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FDA Announces Precertification Program For Digital Health Tools

Posted on October 5, 2017 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

The FDA has recruited some the world’s top technology and medical companies to help it pilot test a program under which digital health software could be marketed without going through the through the agency’s entire certification process.

The participants, which include Apple, Fitbit, Johnson & Johnson, Samsung and Roche, will give the agency access to the measures they’re using to develop, test and maintain their software, and also how they collect post-market data.

Once armed with this information, the FDA will leverage it to determine the key metrics and performance indicators it uses to see if digital health software meets its quality standards.

Companies that meet these new standards could become pre-certified, a status which grants them a far easier path to certification than in the past. This represents a broad shift in the FDA’s regulatory philosophy, “looking first at the software developer digital health technology developer, not the product,” according to a report previously released by the agency.

If the pilot works as planned, the FDA is considering making some significant changes to the certification process. If their processes pass muster, pre-certified companies may be allowed to submit less information to the FDA than they currently must before marketing a new digital health tool.  The agency is also considering the more radical step of allowing pre-certified companies to avoid submitting a product for premarket review in some cases. (It’s worth noting that these rules would apply to lower-risk settings.)

The prospect of pre-certifying companies does raise some concerns. In truth, the argument could be made that digital health software should be regulated more tightly, not less. In particular, the mobile healthcare world is still something of a lawless frontier, with very few apps facing privacy, security or accuracy oversight.

The fact is, it’s little wonder that physicians aren’t comfortable using mobile health app data given how loosely it can be constructed at times, not to mention the reality that it might not even measure basic vital signs reliably.

It’s not that the healthcare industry isn’t aware of these issues. about a year ago, a group of healthcare organizations including HIMSS, the American Medical Association and the American Heart Association came together to develop a framework of principles dressing app quality. Still, that’s far short of establishing a certification body.

On the other hand, the FDA does have a point when it notes that a pre-certification program could make it easier for useful digital health tools to reach the marketplace. Assuming the program is constructed well, it seems to me that this is a good idea.

True, it’s pretty unusual to see the FDA loosen up its certification process – a fairly progressive move for a stodgy agency – while the industry fails to self-regulate, but it’s a welcome change of style. I guess digital health really is changing things up.

 

#HIMSS16 Mobile Health Roundup

Posted on February 17, 2016 I Written By

John Lynn is the Founder of the HealthcareScene.com 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 InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

HIMSS 2016 (or as many prefer #HIMSS16) is just around the corner. The Twitter stream for #HIMSS16 is alive and well. In fact, it’s pretty much overwhelming. However, there are nuggets full of amazingness being shared by incredible people. With that in mind, I thought this week’s post could look at interesting mobile health related tweets shared on the #HIMSS16 hashtag.


The very best mobile health apps will realize this truth. Downloads is great because it illustrates potential. However, value is created by persistent use and improved outcomes.


Unfortunately, I’m not seeing much of a culture shift in this regard. Most in healthcare are afraid to fail. In some ways that’s a good thing. In other ways, it’s hindering our progress.


My gut tells me that most mobile health vendors would fail a HIPAA audit. What do you think?


Changing behaviors is the holy grail of mobile health in my opinion. Although, it’s much harder to do it than to write about it.

Security Concerns Threaten Mobile Health App Deployment

Posted on January 26, 2016 I Written By

Anne Zieger is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.

Healthcare organizations won’t get much out of deploying mobile apps if consumers won’t use them. And if consumers are afraid that their personal data will be stolen, they’ve got a reason not to use your apps. So the fact that both consumers and HIT execs are having what I’d deem a crisis of confidence over mHealth app security isn’t a good sign for the current crop of mobile health initiatives.

According to a new study by security vendor Arxan, which polled 815 consumers and 268 IT decision-makers, more than half of consumer respondents who use mobile health apps expect their health apps to be hacked in the next six months.

These concerns could have serious implications for healthcare organizations, as 76% of health app users surveyed said they would change providers if they became aware that the provider’s apps weren’t secure. And perhaps even more significantly, 80% of consumer health app users told Arxan that they’d switch to other providers if they found out that the apps that alternate provider offered were better secured. In other words, consumer perceptions of a provider’s health app security aren’t just abstract fears — they’re actually starting to impact patients’ health decision making.

Perhaps you’re telling yourself that your own apps aren’t terribly exposed. But don’t be so sure. When Arxan tested a batch of 71 popular mobile health apps for security vulnerabilities, 86% were shown to have a minimum of two OWASP Mobile Top 10 Risks. The researchers found that vulnerable apps could be tampered with and reverse-engineered, as well as compromised to provide sensitive health information. Easily-done hacks could also force critical health apps to malfunction, Arxan researchers concluded.

The following data also concerned me. Of the apps tested, 19 had been approved by the FDA and 15 by the UK National Health Service. And at least where the FDA is concerned, my assumption would be that FDA-tested apps were more secure than non-approved ones. But Arxan’s research team found that both FDA and National Health Service-blessed apps were among the most vulnerable of all the apps studied.

In truth, I’m not incredibly surprised that health IT leaders have some work to do in securing mobile health apps. After all, mobile health app security is evolving, as the form and function of mHealth apps evolve. In particular, as I’ve noted elsewhere, mobile health apps are becoming more tightly integrated with enterprise infrastructure, which takes the need for thoughtful security precautions to a new level.

But guidelines for mobile health security are emerging. For example, in the summer of last year, the National Institute of Standards and Technology released a draft of its mobile health cybersecurity guidance, “Securing Electronic Records on Mobile Devices” — complete with detailed architecture. Also, I’d wager that more mHealth standards should emerge this year too.

In the mean time, it’s worth remembering that patients are paying close attention to health apps security, and that they’re unlikely to give your organization a pass if they’re hacked. While security has always been a high-stakes issue, the stakes have gotten even higher.

Mobile Health Happenings

Posted on April 22, 2015 I Written By

John Lynn is the Founder of the HealthcareScene.com 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 InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

It looks like I might have been wrong about mobile health really cropping up at HIMSS15. Then again, maybe I just missed a bunch of them in the mass of attendees that were at the event. Plus, I knew that I’d see the mobile health related companies at mHealth Summit, Connected Health Symposium, Health 2.0 or CES sooner or later. So, I was more interested in the non mobile health related companies at HIMSS.

With that said, every company has some approach to mobile health. Sure, the Apple Watch announcements from Vocera, Epocrates, and Medisafe (to name just a few that I saw) are going to get the headline. Press releases with Apple Watch in their title seem to get extra attention. Press love the latest shiny object even if we have no idea whether the Apple Watch is going to be adopted by the masses (Personally I think it will be a niche device for the rich). However, there are a few mobile happenings that are worth watching.

Text – Don’t underestimate the power of text. It’s amazing what you can do with 140 characters. Of course, in healthcare you need to use secure text (SMS is not HIPAA secure). Turns out that secure text can actually provide a lot of benefits beyond SMS. I’m still very bullish on the simplicity of a text. Feels like a simple solution, but that’s what makes it beautiful. The fact we haven’t fully leveraged it also illustrates how far behind healthcare is compared to other industries.

Mobile Apps – I think there are two kinds of mobile health apps that are breaking out. First is the mobile apps that are tied to enterprise systems. This could be an EHR app or increasingly we’re seeing the population health or analytics vendors pushing the data and communication channels to mobile devices. More innovative is the wellness gaming apps that I’ve seen. I don’t think anyone’s fully cracked the nut yet, but there are some people really working on wellness motivation and behavior change. I expect we’ll see a game changer in this regard in the next 1-2 years.

Sensors – The smartphone or an iPad are becoming the brain for all of these personal health sensors. In fact, the phone is becoming a health sensor itself. Reminds me of CapsuleTech which has been putting black boxes under hospital beds for years in order to get the data from a medical device. Now we all have a “black box” in our pocket that collects and communicates our health data. Personal health sensors are exploding. Implantables is next.

Telemedicine – We want out healthcare when we want it, where we want it. Telemedicine is going to be the solution that solves that problem. Katherine Rourke has a great post up on EMR and HIPAA about the various telemedicine solutions. So, I won’t rehash those options here. However, there’s a wide spectrum of telemedicine offerings and many of them are mobile.

Those are a few of the biggest trends I see in mobile health. I’m sure there’s something I’ve missed. So, I look forward to hearing what I’ve missed in the comments below.

Growth of mHealth – Where’s the Money?

Posted on April 1, 2015 I Written By

John Lynn is the Founder of the HealthcareScene.com 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 InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.


We all know that the potential for mHealth is massive. Everyone is getting a mobile phone and there is a mobile health app for anything and everything. Although, I’ve often asked myself, where’s the money in all the mobile health adoption?

The above tweet and image creates a pretty compelling image of where you can find the money in mobile health: Services and Device Sales.

I guess this shouldn’t be surprising. It illustrates how it’s likely going to be hard to be a mobile health app that’s just an app. Instead, you have to build some people skills (ie. services) or hardware skills (ie. devices). Many people who just want to roll out an app, might want to consider this finding.

What still bothers me is that we have yet to really have a breakout app. I think it’s coming, but I’m surprised it’s not already here. What do you think will be the breakout app?

The mHealth Tipping Point – See Angry Birds?

Posted on November 26, 2014 I Written By

John Lynn is the Founder of the HealthcareScene.com 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 InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

In a recent #HITsm chat, someone suggested that the mHealth Tipping point would be when mHealth was as addicting as Angry Birds (sorry I can’t find the tweet to give specific credit to the person). I thought about the idea. No doubt, it would be great if mHealth apps were as addicting as Angry Birds or other mobile games like it. However, I don’t think we want mHealth apps to follow a similar adoption curve to Angry Birds. In fact, I think that mHealth apps today are very much like the Angry Birds adoption curve. Here’s my response to the Angry Birds comparison.

The problem with Angry Birds is that someone uses it religiously for a while and then they kind of burn out and stop playing the game. Does that sound like mHealth apps today?

This is why I hope that mHealth apps are more like text messaging app than an Angry Birds app. A text messaging app is something you rely on and use every day. It’s something that provides ongoing value to you and so you never stop using it. It becomes an indispensable part of how you spend your day.

Plus, how many of us think about our text messaging app? You don’t download it. You don’t think, “Oh, I need to use that app.” No, you just use it all the time and other people interact with you through it as well. This is the model that the most successful mHealth apps will have to follow.

Mobile Health Future Infographic

Posted on March 12, 2014 I Written By

John Lynn is the Founder of the HealthcareScene.com 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 InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

Always fun to see an infographic with interesting data. Much of this data wasn’t new, but the stat that stood out to me was 247 million Americans have downloaded a health app. That’s a lot of people involved in mobile health. Although, I bet they were pretty broad with what they considered a mobile health app.
Mobile Health Future Infographic

4 Key Pillars of Effective Mobile Health

Posted on February 3, 2014 I Written By

John Lynn is the Founder of the HealthcareScene.com 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 InfluentialNetworks.com and Physia.com. 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 loved this tweet from HP Healthcare on the 4 Key Pillars for effective mobile health.

 

Here are the 4 pillars for those who might not see the embedded tweet:

  • People
  • Places
  • Payment
  • Purpose

As I look through these pillars, the one that I think we’re missing most is purpose. This isn’t that we have a purpose. All of the apps have the purpose of improving someone’s health. That’s a noble purpose and they all have that as their goal. This purpose in my book means that the app actually achieves the intended purpose.

As I wrote previously, there are so many apps and so few users. The solution to this problem is creating apps that are effective at achieving their goals. An app that can move the needle, change behavior, or somehow provide tangible value to the user is one that will get many, many more users. We’re just not there yet.

Some people are concerned by this fact. I’m not. I’m excited about the potential of it all along with the amazing number of intelligent people that are working to find a solution. We’re still early in this iteration of mobile health companies and I believe we’ll see some major breakthroughs in how we look at health. However, we aren’t there yet.

Breaking Down the Mobile Health Apps by Number

Posted on October 31, 2013 I Written By

John Lynn is the Founder of the HealthcareScene.com 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 InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

Dan Munro has a great blog post on Forbes that offers an overview of the IMS Institute for Healthcare Informatics report on the mobile health app market. Check out his whole article for all the findings, but I was really intrigued by his list of study results:
1. Every app categorized as “health and wellness” or “medical” in Apple’s AAPL -0.11% iTunes store was reviewed
2. Of the 43,000+ mobile health apps assessed for the report – only 23,682 were classified with a legitimate health function
3. 5 apps accounted for 15% of all downloads
4. 16,275 were considered patient facing
5. 7,407 were considered provider facing
6. Smartphone use is lowest (18%) in the 65+ demographic
7. More than 90% of the apps tested scored less than 40 on a scale of 100
8. Apps were further categorized by 7 capabilities:
– Inform (10,840 apps)
– Instruct (5,823 apps)
– Record/Capture data (5,095 apps)
– Display User entered data
– Guide
– Remind/Alert (1,357 apps)
– Communicate
– None of the 7 capabilities (1,622 apps)

I always love data and this is some interesting data. Dan’s headline was also another interesting piece of data: “Over 50% Of Mobile Health Apps Are Downloaded Less Than 500 Times.” We’ve talked about this before. It’s one thing to build a mobile health app and another thing to get someone to actually use it. Many fall short of the later objective.

One other stat in the list above that stood out to me was the split between provider facing mobile health apps and patient facing mobile health apps. I would have thought that more of them would be patient facing. That’s a lot of provider focused mobile health apps considering the size of the provider market. Of course, each of those doctors do control a lot of consumer spend.

Manage Addiction Recovery on Your Smartphone

Posted on September 20, 2013 I Written By

John Lynn is the Founder of the HealthcareScene.com 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 InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

The Hazelden Foundation has put out a mobile app to help manage addiction recovery. Check out the following video to learn more: