On the same day SearchHealthIT.com reported that the Food and Drug Administration (FDA) is continuing internal discussions about tracking electronic health record safety and regulating EHR software,
The nonprofit service, funded in part by medical societies and liability insurers, will share adverse event reports privately with its network participants, which include both the FDA and EHR software vendors. Keeping reports private is key to promoting progress in developing software and improving patient safety, according to Dr. Edward Fotsch, CEO of PDR Network LLC, a federally sanctioned patient safety organization that administers the website.
Considering the nature of EHR systems, making adverse event reports public would give malpractice lawyers much too much ammunition for lawsuits, and discourage vendors from innovating with their EHR technology, Fotsch said. However, given the public-private nature of the iHealth Alliance, and with the FDA's participation, providers can rest assured their adverse event reports will be shared with experts developing guidance documents and with federal officials charged with policing EHR safety, he said.
At first blush it might seem that liability insurers are odd roomers in the EHR safety boardinghouse, but it makes sense, Fotsch said.
"They are interested in promoting EHR adoption but they, at the same time, want to make it safe and effective as possible," Fotsch said. "They said, 'We need to get as much data as we can,' … and they want to help the docs with the learning curve as quickly as possible. Because when there's a problem, [liability insurers are] where the buck stops."
There is much still to be implemented in e-Rx (with FDA oversight), particularly the introduction of security measures to permit e-Rx of schedule 3 and above controlled drugs.
James L. Naughton, medical director, Alliance Medical Group and Affinity Medical Solutions
Liability insurers promote EHR adoption, Fotsch continued, because they believe risk analysis data will eventually prove that EHR systems are safer than their paper counterparts because they remove the problem of sometimes difficult-to-read physician handwriting. EHR technology, however, introduces different risks: online forms prepopulated with data that needs to be reviewed for each patient, for example, or user training difficulties that lead to errors.
Fotsch has not heard any public FDA comment about how the agency plans to regulate EHR systems, but he feels that the FDA's relationship with EHR vendors is "evolving" and will continue to do so over at least the next year. Sites such as EHRevent.org, he said, are a first step toward doing what all stakeholders -- vendors, regulators and users -- can agree on: Collecting data to measure the scope of safety problems with EHR systems.
"There's a difference between having jurisdiction over something and regulating it in the traditional sense of the word," Fotsch said. "You have the two ends of the spectrum. One is, the FDA -- or any other governmental agency -- does absolutely nothing, and people complain about that. The other extreme would be to treat electronic medical records like drugs, where you come out with a new [software version] and then send it through clinical trials … which clearly would stifle any rapid improvements. It would take a long time to bring out new systems."
Having just introduced the site without any adverse event reports in hand to analyze, Fotsch could not really offer an accurate description at this point of how acute the safety issues are with EHR systems, he said. From the anecdotal evidence he has heard, however, he imagines that minor issues that technically could be construed as errors that don't affect a patient's safety, such as marking a patient's gender incorrectly, will turn out to be common, he said.
Reports of truly adverse events -- ones that cause patient harm -- will prove to be rare, Fotsch thinks; however, as the adoption of EHR systems "explodes" and with the federal government championing their implementation, the potential for adverse events will increase as well. Having a reporting system and FDA oversight will help mitigate those risks.
"I'm going to feel better about EHR adoption if I know there are systems in place looking for -- and creating a feedback loop for -- potential problems," Fotsch said. "I know I feel better about flying on airlines knowing that the [Federal Aviation Administration] is there."
The iHealth Alliance also plans to bring RxEvent.org -- a companion site cataloging adverse medication events -- online in two months.
UPDATE: IOM report expected to highlight EHR safety, industry still reluctant to report errors
An Institute of Medicine (IOM) report, due in January 2012, is poised to influence the future of EHR safety -- perhaps, experts say, by giving the FDA the impetus it needs to regulate EHR software.
The IOM report has EHR vendors guessing since it’s unknown how regulations will change how their products must be designed. “I know the EHR vendors are really afraid that their products will come under the purview of regulation by the FDA, said Robert Murry, CMIO at Hunterdon Medical Center in Flemington, N.J., in an email to SearchHealthIT.com. “I think this would put a serious crimp on their development and creativity, which would be a shame in this era of discovery and innovation in the rapidly evolving relationship between physician, patient and computer.”
The IOM report also is likely to have major implications on e-prescribing (e-Rx), noted James Naughton, M.D., medical director of the Alliance Medical Group and Affinity Medical Solutions in the San Francisco Bay area.
"While e-Rx is only a portion of the EHR, these incentives for e-Rx are pushing physicians into adopting EHRs. There is much still to be implemented in e-Rx (with FDA oversight), particularly the introduction of security measures" to permit e-prescribing of controlled substances, Naughton said in an email to SearchHealthIT.com.
The IOM’s work might be affecting vendor and user reluctance to report errors from EHRs, as well. Fotsch, whose PDR Network reporting tool is designed to help capture and potentially fix errors, said the EHR marketplace might be “somewhat on hold” due to the looming research.
Even so, vendors are not reluctant to participate with PDR Network, Fotsch added. PDR Network has contracted with eight vendors to report errors and has nearly three dozen vendors working with them to promote awareness on the importance of reporting for patient safety.
The results, or actual adverse events captured through the tool, have varied, but most stem from a combination of interface confusion and a lack of training. Software bugs and glitches have been generally low, which is the type of information they expected, Fotsch said.
Making adverse event reports public still not on the radar
When asked if keeping adverse events private is still the best method for reporting, Fotsch said releasing information should be based on liability concerns, and provided an example. "If you were a doctor, would you want reporting leaked to The New York Times?" If this type of information is made public, he added, providers would not be willing to file adverse event reports.
But getting around those liability concerns is also key if improvements are going to happen and errors are going to be reduced. Patient safety communication plays a big role in that. The establishment of patient safety organizations (PSO), which are designed to help providers report errors while being ensured data won’t be used against them, is crucial if physicians are to actually take the time to report. "Our experience to date shows that many EHR issues have an aspect of user error or confusion," Fotsch said. "Without the protections of a PSO the physicians will be loathe to report EHR events that involve a user component."
If PSOs were not present, professional liability carriers that insure physicians will advise them not to report adverse EHR events if there is the slightest possibility of user incrimination, Fotsch said.
Murry follows a similar tune, saying the biggest deterrent to adverse event reports is threat of malpractice litigation. "Recognizing and reporting an adverse event forces physicians to admit that they (usually inadvertently and blamelessly) caused harm to the patient," he said.