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What if the FDA Started Regulating EHR?

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.

March 20, 2014 I Written By

John Lynn is the Founder of the blog network which currently consists of 15 blogs containing almost 5000 articles with John having written over 2000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 9.3 million times. John also recently launched two new companies: and, and is an advisor to docBeat. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and Google Plus.

23andMe Saga Doesn’t Bode Well for EMR Genetics Integration

I wrote about the direct-to-consumer genetic testing company 23andMe back in mid-October, posing the idea that genetic information provided by the patient could only serve to enrich EMR data. I noted, “Genetic testing seems to be about empowering patients to take more proactive roles in managing their health today in an effort to prevent what might happen to their health in the future. It would make sense to share these test results with providers who can aid in that journey.”

Two readers chimed in. One noted that, “No [current] EMR can run genetic risk models or use genetic clinical decision support, [and ] [n]one of these fit into Meaningful Use, so it will be years until the EMR have the capability needed to use genomics.”

Another pointed out that, “the price point on 23andMe was all I was waiting for, and I have my gene sequence already. Yes, there are some risks, but that argument falls into the same category as any technology or innovation – it can be used for good or bad. The value this information brings far exceeds the downsides, and is now an essential part of the data feed to my personal healthcare.”

That last comment is especially interesting in light of the well-publicized tiff going on between 23andMe and the FDA. I won’t waste your time attempting to summarize the string of events that have led 23andMe to stop marketing its products, as well as a class action lawsuit and an official petition to overrule the FDA’s decision. Instead, I’ve compiled a few articles that detail the saga as it has unfolded.

Why Genetic Testing Could Endanger Your Health /

The FDA Drops an Anvil on 23andMe – Now What? /

Founder of 23andMe speaks on FDA concerns /

Can 23andMe Survive the FDA? /

Class Action Lawsuit Filed Against 23andMe /

23andMe Shuts down health-related genetics testing to work with FDA / (Updated 12/6)

As far as the connection between genetic information gathered via commercial means by patients being incorporated into EMRs, it doesn’t look like it will happen easily anytime soon. It seems there are bigger debates brewing over the scope of the FDA’s regulatory power over companies like 23andMe, what the definition of a medical device should be, and the value consumers find in these services. Do they really lead to unnecessary medical tests and procedures? Let me know your thoughts on the 23andMe saga in the comments below. You can also join me this Friday at 12 ET for the weekly #HITsm tweet chat. We’ll be touching on the impact 23andMe’s big genetics data could have on healthcare, provided they’re allowed to stay in business.

December 5, 2013 I Written By

As Social Marketing Director at Billian, Jennifer Dennard is responsible for the continuing development and implementation of the company's social media strategies for Billian's HealthDATA and Porter Research. She is a regular contributor to a number of healthcare blogs and currently manages social marketing channels for the Health IT Leadership Summit and Technology Association of Georgia’s Health Society. You can find her on Twitter @JennDennard.

Developing Safety Critical Healthcare Software

The Healthcare IT Guy, Shahid Shah, has a great post up on his blog about writing safety critical software using an agile, risk-based approach. Here’s a portion of the blog post where Shahid really hits the nail on the head:

Much of that [every software being custom] changed in the 90’s and then upended even further in the early part of the 21st century; we should no longer weighed down by the baggage of the past.These days even our hardware is agile and extensible, real-time operating systems are plentiful, software platforms are malleable, mHealth is well established, and programming languages are sophisticated so we need to be open to reconsidering our development approaches, especially risk-based agile.

Why should we use “risk-based” agile? Because not every single line of code in software can or should be treated equally – some parts of our medical device software can kill people, many parts merely annoy people, but most other parts simply aren’t worth the same attention as the safety-critical components. When you treat every line of code the same (as is often true in a plan-driven approach) and you have a finite amount of resources and time you end up with lower quality software and less reliable medical devices. It’s not fair to blame the FDA for our own bad practices.

I’m always amazed by Shahid’s knowledge and ability to describe something in simple terms. I should know since I’m often on calls with Shahid since he’s my partner in Influential Networks and Physia.

The irony is that in the EHR and mHealth world you could argue that many have taken too much of a lean approach to building their applications while the medical device world treats every part of the software as a patient safety issue. Now if we could just bring the two together into a more reasonable balance of what’s important from the safety side and what’s not.

As far as I can tell, the FDA is planning to mostly stay out of regulating the general mHealth and EHR side of healthcare IT and will stick to the medical devices and mHealth devices that fit under the medical device term. I think this is generally a good thing for a number of reasons. Not the least of which is that the FDA doesn’t have the expertise needed to regulate EHR software. However, I wouldn’t mind a touch more patient safety concern from EHR vendors. Maybe the EHR Code of Conduct will help add a little more to this concern.

Of course, as Shahid points out, you don’t have to sacrifice agile software development to develop safety critical software. This is true in medical device development, EHR development, and even mHealth development.

June 21, 2013 I Written By

John Lynn is the Founder of the blog network which currently consists of 15 blogs containing almost 5000 articles with John having written over 2000 of the articles himself. These EMR and Healthcare IT related articles have been viewed over 9.3 million times. John also recently launched two new companies: and, and is an advisor to docBeat. John is highly involved in social media, and in addition to his blogs can also be found on Twitter: @techguy and @ehrandhit and Google Plus.

Study: Drug Problems Most Common EMR Safety Event

When the phrase “EMR problems” comes to mind, most of us get a  mental image of hardware flaws, software bugs or integration problems. But according to a new study, the majority of EMR-related patient care problems stem from issues in how people interact with their system, specifically in documenting and administering medication.

In recent research, the Pennsylvania Patient Safety Authority queried the state’s patient safety reporting database to identify EMR-related events. After sifting out events that didn’t truly appear to be EMR-related, analysts were left with 3,099 patient safety issue reports. The events were then classified by the harm score assigned by the reporter.

As it turns out, the great majority of events (89%) resulted in no harm to the patient. Ten percent of events were reported as “unsafe conditions” but also resulted in no harm to the patient.  Fifteen events actually resulted in temporary harm to the patient:

* Six cases of entering wrong medication data
* Three cases of administering the wrong medication
* Two cases of ignoring a documented allergy
* Two cases of failure to enter lab tests
* Two cases of failure to document

The only event that resulted in significant harm stemmed from failure to properly document an allergy, analysts said:

Patient with documented allergy to penicillin received ampicillin and went into shock, possible [sic] due to anaphylaxis. Allergy written on some order sheets and “soft” coded into Meditech but never linked to pharmacy drug dictionary.

All told, medication errors were the most commonly reported event (81 percent), largely wrong-drug, dose, time patient or route errors (50 percent) or omitted dose (10 percent).

It’s worthy of note that according to the researchers, the narrative reports of EMR-related reports dug up from the Pennsylvania database differed meaningfully from reports found in FDA database MAUDE and Australia’s Advanced Incident Management System, which have different reporting requirements.

It seems that there’s a lot more work to be done in exposing the types of patient safety errors that may be unique to EMRs, but this looks like a good start.

December 13, 2012 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 @annezieger on Twitter.

Wireless Health, HIPAA, and Patient Engagement – Around Healthcare Scene


Wireless Health Data Collection Innovations Getting Hot

Some of the newest health data innovations are wireless. From a chip that can test blood sugar levels to an ECG that connects to a cell phone through blue tooth. The possibilities are endless when it comes to wireless devices.

HIPAA Infographic

HIPAA violations happen frequently. Some are criminal, others civil. This infographic explains some of the most common reason for HIPAA violations, and the penalties associated with them. Last year, over 12,000 companies have either been investigated or had issues resolved concerning HIPAA violations. Definitely an interesting infographic to look over.

Hospital EMR and EHR

FCC Says Wireless Health Should Be “Routine” Within Five Years

An announcement from the FCC pushes for mHealth to be a standard practice in the medical world by 2017. Some doctors are hesitant to implement mobile devices, so this may be difficult for some to grasp. The FCC is working to make this easier, by doing things like working with the FDA to help with creating and introducing devices into the market.

Happy EMR Doctor

Patient Engagement: Who are the Real Targets?

While creators of health technology claim they are trying to reach patients most, what does that mean? Many people who would benefit from these types of technology are lower class, however, upper class people are probably more likely to embrace it. Should companies invest more time in discovering who target markets are?

Smart Phone Health Care

Traqs: One Tool to Rule Them All

Having trouble keeping track of all the health apps and devices that are being created? Traqs, a new device, does it for you. This innovation can track multiple devices and create graphs about activity on them. It makes it much easier to take control of your health and exercise devices.

September 30, 2012 I Written By

Katie Clark is originally from Colorado and currently lives in Utah with her husband and son. She writes primarily for Smart Phone Health Care, but contributes to several Health Care Scene blogs, including EMR Thoughts, EMR and EHR, and EMR and HIPAA. She enjoys learning about Health IT and mHealth, and finding ways to improve her own health along the way.

EMR-EHR Safety Watchdog Unlikely To Emerge Soon

Yesterday, we at got a letter from the organization behind, a patient safety organization allowing people to anonymously report EMR-related safety events, stating that the site was shutting down.  PDR Secure LLC gave little information on the closure, other than to say that it was relinquishing its PSO status.

Curious, John and I took a closer look at the matter. The only other organization which seemed to allow for reporting of EMR-related safety incidents, (“S” capitalized for clarity), seems to have disappeared since it was first launched late last year.

So while Google searches aren’t perfect, it does appear that at the moment, there’s no official source to which providers, hospitals or other interested parties can report patient safety incidents related to problems with an EMR/EHR.

It’s worth noting that the FDA seems quite concerned about establishing EMR safety regulations. In fact, agency members have been in discussion for years on the topic, spurred by reports of HIT-related malfunctions. ”Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist,” Dr. Jeffrey Shuren of the agency’s Center for Devices and Radiological Health told Congress in 2010.

But so far, the agency hasn’t issued any regs. My feeling is that FDA leaders are stalling (prompted in part, I’m guessing from indirect lobbying pressure) on getting such a system started, as it’s definitely going to irritate some very deep-pocketed HIT players out there.

As FierceEMR editor Maria Durben Hirsch noted in an excellent recent column, there’s more than one way the private sector could take up the role of EMR safety watchdog, such as:

*  Creating a one-stop site where users and others can report on their experiences with EMR systems, a step the AMA has apparently considered

*  Launching a new watchdog agency, run by HHS, which would oversee EMR registration, monitor for health IT-related mistakes and investigate adverse event reports.  According to Durben, Congress likes this idea — which was proposed by the Institute of Medicine — but that there’s been no action yet.

Bottom line, it seems that reporting on adverse EMR events is a very unpopular idea in many quarters, or at least a political hot potato.  I suspect someone, perhaps HHS or even the POTUS, is going to have to hammer EMR reporting into place if it’s going to happen anytime soon.

August 13, 2012 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 @annezieger on Twitter.

NIST’s EHR Usability Conference Breaks Both Old Ground and New Focuses on EMR Patient Safety Protocol

Regular reader, Carl Bergman from EHR Selector, attended the recent NIST EMR Usability Conference and sent over the following guest post on what was said. Thanks Carl for sharing your experience with us.

A year ago last June I attended NIST’s (National Institute of Standards and Technology) conference on EMR/EHRs usability. [See Carl's post on the NIST EHR Usability Conference from 2011.] It was a mixed bag. There were several excellent presentations on the fundamentals of usability, how to analyze an EMR and where the field was headed. Unfortunately, NIST’s staff took a narrow view confining their work to EMR error conditions and assiduously avoiding interface, workflow and clinical setting issues. It was odd that an agency that prided itself on redesigning nuclear control rooms after Three Mile Island or the design of airplane cockpits would ignore EMR user interfaces.

New Approach: New Protocol

At this year’s conference at NIST headquarters in Gaithersburg, MD, the past was not prolog. Last week’s conference focus was on a comprehensive EMR usability protocol, NISTIR 7804, that NIST produced last February. (For a good synopsis, see Katherine Rourke’s Design Errors That Cause Patient Harm per NIST.) NIST’s staff pulled together a notable group of speakers on patient safety in general and implementing the protocol in particular. (NIST is posting the presentations here.)

The protocol, designed to review an EMR, is not a trivial undertaking since it has about 180 line item questions. It asks, for example, if the EMR:

  • Keeps patient identities distinct from each other? That is, does the system prevent one record from writing over another or erroneously sharing data elements?
  • Lays out pages in a consistent manner using color, icons and links identically?
  • Uses measurements consistently? That is, if weight is entered in pounds and ounces in one place, do they show that way in other places?
  • Displays fields fully rather than being truncated?
  • Sorts logically based on the subject?
  • Show dosages, etc., with all needed information on the page?
  • Displays multipage entries or lookups with proper navigation choices?
  • Has error messages that state what is wrong and how to cure the problem?
  • Accommodates different levels of user knowledge? That is, does it have extended help for novice users, refresher information for occasional users and short cuts for experienced users?

Developers Present in Force

If NIST’s major intent was to get developer attention, they succeeded. Of the hundred or so attendees, about 20 percent were from major systems. 3m, Allscripts, Athenahealth, Centricity, McKesson, NextGen, etc., each had one or more representatives present. Others present included Kaiser, HIMSS, Medstar, First Choice, ACP, Columbia, etc.

Unfortunately, there is no way to know developer reaction to the protocol. The conference had no comment session. I don’t know if this was by design or if time just ran out. NIST staff did indicate that next year the conference would be two days rather than one. However, a year is a long time to wait for reactions. This is especially pertinent since NIST is not a regulatory agency. Its protocols are strictly voluntary and depend on vendor acceptance.

What NIST did do is offer several presentations that emphasized how fragile patient safety can be in an HIT world. One breakout session used an actual, unnamed product’s screen that had dozens of misleading or ambiguous fields. For example, the screen’s fields cut off drug names, used red to indicate several different findings and used a pop up that blocked a view of a pertinent entry.

In another more broadly based patient safety presentation, University of Pennsylvania’s voluble Ross Koppel drove home how common elements in EMRs such as blood pressure – he’s found 40 different ways to show it so far – are subject to many formats for capture and display. Moreover, if you think EMRs have problems, Koppel shows how bar codes and work arounds can play havoc with workflow and patient safety.

Wanted: One Good Policy Compass

For those of us possessed of an EMR design demon, it was both a good chance to wonder out loud just what it all meant and where, if anywhere, things were headed. Sadly, the most common answer was who knows? There were some common points:

  • It’s better to have NIST’s protocol than not.
  • You can forget the FDA playing a bigger role. It’s under funded and over worked.
  • HIMSS will wait for the industry and the industry has shown no hurry.
  • EMR adverse incident reporting would be great, but who would do it and how open would it be?

In short, if you’re shopping for an EMR, regardless of your size, don’t count on anyone handing you a usability report on an EMR anytime soon. Moreover, don’t try to run NIST’s protocol on your own unless you have full access to the proposed EMR, lots of time on your hands and a good grasp of the protocols details.

There are some things you can do. You can ask potential vendors questions such as these:

  • Have they run the NIST protocol and what did they do as a result?
  • If not NIST, do they have a written usability protocol and, if so, can you see it? How have they implemented it?
  • Have they tested their EMR’s usability with outside, independent users? What were the results?
  • Have they used any interface designers?
  • What usability changes do they plan?

There is no guarantee that you’ll get a great product, but it could mean that you get one that doesn’t bite your patients or you.

June 14, 2012 I Written By

When Carl Bergman’s not 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.

FDA, EHREvent, NIST: Who’s up for an EMR Supercop gig?

Last week I wrote wondering who will police EMRs and EHRs. With the release of IOM’s report recommending the creation of a different federal agency to serve as EMR watchdog, this topic has been generating buzz in healthcare circles. I’m by no means an expert in healthcare IT or policy matters but the discussion surrounding this topic has helped me think things through better than last week. Commenter Don Fluckinger answered the blog post with the first comment on the post – saying “these guys” and pointing to Commenter Carl Bergman said the FDA, which is already tasked with gathering adverse events for medical devices, might be the ideal go-to-agency for software adverse events as well. It is my understanding that medical software would receive Category 3 classification, if FDA were to provide the oversight.

IOM’s approach has been to suggest the creation of a non-regulatory, NTSB-like body. IOM’s rationale for undercutting FDA’s role has been that FDA classification system might stifle health IT innovation. (I’ve only had the time to read the very first few pages summarizing the rest of the IOM report, so I’m not sure if/how they address these concerns later.)

Here’s what I don’t get: What’s the point of creating yet another powerless body to issue guidelines? If there’s already a body with regulatory and oversight powers that covers your domain, has a large database of medical device related adverse events, why can its capabilities not be extended further to medical software as well? Further, why are health IT vendors exempt from any slaps on the wrist?

No offense to anyone, but from what I’m reading about, I don’t see much to recommend them: John says they “are not going to have high enough profile to be able to really collect the reports… a reporting system is great, but if no one knows to report something there, then it’s not worth much. Plus, if someone reports something but the organization doesn’t do anything with that information, it’s not very meaningful”. Valid question but I think there could be some easy workarounds for the problem of not knowing how/where to report shouldn’t be a major issue. Healthcare IT just needs the software equivalents of those “How’s my driving?” flaps adorning the backs of 18-wheelers. The bigger question is what happens when the EMR system fails? Who pays? How much? How does the vendor ensure the failure doesn’t happen again? Do we learn from the cumulative mistakes of the industry? Time will tell.

November 15, 2011 I Written By

Priya Ramachandran is a Maryland based freelance writer. In a former life, she wrote software code and managed Sarbanes Oxley related audits for IT departments. She now enjoys writing about healthcare, science and technology.

Who Will Police EMRs and EHRs?

Amid all the dog-bites-man type health IT news, here are some not-so-positive EMR/EHR stories that have been reported:

- An EMR in Lifespan hospital group gave incorrect prescriptions to some 2000 patients. The article in the Providence Journal says that

The hospitals have placed calls to nearly all the affected patients, although not all have called back, Cooper said. Most patients reached had already obtained the correct medication because the error was noticed by someone at the hospital, or a pharmacist or doctor outside, she said. So far, Cooper said, there is no evidence that any- one was harmed.

Thank goodness for that.

- Incorrectly calculated MU thresholds (GE Centricity). I’m not going to rehash the story, but you can check out Neil Versel’s article in InformationWeek, the spirited discussion on my previous EMR and EHR blog post and John’s EMR and HIPAA blog post.

It might be just be my skewed viewpoint, but GE Centricity related issues are nowhere on par with people being prescribed the wrong prescription. In one case, a few practices may not be able to demonstrate Meaningful Use. Wrong medication could actually be life-threatening to you. So if I had to rank my problems, I’d rather be short by 44K than worry about my EMR inadvertently killing my patients off.

What we need is a governing body, similar to the National Transportation Safety Board, to police EMRs, says Paul Cerrato in a recent InformationWeek Healthcare article.

Cerrato writes:

“An NTSB-like organization for EHRs would at the very least provide a reporting mechanism to keep track of incidents and life-threatening consequences of misusing e-records. More importantly, it could police vendors and healthcare providers who repeatedly ignore these dangers.”

Cerrato goes on to say there are only 120 EHR-specific problems reported to the FDA over the last 18 years. That figure, if correct, to me shows:

  • EMR users don’t know how/where they can report EMR related errors or don’t expect any action to be taken – this certainly is credible, because from all quarters, it seems as if the focus is just to get the healthcare field into electronic data capture, not on whether the experience delivers any tangible and useful benefits
  • Maybe they’re willing to give EMRs a pass assuming the healthcare IT to be in infancy
  • They’re too overwhelmed with the EMRs’ capabilities/inabilities to really see what’s going on

For a national database of EMR problems to be truly relevant, here’s the information I would look for, on problems I’m facing:

  • How critical was the error? How many people did it affect, and in what ways – medically, financially?
  • How was it handled?
  • How common is it – are there others who’ve faced similar problems?
  • If the problem was not sorted, what raps on the fingers did the vendors face?

Read the article here.

November 7, 2011 I Written By

Priya Ramachandran is a Maryland based freelance writer. In a former life, she wrote software code and managed Sarbanes Oxley related audits for IT departments. She now enjoys writing about healthcare, science and technology.

EMR Usability Standards: Do They Make Sense?

The other day I was at a conference where several EMR industry insiders presented on user interface issues. I’ll confess, I was expecting the usual defensiveness — “our user interface is just fine, it’s just that our users don’t understand it” — but instead heard a lot of earnest discussion about the problems with today’s EMR UIs. The problem is, none of them seemed have any clearly-defined ideas on how those problems will be addressed.

Speakers at the conference, who included vendor reps, clinicians, academics and more, did seem to agree that few EMRs had achieved satisfactory usability. More than one cited research suggesting that many EMR interfaces just don’t cut it.

If there could be said to be any consensus, it was that usability standards were at best a slippery issue and at worst, might force development in the wrong direction by measuring the wrong thing. One speaker noted that even if clinicians were satisfied with a system’s UI, this might not be the best way to study its value, as it doesn’t mean that the system is particularly efficient.

But that could be a bit of a cop-out. According to a HIMSS paper from 2009, there are several methods which could emerge as front-running approaches to measuring usability and efficiency (which, it seems, are too often addressed separately).

Interestingly, the HIMSS authors said that two completely unrelated safety programs might provide some  insight into improving developing EMR usability standards:

* The National Highway Traffic Safety Administration Child Safety Seat Usability Rating Program

According to HIMSS, this program offers several lessons, including that the NHTSA spent two years to develop the program, that  it collected data to see how well its ratings were working, and that officials have been flexible enough to change their standards as the market changes.

* FDA and Human Factors Regulation and Guidelines for Device Manufacturers

As some of you may know, the FDA requires device manufacturers to follow Human Factors regs. HIMSS researchers argued that a few aspects of this program can be applied to directly to setting EMR  usability standards, including the requirement that the manufacturer be educated in Human Factors, that manufacturers should adhere to standards set by other standards bodies as well as their own, and that manufacturers must be able to prove Human Factors compliance at any stage of the inspection process.

Folks, I don’t know if the anti-standards talk I heard at the conference was just a bunch of posturing, or whether developing usability standards is a great idea, but this is certainly a hot issue. Where do you stand?  Can the EMR industry benefit from an externally- or even internally-developed set of usability standards, or are there better ways to spend development time?

June 12, 2011 I Written By

Katherine Rourke is a healthcare journalist who has written about the industry for 30 years. Her work has appeared in all of the leading healthcare industry publications, and she's served as editor in chief of several healthcare B2B sites.