Why regulatory compliance is killing innovation in healthcare

Anyone that’s worked in healthcare knows about regulatory compliance. If not, then they should because it takes up about 50% of everyone’s time, energy and effort. I understand the theory behind regulations, i.e. protect the patient, but I think most of the time all additional regulations do is is create work for people that are already over burdened.

Ask a nurse how much time they spend documenting and double documenting things to meet some arbitrary rule or regulation. You’ll be surprised by the answer. Now ask a pharmacist or a physician. You’ll get the same ugly responses. I know a lot of my time as a clinician was spent generating documentation to cover my ass rather than helping care for a patient.

Unfortunately the need to comply with government agencies and silly rules inside the walls of healthcare has generated an unwanted side effect – lack of innovation. Why? Because all that innovative energy is spent on regulatory compliance instead of other, more useful things.

I’ve been involved in several conversations over the last month dealing with how to best use pharmacy automation and technology to increase efficiency and solve problems. Would you like to venture a guess as to what most of those conversations centered on? Yep, how to automate some documentation process or create technology to meet some new regulatory compliance. None of the discussions have been about providing better, safer, more complete patient care.

If you don’t think this is a major problem, think again. I was reading a blog by John Halamka last night in which he discusses the ‘Burden of Compliance’. In the blog John states that “[a]s we draft new regulations that impact healthcare IT organizations, we need to keep in mind that every regulation has a cost in dollars, time, and complexity.” Just remember, there is a finite amount of dollars and time floating around in healthcare these days. If a majority of those dollars and time are gobbled up by regulatory compliance, what does that leave for innovation to actually improve medication distribution, safe administration and better patient care? Precious little if you ask me.

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