Health IT Policy Committee Debates Role of FDA in Overseeing Safety of E-Health Record Systems

As the federal government ramps up its plan to help doctors and hospitals invest in electronic health record systems, the Health IT Policy Committee has been debating what role FDA should play in overseeing the safety of those systems.

In a report to the Office of the National Coordinator for Health IT, the Policy Committee called for the development of a national program that would monitor patient safety problems in health IT systems, but the committee stopped short of saying what agency should run it.

In an iHealthBeat Special Report by Kelly Wilkinson, health IT experts discuss whether FDA should be involved in monitoring the safety of EHR systems.

Some experts say FDA's oversight could extend to the safety of EHR systems, but others worry that FDA's involvement could stifle innovation.

The Special Report includes comments from:

  • Dave deBronkart, an advocate for involving patients in health IT;
  • Deven McGraw, director of the Health Privacy Project at the Center for Democracy and Technology; and
  • Paul Tang, vice chair of the Health IT Policy Committee and chief innovation and technology officer at the Palo Alto Medical Foundation (Wilkinson, iHealthBeat, 6/9).

The complete transcript of this Special Report is available as a PDF.

William Oravecz
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.
john burke
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.
William Oravecz
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.
John Inca
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.
Dale Sanders
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.

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