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Accenture: “Zombie” Digital Health Startups Won’t Die In Vain

Posted on August 24, 2015 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

I don’t know about you, but I’ve been screaming for a while about how VCs are blowing their money on questionable digital health ventures. To my mind, their investment patterns suggest that the smart money really isn’t that smart. I admit that sorting out what works in digital health/mHealth/connected health is very challenging, but it’s far from impossible if you immerse yourself in the industry. And given how much difference carefully-thought out digital health tools can make, it’s exasperating to watch failing digital health startups burn through money.

That being said, maybe all of those dollars won’t be wasted. According to no less an eminence grise than Accenture, failing digital health ventures will feed the stronger ones and make their success more likely. A new report from Accenture predicts that these “zombie” startups — half of which will die within two years, it says — will provide talent and technology to their surviving rivals. (OK, I agree, the zombie image is a bit unsettling, isn’t it?)

To bring us their horror movie metaphor, Accenture analyzed the status of 900 healthcare IT startups, concluding that 51% were likely to collapse within 20 months.  The study looked at ventures cutting across social, mobile, analytics, cloud and sensors technologies, which include wearables, telehealth and remote monitoring.

While most researchers try to predict who the winners will be in a given market, Accenture had a few words to say about the zombie also-rans. And what they found was that the zombies have taken in enough cash to have done some useful things, collecting nearly $4 billion in funding between 2008 and 2013.

The investments are part of an ongoing funding trend. In fact, digital health dollars are likely to pour in over the next two years as well, with healthcare IT startups poised to take in $2.5 billion more over the next two years, Accenture estimates. Funding should focus on four segments, including engagement (25%), treatment (25%), diagnosis (21%) and infrastructure (29%), the study found.

So what use are the dying companies that will soon litter the digital health landscape? According to Accenture, more-successful firms can reap big benefits by acquiring the failing startups. For example, healthcare players can do “acqui-hiring” deals with struggling digital health startups to pick up a deep bench of qualified tech staffers. They can pick up unique technologies (the 900 firms analyzed, collectively, had 1,700 patents). And acquiring firms can harvest the startups’ technology to improve their products and services lineups.

Not only that — and this is Anne, not Accenture talking — acquiring healthcare firms get a wonderful infusion of entrepreneurial energy, regardless of whether the acquired firm was booking big bucks or not. And I speak from long experience. I’ve known the leaders of countless tech startups, and there’s very little difference between those who make a gazillion dollars and those whose ventures die. Generally speaking, anyone who makes a tech startup work for even a year or two is incredibly insightful, creative, and extremely dedicated, and they bring a kind of excitement to any company that hires them.

So, backed by the corporate wisdom of Accenture, I’ve come to praise zombies, not to bury them. While they may give their corporate lives, their visions won’t be wasted. With any luck, the next generation of digital health companies will appreciate the zombies’ hard work and initiative, even if they’re no longer with us.

Are EMRs Getting Worse Or Doctors Getting Smarter?

Posted on August 20, 2015 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

I know it sounds crazy — it’s hard to imagine doctors being more annoyed with EMRs than they already are — but according to one study that’s just what’s happening.

A newly-published study by the American Medical Association and the American College of Physicians’ AmericanEHR division suggests that doctors like the current crop of EMRs less than ever.

About half of study respondents said that their EMR was having a negative impact on costs, efficiency or productivity, the groups reported. Only 22% said they were satisfied with their EMR, and a scant 12% said they were “very satisfied.”

Doctors’ happiness with their EMRs has dropped substantially since five years ago, when 39% reported being satisfied and 22% said they were very satisfied, according to a prior study by AmericanEHR.  In other words, nearly 4 out of 10 doctors surveyed seem to have been content with what they had. But conditions have clearly changed.

The reasons for this are unlikely to be the result of mere peevishness. After all, with EMRs being a reality of doing business today, it seems unlikely that physicians would simply revert into sulking. Actually, my own unofficial survey — of several docs I’ve actually seen as a patient — suggests that most have gone through their stages of grief and decided that EMRs aren’t unholy. (My PCP said it best: “You get used to them, then they’re not so bad.”)

Instead, I’d argue, something good is actually happening, though it may not look that way on the surface. Having adapted to the need to use EMRs, physicians are engaging with them deeply, and beginning to expect more from them than a kludgy interface slapped on a slow database can provide.

Some are actually proposing that EMRs go beyond traditional medical record paradigm, something I see as an exciting development. For example, Dr. Arlen Meyers, CEO of the Society of Physician Entrepreneurs, argues that it’s time to “unbundle and re-engineer the care processes model” by introducing new templates into EMRs. In fact, he’s a fan of rethinking the hallowed SOAP (symptoms, objective findings, assessment and plan) approach to patient notes:

Given how things are changing, it might be time to give the pink slip to SOAP. The main problems are that 1) the model does not prioritize information by levels of urgency, 2) it does not provide decision support when it comes to how one disease affects the other or how one medicine affects another, and 3) it does not add efficiencies to taking care of increasingly complex patients.

And Meyers is not the only one. In fact, a recent paper published in JAMA Internal Medicine suggests that a new format flipping the elements of the SOAP note and reordering them as APSO (assessment, plan, subjective, objective) works well in the EMR age.

According to a 2010 study detailed in the paper, APSO notes were fairly successful at the University of Colorado ambulatory clinics. The study, which looked at APSO use in 13 clinics, found that 73% of participants were “satisfied” or “very satisfied” with the new format, and 75% “preferred” or “strongly preferred” reading APSO notes.

I’m betting that physicians will only be satisfied with EMRs again when EMRs are reshaped to embrace new ways of working. Since new workflow demands are generated by using EMRs, in turn, this cycle may never end. But that’s a good thing. If physicians are engaged enough with their EMRs to propose new ways of working, it will benefit everyone.

Specialty Specific EHR

Posted on June 29, 2015 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

I’ve long been a fan of the specialty specific EHR vendor. I’ve seen over and over again how much of a difference a specialty specific EHR can make in a practice. It’s a slippery slope when a specialty specific EHR starts entering other specialties. We’d like to think that every doctor is the same, but the variation in the needs of different specialties is rarely given the attention it deserves.

What scares me is that if we’re not careful, the specialty specific EHR vendor might be a dying breed. This isn’t because the specialty specific EHR vendors aren’t loved by their users more than the alternatives. Instead it’s the shift towards hospital owned medical practices that puts the specialty specific EHR in danger.

While hospital systems would love to support a best of breed approach to EHR software and allow each specialty to choose their own, I’ve never seen it actually happen. When push comes to shove, the hospital system starts rolling out an EHR vendor that “supports” every one of their specialties. It’s hard to blame an executive for making this choice. The logistics of supporting 20+ EHR vendors is onerous to put it lightly. The efficiency of one EHR vendor for a large multi specialty organization is just impossible to ignore. Long term however, I wonder if the downsides will cause major issues.

I should also declare that I don’t think a specialty specific EHR is always the best option. Some specialty specific EHR software aren’t very good either. In fact, I was recently thinking through the list of medical specialties and there were a lot of specialties where I didn’t know of a specialty specific EHR for them.

The one that struck me the most was that I didn’t know of an OB/GYN specific EHR. Is that really the case? I’ve seen hundreds of EHR and I couldn’t think of ever seeing an OB/GYN specific EHR. Maybe I’ve missed it, and if I have then I’d love to learn about one. I imagine the reason there isn’t one is because many of the larger All in One EHR vendors have put a decent focus on OB/GYN functionality. So, maybe no one wanted to compete with what was out there already? That’s speculation. What’s odd to me though is that OB/GYN seems like the perfect case where a specialty specific EHR could really benefit that specialty. They have some really unique needs and workflows. I’d think there would be massive competition around their specific challenges.

What I’ve also found is even the EHR vendors that are happy to sell to any specialty and probably have a few templates for that specialty (Yes, that’s how many EHR vendors “support” every specialty), even the All In One EHR vendors work better for certain specialties. This is often based on which specialties the EHR vendor had success with first. If 80 of your first 100 EHR sales are to cardiologists, then you can bet that your EHR is going to work better for cardiologists than it will for podiatrists.

With this in mind, let’s work as a community to aggregate a list of specialty specific EHR vendors. I’ll be generous and say that if an EHR vendor works with more than 10 EHR specialties, then it’s not a specialty specific EHR (5 is probably a better number). If you’re an EHR vendor and want to admit which specialties you work better for, then I’d love to hear that too.

Can we find a specialty specific EHR for every medical specialty? I look forward to seeing if we can in the comments.

EMRs Should Include Telemedicine Capabilities

Posted on May 22, 2015 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

The volume of telemedicine visits is growing at a staggering pace, and they seem to have nowhere to go but up. In fact, a study released by Deloitte last August predicted that there would be 75 million virtual visits in 2014 and that there was room for 300 million visits a year going forward.

These telemedicine visits are generating a flood of medical data, some in familiar text formats and some in voice and video form. But since the entire encounter takes place outside of any EMR environment, huge volumes of such data are being left on the table.

Given the growing importance of telemedicine, the time has come for telemedicine providers to begin integrating virtual visit results into EMRs.  This might involve adopting specialized EMRs designed to capture video and voice, or EMR vendors might go with the times and develop ways of categorizing and integrating the full spectrum of telemedical contacts.

And as virtual visit data becomes increasingly important, providers and health plans will begin to demand that they get copies of telemedical encounter data.  It may not be clear yet how a provider or payer can effectively leverage video or voice content, which they’ve never had to do before, but if enough care is taking place in virtual environments they’ll have to figure out how to do so.

Ultimately, both enterprise and ambulatory EMRs will include technology allowing providers to search video, voice and text records from virtual consults.  These newest-gen EMRs may include software which can identify critical words spoken during a telemedical visit, such as “pain,” or “chest” which could be correlated with specific conditions.

It may be years before data gathered during virtual visits will stand on equal footing with traditional text-based EMR data and digital laboratory results.  As things stand today, telemedicine consults are used as a cheaper form of urgent care, and like an urgent care visit, the results are not usually considered a critical part of the patient’s long-term history.

But the more time patients spend getting their treatment from digital doctors on a screen, the more important the mass of medical data generated becomes. Now is the time to develop data structures and tools allowing clinicians and facilities to mine virtual visit data.  We’re entering a new era of medicine, one in which patients get better even when they can’t make it to a doctor’s office, so it’s critical that we develop the tools to learn from such encounters.

Allscripts (MDRX) At Important Moment In Its History

Posted on May 21, 2015 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

Allscripts has announced plans to move more of its software development and operations to India, while cutting 250 jobs in the U.S., or about 3.5% of its 7,200-member workforce.  While this is significant enough as it is, it’s an even more important leading indicator of how Allscripts may perform going forward. Here’s how I think things will net out.

Making a “rebalancing”:  The company has called the changes a “rebalancing” of staff which will allow it to respond more effectively and efficiently to shifts in its software design and product dev plans.

But the decision didn’t happen in a vacuum, either. Allscripts recently reported taking a $10.1 million loss for the first quarter ending March 31. That’s down from a loss of $20.7 million for Q1 2014, but the company still appears to be struggling. Allscripts’ overall revenue dropped 2% to $334.6 million for the quarter ending March 31, compared with Q1 of 2014.

What’s next? What should providers draw from these numbers, and Allscripts’ plan to shift more development work offshore? Let’s consider some highlights from the vendor’s recent past:

* Despite some recent sales gains, the vendor occupies a difficult place in the EMR vendor market — neither powerful enough to take on enterprise leaders like Epic and Cerner directly, nor agile enough to compete in the flexibility-focused ambulatory space against relentless competitors like athenahealth.

* According to an analysis of Meaningful Use data by Modern Healthcare, Allscripts is second only to Epic when it comes to vendors of complete EMRs whose customers have qualified for incentives. This suggests that Allscripts is capable of being an effective provider business partner.

* On the other hand, some providers still distrust Allscripts since the company discontinued sales of and support for its MyWay EMR in 2012. What’s more, a current class action lawsuit is underway against Allscripts, alleging that MyWay was defective and that using it harmed providers’ business.

* Partnering with HP and Computer Sciences Corp., Allscripts is competing to be chosen as the new EMR for the U.S. Department of Defense’s Military Health System, and is still in the running for the $11 billion contract. But so are Epic and Cerner.

The bottom line: Taken together, these data points suggest that Allscripts is at a critical point in its history.

For one thing, cutting domestic staff and shifting dev operations to India is probably a make or break decision; if the change doesn’t work out, Allscripts probably won’t have time to pull back and successfully reorient its development team to current trends.

Allscripts is also at a key point when it comes to growing place in the brutal ambulatory EMR market. With players like athenahealth nipping at its heels from behind, and Epic and Cerner more or less controlling the enterprise market, Allscripts has to be very sure who it wants to be — and I’m not sure it is.

Then when I consider that Allscripts is still in the red after a year of effort, despite being at a peak level for sales, that tears it.  I’m forced to conclude that the awkwardly-positioned vendor will have to make more changes over the next year or two if it hopes to be agile enough to stay afloat. I believe Allscripts can do it, but it will take a lot of political will to make it happen. We’ll just have to see if it has that will.

HHS’ $30B Interoperability Mistake

Posted on May 8, 2015 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

Sometimes things are so ill-advised, in hindsight, that you wonder what people were thinking. That includes HHS’ willingness to give out $30 billion to date in Meaningful Use incentives without demanding that vendors offer some kind of interoperability. A staggering amount of money has been paid out under HITECH to incentivize providers to make EMR progress, but we still have countless situations where one EMR can’t talk to another one right across town.

When you ponder the wasted opportunity, it’s truly painful. While the Meaningful Use program may have been a good idea, it failed to bring the interoperability hammer down on vendors, and now that ship has sailed. While HHS might have been able to force the issue back in the day, demanding that vendors step up or be ineligible for certification, I doubt vendors could backward-engineer the necessary communications formats into their current systems, even if there was a straightforward standard to implement — at least not at a price anyone’s willing to pay.

Now, don’t get me wrong, I realize that “interoperability” is an elastic concept, and that the feds couldn’t just demand that vendors bolt on some kind of module and be done with it. Without a doubt, making EMRs universally interoperable is a grand challenge, perhaps on the order of getting the first plane to fly.

But you can bet your last dollars that vendors, especially giants like Cerner and Epic, would have found their Wilbur and Orville Wright if that was what it took to fill their buckets with incentive money. It’s amazing how technical problems get solved when powerful executives decide that it will get done.

But now, as things stand, all the government can do is throw its hands up in the air and complain. At a Senate hearing held in March, speakers emphasized the crying need for interoperability between providers, but none of the experts seemed to have any methods in their hip pocket for fixing the problem. And being legislators, not IT execs, the Senators probably didn’t grasp half of the technical stuff.

As the speakers noted, what it comes down to is that vendors have every reason to create silos and keep customers locked into their product.  So unless Congress passes legislation making it illegal to create a walled garden — something that would be nearly impossible unless we had a consensus definition of interoperability — EMR vendors will continue to merrily make hay on closed systems.  It’s not a pretty picture.

Epic Belatedly Accepts Reality And Drops Interoperability Fees

Posted on April 21, 2015 I Written By

Anne Zieger is veteran healthcare consultant and analyst with 20 years of industry experience. Zieger formerly served as editor-in-chief of FierceHealthcare.com and her commentaries have appeared in dozens of international business publications, including Forbes, Business Week and Information Week. She has also contributed content to hundreds of healthcare and health IT organizations, including several Fortune 500 companies. Contact her at @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

Unbeknownst to me, and perhaps some of you as well, Epic has been charging customers data usage fees for quite some time.  The EMR giant has been quietly dunning users 20 cents for each clinical message sent to a health information exchange and $2.35 for inbound messages from non-Epic users, fees which could surely mount up into the millions if across a substantial health system.  (The messages were delivered through an EMR module known as Care Everywhere.)

And now, Epic chose #HIMSS15 to announce grandly that it was no longer charging users any fees to share clinical data with organizations that don’t use its technology, at least until 2020, according to CEO Judy Faulkner.  In doing so, it has glossed over the fact that these questionable charges existed in the first place, apparently with some success. For an organization which has historically ducked the press routinely, Epic seems to have its eye on the PR ball.

To me, this announcement is troubling in several ways, including the following:

  • Charging fees of this kind smacks of a shakedown.  If a hospital or health system buys Epic, they can’t exactly back out of their hundreds-of-millions-of-dollars investment to ensure they can share data with outside organizations.
  • Forcing providers to pay fees to share data with non-Epic customers penalizes the customers for interoperability problems for which Epic itself is responsible. It may be legal but it sure ain’t kosher.
  • In a world where even existing Epic customers can’t share freely with other Epic customers, the vendor ought to be reinvesting these interoperability fees in making that happen. I see no signs that this is happening.
  • If Epic consciously makes it costly for health systems to share data, it can impact patient care both within and outside, arguably raising costs and increasing the odds of care mistakes. Doing so consciously seems less than ethical. After all, Epic has a 15% to 20% market share in both the hospital and ambulatory enterprise EMR sector, and any move it makes affects millions of patients.

But Epic’s leadership is unrepentant. In fact, it seems that Epic feels it’s being tremendously generous in letting the fees go.  Here’s Eric Helsher, Epic’s vice president of client success, as told to Becker’s Hospital Review: “We felt the fee was small and, in our opinion, fair and one of the least expensive…but it was confusing to our customers.”

Mr. Helsher, I submit that your customers understood the fees just fine, but balked at paying them — and for good reason. At this point in the history of clinical data networking, pay-as-you-go models make no sense, as they impose a large fluctuating expense on organizations already struggling to manage development and implementation costs.

But those of us, like myself, who stand amazed at the degree to which Epic blithely powers through criticism, may see the giant challenged someday. Members of Congress are beginning to “get it” about interoperability, and Epic is in their sights.

What Happens When An EHR Vendor is Acquired?

Posted on January 12, 2015 I Written By

John Lynn is the Founder of the HealthcareScene.com blog network which currently consists of 10 blogs containing over 8000 articles with John having written over 4000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 16 million times. John also manages Healthcare IT Central and Healthcare IT Today, the leading career Health IT job board and blog. John is co-founder of InfluentialNetworks.com and Physia.com. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

With meaningful use money running out, and as the EHR industry matures, we’re going to see more and more consolidation in the EHR market. Many EHR vendors are going to start running out of money. Other larger EHR vendors are going to want to try and buy up market share. In some ways this has already begun. See Greenway being purchased by Vitera Healthcare Solutions and Cerner acquiring Siemens to name some of the larger ones that have happened recently. Although, anyone that’s been a user of Bond EHR (people still miss that EHR software), Allscripts MyWay, Misys, etc etc etc knows the challenges of when your EHR vendor gets acquired.

While your EHR being acquired by another EHR vendor is almost never a good thing for your EHR software’s future, L Nelms visited this post on EMR and EHR News and offered an even worse story of an EHR being acquired and the fallout the doctors felt. I’ve removed the name of the vendors since the principle could apply to many vendors that get acquired.

After completing Stage one of Meaningful Use, I am now dropping out of the whole damn thing. This decision is based entirely on my continued dissatisfaction with the EMR program I chose. I started using EHR Vendor A in 2012. As many know, EHR Vendor A was subsequently bought by ABC corporation who refused to honor the original contract which promised no additional fees. ABC corporation, knowing that they had customers “right where they wanted them” — knowing that switching programs would incur tremendous costs and disruption to the practices’ work flow, immediately imposed a $250.00 monthly “support fee”, requiring automatic payments from the customers credit card. I do not know what constitutes “support” from this company, as I had problems with the program and attempted to contact them numerous times from Nov 19, 2014 to Dec 9, without a SINGLE reply in any form from them. On Jan 1, 2015, they increased this fee to $300.00.

They continue to inundate us with newsletters telling us how wonderful they are, including an alert urging us to “respond today” to arrange to get the new certified software installed. This was sent on Christmas Eve! They warned us repeatedly that we must be using the new software ON Jan 1,2015, in order to meet MU. What they didn’t mention until the day before the install, was that there is a “one-time installation fee of $99.00” (charged immediately, of course, to you credit card).

I asked if I could do the install myself and was told “yes, but we’re not really charging for the install, we’re charging for the SQL server update (which actually can be done oneself ). But I was told I had to pay. And now, the new certified software, which is COMPLETELY different from the previous version, is a nightmare. It is agonizingly slow, painstakingly labor intensive, and heaven forbid I should require tech support who, on top of being nowhere to be found, are so disrespectful (the last one one I spoke to actually said — when I expressed my dissatisfaction with not being able to get my data when I terminate my contract — “well we didn’t force you to buy our program”

Which doesn’t explain why I feel so violated…..

I should clarify that my data from EHR Vendor A is “available”: after many cryptic replies from them over several days, I was finally told that I can access the data from the server, but then — and you all know the story– I must take out a second mortgage on my home to have the data converted to some semblance of a usable format. This may not be illegal (only because the the recklessness of the companies has not yet been regulated), but it is certainly of questionable ethicacy

I think this is a fear that many doctors have when selecting and purchasing their EHR software. It’s why many of them still choose to go with the big name EHR vendors. Stories like this one scare doctors away from a small EHR vendor with an uncertain future. Although, I’ve written previously about the uncertain future of large EHR vendors as well.

The EHR industry should do better than this. I hope this story is an aberration, but I’m afraid we’re going to see more and more stories like it as the EHR industry consolidates. There will still be many good EHR actors out there that are appalled by these stories like I am. Hopefully, more and more doctors will find those good actors who are sincere in their efforts to provide a quality product with a quality user experience for the doctor. They’re out there, but bad actors like what’s described above give the good apples a bad name.

Adverse Event Reporting and EHRs: The MEDTECH Act’s Effects

Posted on December 18, 2014 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.

Medical systems generate adverse event (AE) reports to improve service delivery and public safety.

As I described in my first blog post on Adverse Events, these reports are both a record of what went wrong and a rich source for improving workflow, process and policy. They can nail responsibility not only for bad acts, but also bad actors and can help distinguish between the two. The FDA gathers AE reports to look for important health related patterns, and if needed to trigger recalls, modifications and public alerts.

EHRs generate AEs, but the FDA doesn’t require reporting them. Reporting is only for medical devices defined by the FDA and EHRs aren’t. However, users sometimes report EHR related AEs. Now, there’s proposed legislation that would preclude EHRs as medical devices and stop any consideration of EHR reports.

MEDTECH Act’s Impact

EHRs are benign software systems that need minimal oversight. At least that’s what MEDTECH Act’s congressional sponsors, Senators Orrin Hatch (R- Utah) and Michael Bennett (D- Colorado) think. If they have their way – and much of the EHR industry hopes so – the FDA can forget regulating EHRs and tracking any EHR related AEs.

EHRs and Adverse Events

Currently, if you ask MAUD, the FDA’s device, adverse event tracking system about EHRs, you don’t get much, as you might expect. Up to October, MAUD has 320,000 AEs. Of these about 30 mention an EHR in passing. (There may be many more, but you can’t search for phrases such as “electronic health,” etc.) While the FDA hasn’t defined EHRs as a device, vendors are afraid it may. Their fear is based on this part of the FDA’s device definition standard:

[A]n instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

…[I]ntended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals…

I think this section clearly covers EHRs. They are intended for diagnostic, cure, mitigation, etc., of disease. Consistent public policy in general and a regard for protecting the public’s health, I think, augers for mandatory reporting of EHR caused AEs.

Why then aren’t EHRs devices that require AE reporting? In a word, politics. The FDA’s been under pressure from vendors who contend their products aren’t devices just software. They also don’t want their products subject to being criticized for failures, especially in instances where they have no control over the process. That may be understandable from a corporate point of view, but there are several reasons for rejecting that point of view. Consider what the FDA currently defines as a medical device.

Other Devices. The FDA captures AE reports on an incredible number of devices. A few examples:

  • Blood pressure computers
  • Crutches
  • Drug dose calculators
  • Ice bags
  • Lab gear – practically all
  • Robotic telemedicine devices, and many, many more.

ECRI on EHR Adverse Events

The respected patient safety NGO, the ECRI Institute, puts the issue squarely. Each year, it publishes its Top Ten Health Technology Hazards. Number one is inadequate alarm configuration policies and practices. Number two: “Incorrect or missing data in electronic health records and other health IT systems.” Its report says:

Many care decisions today are based on data in an electronic health record (EHR) or other IT-based system. When functioning well, these systems provide the information clinicians need for making appropriate treatment decisions. When faults or errors exist, however, incomplete, inaccurate, or out-of-date information can end up in a patient’s record, potentially leading to incorrect treatment decisions and patient harm. What makes this problem so troubling is that the integrity of the data in health IT (HIT) systems can be compromised in a number of ways, and once errors are introduced, they can be difficult to spot and correct. Examples of data integrity failures include the following:

  • Appearance of one patient’s data in another patient’s record (i.e., a patient/data mismatch)
  • Missing data or delayed data delivery (e.g., because of network limitations, configuration errors, or data entry delays)
  • Clock synchronization errors between different medical devices and systems
  • Default values being used by mistake, or fields being prepopulated with erroneous data
  • Inconsistencies in patient information when both paper and electronic records are used
  • Outdated information being copied and pasted into a new report Programs for reporting and reviewing HIT-related problems can help organizations identify and rectify breakdowns and failures.

ECRI spells out why AE reporting is so important for EHRs:

…[S]uch programs face some unique challenges. Chief among these is that the frontline caregivers and system users who report an event—as well as the staff who typically review the reports—may not understand the role that an HIT system played in an event…

The MEDTECH Act’s Effects

The move to curtail the FDA’s EHR jurisdiction is heating up. Senators Hatch and Bennett’s proposed act exempts EHRs from FDA jurisdiction by defining EHRs as passive data repositories.

Most industry chatter about the act has been its exempting EHRs and others from the ACA’s medical device tax. However, by removing FDA’s jurisdiction, it would also exempt EHRs from AE reports. Repealing a tax is always popular. Preventing AE reports may make vendors happy, but clinicians, patients and the public may not be as sanguine.

The act’s first two sections declare that any software whose main purpose is administrative or financial won’t come under device reporting.

Subsection (c) is the heart of the act, which exempts:

Electronic patient records created, stored, transferred, or reviewed by health care professionals or individuals working under supervision of such professionals that functionally represent a medical chart, including patient history records,

Subsection (d) says that software that conveys lab or other test results are exempt.

Subsection (e) exempts any software that makes recommendations for patient care.

There are several problems with this language. The first is that while it goes to lengths to say what is not a device, it is silent about what is. Where is the line drawn? If an EHR includes workflow, as all do, is it exempt because it also has a chart function? The bill doesn’t say

Subsection (d) on lab gear is also distressing. Currently, most lab gear are FDA devices. Now, if your blood chemistry report is fouled by the lab’s equipment ends up harming you, it’s reportable. Under MEDTECH, it may not be.

Then there’s the question of who’s going to decide what’s in and what’s out? Is it the FDA or ONC, or both? Who knows Most important, the bill’s negative approach fails to account for those AEs, as ECRI puts it when: “Default values being used by mistake, or fields being prepopulated with erroneous data.”

Contradictory Terms

The act has a fascinating proviso in subsection (c):

…[P]rovided that software designed for use in maintaining such patient records is validated prior to marketing, consistent with the standards for software validation relied upon by the Secretary in reviewing premarket submissions for devices.

This language refers to information that device manufacturers file with HHS prior to marketing. Oddly, it implies that EHRs are medical devices under the FDA’s strictest purview, though the rest of the act says they are not. Go figure.

What’s It Mean?

The loud applause for the MEDTECH act coming from the EHR industry, is due to its letting vendors off the medical device hook. I think the industry should be careful about what it’s wishing for. Without effective reporting, adverse events will still occur, but without corrective action. In that case, everything will seem to go swimmingly. Vendors will be happy. Congress can claim to being responsive. All will be well.

However, this legislative penny in the fuse box will prove that keeping the lights on, regardless of consequences, isn’t the best policy. When something goes terribly wrong, but isn’t reported then, patients will pay a heavy price. Don’t be surprised when some member of Congress demands to know why the FDA didn’t catch it.

Epic Tries To Open New Market By Offering Cloud Hosting

Posted on November 26, 2014 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.

When you think of Epic, you hardly imagine a company which is running out of customers to exploit. But according to Frost & Sullivan’s connected health analyst, Shruthi Parakkal, Epic has reached the point where its target market is almost completely saturated.

Sure, Epic may have only (!) 15% to 20% market share in both hospital and ambulatory enterprise EMR sector, it can’t go much further operating as-is.  After all, there’s only so many large hospital systems and academic medical centers out there that can afford its extremely pricey product.

That’s almost certainly why Epic has just announced  that it was launching a cloud-based offering, after refusing to go there for quite some time.  If it makes a cloud offering available, note analysts like Parakkal, Epic suddenly becomes an option for smaller hospitals with less than 200 beds. Also, offering cloud services may also net Epic a few large hospitals that want to create a hybrid cloud model with some of its application infrastructure on site and some in the cloud.

But unlike in its core market, where Epic has enjoyed incredible success, it’s not a lock that the EMR giant will lead the pack just for showing up. For one thing, it’s late to the party, with cloud competitors including Cerner, Allscripts, MEDITECH, CPSI, and many more already well established in the smaller hospital space. Moreover, these are well-funded competitors, not tiny startups it can brush away with a flyswatter.

Another issue is price. While Epic’s cloud offering may be far less expensive than its on-site option, my guess is that it will be more expensive than other comparable offerings. (Of course, one could get into an argument over what “comparable” really means, but that’s another story.)

And then there’s the problem of trust. I’d hate to have to depend completely on a powerful company that generally gets what it wants to have access to such a mission-critical application. Trust is always an issue when relying on a SaaS-based vendor, of course, but it’s a particularly significant issue here.

Why? Realistically, the smaller hospitals that are likely to consider an Epic cloud product are just dots on the map to a company Epic’s size. Such hospitals don’t have much practical leverage if things don’t go their way.

And while I’m not suggesting that Epic would deliberately target smaller hospitals for indifferent service, giant institutions are likely to be its bread and butter for quite some time. It’s inevitable that when push comes to shove, Epic will have to prioritize companies that have spent hundreds of millions of dollars on its on-site product. Any vendor would.

All that being said, smaller hospitals are likely to overlook some of these problems if they can get their hands on such a popular EMR.  Also, as rockstar CIO John Halamka, MD of Beth Israel Deaconess Medical Center notes, Epic seems to be able to provide a product that gets clinicians to buy in. That alone will be worth the price of admission for many.

Certainly, vendors like MEDITECH and Cerner aren’t going to cede this market gracefully. But even as a Johnny-come-lately, I expect Epic’s cloud product do well in 2015.