An element of the plan calls for the use of a set of standard formats now only partially developed by the federal Agency for Healthcare Research and Quality for reporting such events to patient safety organizations.
“We certainly support the use of the AHRQ common formats for reporting,” said Dr. Sarah Corley, chair of the patient safety workgroup of the Electronic Health Records Association, an affiliate of the Chicago-based Healthcare Information and Management Systems Society. But there's not enough detail to know what they intend to require.”
The plan says that the ONC “intends to use certification criteria to ensure that EHR technology can be used to easily initiate health IT-related adverse event reports using AHRQ's Common Formats.” The ONC develops the criteria against which EHRs and their modular parts are tested and certified to qualify for use in the federal EHR incentive payment program under the American Recovery and Reinvestment Act of 2009. Corley noted that HHS last year awarded a prize to a developer for creating a means by which providers could conveniently report patient safety issues. The winning application uses a version of the Continuity of Care Document format developed by Health Level Seven, a standards development organization.
Developers are already required to build into qualified EHRs the capability to create patient care summaries using a “consolidated” version of the CDA format, and if that's what ONC adopts for errors reporting, “I don't anticipate that would be problematic” for vendors to add that function in time for inclusion in the testing criteria for Stage 3 of the EHR incentive payment program, for now scheduled to begin in 2016.
“When a user is trying to report something to their hospital or enterprise patient safety workgroup, you want to make it easy for them to do the reporting, and with the consolidated CDA, you would have the patient demographics” already captured, Corley said. “You would still have to have the end user explain what the patient safety issue was,” but some means to capture and transmit the user's observations would be required on virtually any reporting mechanism, she said.
In January, the Food and Drug Administration, with help from the ONC and the Federal Communications Commission, is expected to make recommendations to Congress on establishing a “risk-based regulatory framework for health IT.” The FDA report, mandated by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) could lead to direct FDA regulation of health IT systems. A workgroup with representatives of all three agencies and other public and private-sector experts is looking into the issue. Whether that will lead to FDA regulation of health IT systems such as EHRs is the great unknown in the industry.
Last month, Dr. David Classen, associate professor of medicine at the University of Utah and chief medical information officer at Pascal Metrics, a Washington, D.C.-based patient safety software developer, declared FDA regulation of EHRs to be all but inevitable. Corley said she doesn't think so.
“We're certainly monitoring that and we have two representatives on that workgroup,” Corley said. “From our point of view, there is no evidence, no data to suggest that health IT is causing patient risk or patient harm such as you need a regulatory framework. It would be best to evaluate once we have data and whether or not regulation is warranted.”
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