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The Food and Drug Administration (FDA) is a U.S. health information organization. The FDA is involved in the medical device arena, but its primary purpose is to protect humans against harm from potentially dangerous medications and food. The FDA also serves as a safety reporting agency where whistle blowers can report health safety concerns and outcomes anonymously.
The FDA performs some oversight of health records and health information technology (HIT). In 2010, it reviewed more than 260 reports of electronic health-record-related medical incidents that actually caused patient harm, six of which resulted in patient deaths.
The Office of the National Coordinator (ONC) currently certifies electronic health record (EHR) vendors, private IT professionals and eligible providers who implement EHR systems. The FDA is considering a larger role in regulating EHR software.
The FDA's primary concerns regarding EHR development include the quality of EHR vendors, which must be chosen according to deadlines set by the Health Information Technology for Economic and Clinical Health Act (HITECH). Another concern for the FDA is the absence of quality systems regulations developed within EHR vendors' systems; these are for the provision of audit trails and focus on adverse medical events. Some of the most influential EHR vendors feel that they are not qualified to sort out medical errors within their EHRs, which may influence whether the FDA conjoins with ONC to ensure electronic patient safety reporting and data integrity.
As a result of these concerns, there is a need for independent HIT consultants that are not affiliated with large EHR vendors to write programs that furnish quality assurance results such as electronic prescription errors, morbidity and mortality rates and their causes, and other vital quality systems reporting measures. If nothing else, the FDA could hire outside IT professionals to audit EHR systems.