Sheri A. Alpert

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OBJECTIVE There are benefits and risks of giving patients more granular control of their personal health information in electronic health record (EHR) systems. When designing EHR systems and policies, informaticists and system developers must balance these benefits and risks. Ethical considerations should be an explicit part of this balancing. Our objective(More)
T he Food, Drug and Cosmetic Act of 1938 (the Act) required manufacturers to provide evidence of safety to the Food and Drug Administration (FDA) before drugs could be marketed. Amendments to the Act in 1962 added the requirement of demonstration of effectiveness to the condition for approval (21 CFR 314).1 The Medical Device Amendments of 1976 extended(More)