What Is Food and Drug Administration (FDA)?

Are you concerned about getting medication or food poisoning? Sick of using your local convenience store's coffee maker to brew your morning latte? If so, the Food and Drug Administration (FDA) might be missing in your life. The FDA protects human health by regulating how medical products are made, tested, marketed, and safe food. The FDA reviews over 1,000 reports annually from whistleblowers who report potentially dangerous product reactions or outcomes. In addition to this primary role, The FDA also works to prevent potentially harmful products from entering the U.S. market and ensures compliance with regulations by drug manufacturers. The FDA inspects health records and IT systems to see if they do what they are supposed to, and if they do, it cracks down on them. The agency said in 2010 that it had reviewed 260 medical incidents caused by bad health records and inadequate IT systems, six of which resulted from inpatient deaths. So The FDA has announced that it will consider a more significant role in regulating EHR software. The Office of the National Coordinator certifies electronic health record (EHR) vendors, private IT professionals and eligible providers who implement EHR systems. The two primary concerns for the FDA in EHR development are the quality of EHR vendors and the absence of quality systems regulations. When combined with ONC's work on health information technology and accountable care organizations (ACOs), these two factors will likely influence whether the FDA connects with ONC to ensure electronic patient safety reporting and data integrity within EHRs. The FDA is concerned about the quality of electronic health records as well. They want to ensure that all approved drugs are correctly administered, the morbidity and mortality rates are accurate, and other critical quality measures are being taken care of. In addition to hiring outside IT professionals to audit EHR systems, they could also employ independent HIT consultants that aren't affiliated with prominent EHR vendors to write programs that furnish quality assurance results such as electronic prescription errors and so on for them.