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Digital Disease Management Tools Aren’t Too Popular

Posted on April 19, 2016 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 FierceHealthcare.com 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.

Despite having a couple of chronic illnesses, I don’t use disease management tools and apps, even though I’m about as digital health-friendly as anyone you can imagine. So I guess the results of the new survey, suggesting that I’m not alone, shouldn’t come as a surprise.

The study was conducted by HealthMine, which recently surveyed 500 insured consumers to find out whether they used digital health devices and apps. Researchers found that while 59% of respondents suffer from chronic conditions, only 7% of these individuals used a disease management tool.

This was the case despite the fact that 50% reported using fitness/activity trackers or apps, and that 52% of respondents were enrolled in a wellness program. Not only that, two thirds of those involved in a wellness program said their program offered incentives for using digital health tools.

Disease management tools may not be in wide use, but that doesn’t mean that the consumers weren’t prepared to give digital health a try. When they drilled down further, HealthMine researchers learned that in addition to the half of respondents that used fitness trackers, consumers were interested in a wide variety of digital health options. For example, 46% used food/nutrition apps, 39% used weight loss apps, 38% used wearable activity tracker apps, 30% used heart rate apps, 28% used pharmacy apps, and 22% used patient portals or sleep apps.

To get consumers interested in disease management tools, it might help to know what motivates them to pick up any digital health app for their use. The biggest motivators cited were desire to know their numbers (42%), followed by improving their health (26%), the knowledge that someone on the other side of the app is tracking results (19%), and incentives for using the app (10%). (It’s worth noting that while incentives weren’t the biggest motivator to use digital health tools, 91% of respondents said that incentives would motivate them to use digital health tools more often.)

All that being said, I think I know what’s wrong here. In my experience, the apps consumers reported using are directed at helping consumers handle problems which, though complex, can be addressed in part by measuring a few key indicators. For example, achieving fitness is a broad and multifactorial goal, but counting steps is simple to do and simple to grasp. Or take food/dieting apps: eating properly can be a life’s work, but drawing on a database to dig out carb counts isn’t such a big deal.

On the other hand, managing a chronic illness may call for data capture, interaction with existing databases, monitoring by a skilled outside party and expert guidance. Pulling all of these together into a usable experience that consumers find helpful — much less one that actually transforms their health — is far more difficult than, say, tracking calories in and calories burned.

I’d argue that truly effective disease management tools, which consumers would truly find useful, calls for institutional commitment by vendors or providers that neither is ready to supply. But if disease management tools came with a particularly intuitive interface, a link to live providers and perhaps more importantly, education as to why the items being tracked matter, we might get somewhere.

Heads Up Health Displays Everywhere…Yes Everywhere!

Posted on April 18, 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.

Today I’ve started the first day at the NAB conference in Las Vegas. It’s a unique conference that showcases the best in broadcast media. There’s a lot of things that are of interest to healthcare. One of those things is the variety of displays that are being used to stream the various broadcast media. It’s not hard to see the hospital or home of the future that’s essentially one big electronic display of information.

With that as a backdrop, I was intrigued to read about this electronic tattoo that turns your skin into a screen:

It still has a ways to go before you’ll find it in a hospital or doctor’s office near you. However, it’s fascinating to see how we’re literally working on ways to have a display everywhere. In healthcare that’s really exciting. Plus, the tattoo includes a health sensor as well. Imagine if in a hospital or doctors visit you had one of these “tattoos” that was always showing your vital signs. Would be nice to have all of that information available. No doubt it would be streamed to your EHR or other data store in the cloud.

As this technology progresses it’s not hard to see that these tattoo displays could be a great way for your healthcare team to communicate messages to you. Add a few sensors and/or voice and you’ll be able to communicate back with them. Pretty powerful since some patients can’t lift a smart phone, but they might be able to lift their arm. Or if they can’t life their arm, they could have it left in a position where they could see it.

Getting the right health information communicated to the right people at the right time is going to be a major theme going forward in healthcare IT. We’re already working on it from a hundred different angles, but I think most of us can’t even imagine how much better this communication and data sharing will be over the next 5-10 years.

Lessons Learned from Patient Engagement Efforts in Louisiana

Posted on March 28, 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.

UPDATE: Check out the video recording of our interview:

2016 March - Lessons Learned from Patient Engagement Efforts in Louisiana-blog

For our next Healthcare Scene interview, we’ll be chatting with Jamie Martin and Linda Morgan from the Louisiana Health Care Quality Forum (LHCQF) on Wednesday, March 30, 2016 at Noon ET (9 AM PT). After putting on an incredible session on patient engagement at HIMSS, I can’t wait to have LHCQF join me to share many of the experiences and learnings that have taken place in their efforts to promote patient engagement in Louisiana.

You can join my live conversation with Jamie Martin and Linda Morgan and even add your own comments to the discussion or ask them questions. All you need to do to watch live is visit this blog post on Wednesday, March 30, 2016 at Noon ET (9 AM PT) and watch the video embed at the bottom of the post or you can subscribe to the blab directly. We’re hoping to include as many people in the conversation as possible. The discussion will be recorded as well and available on this post after the interview.

As we usually do with these interviews, we’ll be doing a more formal interview with Jamie Martin and Linda Morgan for the first ~30 minutes of this conversation. Then, we’ll open up the floor for others to ask questions or join us on camera. Jamie, Linda and the team at LHCQF have done some phenomenal work in promoting patient engagement in Louisiana. I’m looking forward to learning from their experience and insights so we can see more of it happen across the nation and world.

If you’d like to see the archives of Healthcare Scene’s past interviews, you can find and subscribe to all of Healthcare Scene’s interviews on YouTube.

The Amazing Power of Tablets Does More for Seniors’ Health Than Just Health Monitoring

Posted on March 18, 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.

This post is sponsored by Samsung Business. All thoughts and opinions are my own.

One of the exploding areas of opportunity for healthcare is the growing senior market. It’s also one of its greatest challenges. Thanks to breakthroughs in medicine, we’re living longer and the number of seniors hitting retirement age continues to grow at an extraordinary rate.

With this growth in mind, we hear over and over again about healthcare solutions for seniors. This makes sense since seniors make up a large portion of healthcare dollars spent. Most of the health solutions targeted at seniors have focused on things like home health monitoring and remote health data collection.

While these solutions are powerful and interesting, lately I’ve come to realize that technology could play a much more powerful role in the health of seniors and it has nothing to do with the home health and remote monitoring technologies that are so in vogue. No, after many conversations I believe that even more powerful than health monitoring technologies is the way technology can improve a senior’s life.

This Samsung blog post highlights 5 major benefits seniors can receive from tablet usage:

  1. Social media: Keeping in touch with friends and family
  2. Content: Accessing information for leisure, learning and emergency preparedness
  3. Commerce: Convenient online shopping and access to user reviews for informed decision making
  4. Entertainment: Games and content that promote mental engagement
  5. Health: Accessing medical information, care plans, health apps and wellness content

One of the keys to keeping seniors healthy is to keep them engaged. Looking through this list might seem pretty rudimentary for the rest of us that live on technology. However, for a senior those social connections can mean the difference between life and death. Not to mention happiness in the life they still have left.

I saw this illustrated perfectly when my mother, who’s nearing retirement, told me that she was thinking about joining Facebook. This came as quite a shock to me since she’d always kind of shunned it as a waste of time and my mother (sweet as she may be) doesn’t have (or want) a cell phone. When I asked her why she was going to get on Facebook, she told me that she wanted to be on there because she believed that it would help her stay in touch with so many people she knows and loves (I hope that includes me, but is more likely my kids).

The great thing is that technology has now become really accessible for seniors. Take for example, the Samsung Galaxy Tab Pro S that was just announced today. It’s taken a number of years, but they’ve finally gotten the mix of tablet and laptop in one device right.

The Galaxy Tab Pro S has a really slim design that’s light. Both of these features are enjoyed by seniors, but especially the light part. As you get older, the weight of items really matters. Plus, the keyboard option is great for seniors since many of them know how to type, but don’t do well with the touchscreen keyboards. The 10.5 hours of battery life is great too since that means they can use it all day and charge it through the night.

Before I hear from all the naysayers about seniors’ aversion to technology (that’s generally a myth that needs to be debunked), It’s surprising how many seniors are really adept at technology. Plus, for those that are less adept, there are great companies like Breezie and grandPad that are building software on top of tablets that simplify using a tablet even more. It’s now easier than ever for seniors to access the internet using tablets.

What we need to remember in healthcare is that our health is determined by much more than visits to the doctor’s office and our vital signs. Our ability to connect with the ones we love impacts our health. The entertainment and education we consume affects our health. Our ability to be independent affects our health. The right technology in seniors’ hands can impact all of these health factors in a significant way.

For more content like this, follow Samsung on Insights, Twitter, LinkedIn , YouTube and SlideShare

Patients Favor Tracking, Sharing Health Data

Posted on February 3, 2016 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 FierceHealthcare.com 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.

To date, I’d argue, clinicians have been divided as to how useful medical statistics are when they come straight from the patient. In fact, some physicians just don’t see the benefit of amateur readings. (For example, when I brought my own cardiologist three months of dutifully-logged blood pressure and pulse readings, she told me not to bother.)

Research suggests that my experience isn’t unique. One study, released mid-last year by market research firm MedPanel, found that only 15% of physicians were recommending wearables or health apps to patients as tools for growing healthier.

But a new study has found that patients side with health-tracking fans. According to a new study released by the Society for Participatory Medicine, 84% of respondents felt that sharing self-tracking stats such as blood glucose, blood pressure, heart rate and physical activity with their clinician would help them better manage their health. And 77% of respondents said that such stats were equally important to both themselves and their healthcare professional.

And growing numbers of healthcare professionals are getting on board. A separate study released last year by Research Now found that 86% of 500 medical professionals said mHealth apps gave them a clearer understanding of a patient’s medical condition, and 76% percent felt that apps were helping patients manage chronic illnesses.

Patients surveyed by the SPM, meanwhile, seemed downright enthusiastic about health trackers and mobile health:

* 76% of adults surveyed would use a clinically-accurate and easy-to-use personal monitoring device
* 57% of respondents would like to both use such a device and share the data generated with a professional
* 81% would be more likely to use a consumer health monitoring device if their healthcare professional recommended such a device

Realistically, medical pros aren’t likely to make robust use of patient-generated data unless that data can be integrated into a patient’s chart quickly and efficiently. Some brave clinicians may actually attempt to skim and mentally integrate data from a health app or wearable, but few have the time, others doubt the data’s accuracy and yet another subgroup simply finds the process too awkward to endure.

The bottom line, ultimately, seems to be that patient-generated data won’t find much favor until hospitals and medical practices roll out technologies like Apple’s HealthKit, which pull the data directly into an EMR and present it in a clinician-friendly manner. And some medical pros won’t even be satisfied with a good presentation; they’ll only take the data seriously if it was served up by an FDA-approved device.

Still, I personally love the idea of participatory medicine, and am happy to learn that health trackers and apps might help us get closer to this approach. As I see it, there’s no downside to having the patient and the clinician understand each other better.

#HIMSS16: Some Questions I Plan To Ask

Posted on February 1, 2016 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 FierceHealthcare.com 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.

As most readers know, health IT’s biggest annual event is just around the corner, and the interwebz are heating up with discussions about what #HIMSS16 will bring. The show, which will take place in Las Vegas from February 29 to March 4, offers a ludicrously rich opportunity to learn about new HIT developments — and to mingle with more than 40,000 of the industry’s best and brightest (You may want to check out the session Healthcare Scene is taking part in and the New Media Meetup).

While you can learn virtually anything healthcare IT related at HIMSS, it helps to have an idea of what you want to take away from the big event. In that spirit, I’d like to offer some questions that I plan to ask, as follows:

  • How do you plan to support the shift to value-based healthcare over the next 12 months? The move to value-based payment is inevitable now, be it via ACOs or Medicare incentive programs under the Medicare Access and CHIP Reauthorization Act. But succeeding with value-based payment is no easy task. And one of the biggest challenges is building a health IT infrastructure that supports data use to manage the cost of care. So how do health systems and practices plan to meet this technical challenge, and what vendor solutions are they considering? And how do key vendors — especially those providing widely-used EMRs — expect to help?
  • What factors are you considering when you upgrade your EMR? Signs increasingly suggest that this may be the year of the forklift upgrade for many hospitals and health systems. Those that have already invested in massiveware EMRs like Cerner and Epic may be set, but others are ripping out their existing systems (notably McKesson). While in previous years the obvious blue-chip choice was Epic, it seems that some health systems are going with other big-iron vendors based on factors like usability and lower long-term cost of ownership. So, given these trends, how are health systems’ HIT buying decisions shaping up this year, and why?
  • How much progress can we realistically expect to make with leveraging population health technology over the next 12 months? I’m sure that when I travel the exhibit hall at HIMSS16, vendor banners will be peppered with references to their population health tools. In the past, when I’ve asked concrete questions about how they could actually impact population health management, vendor reps got vague quickly. Health system leaders, for their part, generally admit that PHM is still more a goal than a concrete plan.  My question: Is there likely to be any measurable progress in leveraging population health tech this year? If so, what can be done, and how will it help?
  • How much impact will mobile health have on health organizations this year? Mobile health is at a fascinating moment in its evolution. Most health systems are experimenting with rolling out their own apps, and some are working to integrate those apps with their enterprise infrastructure. But to date, it seems that few (if any) mobile health efforts have made a real impact on key areas like management of chronic conditions, wellness promotion and clinical quality improvement. Will 2016 be the year mobile health begins to deliver large-scale, tangible health results? If so, what do vendors and health leaders see as the most promising mHealth models?

Of course, these questions reflect my interests and prejudices. What are some of the questions that you hope to answer when you go to Vegas?

Patient Engagement Distracts the Health Care Field From Reform (Part 2 of 2)

Posted on January 12, 2016 I Written By

Andy Oram is an editor at O'Reilly Media, a highly respected book publisher and technology information provider. An employee of the company since 1992, Andy currently specializes in open source, software engineering, and health IT, but his editorial output has ranged from a legal guide covering intellectual property to a graphic novel about teenage hackers. His articles have appeared often on EMR & EHR and other blogs in the health IT space. Andy also writes often for O'Reilly's Radar site (http://radar.oreilly.com/) and other publications on policy issues related to the Internet and on trends affecting technical innovation and its effects on society. Print publications where his work has appeared include The Economist, Communications of the ACM, Copyright World, the Journal of Information Technology & Politics, Vanguardia Dossier, and Internet Law and Business. Conferences where he has presented talks include O'Reilly's Open Source Convention, FISL (Brazil), FOSDEM, and DebConf.

The previous segment of this article looked at the movement for patient engagement, or the patient experience. Now I’ll highlight a true reform in the health care system.

Patients Left Out in the Cold
What activist patients and doctors have been demanding for years is not engagement or a better experience, but a central role for the patient in choosing treatment and carrying it out when they leave the doctor’s office. Patient empowerment is the key to all the things doctors profess to care about, such as preventing readmissions. It’s even more critical with chronic diseases that have a lifestyle component, such as congestive heart failure and diabetes.

Some patients come to the clinical setting endowed with more education than others, or a personality suited to pushing back and demanding rights. But some fight for years for such basics as access to their records. I was dejected to read just a few weeks ago of an attempt to improve care in Rhode Island, endorsed no less by the American College of Physicians, that boasts about giving access to everybody except the patient to health records.

The American College of Physicians is concerned about the hypothetical patient who “doesn’t know the name of the peach-colored pill that the orthopedist prescribed.” That particular patient is clearly not asking for empowerment. But millions do keep track of their medications and deserve equal knowledge about the rest of the information about their medical condition. If the peach-colored pill had been recorded in a patient health record, accessible to the patient (or a responsible care-giver) wherever she goes, all the complex Health Information Exchange infrastructure praised in the article could go by the wayside. Another article describes an emerging PHR solution.

Another recent example of the disdain for patients comes in a complaint by AHIMA about the difficulties of matching records for a single patient. Duplicate records are undeniably a serious problem (as is information mistakenly entered in a different person’s record). But instead of recognizing the obvious solution of a PHR, all they can come up with is a universal identifier (which is a privacy risk as well as a target for security attacks) and more determined efforts to match patients the old-fashioned way.

Empowered patients have control over their own information. Doctors guide them to make reasonable choices that affect their health, which includes sharing those records. Empowered patients set their own goals and timetables. A grant of power and information to patients will inevitably empower and inform the other health professionals with whom those patients interact, leading to a learning health system and a true team approach to care.

What’s the difference?
As I eventually admitted, the movement for patient engagement offers many good ideas that can contribute not only to a better experience in the health care center but to patient empowerment and better outcomes. What I complain about is the motive behind patient engagement.

Let’s take patient portals. To proponents of patient engagement, it serves a few purposes related to public relations. The portal hopefully:

  • Indulges people’s preference for fast information, endearing them to the practice

  • Keeps them more “engaged,” meaning that they’ll come back and spend more money at the health care center.

  • Delivers information in more appealing ways (such as through video, when practices use it).

  • Takes routine tasks off the shoulders of staff, freeing them to do other things that improve the patient experience.

This poverty of vision is why most portals lack useful information that patients can use to actually improve their care. Discharge instructions are usually a crumpled page. Doctor notes are hidden away, available to malicious attackers more easily than to patients. Medical codes and raw numbers appear on the portal without further elucidation.

Modern health facilities use web sites along with text messaging, old-fashioned phone calls, and other tools as part of a strategy to keep patients on their treatment plans. They may have full discharge instructions, along with instructional videos for such important tasks as changing bandages, on a patient’s personal site. The patient is encouraged to report her progress along with any setbacks, and gets quick feedback when there is a change. Many face-to-face visits can be averted, and patients who can update their caretakers without leaving home are less likely to exhaust themselves at vulnerable times. The patient’s family members can easily keep up with changes and find out what they need to do, as can other professionals working on the case.

For every element of empowerment, there is a tawdry alternative that can be offered as “engagement.” That’s the risk in the patient experience movement. Unless the health care institutions start out with the philosophy of empowerment, it’s just another distraction from the work we need to do.

Time For A Health Tracking Car?

Posted on December 30, 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 FierceHealthcare.com 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.

Several years ago, I attended a conference on advanced health technologies in DC. One of the speakers was Dr. Jay Sanders, president and CEO of The Global Telemedicine Group. And he had some intriguing things to say — especially given that no one had heard of a healthcare app yet and connected health was barely a vision.

One of Dr. Sanders’ recommendations was that automobile seat belts should integrate sensors that tracked your heart rhythm. After all, he noted, many of us spend hours a day behind the wheel, often under stressful conditions — so why not see how your heart is doing along the way? After all, some dangerous arrhythmias don’t show up at the moment you’re getting a checkup.

Flash forward to late 2015, and it seems Dr. Sanders’ ideas are finally being taken seriously. In fact, Ford Motor Co. and the Henry Ford Health System are co-sponsoring a contest offering $10,000 in prize money to employees creating smartphone apps linking healthcare with vehicles. While this doesn’t (necessarily) call for sensors to be embedded in seat belts, who knows what employees will propose?

To inspire potential entrants, the Connected Health Challenge sponsors have suggested a few ideas for possible designs, including in-vehicle monitoring and warnings and records access from the road. Other suggestions included appointment check-ins and technology allowing health data to be transmitted to providers. The contest kicks off on January 20th.

In some ways, this isn’t a huge surprise. After all, connected vehicles are already a very hot sector in the automotive business. According to research firm Parks Associates, there will be 41 million active Internet connections in U.S. vehicles by the end of this year.

At present, according to Parks, the connect car applications consumers are most interested in include mapping/navigation, information about vehicle performance, Bluetooth technology and remote control of vehicles using mobile phones. But that could change quickly if someone finds a way to interest the well-off users of wearables in car-based health tracking. (A possible direction for Fitbit, perhaps?)

Ordinarily, I’d have some doubts about Henry Ford Health System employees’ ability to grasp this market. But as I’ve reported elsewhere on Healthcare Scene, Henry Ford takes employee innovation very seriously.

For example, last year HFHS awarded a total of $10,000 in prizes to employees who submitted the best ideas for clinical applications of wearable technology. Not only that, the health system offers employees a 50% share of future revenues generated by their product ideas which reach the marketplace.

Now, it’s probably worth bearing in mind that the wearables industry is far more mature than the market for connected health apps in automobiles. (In fact, as far as I can tell, it’s still effectively zero.) Employees who participate in the challenge will be swinging at a far less-defined target, with less chance of seeing their ideas be adopted by the automotive industry.

Still, it’s interesting to see Ford Motor Co. and HFHS team up on this effort. I think something intriguing will come of it.

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 FierceHealthcare.com 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?

The New World of Health Monitoring

Posted on December 23, 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.

I thought that this image was really interesting in the context of another post about the medical smart phone. Ironically, I think the image below actually only depicts a small part of the health monitoring that’s coming. I’m sure that scares the heck out of many people and excites many people. It’s a hard balance. Personally, I’m on the excited side of things. Chew on this graphic as you open your various health tracking devices this Christmas.
New Extreme Health Monitoring