The physician must explain to the patient the diagnosis, the nature of the procedure, including the risks involved and the chances of success, and the alternative methods of treatment that are available. In nonemergency situations, written informed consent is generally required before many medical procedures, such as surgery, including biopsies, endoscopy, and radiographic procedures involving catheterization. If all of the criteria are met except that the person rejects the plan, that person makes an informed refusal. A person gives informed consent only if all of these criteria are met.
Seven criteria define informed consent: (1) competence to understand and to decide, (2) voluntary decision making, (3) disclosure of material information, (4) recommendation of a plan, (5) comprehension of terms (3) and (4), (6) decision in favor of a plan, and (7) authorization of the plan. With limited exceptions, covered entities may not condition treatment or coverage on the individual providing an authorization.Informed consent consent of a patient or other recipient of services based on the principles of autonomy and privacy this has become the requirement at the center of morally valid decision making in health care and research. An authorization is a detailed document that gives covered entities permission to use protected health information for specified purposes, which are generally other than treatment, payment, or health care operations, or to disclose protected health information to a third party specified by the individual.Īn authorization must specify a number of elements, including a description of the protected health information to be used and disclosed, the person authorized to make the use or disclosure, the person to whom the covered entity may make the disclosure, an expiration date, and, in some cases, the purpose for which the information may be used or disclosed. Where the Privacy Rule requires patient authorization, voluntary consent is not sufficient to permit a use or disclosure of protected health information unless it also satisfies the requirements of a valid authorization.
Covered entities that do so have complete discretion to design a process that best suits their needs.īy contrast, an “authorization” is required by the Privacy Rule for uses and disclosures of protected health information not otherwise allowed by the Rule. The Privacy Rule permits, but does not require, a covered entity voluntarily to obtain patient consent for uses and disclosures of protected health information for treatment, payment, and health care operations.
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