Should electronic medical records (EMRs) be regulated for safety just like any other medical device?
At first glance, the answer seems to be, “No.” After all, EMRs are just computer versions of the old paper chart, right? Nobody regulated paper charts for safety, so why should we be questioning EMRs?
On closer scrutiny, however, the answer is not so clear, because EMRs are more than simple repositories of clinical data. They are used to enter and transmit orders for things like procedures, tests, and medications, as well as to transmit results back to physicians. While errors due to bad doctor handwriting have diminished, there is a growing body of data documenting new errors and harms to patients caused by EMRs. The Institute of Medicine (IOM) catalyzed the headlong rush to adopt EMRs with its 1999 report asserting that increasing the use of information technology (IT) would lead to decreased patient errors and increased safety; in 2011 it published a report calling for the formation of an independent federal body to investigate patient deaths and other adverse events caused by health IT.
Now the large industry that has grown up around EMRs is fighting federal regulation that would treat EMRs like any other medical device and monitor their effect on patient safety. As the IOM’s 2011 report points out, the precise effect EMRs have had on patient safety is difficult to quantify because of “contractual barriers (e.g., nondisclosure, confidentiality clauses) that can prevent users from sharing information about health IT–related adverse events . . . these types of contractual restrictions limit transparency, which significantly contributes to the gaps in knowledge of health IT–related patient safety risks. These barriers to generating evidence pose unacceptable risks to safety.”
It appears that the Health IT industry believes that it is not in its best interest to gather data on how its products might adversely affect patients. On the other hand, it appears that gathering such data and using it to improve systems is in the best interests of patients. In this conflict of interests, the patients’ interests should clearly prevail.
This is not to say that it should necessarily be the FDA that regulates the industry. In fact, I believe a transparent and trustworthy private body would be a better option. But the Federal Government has spent literally billions of dollars (our dollars) to induce physicians and hospitals to adopt EMRs. Most of that money is ultimately finding its way into the coffers of the Health IT industry. The government has not only the right to determine what harms that money may be causing, but the responsibility to do so.