The Health IT Policy Committee endorsed recommendations for the creation of a national database to which healthcare providers can confidentially report patient data errors and unsafe conditions they encounter using electronic health records. Reporting of safety issues would become part of Stage 2 of meaningful use requirements.
A patient safety organization will also be established to analyze the reports and will emphasize tracking and sharing information from the database to make healthcare a learning system, according to the Health and Human Services Department advisory panel at its meeting April 21.
The committee will deliver the recommendations to the Office of the National Coordinator (ONC) to decide whether to adopt them and to define how the patient safety proposals would be put into practice, said Paul Egerman, who co-chairs the certification and adoption panel that authored the working document.
Only a minority of patient safety risks are the result of software flaws, said Egerman.
"It's more issues of complex interactions of people and technology, training and interoperability," he said. For instance, when providers order medications through their electronic health record systems (EHRs), "so many alerts are presented to the ordering physician that they ignore 90 percent of them. When you start to ignore the alerts, it is possible you will miss something important," Egerman said.
Patient safety concerns also has raised the question of government regulation. Although the Food and Drug Administration has authority to regulate health IT, the agency has refrained from doing so because EHRs are not stand-alone products and are linked with each other in networks, according to Dr. Jeff Shuren, director of FDA's Center for Devices and Radiological Health.
Policy committee members were skittish about FDA regulation because it could inhibit innovation, like iPhone mobile health applications, and increase costs. Egerman said. However, the agency worked with the panel, providing it with data and expertise.
"They are trying hard to be helpful," he said. FDA also has experience with reporting systems for adverse events, unexpected consequences and near misses related to devices.
Additionally, ONC and FDA could collaborate on certification criteria that improve patient safety and selected health IT areas, such as design quality, that are creating safety risks for EHR implementations, Egerman said.
Among other recommendations, the committee said that EHR certification criteria for each stage of meaningful use should be available at least 18 months before the beginning of the eligibility period.
Vendors need time to develop, test and certify their software, and then customers need to test, train and deploy software to be ready for the period of eligibility, he said. For instance, the certification criteria for Stage 2 meaningful use should be available for vendors in April 2011 so providers can be ready to use that software by October 2012.
Among the other recommendations, vendors should include a feature, such as a "feedback" button, that makes it easier for providers to report problems. Vendors should maintain records on patient safety concerns reported by their customers and establish safety alerts.
More research is needed to develop a complete response to patient safety and EHRs, Egerman said. To that end, ONC should commission a formal study to evaluate health IT and patient safety concerns. Despite patient safety concerns, Egerman said he never heard any comments that EHRs and computerized order entry systems should not be deployed.
"We believe the biggest risk to patient safety would be to either avoid or delay the proper implementation of HER and CPOE systems," he said.
