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The Healthcare AI Future, From Google’s DeepMind

Posted on February 22, 2017 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.

While much of its promise is still emerging, it’s hard to argue that AI has arrived in the health IT world. As I’ve written in a previous article, AI can already be used to mine EMR data in a sophisticated way, at least if you understand its limitations. It also seems poised to help providers predict the incidence and progress of diseases like congestive heart failure. And of course, there are scores of companies working on other AI-based healthcare projects. It’s all heady stuff.

Given AI’s potential, I was excited – though not surprised – to see that world-spanning Google has a dog in this fight. Google, which acquired British AI firm DeepMind Technologies a few years ago, is working on its own AI-based healthcare solutions. And while there’s no assurance that DeepMind knows things that its competitors don’t, its status as part of the world’s biggest data collector certainly comes with some advantages.

According to the New Scientist, DeepMind has begun working with the Royal Free London NHS Foundation Trust, which oversees three hospitals. DeepMind has announced a five-year agreement with the trust, in which it will give it access to patient data. The Google-owned tech firm is using that data to develop and roll out its healthcare app, which is called Streams.

Streams is designed to help providers kick out alerts about a patient’s condition to the cellphone used by the doctor or nurse working with them, in the form of a news notification. At the outset, Streams will be used to find patients at risk of kidney problems, but over the term of the five-year agreement, the developers are likely to add other functions to the app, such as patient care coordination and detection of blood poisoning.

Streams will deliver its news to iPhones via push notifications, reminders or alerts. At present, given its focus on acute kidney injury, it will focus on processing information from key metrics like blood tests, patient observations and histories, then shoot a notice about any anomalies it finds to a clinician.

This is all part of an ongoing success story for DeepMind, which made quite a splash in 2016. For example, last year its AlphaGo program actually beat the world champion at Go, a 2,500-year-old strategy game invented in China which is still played today. DeepMind also achieved what it terms “the world’s most life-like speech synthesis” by creating raw waveforms. And that’s just a couple of examples of its prowess.

Oh, and did I mention – in an achievement that puts it in the “super-smart kid you love to hate” category – that DeepMind has seen three papers appear in prestigious journal Nature in less than two years? It’s nothing you wouldn’t expect from the brilliant minds at Google, which can afford the world’s biggest talents. But it’s still a bit intimidating.

In any event, if you haven’t heard of the company yet (and I admit I hadn’t) I’m confident you will soon. While the DeepMind team isn’t the only group of geniuses working on AI in healthcare, it can’t help but benefit immensely from being part of Google, which has not only unimaginable data sources but world-beating computing power at hand. If it can be done, they’re going to do it.

Denmark’s Health System Suffering Familiar EMR Woes

Posted on February 21, 2017 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.

If you’re trying to navigate the US healthcare system – or worse, trying to pay for your care — Denmark’s alternative may sound pretty sweet. The Danish health system, which is funded through income taxes, offers free care to all Danish residents and EU citizens, as well as free emergency treatment to visitors from all other countries. And the Danes manage to deliver high-quality healthcare while keeping costs at 10.5% of its GDP (as opposed the US, which spends nearly 18% of the GDP on healthcare).

That being said, when it comes to health IT, Denmark is going through some struggles which should be familiar to us all. Starting in 2014, the Danish government began modernizing its healthcare system, an effort which includes developing both new hospitals and a modern health IT infrastructure. One of the linchpins of its efforts is a focus on directing care to fewer, more specialized hospitals – cutting beds by 20% and hopefully reducing average lengths of hospital stays from five to three days – supported by its HIT expansion.

You probably won’t be surprised to learn, meanwhile, that Epic has inserted itself into this effort, winning a $1B project to put its systems in place across 20 hospitals with 44,000 concurrent users. Unfortunately for the Danes, who are starting with a few hospitals in one of the country’s five regions, the effort has run into some early snags. Apparently, the Epic installs at these initial test hospitals aren’t going according to plan.

According to one publication, initial hospital go-lives in May and June of last year have seen  major problems, including errors that have put patients at risk, as well as creating erroneous test reports, results and prescriptions. The Epic systems were also having trouble communicating with the Danish health card, which stores patient information on a magnetic stripe.

The questionable rollout has since caused some controversy. As of August 2016, the local doctors’ union was demanding that a planned deployment in Copenhagen, at Denmark’s busiest hospital, be put off until authorities had figured out what was going wrong at the other two.

At first, I was surprised to hear about about Denmark’s IT woes, as I’d blithely assumed that a government-run health system would have a “central planning” advantage in EMR implementations. But as it turns out, that’s clearly not the case. It seems some frustrations are universal.

I got some insight into this yesterday, when I took a call from an earnest Danish journalist who was trying to understand what the heck was going on with Epic. “Things are going badly here,” she said. “There are lots of complaints from the first two hospitals. And the systems can’t talk to each other.”

I told her not to be surprised by all of this, given how complex Epic rollouts can be. I also warned that given the high cost of Epic software and support, it would not be astonishing if the project ended up over budget. I then predicted that without pulling Epic-trained (and perhaps Epic certified) experts into the project, things might get worse before they get better. “Just hire a boatload of American Epic consultants and you’ll be fine,” I told her, perhaps a bit insensitively. “Maybe.”

When I said that, she was clearly taken aback. Even from thousands of miles away, I could tell she was unhappy. “I was hoping you had a solution,” she finally said. “I wish,” I replied. And I had to laugh so I wouldn’t cry.

Switching Out EMRs For Broad-Based HIT Platforms

Posted on February 8, 2017 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.

I’ve always enjoyed reading HISTalk, and today was no exception. This time, I came across a piece by a vendor-affiliated physician arguing that it’s time for providers to shift from isolated EMRs to broader, componentized health IT platforms. The piece, by Excelicare chief medical officer Toby Samo, MD, clearly serves his employer’s interests, but I still found the points he made to be worth discussing.

In his column, he notes that broad technical platforms, like those managed by Uber and Airbnb, have played a unique role in the industries they serve. And he contends that healthcare players would benefit from this approach. He envisions a kind of exchange allowing the use of multiple components by varied healthcare organizations, which could bring new relationships and possibilities.

“A platform is not just a technology,” he writes, “but also ‘a new business model that uses technology to connect people, organizations and resources in an interactive ecosystem.’”

He offers a long list of characteristics such a platform might have, including that it:

* Relies on apps and modules which can be reused to support varied projects and workflows
* Allows users to access workflows on smartphones and tablets as well as traditional PCs
* Presents the results of big data analytics processes in an accessible manner
* Includes an engine which allows clients to change workflows easily
* Lets users with proper security authorization to change templates and workflows on the fly
* Helps users identify, prioritize and address tasks
* Offers access to high-end clinical decision support tools, including artificial intelligence
* Provides a clean, easy-to-use interface validated by user experience experts

Now, the idea of shared, component-friendly platforms is not new. One example comes from the Healthcare Services Platform Consortium, which as of last August was working on a services-oriented architecture platform which will support a marketplace for interoperable healthcare applications. The HSPC offering will allow multiple providers to deliver different parts of a solution set rather than each having to develop their own complete solution. This is just one of what seem like scores of similar initiatives.

Excelicare, for its part, offers a cloud-based platform housing a clinical data repository. The company says its platform lets providers construct a patient-specific longitudinal health record on the fly by mining existing EHRs claims repositories and other data. This certainly seems like an interesting idea.

In all candor, my instinct is that these platforms need to be created by a neutral third party – such as travel information network SABRE – rather than connecting providers via a proprietary platform created by companies like Excelicare. Admittedly, I don’t have a deep understanding of Excelicare’s technology works, or how open its platform is, but I doubt it would be viable financially if it didn’t attempt to lock providers into its proprietary technology.

On the other hand, with no one interoperability approach having gained an unbeatable lead, one never knows what’s possible. Kudos to Samo and his colleagues for making an effort to advance the conversation around data sharing and collaboration.

EMR Data Use For Medical Research Sparks Demand For Intermediaries

Posted on February 7, 2017 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.

Over the last couple of years, it’s become increasingly common for clinical studies to draw on data gathered from EMRs — so common, in fact, that last year the FDA issued official guidance on how researchers should use such data.

Intermingling research observations and EMR-based clinical data poses different problems than provider-to-provider data exchanges. Specifically, the FDA recommends that when studies use EMR data in clinical investigations, researchers make sure that the source data are attributable, legible, contemporaneous, original and accurate, a formulation known as ALCOA by the feds.

It seems unlikely that most EMR data could meet the ALCOA standard at present. However, apparently the pharmas are working to solve this problem, according to a nice note I got from PR rep Jamie Adler-Palter of Bayleaf Communications.

For a number of reasons, clinical research has been somewhat paper-bound in the past. But that’s changing. In fact, a consortium of leading pharma companies known as TransCelerate Biopharma has been driving an initiative promoting “eSourcing,” the practice of using appropriate electronic sources of data for clinical trials.

eSourcing certainly sounds sensible, as it must speed up what has traditionally been the very long process of biopharma innovation. Also, I have to agree with my source that working with an electronic source beats paper any day (or as she notes, “paper does not have interactive features such as pop-up help.”) More importantly, I doubt pharmas will meet ALCOA objectives any other way.

According to Adler-Palter, thirteen companies have been launched to provide eSource solutions since 2014, including Clinical Research IO (presumably a Bayleaf client). I couldn’t find a neat and tidy list of these companies, as such solutions seem to overlap with other technologies. (But my sense is that this is a growing area for companies like Veeva, which offers cloud-based life science solutions.)

For its part CRIO, which has signed up 50 research sites in North America to date, offers some of the tools EMR users have come to expect. These include pre-configured templates which let researchers build in rules, alerts and calculations to prevent deviations from the standards they set.

CRIO also offers remote monitoring, allowing the monitor to view a research visit as soon as it’s finished and post virtual “sticky notes” for review by the research coordinator. Of course, remote monitoring is nothing new to readers, but my sense is that pharmas are just getting the hang of it, so this was interesting.

I’m not sure yet what the growth of this technology means for providers. But overall, anything that makes biopharma research more efficient is probably a net gain for patients, no?

External Incentives Key Factor In HIT Adoption By Small PCPs

Posted on January 25, 2017 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 new study appearing in The American Journal of Managed Care concludes that one of the key factors influencing health IT adoption by small primary care practices is the availability of external incentives.

To conduct the study, researchers surveyed 566 primary care groups with eight or fewer physicians on board. Their key assumption, based on previous studies, was that PCPs were more likely to adopt HIT if they had both external incentives to change and sufficient internal capabilities to move ahead with such plans.

Researchers did several years’ worth of research, including one survey period between 2007 and 2010 and a second from 2012 to 2013. The proportion of practices reporting that they used only paper records fell by half from one time period to the other, from 66.8% to 32.3%. Meanwhile, the practices adopted higher levels of non-EMR health technology.

The mean health IT summary index – which tracks the number of positive responses to 18 questions on usage of health IT components – grew from 4.7 to 7.3. In other words, practices implemented an average of 2.6 additional health IT functions between the two periods.

Utilization rates for specific health IT technologies grew across 16 of the 18 specific technologies listed. For example, while just 25% of practices reported using e-prescribing tech during the first period of the study, 70% reported doing so during the study’s second wave. Another tech category showing dramatic growth was the proportion of practices letting patients view their medical record, which climbed from one percent to 19% by the second wave of research.

Researchers also took a look at the impact factors like practice size, ownership and external incentives had on the likelihood of health IT use. As expected, practices owned by hospitals instead of doctors had higher mean health IT scores across both waves of the survey. Also, practices with 3 to 8 physicians onboard had higher scores than those were one or two doctors.

In addition, external incentives were another significant factor predicting PCP technology use. Researchers found that greater health IT adoption was associated with pay-for-performance programs, participation in public reporting of clinical quality data and a greater proportion of revenue from Medicare. (Researchers assumed that the latter meant they had greater exposure to CMS’s EHR Incentive Program.)

Along the way, the researchers found areas in which PCPs could improve their use of health IT, such as the use of email of online medical records to connect with patients. Only one-fifth of practices were doing so at the time of the second wave of surveys.

I would have liked to learn more about the “internal capabilies” primary care practices would need, other than having access to hospital dollars, to get the most of health IT tools. I’d assume that elements such as having a decent budget, some internal IT expertise and management support or important, but I’m just speculating. This does give us some interesting lessons on what future adoption on new technology in healthcare will look like and require.

The Digital Health Biography: There’s A New Record In Town

Posted on January 18, 2017 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.

Few of us would argue that using EMRs is not a soul-sucking ordeal for many clinicians. But is there any alternative in sight? Maybe so, according to Robert Graboyes and Dr. Darcy Nikol Bryan, who are touting a new model they’ve named a “digital health biography.”

In a new article published in Real Clear Health, Graboyes, an economist who writes on technology, and Bryan, an OB/GYN, argue that DHBs will be no less than “an essential component of 21st century healthcare.” They then go on to describe the DHB, which has several intriguing features.

Since y’all know what doctors dislike (hate?) about EMRs, I probably don’t need to list the details the pair shares on why they generate such strong feelings. But as they rightly note, EMRs may take away from patient-physician communication, may be unattractively designed and often disrupt physician workflow.

Not only that, they remind us that third parties like insurance companies and healthcare administrators seem to get far more benefits from EMR content than clinicians do. Over time, data analytics efforts may identify factors that improve care, which eventually benefits clinicians, but on a transactional level it’s hard to dispute that many physicians get nothing but aggravation from their systems.

So what makes the DHB model different? Here’s how the authors lay it out:

* Patients own the DHB and data it contains
* Each patient should have only one DHB
* Patient DHBs should incorporate data from all providers, including PCPs, specialists, nurse practitioners, EDs, pharmacists and therapists
* The DHB should incorporate data from wearable telemetry devices like FitBits, insulin pumps and heart monitors
* The DHB should include data entered by patients, including family history, recollections of childhood illness, fears and feelings
* DHB data entry should use natural language rather than structured queries whenever possible
* The DHB should leverage machine learning to extract and organize output specific to specific providers or the patient
* In the DHB model, input and output software are separated into different categories, with vendors competing for both ends separately on functionality and aesthetics
* Common protocols should minimize the difficulty and cost of shifting from one input or output vendor to the other
* The government should not mandate or subsidize any specific vendors or data requirements
* DHB usage should be voluntary, forcing systems to keep proving their worth or risk being dumpted
* Clinical applications shouldn’t be subservient to reimbursement considerations

To summarize, the DHB model calls for a single, patient-controlled, universal record incorporating all available patient health data, including both provider and patient inputs. It differ significantly from existing EMR models in some ways, particularly if it separated data input from output and cut vendors out of the database business.

As described, this model would eliminate the need for separate institutions to own and maintain their own EMRs, which would of course stand existing health IT structures completely on their head. Instead of dumping information into systems owned by providers, the patient would own and control the DHB, perhaps on a server maintained by an independent intermediary.

Unfortunately, it’s hard to imagine a scenario in which providers would be willing to give up control to this great an extent, even if this model was more effective. Still, the article makes some provocative suggestions which are worth discussing. Do you think this approach is viable?

E-Patient Update:  When Your Tech Fails, Own It!

Posted on December 30, 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.

I am reasonably comfortable with my primary care practice which, though not exactly chi-chi – no latte machine in the lobby! — does a reasonably good job with the basics of scheduling, payment, referrals and the like.  And I also like that my PCP is part of a multispecialty group linked together by an athenahealth EMR and portal, which makes it easier to coordinate my care.

But recently, I’ve run into some technical problems with the practice portal, repeatedly and inconveniently. And rather than take action, apologize or even acknowledge the problem on an executive level, the group appears to be doing nothing whatsoever to address the issue.

The issue I’m having is that while the portal is supposed to let you schedule appointments online, my last two didn’t show up in the group’s live schedule. This may not sound like a big deal, but it is. One of the appointments was to see a neurologist for help with blinding migraines, and trying to attend the non-existent meeting was a nightmare.

Because I needed my neurologist, I scraped myself out of bed, put on an eye mask to avoid extra light exposure – migraine makes you terribly light-sensitive – and had my husband guide me to the car. But when I walked into the lobby (peeking out from under the mask to avoid crashing into things) I was told that they had nothing for me on the schedule.

Almost crying at this point, and with migraine-induced tears streaming down my cheeks, I begged them to squeeze me in, but they refused. To add insult to injury, they all but told me that it must have been my fault that the appointment booking didn’t take. There was no “I’m sorry this happened” whatsoever, nor any suggestion that their technology might be glitchy. If I hadn’t been so sick I might have gotten into a screaming match with the supercilious receptionist, but given my condition I just slinked away and went back to bed.

I’ve since learned, from a much nicer clerk at the affiliated primary care practice, that the group has been getting scores of calls from similarly aggrieved patients whose time had been wasted – and health needs unmet. “Tell the doctor, so she can tell the practice management committee,” she told me. “This is happening all the time.”

Of course, because I write about health IT, I realize that practice leaders may be struggling with issues that defy an easy fix, but I’m still disappointed with their failure to respond publicly. There are many steps they could have taken, including:

* Putting a warning on their practice website, and (if possible) the portal that the scheduling function has issues and to double-check that their appointment registered
* Disabling the scheduling function entirely until they’re reasonably certain it works
* Putting a sign in on the practice’s front desk alerting patients about the problem
* Updating the practice’s “hold” message with an advisory

And that’s just what came to mind immediately. They could do postcards, email messages, letters, robocalls…I don’t care if they drive around town with a guy who shouts the message into a megaphone. I just want expect them to take responsibility and treat my time and health with respect. Sure, tech will go south, but if it does, own it! There’s no excuse for ignoring problems like these.

E-Patient Update: The Smart Medication Management Portal

Posted on December 16, 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 I work to stay on top of my mix of chronic conditions, one thing that stands out to me is that providers expect me to do most of my own medication tracking and management. What I mean by this is that their relationship to my med regimen is fairly static, with important pieces of the puzzle shared between multiple providers. Ultimately, there’s little coordination between prescribers unless I make it happen.

I’ve actually had to warn doctors about interactions between my medications, even when those interactions are fairly well-known and just a Google search away online. And in other cases, specialists have only asked about medications relevant to their treatment plan and gotten impatient when I tried to provide the entire list of prescriptions.

Sure, my primary care provider has collected the complete list of my meds, and even gets a updates when I’ve been prescribed a new drug elsewhere. But given the complexity of my medical needs, I would prefer to talk with her about how all of the various medications are working for me and why I need them, something that rarely if ever fits into our short meeting time.

Regardless of who’s responsible, this is a huge problem. Patients like me are being sent with some general drug information, a pat on the back, and if we experience side effects or are taking meds incorrectly we may not even know it.

So at this point you’re thinking, “Okay, genius, what would YOU do differently?” And that’s a fair question. So here’s what I’d like to see happen when doctors prescribe medications.

First, let’s skip over the issue of what it might take to integrate medication records across all providers’s HIT systems. Instead, let’s create a portal — aggregating all the medication records for all the pharmacies in a given ZIP Code — and allow anyone with a valid provider number and password to log in and review it.  The same site could run basic analytics examining interactions between drugs from all providers. (By the way, I’m familiar with Surescripts, which is addressing some of these gaps, but I’m envisioning a non-proprietary shared resource.)

Rather than serving as strictly a database, the site would include a rules engine which runs predictive analyses on what a patient’s next steps should be, given their entire regimen, then generate recommendations specific to that patient. If any of these were particularly important, the recommendations could be pushed to the provider (or if administrative, to staff members) by email or text.

These recommendations, which could range from reminding the patient to refill a critical drug to warning the clinician if an outside prescription interacts with their existing regimen. Smart analytics tools might even be able to predict whether a patient is doing well or poorly by what drugs have been added to their regimen, given the drug family and dosage.

Of course, these functions should ultimately be integrated into the physicians’ EMRs, but at first, hospitals and clinics could start by creating an interface to the portal and linking it to their EMR. Eventually, if this approach worked, one would hope that EMR vendors would start to integrate such capabilities into their platform.

Now I imagine there could be holes in these ideas and I realize how challenging it is to get disparate health systems and providers to work together. But what I do know is that patients like myself get far too little guidance on how to manage meds effectively, when to complain about problems and how to best advocate for ourselves when doctors whip out the prescription pad. And while I don’t think my overworked PCP can solve the problem on her own, I believe it may be possible to improve med management outcomes using smart automation.

Bottom line, I doubt anything will change here unless we create an HIT solution to the problem. After all, given how little time they have already, I don’t see clinicians spending a lot more time on meds. Until then, I’m stuck relying on obsessive research via Dr. Google, brief chats with my frantic retail pharmacist and instincts honed over time. So wish me luck!

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.

Consider The Portable EMR

Posted on October 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.

The other day I was reading the Huffington Post, and was surprised to stumble across a rather interesting article promoting the benefits of a “portable” EMR. Now, for HIT fans like ourselves, the word portability implies having data travel from one provider directly to another in a usable manner. But author David Black, who describes himself as a “software guy” and Technology Partner at Oak HC/FT, has something different in mind.

For Black, the best way to share healthcare data would be if the patient carried it around from place to place and updated it as they travel from provider to provider. To be more specific, the portable EMR is an app with all of the patient’s healthcare data and history stored in it. The app would serve the purpose Microsoft Outlook does for email, with the data stored and backed up in the cloud, available to sync to any device.

As Brown sees it, not only would this be a way to keep data at patients’ fingertips, it would be a better way to control access to PHI as well. As he notes, many apps ask permission to access data such as email contacts. In this case, the app would ask permission before sharing the data with medical professionals. None of the data would be “locked up” in an EMR, he says.

Now, while I’m intrigued by this idea, I can see several problems that would result from wide adoption of this approach, including the following:

* Safety and security of the data stored in the cloud:  I’m no legal expert, but from what I’ve read about the healthcare cloud, any cloud vendor with which a provider works must be a full Business Associate under HIPAA, and meet the data security standards involved. I doubt many cloud services chosen by a consumer are in compliance, and that needs to be resolved before these become too popular.

* Securing of the consumers’ data:  Ok, let’s say that the cloud-based backup arrangements were kosher. Live ePHI is still resident (and probably quite hackable) on the consumer device which contains the EMR portability app. How can consumers protect it adequately, and if they don’t what happens to systems within the provider organization that access it?

* Carrying the device:  Even if the consumer data in the portability app is secure both in the cloud and on the device, that device still has to travel with the patient. No one wants to carry a laptop everywhere, smartphones and tablets have usability issues and other devices come with their own questions. Also, if the patient’s phone or laptop gets smashed in a car wreck, but providers need current health data to treat them, where do they get it?

Despite these complaints, I do see the benefits of Brown’s approach. Putting portability into the patients’ hands has not only accessibility benefits, but also stands to boost patient engagement. (And in fact, I know of at least one company – full disclosure, a client – that’s actually doing something along these lines.) But the model that Brown is proposing has many challenges to address.