds like Intermountain is still doing some work on their end to make the CPOE happen. I’m also quite interested to see if a simple mobile app like this will see broad adoption or if more features will need to be added to get the wide adoption. However, it was almost like magic to see it take a recorded voice and convert it into 5-7 fields on the screen. I’d be interested to see the accuracy of the implementation across a large set of doctors, but the possibilities are quite interesting for transforming the CPOE interface.

Cerner Mobile – One of the new Cerner ambulatory EHR features is an iPad interface for the doctor. I’m sure that many will think this is old news since so many other iPad EHR interfaces are out there. In some ways it is, but there was a slickness to their app that I hadn’t seen a lot of places. In fact, the demo of their ambulatory EHR iPad app reminded me a lot of the features that I saw in this video Jonathan Dreyer from Nuance created (bottom video) that demonstrated some of the mobile voice capabilities. Plus, the app had a nice workflow and some crazy simple features like doing a refill. One swipe and the med was refilled. Almost makes it too easy.

Canon – This is a little different than some of the other EHR interface things I talk about above. In the case of Canon it was interesting to see the tight integration that’s possible between the Canon scanners and EHR software. Instead of the often laborious process of scanning to your EHR and assigning it to a patient, Canon has a scan direct to EMR option including analyzing the cover sheet to have the scanned document attached to the right patient and EHR chart location. While we’d all love to have paper gone, it will be a part of healthcare for the forseeable future. The scan direct to EMR is a pretty awesome feature.

Those are a number of the EHR interface things that I’ve seen so far at HIMSS. I’m sure there are dozens of others out there as well. I think this is a great trend. Sure, each of these things is only a small incremental change, but with hundreds of EHR vendors all doing small incremental changes we’re going to see great things. That’s good, because many of the current EHR interfaces are terribly unusable.

In an related topic, Eric Topol gave a keynote address at HIMSS today. He had glowing reviews from what I could tell. Although, what’s an even more powerful story is to see the message he shared at HIMSS in action. On Topol’s flight home to San Diego a patient was having some medical issue. He did the ECG right on the plane using his smartphone and the passenger was able to make it safely to the destination. You can read the full story here. What’s even more amazing is that this is the second time something like this has happened to Topol. This probably means he flies too much, but also is an incredible illustration of the mHealth technology at work. Truly amazing!

Full Disclosure: Cerner and Canon are advertisers on this site.