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Will Health Analytics Be Regulated?

Posted on March 29, 2017 I Written By

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

We’re seeing healthcare analytics pop up everywhere. There are a lot of definitions of healthcare analytics out there, but I like the idea that healthcare analytics makes healthcare data useful. Does that sound like something we desperately need in healthcare?

I do think that there are lots of kinds of healthcare anayltics. One kind is an analytic that determines how you’re doing financially. I actually think that most organizations are doing pretty well with these kind of analytics. Is there more to do? Sure, but there are some pretty advanced healthcare financial analytics.

The next generation of healthcare analytics is going focus on improving care. We’re talking about real time analytics that analyze a patient’s health and wellness. We’re talking about analytics that help determine a course of treatment for a patient with a complex clinical history. We’re talking about analytics that influence the care a patient receives.

When I describe healthcare analytics in this way, does this sound any different than a medical device? It doesn’t to me when it comes to the risks associated with what the analytics could do for both good and bad. If that’s the case, should health analytics be regulated?

The answer is pretty clear to me that they should be regulated in some form or fashion. However, that doesn’t mean I think they will. There are a couple of major reasons why. First, the industry is unlikely to allow it to happen. Second, the government isn’t built to regulate healthcare analytics.

The first is pretty straight forward. There’s a reason why most software hasn’t been regulated yet. The second idea is a little more challenging. On face value, you’d think that the FDA could just start regulating healthcare analytics the way they do medical devices. The problem is that they are very different things to regulate. What’s required to regulate a medical device and for someone to oversee that regulation is very different than what’s needed to regulate a healthcare analytic. You can’t just flip a switch to turn on software and data regulation. It’s very different than medical device regulation.

While I certainly think there’s an argument to be made that healthcare analytics could and maybe even should be regulated, I don’t think that it will be regulated.

What do you think? Will we see healthcare analytics regulation?

The Paperless Healthcare Startup – lol

Posted on February 9, 2015 I Written By

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

One of my healthcare IT friends posted this picture and caption to their Facebook page:

Paper Regulation in a Healthcare World

The past 8 months of my life can be summed up in just under 2k pages of internal documentation and reporting evidence. I’ll be so happy when this is over. Two days and counting…

Yeah, federal regs don’t choke healthcare startups at all. < /sarcasm>

I asked about which regulations (there are so many to choose from) and she said ISO and they also were lucky enough to get slapped with an FDA audit as well.

While not all regulation is bad and in fact some regulations is good, I’m pretty sure that these notebooks will almost never be cracked open. They’ll gather dust on a shelf. Of course, many would argue that the real value was the evaluation process that the company went through in creating these documents.

Regardless, this image is a good illustration of why many tech folks don’t get into healthcare.

What if the FDA Started Regulating EHR?

Posted on March 20, 2014 I Written By

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

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.