Free EMR Newsletter Want to receive the latest news on EMR, Meaningful Use, ARRA and Healthcare IT sent straight to your email? Join thousands of healthcare pros who subscribe to EMR and EHR for FREE!

Long Standing EHR Issues That Remain Unaddressed

Posted on June 17, 2016 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.

Dr. Jayne has presented a pretty great voice of reason in her blog posts about the realities of being a doctor in the meaningful use era. In a recent post she offered this comment which I’ve heard from many doctors:

And while we as physicians are having to cope with arduous workflows as a result of the regulations, there are advancements that would really benefit us that remain unaddressed.

I realize that EHR vendors have to prioritize requests from users. Plus, they have to deal with massive government regulation which has made it hard to prioritize user requests over government regulations. However, I know from the end user standpoint Dr. Jayne’s comment about the advancements that could be made in an EHR that still haven’t been added creates a really awful feeling.

Dr. Jayne also added this sad observation:

We’re forced to gather loads of information that could be put to good use but isn’t. For example, we collect information on race, ethnicity, religious preference, language preference, sexual orientation, and more. In many cases, it’s not used to further clinical care. It would have been great to have a prompt to ask about religious fasting the other night when I was treating a patient with profound dehydration. Although it occurred to me to ask, it didn’t occur to my patient care technician or to the resident I was supervising.

The optimistic side of me says that comments like this are a very good thing. 5-10 years ago, doctors wouldn’t have even thought to request this kind of feature. All they wanted to do was automate the paper charts. So, it’s progress that now we’re talking about ways we can incorporate the data in an EHR at the point of care in a much more effective way.

Now if EHR vendors can just be given the flexibility to work on these challenging problems instead of a list of prescriptive goverment regulations which just add to the burden of doctors as opposed to creating magical experiences.

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, 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.

EHR Regulation Vs. Innovation

Posted on February 19, 2014 I Written By

The following is a guest blog post by Marina Simonian, Product Manager and Jessica Naftaniel, Sales & Marketing Coordinator at gMed. Check out gMed’s whitepaper on Independent Gastroenterology.

In the past few years EHR technology vendors and healthcare providers alike have struggled with a myriad of regulatory requirements, from PQRS and eRX incentive programs, to ASC quality reporting, to Meaningful Use, ICD-10 and beyond. The next few years are set to bring even more challenging requirements for interoperability, patient engagement, quality metrics and clinical decision support. Being a technology and services vendor, we always strive to provide the most efficient, innovative and high quality products to our clients.

But how innovative can you get in this era of regulatory overload?

On one hand, innovation on a deadline is almost an oxymoron. Especially with such restrictive guidelines. One could only imagine what type of innovative, amazing solutions could be developed with the amount of time and resources that have been thrown in to meeting regulatory requirements.

On the other hand, necessity is the mother of invention.

As a direct result of numerous new regulatory measures and government requirements, many EHR providers are simply throwing components together to meet requirements and pass a certification.  Features which are put together hastily may make life more difficult for the people using their products, and might not last long on the market.

However, keeping your eye on the long term goal and looking beyond regulation helps to see some of the great benefits that can still arise from this race. When, for example, the DirectTrust and similar organizations come together to facilitate sharing of patient information securely across various healthcare entities, this may be a huge step to, perhaps, someday in the future, being able to tap into a centralized patient record and get the data you need, exactly when you need it, regardless of your location or affiliation.

And while for some vendors it makes perfect sense to focus on a limited number of features and bring value with those few, there are some others who choose to bring the value of integration and are a one-stop-shop for all of their users’ Electronic Health Record software needs. It is not an easy task by any means. And the best attestation to that is in the astounding difference in complete certified EHRs between 2011 and 2014.  In the end, whichever path one chooses, only those who are able to keep the long term focus on innovation above regulation, to put efficiency and ease of use above merely meeting a requirement, and to remember that improvement of patient care and overall population health is the ultimate goal, will be able to withstand the regulatory storms.

For more information on gMed’s innovative technology, visit us at gMed provides the gastroenterology industry with a fully integrated platform consisting of an Electronic Health Record, Endoscopy Report Writer, Practice Management solution, Patient Portal and a Data Analytics tool. Fully scalable through the cloud or using an on-site server, gMed’s products are all Meaningful Use Certified and ICD-10 ready.

Full Disclosure: gMed is an advertiser on this site.