Mr. Burke, Thank you for making reference to the situation regarding Laboratory-Developed Tests (LDTs) in the area of in-vitro diagnostic (IVD) multi-variant index assay (MIA).

There’s a lot of debate going on between industry and the FDA about how to regulate diagnostic tests that “classify” a patient based on multiple genetic or biological variables.

Perhaps this will set precedence for hospital developed healthcare software applications.

That being said, it's hard to appreciate why there is even debate about the FDA regulation of commercial EHR systems.

Why can't innovation exist that can provide a 3rd party assurance of safety and effectiveness of healthcare tools for Americans.

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One reader stated "The FDA is [only]concerned with medical devices that are in commerce, not privately developed, such as Kaiser's." I would ask this reader to look at IVD LDT/IVD MIA discussions curentlty taking place and reevaluate their comment.

The FDA is concerned with medical devices that are in commerce, not privately developed, such as Kaiser's. However, Kaiser does have a moral and ethical obligation to those it serves to have systems that are safe and effective.

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The FDA is going to have a fine time evaluating Kaiser Permanente's "HealthConnect" EMR. Kaiser Permanente so poorly managed its implementation that Kaiser lost their baseline in mid-2004. The number of environments (300+) and patch rate increased so much -- in both size and frequency -- that KP HealthConnect was untestable, thus untested.

The FDA should definitely be involved... it's overdue. Were it not for HIPAA, the healthcare industry would still be in the dark ages of IT security. Until there is federal oversight, EMRs/EHRs will continue to place patient safety at risk. Here's another post with more details.

http://healthsystemcio.com/2010/04/20/patient-safety-and-electronic-health-records/

The role of the FDA has been to ensure that the general public is not harmed by foods, drugs and medical devices put into U.S. commerce. Since an EHR system/module can have an effect (intended or not, hence the concern)on the course and reporting of patient healthcare, who else has the experience to ensure EHR systems/modules are "safe and effective"?

http://www.hitechanswers.net

FDA has always had oversight regarding the safety and effectiveness of medical devices placed into commerce. With that said, would anyone argue that that an EHR system/module is not a medical device?

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