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Researcher Puts Epic In Third Place For EMR Market Share

Posted on May 16, 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 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 research report tracking market share held by EMR vendors puts Epic in third place, behind Cerner and McKesson, a conclusion which is likely to spark debate among industry watchers.

The analyst firm behind the report, Rockville, MD-based Kalorama Information, starts by pointing out that despite the hegemony maintained by larger EMR vendors, the competition for business is still quite lively. With customers still dissatisfied with their systems, the hundreds of vendors still in the market have a shot at thriving, it notes.

Kalorama publisher Bruce Carlson argues that until the larger firms get their act together, there will still be plenty of opportunity for these scrappy smaller players: “It’s still true to say no company, not even the largest healthcare IT firms, have even a fifth of this market,” Carlson said in a published statement. “We think that is because there’s still usability, vendor-switching, lack of mindshare in the market and customers are aching for better.”

In calculating how much each vendor has of the EMR market, the analyst firm estimated each vendors’ hardware, software and services revenue flowing directly from EMRs, breaking out the percentage each category represented for each vendor. All projects were based on 2016 data.

Among the giants, Kalorama ranks Cerner as having the biggest market share, McKesson as second in place and Epic as third. The report’s observations include:

  • That Cerner is picking up new business, in part, due to the addition of its CernerITWorks suite, which works with hospital IT departments, and Cerner RevWorks, which supports revenue cycle management functions. Kalorama also attributes Cerner’s success to the acquisition of Siemens IT and its having won the Department of Defense EMR contract.
  • That McKesson is building on its overall success as a health IT vendor, which puts it in a good position to build on its existing technology. For example, it has solutions addressing medication safety, information access, revenue cycle management, resource use and physician adoption of EMRs, including Paragon, Horizon, EHRM, Star and Series for hospitals, along with Practice Partners, Practice Point Plus and Fusion for ambulatory care.
  • That Epic serves giant customers like Kaiser Permanente, as well as holding a major share of new business in the EMR market. Kalorama is predicting that Epic will pick up more ambulatory customers, which it has focused on more closely of late.

The report also lists Allscripts Healthcare Solution, which came in fourth. Meanwhile, it tosses in GE Healthcare, Athenahealth’s Intersystems, QSI/NextGen, MEDITECH, Greenway and eClinicalWorks in with a bundle of at least 600 companies active in the EMR market.

The report summary we editors got didn’t include some details on how the market components broke down. I would like to know more about the niches in which these vendors play.

For example, having seen a prediction earlier this year that the physician practice market would hit $17.6 billion worldwide within seven years, it would be interesting to see that dot connected with the rest of the market share information. Specifically, I’d like to know how much of the ambulatory EMR market included integrated practice management software. That would tell me something about where overall solutions for physicians were headed.

However, I still got something out of the information Kalorama shared.  As our esteemed publisher John Lynn often notes, all market share measurements are a bit, um, idiosyncratic at best, and some are not even that reliable. But as I see it the estimates are worth considering nonetheless, as they challenge us to look at the key moving parts in the EMR market. Hey, and it gives us something to talk about at tradeshow parties!

Reinventing Claims Management for the Value-Based Era

Posted on February 16, 2017 I Written By

Provider claims management as we once knew it is not enough to thrive in a value-based era. Here’s what you need to know about taking claims management to a higher level.

The following is a guest blog post by Carmen Deguzman Sessoms, FHFMA, AVP of Product Management at RelayAssurance Plus RelayHealth Financial.

Provider claims management as we know it can no longer exist as a silo. With the rapid transformation from fee-for-service to value-based models, denial rates remain high–nearly 1 in 5 claims–despite advances in technology and automation. The complexity of value-based payment models almost guarantees an increase in denials, simply because there’s so much to get wrong.

For provider CFOs and their organizations to be effective–and thrive–in this environment, the touchpoints across the revenue cycle continuum must be re-examined to see if there are opportunities for improvement that have not presented themselves in the fee-for-service era. One such area is claims management, which is ripe to be elevated into an integral part of a denials management strategy.

What are the implications for providers? Well, for perspective, consider the savings realized through electronic claims submission.  CAQH research reveals that submitting a claim manually costs $1.98, compared to just $0.44 per electronic transaction. Likewise, a manual claims status inquiry costs $7.20 versus $0.94 for processing electronically.

This paper outlines the features and benefits of a technology platform that is geared toward elevating traditional claims management into the realm of strategic denial prevention and management, along with some recommended denial management best practices.

From Claim Scrubbing to Strategic Denial Management

Simple claims management as we know it is becoming obsolete. By “simple” we mean a claims process with a basic set of capabilities: creating claims, making limited edits, and ensuring that procedures are medically necessary. Today, a new class of integrated claim and denials management solutions augment this traditional approach to include pre- and post-filing activities that help automate and streamline claim submission, proactively monitor status, and expedite the appeals process for those that are denied.

In its simplest form, denials management can be defined as a process that leads to cleaner submitted claims and fewer denials from payers. But there are a lot of interim steps and variables that lead to “clean” claims, and a growing number of factors that influence denials. With the shift to alternative payment models and increasing consumerism, it’s more important than ever for providers to process claims properly the first time and to keep staff intervention to a minimum.

A big part of denials management is to improve the quality of patient data at registration, the source of many errors that lead to denials. Nonetheless, integrated claim and denial management processes span the entire revenue cycle, and technology brings new opportunities to manage costs and improve efficiencies. For example, having the ability to manage claims within a unified platform that can share and integrate data with the organization’s EHR prevents the need to toggle back and forth between systems to determine the status of a patient encounter.

A comprehensive claims management platform that advances denials management efforts integrates the following capabilities:

  • Eligibility verification prior to claim submission. It sounds pretty basic, but eligibility and registration errors on claims continue to be the top reason for denials. Automating the real-time verification of eligibility data helps identify avoidable denials and alert staff to claims needing attention before submission.
  • Maintenance of and compliance with oftenchanging payer business rules and regulatory requirements, including Medicare and state-specific updates, so that claims go out as cleanly as possible on the front end. With multiple payers and a growing roster of alternative payment models, manual in-house maintenance of edits is becoming an overwhelming task.
  • Digitization of attachments for Medicare pre- and post-payment audits, commercial claims adjudication and integrity audits, and workers compensation billing support. Integrating digital data exchange into the claims management workflow can help providers better control administrative costs, ensure regulatory compliance, and help automate and streamline claims processing and reimbursement.
  • Visibility into claim status lifecycle, with guidance for proactive follow-up. This lets providers only focus on those potential “problem” claims, and address any issues, before they are denied or delayed.
  • Automation of repetitive and labor-intensive tasks such as checking payer portals or placing phone calls to determine the status of pended or denied claims. This helps drastically reduce the amount of staff time spent perusing payer sites, and sitting on the phone on hold when an answer can’t be found.
  • Predictive intelligence to determine timing of payer acknowledgements and requests for additional information, as well as when payment will be provided. Analytics-driven claims management provides insight into how long responses should take, alerting providers when follow-up is required.
  • Management of remittances from all sources. Automated management of transaction formats, adjudication information, remittance translation and posting can help reduce A/R days, boost staff productivity, and accelerate cash flow.
  • Denial management and data analysis to guide corrective action and prevent future denials. Revenue cycle analytics can monitor the number of claims per physician, payer, or facility, enabling the health system to be proactive in interventions.
  • Creation and tracking of appeals for denied claims, including pre-population and assembly of appropriate forms. This not only helps cut down on resource-intensive manual work and paper attachments, but streamlines the appeals process.

Tying these capabilities together within an exception-based workflow helps address the challenge by providing visibility into problem claims. At-a-glance access to claim status helps cut down on the back-and-forth between billing departments and payers, and allows staff to focus only on those claims that require attention.

Pulling it all Together

Once you’ve integrated these capabilities, what are some of the claims management best practices to improve denial management and prevention? Consider the following actions:

  • Embed denial management within the entire workflow–Strong edits lead to clean claims, whether they pertain to Medicare, commercial payers or state-specific regulations. Edits should be constantly refined and seamlessly implemented, and pushed out to providers as often as possible–at minimum on a twice-weekly basis.
  • Adopt analytics-driven claims management–Claims management systems and connectivity channels to payers (i.e. clearinghouse) produce a wealth of operational information, most importantly data evidencing the speed of the payment path and claim status. Analyzed and served up in meaningful formats, this data becomes targeted business intelligence that can help providers better see obstacles and identify the root cause of denials and payment slowdowns.
  • Resolve issues before they result in denials–Providers should know claims location and status at all times. For example, has the claim been released by the EHR system? Has it been received and approved by the payer—or does a problem need to be addressed? Has a problem been rectified? Has the claim been released to a clearinghouse? Historical trends establish guidelines for the timing of events (e.g., whether claim status or payment should have been received from a particular payer by a certain date).
  • Be ready to identify claims denials and submit appeals. Nationwide revenue cycle statistics show that 1 in 5 claims are denied / delayed and can be avoided with the right software and better business processes.  In addition 67% of these denied claims are recoverable Identifying denials and submitting appeals to supply information not included on the initial claim can recoup lost revenue. To help streamline the process, additional claims information, such as medical records or lab results, should be supported by structured electronic attachments rather than faxed paper records or uploaded files to payer portals.

An Ounce of Prevention = Big Returns

Reducing and managing denials will have a significant impact on any healthcare organization’s bottom line. First, it costs $25 to rework a claim, and success rates vary widely. Additionally, when denials must be written off, the drop in patient revenue may total several million dollars for a medium-sized hospital, according to Advisory Board estimates.

The new look and feel of claims management is moving quickly toward analytics-driven, exception-based processing. By implementing and leveraging these capabilities and best practices in a cloud environment, providers can look forward to accelerated cash flow, reduced denials, increased automation with less staff involvement, and lower IT overhead.

About Carmen Sessoms
With over 20 years of progressive strategic leadership and healthcare experience in product management, business development, strategic planning and consulting, Carmen Sessoms has worked with all organizational levels in the ambulatory and acute care markets for patient access and reimbursement.

Prior to joining RelayHealth, Carmen was the regional vice president of operations for an outsourcing firm, where she led the eligibility side of the business and was instrumental in many process improvements that brought efficiencies to the company, its provider customers and their patients. Additionally, she has 10 years’ previous experience with McKesson in Product Management roles in which she directed projects related to the design and development of revenue cycle solutions, including initiatives with internal and external partners.

Carmen is a past president of the Georgia HFMA chapter, a recipient of HFMA’s Medal of Honor, and holds the designations of CHFP (Certified Healthcare Financial Professional) and FHFMA (Fellow in HFMA).

Rival Interoperability Groups Connect To Share Health Data

Posted on December 27, 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 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.

Two formerly competitive health data interoperability groups have agreed to work together to share data with each others’ members. CommonWell Health Alliance, which made waves when it included Cerner but not Epic in its membership, has agreed to share data with Carequality, of which Epic is a part. (Of course, Epic said that it chose not to participate in the former group, but let’s not get off track with inside baseball here!)

Anyway, CommonWell was founded in early 2013 by a group of six health IT vendors (Cerner, McKesson, Allscripts, athenahealth, Greenway Medical Technologies and RelayHealth.) Carequality, for its part, launched in January of this year, with Epic, eClinicalWorks, NextGen Healthcare and Surescripts on board.

Under the terms of the deal, the two will shake hands and play nicely together. The effort will seemingly be assisted by The Sequoia Project, the nonprofit parent under which Carequality operates.

The Sequoia Project brings plenty of experience to the table, as it operates eHealth Exchange, a national health information network. Its members include the AMA, Kaiser Permanente, CVS’s Minute Clinic, Walgreens and Surescripts, while CommonWell is largely vendor-focused.

As things stand, CommonWell runs a health data sharing network allowing for cross-vendor nationwide data exchange. Its services include patient ID management, record location and query/retrieve broker services which enable providers to locate multiple records for patient using a single query.

Carequality, for its part, offers a framework which supports interoperability between health data sharing network and service providers. Its members include payer networks, vendor networks, ACOs, personal health record and consumer services.

Going forward, CommonWell will allow its subscribers to share health information through directed queries with any Carequality participant.  Meanwhile, Carequality will create a version of the CommonWell record locator service and make it available to any of its providers.

Once the record-sharing agreement is fully implemented, it should have wide ranging effects. According to The Sequoia Project, CommonWell and Carequality participants cut across more than 90% of the acute EHR market, and nearly 60% of the ambulatory EHR market. Over 15,000 hospitals clinics and other healthcare providers are actively using the Carequality framework or CommonWell network.

But as with any interoperability project, the devil will be in the details. While cross-group cooperation sounds good, my guess is that it will take quite a while for both groups to roll out production versions of their new data sharing technologies.

It’s hard for me to imagine any scenario in which the two won’t engage in some internecine sniping over how to get this done. After all, people have a psychological investment in their chosen interoperability approach – so I’d be astonished if the two teams don’t have, let’s say, heated discussions over how to resolve their technical differences. After all, it’s human factors like these which always seem to slow other worthy efforts.

Still, on the whole I’d say that if it works, this deal is good for health IT. More cooperation is definitely better than less.

#HIMSS16: Some Questions I Plan To Ask

Posted on February 1, 2016 I Written By

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

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

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

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

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

Will New Group Steal Thunder From CommonWell Health Alliance?

Posted on January 26, 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 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.

Back in March 0f 2013, six health IT vendors came together to announce the launch of the CommonWell Health Alliance. The group, which included Cerner, McKesson, Allscripts, athenahealth, Greenway Medical Technologies and RelayHealth, said they were forming the not-for-profit organization to foster national health data interoperability. (Being a cynical type, I immediately put it in a mental file tagged “The Group Epic Refused To Join,” but maybe that wasn’t fair since it looks like the other EHR vendors might have left Epic out on purpose.)

Looked at from some perspectives, the initiative has been a success. Over the past couple of years or so, CommonWell developed service specifications for interoperability and deployed a national network for health data sharing. The group has also attracted nearly three dozen HIT companies as members, with capabilities extending well beyond EMRs.

And according to recently-appointed executive director Jitin Asnaani, CommonWell is poised to have more than 5,000 provider sites using its services across the U.S. That will include more than 1,200 of Cerner’s provider sites. Also, Greenway Health and McKesson provider sites should be able to share health data with other CommonWell participants.

While all of this sounds promising, it’s not as though we’ve seen a great leap in interoperability for most providers. This is probably why new interoperability-focused initiatives have emerged. Just last week, five major HIT players announced that they would be the first to implement the Carequality Interoperability Framework.

The five vendors include, notably, Epic, along with athenahealth, eClinicalWorks, NextGen Healthcare and Surescripts. While the Carequality team might not be couching things this way, to me it seems likely that it intends to roll on past (if not over) the CommonWell effort.

Carequality is an initiative of The Sequoia Project, a DC-area non-profit. While it shares CommonWell’s general mission in fostering nationwide health information exchange, that’s where its similarities to CommonWell appear to end:

* Unlike CommonWell, which is almost entirely vendor-focused, Sequoia’s members also include the AMA, Kaiser Permanente, Minute Clinic, Walgreens and Surescripts.

* The Carequality Interoperability Framework includes not only technical specifications for achieving interoperability, but also legal and governance documents helping implementers set up data sharing in legally-appropriate ways between themselves and patients.

* The Framework is designed to allow providers, payers and other health organizations to integrate pre-existing connectivity efforts such as previously-implemented HIEs.

I don’t know whether the Carequality effort is complimentary to CommonWell or an attempt to eclipse it. It’s hard for me to tell whether the presence of a vendor on both membership lists (athenahealth) is an attempt to learn from both sides or a preparation for jumping ship. In other words, I’m not sure whether this is a “game changer,” as one health IT trade pub put it, or just more buzz around interoperability.

But if I were a betting woman, I’d stake hard, cold dollars that Carequality is destined to pick up the torch CommonWell lit. That being said, I do hope the two cooperate or even merge, as I’m sure the very smart people associated with these efforts can learn from each other. If they fight for mindshare, it’d be a major waste of time and talent.

Is Cerner Edging Up On Epic?

Posted on January 7, 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 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.

At Verona, Wisc.-based Epic Systems, growth is a way of life. In fact, the EMR vendor now boasts a workforce of 9,400, which is estimated to be an increase of 1,400 staffers over the past year.

Not only that, Epic is confident enough to build cute. Its Campus 4, dubbed the “Wizards Academy Campus,” is designed to resemble the fictional Hogwarts school of Harry Potter fame — or if you’re academically-minded, England’s Oxford University. When completed this summer, Campus 4 will add 1,508 offices and 2,000 parking spaces to the Epic headquarters.

I could go on with details of the Disneyland Epic is making of its HQ, but you get the picture. Epic leaders are confident that they’re only going to expand their business, and they want to make sure the endless streams of young eggheads they recruit are impressed when they visit. My guess is that the Epic campus is being designed as a, well, campus speaks to the idea of seeing the company as a home. When I was 25, unique surroundings would have worked on me!

In any event, if I was running the place, I’d be pretty confident too. After all, if its own stats are correct, Epic software is either being used by or installed at 360 healthcare organizations in 10 countries. The EMR giant also reports that its platform manages records for 180 million Americans, or about 55 percent of the entire U.S. population. It also reported generating a not-so-shabby $1.8 billion in revenues for 2014.

But a little-noticed report issued by analyst firm KLAS last year raises questions as to whether the Epic steamroller can maintain its momentum. According to the report, which admittedly came out about a year ago, “the competition between Epic and Cerner is closer than it has been in years past as customers determine their future purchasing plans,” analysts wrote.

According to KLAS researchers, potential EMR buyers are largely legacy customers deciding how to upgrade. These potential customers are giving both Cerner and Epic a serous look, with the remainder split between Meditech and McKesson upgrades.

The KLAS summary doesn’t spell out exactly why researchers believe hospital leaders are beginning to take Cerner as seriously as Epic, but some common sense possibilities occur to me:

The price:  I’m not suggesting that Cerner comes cheap, but it’s become clear over the years that even very solvent institutions are struggling to pay for Epic technology. For example, when traditionally flush-with-cash Brigham and Women’s Hospital undershoots its expected surplus by $53 million due (at least in part) to its Epic install, it’s gotta mean something.

Budget overruns: More often than not, it seems that Epic rollouts end up costing a great deal more than expected. For example, when New York City-based Health and Hospital Corp. signed up to implement Epic in 2013, the deal weighed in at $302 million. Since then, the budget has climbed to $764 million, and overall costs could hit $1.4 billion. If I were still on the fence I’d find numbers like those more than a little concerning. And they’re far from unique.

Scarce specialists:  By the company’s own design, Epic specialists are hard to find. (Getting Epic certified seems to take an act of Congress.) It must be quite nerve-wracking to cut a deal with Epic knowing that Epic itself calls the shots on getting qualified help. No doubt this contributes to the high cost of Epic as well.

Despite its control of the U.S. market, Epic seems pretty sure that it has nowhere to go but up. But that’s what Microsoft thought before Google took hold. If that comparison bears any weight, the company that will lap up Epic’s business and reverse its hold on the U.S. market probably already exists. It may not be Cerner, but Epic will face meaningful competition sometime soon.

FDA Limitations Could Endanger Growth Of mHealth

Posted on December 28, 2015 I Written By

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

mHealth technology has virtually unlimited potential. But until the FDA begins putting its stamp of approval on mHealth tools, many providers won’t take them seriously. And that could be a big problem for mHealth’s future.

Unfortunately, early signs seem to suggest that the FDA is in over its head when it comes to regulating mHealth. According to speakers at a recent FDA Law Institute conference, it could be years before the agency even has a solid idea of how to proceed, Bloomberg reports.

Jeffrey Shapiro, a member of the Washington, D.C. law firm of Hyman Phelps & McNamara P.C., told the conference the FDA just isn’t equipped to handle the flood of new mHealth approaches. “Experience has shown that the FDA’s almost 40-year-old regulatory framework is a bad fit for much of today’s health IT with its networked ecosystems, rapid iterative improvement, deep collaboration between providers and end-users and focus on clinical decision support rather than direct diagnosis or treatment,” he told the audience.

The FDA dismisses the notion that it’s not prepared to regulate mHealth technologies. Bakul Patel, the agency’s associate director for digital health, told Reuters that the agency is planning to fill three new senior health scientist positions focused on digital health soon. That’s an encouraging step, though given that there are more than 165,000 health apps on the market, probably an inadequate one.

Sure, few of those app developers will apply for FDA approval. And the agency only plans to demand approval for technologies that are designed to be used as an accessory to a regulated medical devices, or transform a mobile platform into a regulated medical device. mHealth devices it has already approved include Airstrip Remote Patient Monitoring, the AliveCor Heart Monitor for iPhone and McKesson Cardiology’s ECG Mobile.

On the other hand, if Shapiro is right, the FDA could become a bottleneck which could severely stunt the growth of the U.S. mHealth industry. If nothing else, mHealth developers who seek FDA approval could be faced with a particularly prolonged approval process. While vendors wait for approval, they can keep innovating, but if their proposed blockbuster product is in limbo, it won’t be easy for them to stay solvent.

Not only that, if the FDA doesn’t have the institutional experience to reasonably evaluate such technologies, the calls it makes as to what is safe and efficacious may be off base. After all, apps and remote monitoring tools don’t bear much resemblance to traditional medical devices.

In theory, upstart mHealth companies which don’t have the resources to go through the FDA approval process can just proceed with their rollout. After all, the agency’s guidelines for requiring its approval are reasonably narrow.

But in reality, it seems unlikely that providers will adopt mHealth devices and apps wholesale until they get the FDA stamp of approval.  Whether they geniunely consider non-approved devices to be too lightweight for use, or fear being sued for using questionable technology, providers seem unlikely to integrate mHealth technology into their daily practice without the agency’s green light.

Given these concerns, we’d best hope that the FDA doesn’t begin requiring its approval for EMRs. Or at the very least, we should be glad that it didn’t jump in early. Who knows where EMR infrastructure would be if vendors had had to play patty-cake with the FDA from day one?

What if the FDA Started Regulating EHR?

Posted on March 20, 2014 I Written By

John Lynn is the Founder of the 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 and John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and LinkedIn.

In the world of mobile health, we’ve often talked about what will happen if the FDA starts to regulate the various mobile health apps out there. In fact, the FDA has come out with some pretty detailed guidelines on what mobile health applications and devices need FDA clearance. To date, the FDA has stayed away from any regulation of EHR software.

On my ride to the airport after the Dell Healthcare Think Tank event, we had an interesting and engaging conversation about the FDA when it comes to EHR software. Some of the discussion was around whether the FDA would start regulating EHR software.

Shahid Shah suggested that it was extremely unlikely that the FDA would touch EHR software at least until meaningful use was complete and the current President was out of office. He rightfully argues that this administration has hung their hat on EHR and the FDA wasn’t going to step in and stop that program. Plus, Shahid suggested that ONC wouldn’t let the FDA do it either. Janet Marchibroda from the Bipartisan Policy Center was hopeful that Shahid was right, but wasn’t as confident of this analysis.

After hearing them discuss this, I asked them the question:

What would happen to the EHR Market if the FDA started regulating EHR?

Shahid quickly responded that the majority of EHR vendors would go out of business and only a small handful of companies would go through the FDA clearance process. Then, he suggested that this is exactly why the FDA won’t regulate EHR software. FDA regulation of EHR would wipe out the industry.

This is a really interesting question and discussion. The reality is that there are a lot of similarities between EHR software and medical devices. One could make a really good case for why the FDA should regulate it like medical devices. One could make a case for the benefit of some rigor in the development of EHR software. However, there’s no appetite for such a change. In fact, the only people I’ve seen calling for it are those who think that EHR is unusable and potentially harmful to patients. I’m not sure FDA regulation will make them more usable though.

Now, juxtaposition the above conversation with this post by William Hyman titled “A Medical Device Recall of an EHR-like Product” In this case, the FDA announced McKesson’s voluntary recall of it’s Anesthesia Care system. This software was tightly integrated with other FDA regulated medical devices. I wonder what this means for other EHR software that is starting to integrate with a plethora of FDA cleared medical devices and other non FDA cleared medical devices.

I’m personally with Shahid in that I don’t think the FDA is going to touch EHR software with a long pole. At least, not until after meaningful use. After meaningful use, I guess we’ll see what they decide to do.

KLAS Names Top EMR Vendors For Mid-Sized Practices

Posted on January 27, 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 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 report by KLAS has designated Epic, athenahealth and Greenway as the top three EMR vendors among mid-sized healthcare practices.  The report, which also identified unpopular EMRs in the space, drew its conclusions based on analysis of ability, workflow and integration capabilities, according to iHealthBeat.

To do the study, KLAS interviewed clinicians and IT personnel at practices with 11 to 75 doctors.

Researchers named the top three mid-sized EMR vendors as Epic Systems, which scored a 85.3 points out of 100; athenahealth, which scored 83.5 points; and Greenway, which scored 81.3 points.

Each of the top three vendors distinguished themselves in unique ways.  For example, researchers found that practices liked Epic’s consistent delivery in large hospital-based practices, athenahealth’s “nimble deployment” and system updates, and Greenway’s exceptional service to smaller, independent practices.

Meanwhile, KLAS noted that Allscripts, McKesson and Vitera had the highest percentage of dissatisfied customers, practices which felt stuck with their current EMR system but would not purchase it again.  Reasons for their dissatisfaction included upgrade issues, lack of support, and a perceived lack of vendor partnership, iHealthBeat said.

When it comes down to it, it’s pretty clear when these practices need from their vendors, and a feeling of partnership and mutual support seems to top the list of matter which researchers is doing the study.  But it’s clear that these characteristics can be pretty hard to come by, even from companies you’d think had plenty of resources to deliver a sense of support and availability to their customers.  Allscripts, McKesson and Vitera (although it is Greenway now) had better get their act together quickly, as mid-sized medical practices are a major market, even if they don’t spend quite as much as hospitals.

McKesson, Meditech Chosen As EHR Test Systems for Meaningful Use

Posted on January 23, 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 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.

Here’s an interesting situation which is just popped up on my radar screen.  CMS and the ONC have chosen the first two vendors to serve as designated test EHR systems, and they’ve gone with McKesson and Meditech.

These test vendors are there to help eligible providers meet the requirements of Meaningful Use Stage 2.  To meet MU Stage 2 requirements, providers must successfully conduct at least one exchange test with a CMS-designated test EMR. (The providers can also meet the requirements by performing one electronic exchange of a summary of care document with a recipient using a different EMR technology.)

What intrigued me about this is that CMS and ONC are starting out with only two vendors for use as test EMR providers.  Given the diversity in the marketplace, you’d think that CMS would want to have fuller stock of vendors lined up before it went forward announcing its plans.

If I were an eligible provider going this route, I’d want to have the choice of a wider range test EMRs. Given how little real interoperability there is between EMRs, I’d like to know that I had a fallback position if my original tests didn’t work out.  After all, nothing I’ve read here suggests that EPs won’t have a chance to try again if the initial testing doesn’t go through, and if I were a provider, it’d be good to know that I could take the shot with other test EMRs. But I could be wrong, and that could have an effect on whether vendors see this as a win.

Let’s see if other substantial EMR vendors take up the ONC’s call to serve as test EMR participants.  It will be interesting to see whether vendors see participation as a credibility-raiser or a chance to get pantsed publicly if interoperating with their systems is a pain.