title: FDA weighs policing electronic patient record.
abstract: New regulations now being considered by the Food and Drug Administration (FDA) could affect the software you use to run your electronic patient record and electronic clinical pathway systems. The standards would impose a federal approval process on all computerized medical record programs and financial systems currently in use at hospitals. The FDA's primary focus is on commercially developed software. Although some worry that the agency will also attempt to regulate software developed in-house by hospitals, it's now likely that such software will be exempted from regulation. Although the agency has not released a final version of the regulatory standards, FDA officials expect action to be taken within the next few months.
mesh_terms: D016494:Computer Security; D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D016347:Medical Records Systems, Computerized / Q000331:legislation & jurisprudence* / Q000592:standards; D012984:Software; D014481:United States; D014486:United States Food and Drug Administration