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The Challenge of FDA Clearance

Posted on March 16, 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.

As I’ve talked to 100s of companies creating devices for healthcare, there’s inevitably the question: “Are you FDA cleared?” There answer usually tells me a lot about the company and what their goals are for the product. Generally, it’s a question of if they’re going to go after the consumer space (ie. no FDA clearance) or after the medical market (ie. FDA clearance preferred).

In a few cases, I’ve talked to companies like EarlySense that have an FDA cleared product for hospital beds and a non-FDA cleared product for consumers. It was interesting to hear the reasons why they chose to release a non-FDA cleared product for consumers since they already knew they had the capability to go through the FDA clearance process. Their answer to me was instructive.

The core of their response was that FDA clearance is not a one time event and so this limits their ability to iterate and release product updates.

For anyone working in the startup world, it runs completely counter to the startup culture. The idea of iterating quickly and often is part of the mantra of most startup companies in silicon valley and now around the world. The FDA’s clearance process runs almost completely counter to this idea.

With this type of restriction, it makes sense why so many companies would avoid FDA clearance and just create a direct to consumer product that doesn’t require FDA clearance. The ongoing FDA clearance requirements can be a bear. What company wouldn’t want to bypass it and just iterate as they please?

The challenge with this approach is that there are reasons that FDA clearance is so challenging. First, it searches to provide a level of safety as far as what’s being implemented and the results of the device actually being tested and confirmed. Second, it creates a trust that most doctors (and their malpractice and insurance companies) want to see before using it.

Certainly, we could argue about how effective the FDA clearance is about ensuring safety and results, but that’s a topic for another day. If nothing else, it requires many organizations to think deeply about what the safety of the patients that are impacted by the device and consider the promises they make to customers. Those are two things that are missing in my consumer health devices and apps.

It’s a tough balance and I don’t think we’ve fully figured it out. How do you ensure safety and efficacy while still allowing the entrepreneurial spirit of innovation to thrive?

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.