Getting Closer to Safety Standardization for HIT?

Originally posted 12-23-2010:
As the use of Electronic Health Records (EHRs) continue to grow in healthcare, more questions are getting asked around the safety of such systems. Despite the innovation and efficiencies they bring, there are also potentially dangerous side effects to bringing the technology into the healthcare environment.  I've written about how the lack of standardization and poor software design are some of the culprits that leave a patient safety hole in the health system.  It goes without saying that I was pleased to see the Institute of Medicine has created the Committee on Patient Safety and Health Information Technology.

According to this New York Times article, the committee has been tasked with a year long study of such safety concerns with Healthcare Information Technology (HIT).  I am really glad to see that there is some serious action being taken to look closer at this.  The article pointed out the FDA has seen 260 reports of HIT malfunctions that had the potential to create harm. Since reporting HIT issues (which are not currently considered medical devices) is voluntary, I agree with Dr. Shuren that this may be "the tip of the iceberg." I also liked Dr. David's Blumenthal's quote on this: "At the same time, any time you change the world you create risks. We want to make sure that implementation is as safe as it can be and all safety benefits are realized.” 

I hope the committee takes a careful look at this and identifies the biggest HIT safety concerns. Hopefully they propose potential solutions around these concerns and deliver a smart list of recommendations for HIT systems.  For years, there have standards on medical devices to ensure their safety to the patient.  HIT systems provide data that directly impacts decision making for care givers, which does impact the quality of care a patient receives.  

I know there are concerns about government HIT regulations. Carl Dvorak's quote summarizes the concerns of the HIT vendors well: "The policing of design by a third party or agency, however well intended, will likely stifle innovation and inhibit the growth and development of electronic health records in the future."  I understand this concern, as I have seen how the FDA and other government mandated medical error reporting systems can slow things down and be a bear to work with.  That's why I said a "smart list" should be delivered.  I think it is possible to develop standardization that promotes safety, yet is viable for the manufacturers.  Medical device manufacturers are still delivering innovative products, so it is no impossible for this to happen in the HIT world. Regardless, safety should be a priority and shouldn't be sacrificed in HIT development.

This should make 2011 a little more interesting for world of Patient Safety. Have a wonderful holiday!