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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.For the last dozen years, he’s concentrated on EHR consulting and writing. He spent the 80s and 90s as an itinerant project manager 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, a role he recently repeated for a Council member.

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!

When Providing a Health Service, the Infrastructure Behind the API is Equally Important

Posted on May 2, 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://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.

In my ongoing review of application programming interfaces (APIs) as a technical solution for offering rich and flexible services in health care, I recently ran into two companies who showed as much enthusiasm for their internal technologies behind the APIs as for the APIs themselves. APIs are no longer a novelty in health services, as they were just five years ago. As the field gets crowded, maintenance and performance take on more critical roles in offering a successful business–so let’s see how Orion Health and Mana Health back up their very different offerings.

Orion Health

This is a large analytics firm that has staked a a major claim in the White House’s Precision Medicine Initiative. Orion Health’s data platform, Amadeus, addresses population health management as well as “considering how they can better tailor care for each chronically ill individual,” as put by Dave Bennett, executive vice president for Product & Strategy. “We like to say that population health is the who and precision medicine is the how.” Thus, Amadeus can harmonize a huge variety of inputs, such as how many steps a patient takes each day at home, to prevent readmissions.

Orion Health has a cloud service, a capacity for handling huge data sets such as genomes, and a selection of tools for handling such varied sources as clinical, claims, pharmacy, genetic, and consumer device or other patient-generated data. Environmental and social data are currently being added. It has more than 90 million patient records in its systems worldwide.

Patient matching links up data sets from different providers. All this data is ingested, normalized, and made accessible through APIs to authorized parties. Customers can write their own applications, visualizations, and SQL queries. Amadeus is used by the Centers for Disease Control, and many hospitals join the chorus to submit data to the CDC.

So far, Orion Health resembles some other big initiatives that major companies in the health care space are offering. I covered services from Philips in a recent article, and another site talks about GE. Bennett says that Orion Health really distinguishes itself through the computing infrastructure that drives the analytics and data access.

Many companies use conventional relational database as their canonical data store. Relational databases are 1980s-era technology, unmatched in their robustness and sophistication in querying (through the SQL language), but becoming a bottleneck for the data sizes that health analytics deals with.

Over the past decade, every industry that needs to handle enormous, streaming sets of data has turned to a variety of data stores known collectively as NoSQL. Ironically, these are often conceptually simpler than SQL databases and have roots going much farther back in computing history (such as key/value stores). But these data stores let organizations run a critical subset of queries in real time over huge data sets. In addition, analytics are carried out by newer MapReduce algorithms and in-memory services such as Spark. As an added impetus for development, these new technologies are usually free and open source software.

Amadeus itself stores data in Cassandra, one of the most mature NoSQL data stores, and uses Spark for processing. According to Bennett, “Spark enables Amadeus to future proof healthcare organizations for long term innovation. Bringing data and analytics together in the cloud allows our customers to generate deeper insights efficiently and with increased relevancy, due to the rapidity of the analytics engine and the streaming of current data in Amadeus. All this can be done at a lower cost than traditional healthcare analytics that move the data from various data warehouses that are still siloed.” Elastic Search is also used. In short, the third-party tools used within Orion Health are ordinary and commonly found. It is simply modern in the same way as computing facilities in other industries–così fan tutte.

Mana Health

This company integrates device data into EHRs and other data stores. It achieved fame when it was chosen for the New York State patient portal. According to Raj Amin, co-founder and Executive Chairman, the company won over the judges with the convenient and slick tile concept in their user interface. Each tile could be clicked to reveal a deeper level of detail in the data. The company tries to serve clinicians, patients, and data analysts alike. Clients include HIEs, health systems, medical device manufacturers, insurers, and app developers.

Like Orion Health, Mana Health is very conscious of staying on the leading edge of technology. They are mobile-friendly and architect their solutions using microservices, a popular form of modular development that attempts to maximize flexibility in coding and deploying new services. On a lark, they developed a VR engine compatible with the Oculus Rift to showcase what can creatively be built on their API. Although this Rift project has no current uses, the development effort helps them stay flexible so that they can adapt to whatever new technologies come down the pike.

Because Mana Health developed their API some eighteen months ago, they pre-dated some newer approaches and standards. They plan to offer compatibility with emerging standards such as FHIR that see industry adoption. The company recently was announced as a partner in the Commonwell Alliance, a project formed by a wide selection of major EHR vendors to pursue interoperability.

To support machine learning, Mana Health stores data in an open source database called Neo4j. This is a very unusual technology called a graph database, whose history and purposes I described two years ago.

Graphs are familiar to anyone who has seen airline maps showing the flights between cities. Graphs are also common for showing social connections, such as your friends-of-friends on Facebook. In health care, as well, graphs are very useful tools. They show relationships, but in a very different way from relational databases. Graphs are better than relational databases at tracing connections between people or other entities. For instance, a team led by health IT expert Fred Trotter used Neo4J to store and query the data in DocGraph, linking primary care physicians to the specialists to which they refer patients.

In their unique ways, Mana Health and Orion Health follow trends in the computing industry and judiciously choose tools that offer new forms of access to data, while being proven in the field. Although commenters in health IT emphasize the importance of good user interfaces, infrastructure matters too.

Randomized Controlled Trials and Longitudinal Analysis for Health Apps at Twine Health (Part 2 of 2)

Posted on February 18, 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://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 section of this article described the efforts of Dr. John Moore of Twine Health to rigorously demonstrate the effectiveness of a digital health treatment platform. As Moore puts it, Twine Health sought out two of the most effective treatment programs in the country–both Harvard’s diabetes treatment and MGH’s hypertension treatment are much more effective than the standard care found around the country–and then used their most effective programs for the control group of patients. The control group used face-to-face visits, phone calls, and text messages to keep in touch with their coaches and discuss their care plans.

The CollaboRhythm treatment worked markedly better than these exemplary programs. In the diabetes trial, they achieved a 3.2% reduction in diabetic patients’ A1C levels over three months (the control group achieved 2.0%). In the hypertension trial, 100% of patients reached a controlled blood pressure of less than 140/90 and the average reduction in blood pressure was 26mmHg (the control group had an average 16mmHg reduction and fewer than one-third of the patients went down less than 140/90).

What clinical studies can and cannot ensure

I see a few limitations with these clinical studies:

  • The digital program being tested combines several different intervention, as described before: reminders, messaging, virtual interactions, reports, and so on. Experiments show that all these things work together. But one can’t help wondering: what if you took out some time-consuming interaction? Could the platform be just as successful? But testing all the options would lead to a combinatorial explosion of tests.

    It’s important that interventions by coaches started out daily but decreased over the course of the study as the patient became more familiar and comfortable with the behavior called for in the care plans. The decrease in support required from the human coach suggests that the benefits are sustainable, because the subjects are demonstrating they can do more and more for themselves.

  • Outcomes were measured over short time frames. This is a perennial problem with clinical studies, and was noted as a problem in the papers. The researchers will contact subjects in about a year to see whether the benefits found in the studies were sustained. Even one year, although a good period to watch to see whether people bounce back to old behaviors, isn’t long enough to really tell the course of chronic illness. On the other hand, so many other life events intrude over time that it’s unfair to blame one intervention for what happens after a year.

  • Despite the short time frame for outcomes, the studies took years to set up, complete, and publish. This is another property of research practice that adds to its costs and slows down the dissemination of best practices through the medical field. The time frames involved explain why the researchers’ original Media Lab app was used for studies, even though they are now running a company on a totally different platform built on the same principles.

  • These studies also harbor all the well-known questions of external validity faced by all studies on human subjects. What if the populations at these Boston hospitals are unrepresentative of other areas? What if an element of self-selection skewed the results?

Bonnie Feldman, DDS, MBA, who went from dentistry to Wall Street and then to consulting in digital health, comments, “Creating an evidence base requires a delicate balancing act, as you describe, when technology is changing rapidly. Right now, chronic disease, especially autoimmune disease is affecting more young adults than ever before. These patients are in desperate need of new tools to support their self-care efforts. Twine’s early studies validate these important advances.”

Later research at Twine Health

Dr. Moore and his colleagues took stock of the tech landscape since the development of CollaboRhythm–for instance, the iPhone and its imitators had come out in the meantime–and developed a whole new platform on the principles of CollaboRhythm. Twine Health, of which Moore is co-founder and CEO, offers a platform based on these principles to more than 1,000 patients. The company expects to expand this number ten-fold in 2016. In addition to diabetes and hypertension, Twine Health’s platform is used for a wide range of conditions, such as depression, cholesterol control, fitness, and diet.

With a large cohort of patients to draw on, Twine Health can do more of the “big data” analysis that’s popular in the health care field. They don’t sponsor randomized trials like the two studies cited early, but they can compare patients’ progress to what they were doing before using Twine Health, as well as to patients who don’t use Twine Health. Moore says that results are positive and lasting, and that costs for treatment drop one-half to two-thirds.

Clinical studies bring the best scientific methods we know to validating health care apps. They are being found among a small but growing number of app developers. We still don’t know what the relation will be between randomized trials and the longitudinal analysis currently conducted by Twine Health; both seem of vital importance and they will probably complement each other. This is the path that developers have to take if they are to make a difference in health care.