Health law: medical record implications of the Safe Medical Devices Act of 1990.
Health information management professionals have involuntarily been placed by Congress and the FDA not only in the important position of being able to assist their employers in complying with the SMDA, but also at the cutting edge in the development of new and more pervasive techniques of healthcare regulation. The implementation of the SMDA in the near term and over the next 48 months promises to have substantial implications for those charged with responsibility for medical record information.
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D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D004865:Equipment and Supplies, Hospital / Q000592:standards; D006753:Hospital Records / Q000331:legislation & jurisprudence*; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration