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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.

Will 2013 Be The Year Of EMR/Device Convergence? Nope.

Posted on December 31, 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 @ziegerhealth on Twitter or visit her site at Zieger Healthcare.

Increasingly, healthcare organizations are introducing wireless medical devices which can hook up to EMRs.  And this makes a lot of sense, given that data from, say, infusion pumps offers a critical part of a patient’s overall picture and can boost safety as well.  On the other  hand, equipment and integration costs have held back hospitals from widespread convergence.

Given these opposing forces, it it looks like we’re poised at a point where adoption of wireless, EMR-connectible devices could gather momentum or stall out and drag into 2014 or beyond. But don’t get your hopes up for 2013. Here’s some trends that are likely to drag down the progress of medical device connectivity for the coming year:

* Device interoperability not required for Stage 2:  According to one blogger, William Hyman of Medical Connectivity, Stage 2 of Meaningful Use doesn’t directly doesn’t require providers to connect most traditional devices to the EMR. (Imaging and lab systems are exceptions, he notes.)  Well, if Stage 2 doesn’t require smart devices, must less connected ones, it’s hard to imgine CIOs making this a priority.

FCC initiatives to benefit wireless medical device use aren’t mature yet:  The FCC is taking several steps to encourage the use of connected medical devices. These include promoting the use of medical body area networks (MBANs), for which it has reserved spectrum, as well as making frequencies available for medical micropower networks. The agency is also working on making it easier to experimentally license spectrum for wireless health test beds for wireless medical devices.  These initiatives are just getting rolling, however.

Medical devicemakers face big EMR challenges:  As Medical Connectivity’s Tim Gee notes, creating device software that will smoothly pump data into an EMR is actually a pretty big challenge.  Devicemakers will need to export data in digital form, work with a central server aggregating data from your medical devices and translate you device data into HL7 for the EMR. Device vendors face big development expenses if they hope to get this right, he notes.

Will the wireless medical device become a standard part of hospital gear? I’d say it’s only a matter of time. But this year, progress is likely to be slow.