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AMA Approves List Of Best Principles For Mobile Health App Design

Posted on November 29, 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.

The American Medical Association has effectively thrown her weight behind the use of mobile health applications, at least if those apps meet the criteria members agreed on at a recent AMA meeting. That being said, the group also argues that the industry needs to expand the evidence base demonstrating that apps are accurate, effective, safe and secure. The principles, which were approved at its recent Interim Meeting, are intended to guide coverage and payment policies supporting the use of mHealth apps.

The AMA attendees agreed on the following principles, which are intended to guide the use of not only mobile health apps but also associated devices, trackers and sensors by patients, physicians and others. They require that mobile apps and devices meet the following somewhat predictable criteria:

  • Supporting the establishment or continuation of a valid patient-physician relationship
  • Having a clinical evidence base to support their use in order to ensure mHealth apps safety and effectiveness
  • Following evidence-based practice guidelines, to the degree they are available, to ensure patient safety, quality of care and positive health outcomes
  • Supporting data portability and interoperability in order to promote care coordination through medical home and accountable care models
  • Abiding by state licensure laws and state medical practice laws and requirements in the state in which the patient receives services facilitated by the app
  • Requiring that physicians and other health practitioners delivering services through the app be licensed in the state where the patient receives services, or will be providing these services is otherwise authorized by that state’s medical board
  • Ensuring that the delivery of any service via the app is consistent with the state scope of practice laws

In addition to laying out these principles, the AMA also looked at legal issues physicians might face in using mHealth apps. And that’s where things got interesting.

For one thing, the AMA argues that it’s at least partially on a physician’s head to school patients on how secure and private a given app may be (or fail to be). That implies that your average physician will probably have to become more aware of how well a range of apps handle such issues, something I doubt most have studied to date.

The AMA also charges physicians to become aware of whether mHealth apps and associated devices, trackers and sensors are abiding by all applicable privacy and security laws. In fact, according to the new policy, doctors are supposed to consult with an attorney if they don’t know whether mobile health apps meet federal or state privacy and security laws. That warning, while doubtless prudent, must not be helping members sleep at night.

Finally, the AMA notes that there are still questions remaining as to what risks physicians face who use, recommend or prescribe mobile apps. I have little doubt that they are right about this.

Just think of the malpractice lawsuit possibilities. Is the doctor liable because they relied on inaccurate app results collected by the patient? If the app they recommended presented inaccurate results? How about if the app was created by the practice or health system for which they work? What about if the physician relied on inaccurate data generated by a sensor or wearable — is a physician liable or the device manufacturer? If I can come up with these questions, you know a plaintiff’s attorney can do a lot better.

How IRIS Puts the Real Triple Aim of Healthcare In Action

Posted on November 22, 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.

As I’ve been doing my Fall Healthcare IT Conference tour, I’ve had the chance to meet with hundreds of companies and thousands of people working to improve healthcare. While all this travel takes its toll, I also come away from all of these meetings invigorated by the quality of people and their desire to make healthcare better. That’s true almost across the board.

While most of the solutions I see are an evolution of something I’ve seen before, every once in a while I meet with a company that’s really impacting healthcare in a unique and interesting way. I found just such a case when I met with Patrick Cresson from IRIS – Intelligent Retinal Imaging Systems.

On face value, many might look at IRIS as just another diabetic retinopathy exam that’s been done by ophthalmologists forever. While this is true, what makes IRIS unique is that they have an FDA cleared exam that can be done in the primary care setting as opposed to being referred to an ophthalmologist. As Patrick pointed out to me, of all the diabetic screenings that need to be done for diabetic patients can be done in the primary care setting except for the retinal exam. At least that was the case before IRIS brought those exams to the primary care setting.

A look at the numbers is quite telling. There are 116 million patients with diabetes or pre-diabetes and that number is increasing every day. It’s estimated that 30 million diabetes patients get referred for an eye exam every year and 19 million diabetes patients do not get the annual retinal exam. There are plenty of reasons why this is the case, but it’s not hard to see why this happens. The same thing happens with referrals across healthcare. Diabetic patients that can’t tell any difference in their eyesight are unlikely to keep going back for an annual retinal exam. Who really wants to go to the pain of scheduling an appointment for what doesn’t seem to be an issue? So, they don’t.

The problem with this thinking is that diabetic retinopathy is asymptomatic. The only way to know if you’re heading for trouble is to have a retinal exam. The good news is that early detection can solve the problem and literally save diabetic patients’ eyesight. I know this first hand since it saved my grandfather’s eyesight.

This is the compelling story that IRIS tells as it pushes the retinal exam into the primary care setting where they can ensure patients are getting the early screenings they’ve so often missed in the past. This plays out in the numbers. Over the past 3 years, IRIS has performed 120,000 diabetic retinopathy exams which resulted in 56,000 patients identified with a pathology and 11,600 patients saved from potential blindness.

While this type of early detection can help healthcare organizations HEDIS compliance, I’m intrigued by the way IRIS straddles the fee for service and value based care worlds. I’ve seen very few models that get a primary care provider paid in the fee for service world, but also work to significantly lower the costs of healthcare in a value based care world. However, that’s exactly what you get from IRIS’s early screening exams.

What’s also fascinating to consider about IRIS is ophthalmologists’ response. It’s easy to see how many ophthalmologists could be afraid of diabetic retinal exams being done in the primary care setting and not in the ophthalmologists’ offices. That’s taking business away from them. While this is true, it’s also easy to see how an increase in retinal exams will drive more previously undiagnosed higher acuity exams, surgeries and interventions to ophthalmologists. Every ophthalmologist I know would much rather do a higher acuity surgery than a basic diabetic retinopathy exam. That’s the reality that IRIS creates since it’s an FDA cleared exam for diabetic retinopathy, but it’s only a screening tool for other eye diseases that require a full exam by an ophthalmologist.

Stories like IRIS are why I love blogging about healthcare IT. IRIS is changing healthcare as we know it by reducing healthcare costs, improving the patient experience, and getting doctors paid. That’s the real triple aim of healthcare in action.

FDA Under Pressure To Deliver Clinical Decision Support Guidelines

Posted on November 10, 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.

The world of clinical decision support technologies may change soon, as the FDA may soon be releasing guidelines on how it will regulate such technology. According to a new report in Politico, the agency has been working on such guidelines since 2011, but it’s not clear what standards it will use to establish these rules.

Software vendors in the CDS business are getting antsy. Early this year, a broad-based group known as the Clinical Decision Support Coalition made headlines when it challenged the agency to clarify the scope of CDS software it will regulate, as well as what it will require from any software that does fall under its authority.

At the time, the group released a survey which found that one-third of CDS developers were abandoning CDS product development due to uncertainty around FDA regulations. Of CDS developers that were moving ahead despite the uncertainty, the only two-thirds were seeing significant delays in development, and 20% of that group were seeing delays of greater than one year.

The delay has caught the attention of Congress, where Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) have filed the Medical Electronic Data Technology Enhancement for Consumers’ Health Act, legislation designed to resolve open questions around CDS software, but the problem still remains.

The FDA has had a research project in place since late 2014 which is creating and evaluating a CDS system for safe and appropriate use of antibiotics. The researcher-developed system generates alerts when a provider prescribes an antibiotic that poses a risk of serious cardiac adverse events for specific patients. Two of the 26 hospitals in the Banner Health network are participating in the study, one of which will use the system and the other which will not. The results aren’t due until April of next year.

It’s hard to say what’s holding the FDA up in this case, particularly given that the agency itself has put CDS guidance on his list of priority projects. But it could be a simple case of too much work and too few staff members to get the job done. As of late last year, the agency was planning to fill three new senior health scientist positions focused on digital health, a move which could at least help it keep up with the flood of new health technologies flooding in from all sides, but how many hours can they work?

The truth is, I’d submit, that health IT may be moving too quickly for the FDA to keep up with it. While it can throw new staff members at the problem, it could be that it needs an entirely new regulatory process to deal with emerging technology such as digital health and mobile device-based tools; after all, it seems to be challenged by dealing with CDS, which is hardly a new idea.

Point Of Care Testing Expansion Poses Data Management Challenges

Posted on November 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.

With the advent of remote monitoring and other mHealth tools, the treatment process is again moving out towards the perimeter, perhaps not with a full return to house calls, but certainly a far greater emphasis on providing care in the field. And that will pose some new data collection and management challenges with their own unique character.

Collecting results from these devices won’t be difficult in and of itself. But we should think about how testing results vary from other types of physician-generated and patient-generated data before we pour it into existing oceans of clinical data.

A revolution in the wings
While you may not be familiar with the point of care diagnostics market, it’s definitely worth a look. The POC diagnostics industry, which includes both professional point of care testing and consumer options, should be worth almost $40 billion within five years, according to research firm Markets and Markets.

Over the next five years, a wide range of new POC options are likely to emerge, in categories that include ultrasound and other imaging, blood tests, cardiovascular imaging and more, Markets and Markets reports. And the devices that fuel this revolution are far more capable than a testing strip in a box; they’re emerging in a world where health advances are almost always found somewhere along the digital spectrum.

Want an example? Consider Scanadu Urine, a urine test kit designed to help monitor maternal and women’s health. The product package does include an old-fashioned paddle to dip in a urine sample, but it doesn’t stop there. Once the user dips the disposable paddle into the sample, they use the Scanadu app and their smartphone to read and interpret color changes on the paddle. Then, they can display, store or share the results via the app. Like many of its competitors, parent company Scanadu hasn’t gotten FDA approval for this or its other health monitoring devices, but that’s in the works.

Other niches already have multiple FDA-approved entrants, such as the mobile ultrasound category, but also emerging smartphone-based competitors such as Clarius Mobile Health. Like Scanadu Urine, Clarius isn’t FDA-approved yet, but the company reports that approval is pending.

As long as these devices remain unapproved by the FDA, they’ll stay in the background. But once devices like these get approved and start hitting the market, they should shake up the healthcare industry. After all, they don’t just empower consumers doing routine tests, they should also make it possible for patients to share important, reliable testing results to telemedicine doctors more or less in real time.

Managing POC data

Eventually, POC diagnostics data – even devices aimed almost exclusively at consumers — will become a completely standard part of the clinical diagnostic process. This much seems obvious. After all, if we want patients to engage with their health, putting powerful, reliable urine testing devices in their hands makes as much sense as giving them a connected glucose monitor, doesn’t it?

That being said, managing and integrating this data into patient data warehouses poses some unique challenges.

For example, how do providers weight the importance of various data streams when integrating them into databases?  After all, some devices are FDA-approved and some are not; some tests are administered by consumers and some by mobile professionals; some data comes from hospital- or clinic-provided remote monitoring devices and some from consumer-grade wearables or sensors.

Another question is how we’ll integrate these results. Even if we were to treat all data as equal (consumer- and professional-grade testing devices alike) do we have to integrate it in real time? Do we only do analysis and data dumps POC data into a big pool, do we pair it with other relevant data as needed or ignore it unless it seems immediately relevant?  We need to figure this out.

Bottom line, it’s probably smart to handle these data streams differently, but figuring out how to do so will be a challenge. We’ll have to develop algorithms for sorting this data soon, or risk being overwhelmed.

AMA Touts Physician Interest In Digital Health Tools

Posted on October 13, 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.

A few months ago, the group’s annual meeting, American Medical Association head Dr. James Madara ignited a firestorm of controversy when he suggested that many direct to consumer digital health products, apps and even EMRs were “the digital snake oil of the early 21st century.” Madara, who as far as I can tell never backed down completely from that statement, certainly raised a few hackles with his pronouncement.

Now, the AMA has come out with the results of physician survey whose results suggest that community doctors may be more excited about digital health’s potential than the AMA leader. The survey found that physicians are optimistic about digital health, though some issues must be addressed before they will be ready to adopt such technologies.

The study, which was backed by the AMA and conducted by research firm Kantar TNS, surveyed 1,300 physicians between July 7 and 18. Its content addressed a wide range of digital health technologies, including mobile apps, remote monitoring, wearables, mobile health and telemedicine.

Key findings of the study include the following:

  • While physicians across all age groups, practice settings and tenures were optimistic about the potential for digital health, their level of enthusiasm was greater than their current adoption rates.
  • The majority of physicians surveyed (85% of respondents) believe that digital health solutions can have a positive impact on patient care.
  • Physicians reported that they were optimistic a digital health can reduce burnout, while improving practice efficiency, patient safety and diagnostic capabilities.
  • Physicians said liability coverage, data privacy and integration of digital health tools with EMR workflows were critical to digital health adoption, as well as the availability of easy-to-use technologies which are proven to be effective and reimbursement for time spent conducting virtual visits.

All told, physicians seem willing to use digital health tools if they fit into their clinical practice. And now, it seems that the AMA wants to get out ahead of this wave, as long as the tools meet their demands. “The AMA is dedicated to shaping a future when digital health tools are evidence based, validated, interoperable, and actionable,” said AMA Immediate Past President Steven J. Stack, M.D

By the way, though it hasn’t publicized them highly, the AMA noted that it has already dipped its oar into several digital health-related ventures:

  • It serves as founding partner to Health2047, a San Francisco-based health care innovation company that combines strategy, design and venture disciplines.
  • It’s involved in a partnership with Chicago-based incubator MATTER, to allow entrepreneurs and physicians to collaborate on the development of new technologies, services and products in a simulated health care environment.
  • It’s collaborating with IDEA Labs, a student-run biotechnology incubator, that helps to support the next generation of young entrepreneurs to tackle unmet needs in healthcare delivery and clinical medicine.
  • It’s playing an advisory role to the SMART project, whose key mission is the development of a flexible information infrastructure that allows for free, open development of plug-and-play apps to increase interoperability among health care technologies, including EHRs, in a more cost-effective way.
  • It’s involved in a partnership with Omada Health and Intermountain Healthcare that has introduced evidence-based, technology-enabled care models addressing prediabetes.

Personally, I have little doubt that this survey is a direct response to the “snake oil” speech. But regardless of why the AMA is seeking a rapproachment with digital health players, it’s a good thing. I’m just happy to see the venerable physicians’ group come down on the side of progress.

 

I’m Now a Thing on the Internet of Things

Posted on October 11, 2016 I Written By

When Carl Bergman isn't rooting for the Washington Nationals or searching for a Steeler bar, he’s Managing Partner of EHRSelector.com, a free service for matching users and EHRs. For the last dozen years, he’s concentrated on EHR consulting and writing. He spent the 80s and 90s as an itinerant project manger doing his small part for the dot com bubble. Prior to that, Bergman served a ten year stretch in the District of Columbia government as a policy and fiscal analyst.

Thanks to a Biotronik Eluna 8 DR-T pacemaker that sits below my clavicle, I’m now a thing on the internet of things. What my new gizmo does, other than keeping me ticking, is collect data and send it to a cell device sitting on my nightstand.

biotronik-eluna
Once a day, the cell uploads my data to Biotronik’s Home Monitoring website, where my cardiologist can see what’s going on. If something needs prompt attention, the system sends alerts. Now, this is a one way system. My cardiologist can’t program my pacemaker via the net. To do that requires being near Biotronik’s Renamic inductive system. That means I can’t be hacked like Yahoo email.

The pacemaker collects and sends two kinds of data. The first set shows the unit’s functioning and tells a cardiologist how the unit is programmed and predicts its battery life, etc. The second set measures heart functioning. For example, the system generates a continuous EKG. Here’s the heart related set:

  • Atrial Burden per day 

  • Atrial Paced Rhythm (ApVs) 

  • Atrial Tachy Episodes (36 out of 48 criteria) 

  • AV-Sequences 

  • Complete Paced Rhythm (ApVp)
  • Conducted Rhythm (AsVp) 

  • Counter on AT/AF detections per day 

  • Duration of Mode Switches
  • High Ventricular Rate Counters
  • Intrinsic Rhythm (AsVs) 

  • Mode Switching
  • Number of Mode Switches 

  • Ongoing Atrial Episode Time
  • Ventricular Arrhythmia

Considering the pacemaker’s small size, the amount of information it produces is remarkable. What’s good about this system is that its data are available 24/7 on the web.

The bad news is Biotronik systems don’t directly talk to EHRs. Rather, Renamic uses EHR DataSynch, a batch system that complies with IEEE 11073-10103, a standard for implantable devices. EHR DataSynch creates an XML file and ships it along with PDFs to an EHR via a USB key or Bluetooth. However, Renamic doesn’t support LANs. When the EHR receives the file, it places the data in their requisite locations. The company also offers customized interfaces through third party vendors.

For a clinician using the website or Renamic, data access isn’t an issue. However, access can be problematic in an EHR. In that case, the Biotronik data may or may not be kept in the same place or in the same format as other cardiology data. Also, batch files may not be transferred in a timely fashion.

Biotronik’s pacemaker, by all accounts, is an excellent unit and I certainly am glad to have it. However, within the EHR universe, it’s one more non-interoperable device. It takes good advantage of the internet for its patients and their specialists, but stops short of making its critical data readily available. In Biotronik’s defense, their XML system is agnostic, that is, it’s one that almost any EHR vendor can use. Also, the lack of a widely accepted electronic protocol for interfacing EHRs is hardly Biotronik’s fault. However, it is surprising that Biotronik does not market specific, real time interfaces for the products major EHRs.

Smartphone Strategy May Cause Health Data Interoperability Problems

Posted on July 13, 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.

Tonight I was out at my local electronics store looking over the latest in Samsung gear. While chatting with the salesman behind the Samsung counter, I picked up a wireless charging pad and asked what it cost. “Don’t bother,” he said. “That won’t work with your phone,” which happens to be a none-too-old Galaxy Note Edge.

New batteries? Same problem. I strongly suspect that the lovely VR gear, headset and smart watch on display suffer from the same limitations. And heaven knows that these devices wouldn’t work with products produced by other Android-compatible manufacturers.

Now, I am no communications industry expert. So I won’t hold forth on whether Samsung’s decision to create a network of proprietary devices is a smart strategy or not. Intuitively, my guess is that the giant manufacturer is making a mistake in trying to lock in customers this way, but I don’t have data upon which to base that claim.

But when it comes to health IT, it’s clearer to me how things might play out. And I’d argue that Samsung’s emerging strategy should generate concern among providers.

Interconnecting proprietary tech is far from new. In fact, Apple long ago won the battle to force its users onto its proprietary platform, and AFAIK, the computing and media giant has never back down from the stance, including where its telecommunications gear was concerned. But at least until recently, we’ve had interoperable Android phones and tablets to work with, which ran on a freely-available operating system that played nicely with other devices running the system.

But with the device maker moving away from “works on Android” to “works on Samsung Android devices,” the chain of interoperability is broken. This could lead to shifts in the telecommunications industry which don’t bode well for healthcare users.

On the surface, we are only looking at relatively petty IT concerns for HIT leaders, such as seeing to it that the Samsung user gets a Samsung charging pad. Like enterprises in other industries, health leaders will adapt to this inconvenience. But the problems don’t stop there.

If telecommunications manufacturers follow Samsung’s lead, and decide to add proprietary quirks to their devices, providers may pay the price. Depending on how these newly-proprietary devices are configured, and how they must be supported, it could become much harder to dig data out of them on an ongoing basis. That’s the last thing we need right now.

Not only that, what happens if proprietary differences between Android phones and tablets make it harder for them to communicate with medical devices, a tantalizing possibility which is just beginning to present itself? While we don’t yet know how devices such as infusion pumps to interoperate with mobile devices, nor the latter two with desktops, wearables and servers, we don’t want to close off options.

Bottom line, I may be crying wolf too soon, but these developments alarm me. I’d hate to see additional walls go up between various data sources, particularly before we even know what we can do with them.

Sometimes Health Is About A Simple Connection to the Right People

Posted on June 24, 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 our biggest health care costs comes from our aging population. No doubt they’re a challenging group that often has multiple chronic conditions and is generally seen as anti-technology. While their medical conditions can be a challenge, it’s unfair to say that technology can’t have a great impact for good on even senior citizens.

In fact, one of the biggest health challenges senior citizens face is loneliness. It’s amazing the health impact being lonely can have on a person. The great thing is that technology as simple as a tablet can have a dramatic impact for good on senior citizens. Here’s a great video from Samsung and Breezie that illustrates this point:

I’ve seen a number of solutions like the Breezie tablets that have made the internet extremely accessible for senior citizens. It’s extraordinary to watch the impact for good that connecting to their friends and family on a tablet can have on a person. Plus, once their emotional state is in a better place, it’s often much easier for them to deal with their physical health challenges as well.

The amazing part is that these tablets don’t need some sort of complex health apps. They don’t need an AI generated dog to be their friend (Although, people are working on this). They don’t need dozens of healthcare sensors that are constantly monitoring their every health stat (Although, people are working on this too). All these seniors need is simple apps like Facebook where they can see pictures of their grandkids and email where they can communicate with their family and friends.

I’m sure that as things progress we’ll see more and more advanced health apps on these tablets. Many seniors have a challenge traveling to see their doctor, so you can easily see how a telemedicine app would be very convenient for both patient and doctor. Plus, sometimes you don’t even need video, but just a personal message from your trusted caregiver to help a patient feel better. All of this will come to the tablets, but we can start with something much simpler. A basic connection to the right people for that person.

I heard of one project where the patient improvement came as much from the daily call these lonely, elderly patients received as it was the actual study that was being conducted. While we could throw more people at the problem, that only scales so far. If we really want to scale this type of care to seniors, we’re going to need to utilize technology. These tablets designed for seniors are a great place to start. Then, we can build from there.

I don’t think it will be long before we see doctors prescribing tablets to patients. It’s not currently in doctors normal line of thinking, but maybe it should be.

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

Practice Fusion Founder Launches Wearables Startup

Posted on May 31, 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.

Free EMR vendor Practice Fusion has always been something of a newsmaker. Since its launch in 2005, the company has drawn both praise and controversy for its revenue-generation approach, which has included the analysis and sale of de-identified patient data and advertising to physicians.

But it’d be hard to question Practice Fusion’s success, particularly given that it found its legs during a hyper-competitive period of EMR vendor growth capped by the Meaningful Use incentive program. Over the company’s lifespan, it has grown to serve over 110 million patients, and reportedly supported more than 70 million patient visits over 2015. It also attracted over $150 million in venture and private equity funding. Will it provide a great return for investors, time will tell, but they’ve definitely left their mark on the EHR industry.

At the helm of Practice Fusion until last year was CEO and Founder Ryan Howard. Howard – whom I’ve interviewed now and again over the years — certainly doesn’t lack for confidence or creative thinking. So I was intrigued to learn that Howard has stuck his toe into the wearables market. Clearly, Howard has not wasted time since August 2015, when he was booted out as Practice Fusion CEO. And if he believes a wearables startup can make money in this rapidly-maturing niche, I’m inclined to give it a look.

Howard’s new startup, dubbed iBeat, is creating a watch which constantly monitors and analyzes users’ heart activity. The device, which transmits its data to a cloud platform, can alert emergency medical services and, using an onboard GPS, provide the wearer’s location when a user has a heart attack or their heart slows down below a certain level. Unlike competitor AliveCor, whose electrocardiogram device can detect heart rhythm abnormalities such as atrial fibrillation, it has no immediate plans to get FDA approval for its technology.

iBeat expects to sell the device for less than $200, though if users want the emergency alert service they’ll have to pay an as-yet unnamed extra monthly fee. That puts it smack in the middle of the pack with competitors like the Apple Watch. However, the startup’s focus on cardiac events is fairly unusual. Another unusual aspect to the launch is that Howard is targeting the 50- to 70-year-old Baby Boomer market. (Imagine a more-focused version of the LifeAlert “I’ve fallen and I can’t get up” service, which focuses on the 75-plus market, Howard told MobiHealthNews.)

My take on all of this is that there may very well be something here. As I wrote about previously, my own heart rhythm is being monitored by a set of devices created by Medtronic, a set-up which probably cost a few thousand dollars in addition to the surgical costs of implanting the monitoring device. While Medtronic’s technology is doubtless FDA approved, for not-so-serious cases such as my own a $200+ plus smart watch might be just the ticket.

On the other hand, I doubt that uncertified devices such as the iBeat watch will attract much support from providers, as they simply don’t trust the data. So consumers are really going to have to drive sales. And without a massive consumer marketing budget, it will be difficult to gain traction in a niche contested by Apple, Microsoft, Fitbit and many, many other competitors. Not to mention all the competitors in the “I’ve fallen and I can’t get up” category as well.

Regardless of whether iBeat survives, though, I think its strategy is smart. My guess is that more-specialized wearables (think, I don’t know, iSugar for diabetics?) have a bright future.

E-patient Update: Remote Monitoring Leaves Me Out of The Loop

Posted on May 24, 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 some readers may recall, I don’t just write about digital health deployment — I live it. To be specific, my occasional heart arrhythmia (Afib) is being tracked remotely by device implanted in my chest near my heart. My cardiac electrophysiologist implanted the Medtronic device – a “loop recorder” roughly the size of a cigarette lighter though flatter — during a cardiac ablation procedure.

The setup works like this:

  • The implanted device tracks my heart rhythm, recording any events that fit criteria programmed into it. (Side note: It’s made entirely of plastic, which means I need not fear MRIs. Neat, huh?)
  • The center also includes a bedside station which comes with a removable, mouse shaped object that I can place on my chest to record any incidents that concern me. I can also record events in real time, when I’m on the road, using a smaller device that fits on my key ring.
  • Whether I record any perceived episodes or not, the bedside station downloads whatever information is stored in the loop recorder at midnight each night, then transmits it to the cardiac electrophysiologist’s office.
  • The next day, a tech reviews the records. If any unusual events show up, the tech notifies the doctor, who reaches out to me if need be.

Now, don’t get me wrong, this is all very cool. And these devices have benefited me already, just a month into their use. For example, one evening last week I was experiencing some uncomfortable palpitations, and wondered whether I had reason for concern. So I called the cardiac electrophysiologist’s after-hours service and got a call back from the on-call physician.

When she and I spoke, her first response was to send me to my local hospital. But once I informed her that the device was tracking my heart rhythms, she accessed them and determined that I was only experiencing mild tachycardia. That was certainly a relief.

No access for patients

That being said, it bugs me that I have no direct access to this information myself. Don’t get me wrong, I understand that interacting with heart rhythm data is complicated. Certainly, I can’t do as much in response to that information as I could if the device were, say, tracking my blood glucose levels.

That being said, my feeling is that I would benefit from knowing more about how my heart is working, or failing to work appropriately in the grand scheme of things, even if I can’t interpret the raw data of the device produces. For example, it would be great if I could view a chart that showed, say, week by week when events occurred and what time they took place.

Of course, I don’t know whether having this data would have any concrete impact on my life. But that being said, it bothers me that such remote monitoring schemes don’t have their core an assumption that patients don’t need this information. I’d argue that Medtronic and its peers should be thinking of ways to loop patients in any time their data is being collected in an outpatient setting. Don’t we have an app for that, and if not, why?

Unfortunately, no matter how patients scream and yell about this, I doubt we’ll make much progress until doctors raise their voices too. So if you’re a physician reading this, I hope you’re willing to get involved since patients deserve to know what’s going on with their bodies. And if you have the means to help them know, make it happen!