At intervals, I've posted about the dangers associated with electronic health records (EHRs), due not to the basic concept which most agree is excellent, but to the too-often slipshod implementation, especially as the software industry moves in to capitalize on the promised bonanza. I have just read (thanks to my colleague Dr. Scott Monteith) one of the best brief articles summarizing the problem that I have yet seen, by Elizabeth Gardner in Health Data Management:
A couple of pearls... The article notes that EHRs are, by most any definition of the term, medical devices. That justifies the FDA in regulating them. But the FDA had a bad experience trying to do pre-market approval of blood-bank software in the 1990s. The general sense at the time was that the demand for pre-approval put such a damper on potential profits that major vendors pulled out of that line of business, creating a huge lag in technological innovation. Thus the FDA is really gun-shy about getting into the business of regulating EHRs. Just to show how primitive it all is, the article states, "The Agency for Healthcare Research and Quality is currently working with the FDA, VA and other federal agencies to develop a common format for reporting I.T.-related patient safety events and unsafe conditions." In other words, a bunch of Federal agencies are going through a big-deal negotiation simply to develop a form that the rest of us can use to report problems--nothing being said yet about fixing the problems!
Another quote: "When Geisinger Health System first installed its EHR, the I.T. staff was dismayed to find that there was no safe way to link it with a state-of-the-art pharmacy system from another vendor. ... To the pharmacy's chagrin, its lovely system had to go, to be replaced by the EHR vendor's pharmacy offering. Chief health information officer James Walker, M.D., later learned of research showing that at least 62 other institutions had found the same problem, no matter which EHR or pharmacy vendors they were using." Now, sorry to be so cynical, but you are going to have to talk for a long time to convince me that this was not basically about increasing the market for each firm's own software products, and not about insuring the quality of patient care by maximizing the interchangeability and interfacing of the EHR.
Final quote: "'It's inevitable that some new errors will be introduced [with EHRs],' says David Bates, M.D., chief of general medicine at Brigham and Women's Hospital, Boston, a patient safety expert, and a member of the information technology executive committee of Partners HealthCare, Brigham's parent. 'The key thing is to devote enough resources and attention to fixing them after they happen. Your EHR may prevent 10 errors for every new one it causes, but you have to have an approach for dealing with the new ones.'" Now, to the best of my knowledge, Dr. Bates is basically correct, though some would quarrel about the 1-10 ratio. My only wish is that the cheerleaders, including those in the Obama administration, that are currently waving the pom-poms and urging all hospitals and docs to adopt an EHR (any EHR) and to do it yesterday, would be as frank in their own descriptions of the state of the art.