As electronic medical records receive growing amounts of attention, so do its byproducts. On byproduct of electronic data is Bioinformatics. Bioinformatics, or just Informatics, are evolving terms. In general these terms refer to the leveraging of computer technologies to improve delivery and analysis of health care data.
From the provider and vendor side, one area of interest in informatics has been the development of computer-based decision support systems. As we discuss quality and improvements in health care, exploration of new applications such as these are absolutely critical to achieving the goal of better quality health care.
However, there is a potential difficulty as we attempt to grow and improve. That difficulty is potentially-cumbersome government regulation.
While at the American Medical Informatics Association Summit on Translational Bioinformatics in March of this year, I listened to an interesting panel discussion. The panel was designed to discuss regulatory issues associated with clinical support tools. I learned that the FDA is watching the development of this area closely. Currently, they consider computer-based decision support systems to be “medical devices” which means that computer programs such as these fall under their watch. Therefore, before use in the clinical realm, FDA approval is required. This means that nobody in his or her right mind who knows this will want to go through an FDA-approval process. Therefore this area will not develop. Luckily, not many people are aware of this regulation.
I was reminded of this fact after seeing another complication of government regulation on a post on the Commonwealth Fund website.
Vida Foubister wrote an article summarizing the drama surrounding the initial shut-down (and later re-opening) of a Michigan quality improvement project. The Michigan project was an amazing initiative that won widespread praise in the Medical community. With their initiative, they were able to reduce the number of life-threatening catheter-related bloodstream infections in over 100 intensive care units. Most ICUs are now trying to mimic their process to improve their outcomes. Sounds like progress. Until they were shut down.
Without going into the regulatory details, the debacle centered on whether the project was a quality improvement project exempt from many federally-established regulations, or whether it was a research project that required more oversight. Vida summarized the consequence of the confusion and temporary shutdown:
While OHRP concluded in a February determination letter that the Michigan hospitals could continue implementing the checklist "without falling under regulations governing human subjects research," the implications of its initial action have been far reaching. "There's been an awful lot of quality improvement that has been stalled or put on hold, trying to understand this IRB issue," says Pronovost. "The chill sent through the quality improvement field has been very, very real."
With the national debates centering on improving electronic data and improving quality of care, why is it that our regulatory agencies are not aligned along the same goals?
Now, this is not meant to be a slam on the FDA. I strongly believe there must be oversight of the medical field in order to protect the population.
Instead, I believe that we need to seriously consider where we want Medicine as a field to go. This means that we need national priorities that are not just articulated, but applied to the regulatory agencies that could potentially resist that growth.
It is easy to globally talk about “coverage for all” and “improving quality,” but without looking at some gritty details and addressing barriers to change, this will remain just talk.
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