HHS and CMS reiterate and provide clarity regarding hospital requirements for informed consent.
Today, the Department of Health and Human Services , through the Centers for Medicare & Medicaid Services , releasedto reiterate and provide clarity regarding hospital requirements for informed consent from patients as it relates to medical professionals performing sensitive examinations, particularly on patients under anesthesia. Please share this guidance with your members.
The Department is aware of media reports as well as medical and scientific literature highlighting instances where, as part of medical students’ courses of study and training, patients have been subjected to sensitive and intimate examinations – including pelvic, breast, prostate, or rectal examinations – while under anesthesia without proper informed consent being obtained prior to the examination.
In addition, the Office for Civil Rights investigates complaints alleging that patients’ protected health information was used or disclosed to medical trainees in violation of the Health Insurance Portability and Accountability Act of 1996 Privacy Rule.
While we recognize that medical training on patients is an important aspect of medical education, this guidance aligns with the standard of care of many major medical organizations, as well as state laws that have enacted explicit protections as well. Informed consent is the law and essential to maintaining trust in the patient-provider relationship and respecting patients’ autonomy.
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