FDA plays hardball with software

Article Abstract:

The Food and Drug Administration (FDA) plans to revise its policy concerning the regulation of medical software. In 1989, the FDA issued a policy stating that stand-alone medical software would be exempt from active regulatory scrutiny. However, the agency plans to release a new policy in Sep 1996. Under the new policy, the level of regulation of software will depend on the level of risk the software poses. Such a policy may cripple efforts of develop innovative new software for hospital information systems and patient records.

Health, Science Software Pkgs, Product Safety-Medical Equip, Software, Medicine, Column, Medical equipment, Product safety, United States. Food and Drug Administration

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Reform law boosts electronic records; insurance act promises standards for claims processing

Article Abstract:

Congress passed legislation during Aug 1996, entitled the Health Insurance Portability and Accountability Act of 1996, that sets standards for the handling of medical records and claims processing. The new legislation is expected to spur a shift towards electronic claims processing that promises to revolutionize the handling of such claims and associated medical records. The standards involve such issues as business transactions, identifiers, electronic signatures, and privacy matters.

Medical Records Services, All Other Business Support Services, Health Regulation NEC, Standards, United States. Congress, Medical law

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Electronic signature option can slash paperwork hassles

Article Abstract:

Electronic signature systems allow physicians to review medical records and transcripts electronically and to sign each one with a simple keystroke or the click of a mouse. The systems can greatly reduce paperwork bottlenecks created by the need to obtain physician signatures on a variety of medical records. Hospitals are often unable to process bills without the proper signature. The systems are becoming increasingly popular because of the time and money savings which they offer.

Hospital Software (ex Micro), Technology application, Records and correspondence, Signatures (Writing)

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