HHS on Monday revised and clarified requirements for informed consent for certain procedures done in the hospital, especially examinations done while the patient is under anesthesia.
“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,” the agency said in a press release. “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.”
The agency noted that the guidance also comes amidst “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.”
A recent story posted by the Cleveland, Ohio, ABC News affiliate noted that 25 states have banned the performance of pelvic exams by medical students without specific patient consent. A study by the Hastings Center, a bioethics research institute, estimated as many as 3.6 million U.S. women and men may have received an intimate exam without their consent within the past 5 years, the story said; it quoted Alexandra Fountaine, a fourth-year Ohio University medical student, who said having medical students perform pelvic exams without patient consent “is very common practice” and “happens a lot.”
On Monday, HHS Secretary Xavier Becerra, CMS Administrator Chiquita Brooks-LaSure, and HHS Office for Civil Rights (OCR) Director Melanie Fontes Rainer wrote a letter to teaching hospitals and medical schools reminding them that the 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 (HIPAA).
HIPAA “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,” they wrote, adding that the OCR recently issued a frequently asked questions document explaining this right.
OCR also enforces federal civil rights laws, including a provision in the Affordable Care Act which prohibits discrimination on the basis of sex, race, national origin, age, and disability, the letter said. “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,” they concluded. “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.”
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