Regulating EHR Safety (II): Post-Market Surveillance

We have argued previously that ONC has an obligation to assure that EHRs are safe and effective, and that a two-part regulatory strategy could achieve this goal without hindering ONC’s primary mission to foster rapid uptake of EHRs by US providers.

In Monday’s post, we reviewed the first part of this strategy, which is to extend EHR certification to include more patient safety criteria than they do currently. Here, we outline the second part, a post-market surveillance system governing EHR safety.

Introduction
HITECH is based on the assumption that EHRs can help achieve many of the goals we share for improving our health system, including improved quality, reduced costs and efficient responses to public health emergencies.

Few believe this assumption is flat-out wrong, but the scientific literature contains surprisingly few studies which confirm that EHRs are safe, and these are offset by others showing EHRs actually cause safety incidents and patient harm.

Concerns about EHR safety were raised recently by Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health. He noted in public testimony last week that his agency received reports of 6 deaths and dozens of injuries associated with EHRs in the last 2 years alone.

The incidents included patient mix-ups, misfiled test results and failure to display allergy information, among other things.

The frequency of such incidents might be expected to increase as HITECH incentives drive hospitals to adopt EHRs. This is because legacy EHR vendors have neither the manpower nor the platform/software flexibility to handle the flood of customization projects required to accommodate local workflows.

Post-Market Safety Surveillance for EHRs
To address the problem, ONC should implement a mandatory EHR/Patient Safety reporting system that requires providers and vendors to report safety-related issues to a national clearinghouse, whether they have caused harm to patients or simply have the potential to do so.

The idea of a national clearinghouse for EHR safety--which is a form of post-market surveillance--was first proposed by Walker et. al. In their proposal, vendors can see all incidents in the data base, in anonymized form. Scientists have access to the anonymized data as well.

The clearinghouse should categorize safety issues to facilitate analysis. Although a proper taxonomy of EHR-related safety issues has not yet been developed, it should be possible to leverage related work in the narrower field of computerized physician order entry to develop such a system.

Once an EHR-related safety concern has been logged into the clearinghouse, ONC must alert several groups including affected customers and, if the concern is generalizable to other EHRs, their users as well. Of course the EHR vendor must then also address the issue to the satisfaction of ONC.

In addition to a clearinghouse, Settig and Classen recommend that ONC establish an EHR Adverse Event Investigation Board which can investigate and publicize serious adverse events or hazards involving EHRs. This agency would function like the National Transportation Safety Board does when it investigates airline disasters.

In particular, it would analyze the complex, sociotechnical interactions between clinicians and EHRs that lead to the mishap, and report its findings to ONC, EHR vendors, providers and the public for learning purposes. The board would have unlimited access to all aspects of the EHR, including system backups and change logs.

Conclusions
Frankly, neither EHR vendors nor the regulatory agencies overseeing them have systems in place to assure that EHRs are safe. EHRs profoundly impact clinical workflows and provider communication patterns, especially in hospital settings, so it is essential to establish mechanisms assuring they are indeed safe. A post-market surveillance system can meet this objective without impeding the government-desired roll-out of EHRs throughout the US health care system.

Glenn Laffel, MD, PhD
Sr. VP Clinical Affairs, Practice Fusion