Additional EMR Regulations – Good or Bad?
Suppose the DMV added 1000 new rules to driving. Would that make driving saver? Would that help the police write better tickets? It would help the regulatory bodies better split hairs. It would allow more and bigger DMV offices.
I got the above comment emailed to me by Paul Lund who subscribes to the EMR and HIPAA email list. It’s an interesting comment and EMR and healthcare can likely learn from the rules of the road. I think the biggest challenge is that we seem to all understand about driving and the issues related to driving. In healthcare, we all think we know about the challenges of healthcare, but it’s often much more complex.
As I think of the analogy of driving to EMR, I agree with the general idea that less EMR regulation is better than more EMR regulation. For example, have we seen a measurable benefit from all of the EHR certification or meaningful use regulation>? I have yet to see it, but could point to plenty of areas where the EHR certification and MU regulations have caused a negative to healthcare.
However, just like in driving, I don’t think there should be no regulation at all of EMR and EHR software. As usual, I have a much more nuanced view. Can you imagine driving with no rules? The odd thing is that in some ways that’s what it feels like in EMR today.
A simple example is having a true standard for EMR interoperability. I’ve long wished that the EHR incentive money focused exclusively on this challenge. It’s a place where an adopted and supported standard for EHR data could really benefit the community. Plus, holding EHR vendors, hospitals, HIEs, and physician offices to that standard could be a real benefit. Right now every EMR seems to be doing what they want. Yes, we have CCD, but try transferring a CCD from one EMR to another right now. It’s a mess of multiple versions and challenging delivery. Works great in the HIMSS interoperability showcase, but somehow isn’t getting translated to real work.
Is it too much to ask for meaningful EMR regulation and nothing more?
While I agree that there should be some concern that the FDA will slow down the adoption of EMRs, I do think it’s worthwhile to discuss that the entire health system runs off software systems that has never been through a formal verification or validation process.
We wouldn’t have the rules – that is the meaningful use requirements, if the Gov wasn’t handing out $$ to docs trying to get the to modernize.
Justin,
All of the major companies in the world run off software that hasn’t been through a formal verification and validation process. Why should healthcare be different?
The problem with the analogy is that it assumes that EHRs are a mature, well-established technology, when they’re really anything but. Consider instead the state of driving regulations now versus back when cars were first becoming popular – there are many more than a thousand rules added since, and safety has only increased. How many rules surround the necessity of manufacturers including seatbelts? Air bags? Rollover protections?
Again, the feds wouldn’t be involved beyond HIPAA if they weren’t handing out checks.
HIPAA is big picture-ish.
Meaningful use is micro-managing.
Once you accept a check from the feds, you have to live with the craziness that ensues.
John:
Good point on software, although much of the software that does heavy lifting is open-source with some level of transparency with respect to how its running. And companies that are the size of large hospitals don’t typically spend as much as hospitals are spending on what is essentially a basic database with order entry and monitoring capabilities.
To me, the EMR should be the least interesting part of the digitization of hospitals. It’s just the foundation upon which clinically useful things, like analytics and alerts, should be built. To allow hospitals to innovate on that front, I think interoperability should be an absolute requirement sent down from the FDA. Decision support should also have consistent regulation. Right now, much of the software provides specific alerts and alarms, which are typically considered Class II medical devices.
Information Week had an interesting critique — “Latest RAND report suggests we might be throwing taxpayer dollars away on EHRs and other healthcare IT systems.”
See “Healthcare IT: Savior Or Sinkhole?”
http://www.informationweek.com/healthcare/electronic-medical-records/healthcare-it-savior-or-sinkhole/240146137?cid=nl_IW_healthcare_2013-01-16_html&elq=57b516a5fac4440789b6d6107e7dc912