'Innovation is associated with risk'

Mary Stevens, editor, CMIO

As the Certified Health IT Product List expands, the U.S. federal government sees the EHR certification program as a big success because of the numbers—the Certified Health IT Product List includes more than 700 products listed, said Karen Bell, MD, MMS, chair of the Certification Commission for Health IT, (CCHIT) during the CMIO Summit Clinical T Leadership Forum in Boston last week.

Addressing EHRs in a roomful of CMIOs makes for an informative discussion. Here are some of the questions and answers from Bell’s session.

You touched on issues about vendor products. What if your vendor says you have to buy the entire package in order to be considered meaningful use? Didn't CMS clarify that you actually only need to implement the tools you’ll use?
Bell: Right now, if it’s a complete EHR, you have to buy the whole thing. You don’t have to use the whole thing, but that means you’re buying software you don’t need.

Is there a future in a mandatory or voluntary usability certification?
Bell: No: The reason I say that is it’s going to take a very long time to understand even the testing and how you can evaluate usability. The usability testing the CCHIT does is very specific to the Windows environment. If you are in an iPad envorinment, it's going to be different, and it's different in hospitals.

How about patient safety?
Patient safety certification may come down the line. I believe the Institute of Medicine will drive a lot of that.

As it stands today, you can’t necessarily attest to something if you’ve made modifications to your system?
Bell: If you have a certified system, that part is OK. They’re not going to be worried about your certification status; they’re going want to know if you did what you said you did.

The FDA again is contemplating the patient safety component of smartphone apps. The discussion has been going on for almost a decade regarding software and medical devices, etc. What’s your perspective about where FDA’s boundaries may evolve and where they may or not overlap with certification?
Bell: The current administration does not want the FDA getting involved in the EHR world. That will be for the foreseeable future. The problem will come when there is a major patient safety issue that occurs with a current EHR system. Innovation is associated with risk. We need innovation in a lot of different areas in healthcare. But there’s always a trade-off, and the trade-off in healthcare could be patient safety. So we’re putting a lot of emphasis on innovation in HIT and EHR space, but there could be patient safety risks if we don’t watch this very carefully.


You can see all of our CMIO Summit coverage here.

Mary Stevens
Editor of CMIO
mstevens@trimedmedia.com