To the nation’s teaching hospitals and medical schools:

Today, the Department of Health and Human Services (the Department), through the Centers for Medicare & Medicaid Services (CMS), released new guidance to 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.  It is critically important that hospitals set clear guidelines to ensure providers and trainees performing these examinations first obtain and document informed consent from patients before performing sensitive examinations in all circumstances.  Informed consent includes the right to refuse consent for sensitive examinations conducted for teaching purposes and the right to refuse to consent to any previously unagreed examinations to treatment while under anesthesia.

In addition, the Office for Civil Rights (OCR) 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 (HIPAA) Privacy Rule.  The HIPAA Privacy Rule safeguards protected health information (PHI) from impermissible use and disclosure and further gives individuals the right to restrict who has access to their PHI, including in scenarios where they may be unconscious during a medical procedure. OCR recently issued a Frequently Asked Questions document explaining this right.

OCR also enforces federal civil rights laws, such as Section 1557 of the Affordable Care Act, which prohibits discrimination on the basis of sex, race, national original, age, and disability.  OCR has previously worked with, and will continue to work with, covered entities to ensure that their policies and practices related to sensitive examinations do not discriminate against patients on any of these bases.

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.  We welcome the opportunity to work with providers to promote compliance with existing federal laws and plan to hold a webinar regarding this requirement soon.

Sincerely,

Xavier Becerra
Secretary, U.S. Department of Health and Human Services

Chiquita Brooks-LaSure
Administrator, CMS

Melanie Fontes Rainer
Director, OCR