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?
Your article is great for opening a conversation about regulation in general. A couple of points to thinks about
1. A significant result of regulation is creation of barrier to new entrants, and protect incumbent interests. Example: EMRs – certified HIT- did not help, it hindered competition and innovation – certified HIT had no teeth to sharing medical records as an illustration.
2. Regulation is an overreach of need for common-sense surveillance and watch-dogs. And as an effect, regulation has resulted in less surveillance and fewer watch-dogs – to the detriment of population in general.
3. Not only should healthcare analytics not be regulated, none of the software applications should be regulated – instead due to their nature – there should strong surveillance and watch-dog groups and reputation matters a lot in the industry.
4. Your point “what to regulate” is exactly an example of need for increased surveillance but less regulation – that can be applied to other regulated software (e.g. EMR and PACS). Even software medical devices – such as diagnostic workstations – might benefit from lack of regulation but increased surveillance and watch-dog groups. Would you support regulation of deep image analysis for automated diagnosis of diseases? What would FDA or any agency regulate?
5. Regulation should be supported for things that touch a patient or have potential for direct physical impact (mechanical, chemical, physical body or fluid-medication etc).