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  • Title: FDA regulation of medical software.
    Author: Fried BM, Zuckerman JM.
    Journal: J Health Law; 2000; 33(1):129-40. PubMed ID: 10788227.
    Abstract:
    Currently the FDA is reviewing its policy on the regulation of computer software in the medical arena. Healthcare practitioners hope that the FDA will take the least possible regulatory action required by law to fulfill its public health responsibility and will take into account the unique status of the ever-changing software industry. Innovations in telemedicine and medical informatics have yielded significant improvements in the quality and cost of healthcare, and the imposition of cumbersome regulatory requirements on the medical software industry would slow the development and introduction of medical software products.
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