New Federal Rule Means Hospitals Need Written Consent for Pelvic, Prostate Exams

In a letter sent to teaching hospitals and medical schools across the country, the U.S. Department of Health and Human Services said Monday that written consent must be obtained from patients before performing sensitive procedures such as pelvis and prostate exams.

The agency noted that it “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,” the agency stressed in its letter.

The HHS also issued a new set of guidelines clarifying a longstanding requirement that hospitals must obtain written informed consent as a condition for being reimbursed by Medicare and Medicaid.

“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,” the HHS noted. “Informed consent is the law and essential to maintaining trust in the patient-provider relationship and respecting patients’ autonomy.”

But that hasn’t always been happening.

In 2020, a New York Times investigation found that hospitals, doctors and doctors in training sometimes conducted pelvic exams on women who were under anesthesia, even when those exams were not medically necessary and when the patient had not authorized them. Sometimes these exams were done solely to educate medical trainees.

“Patients who are participating in future clinicians’ education should be aware, should have the opportunity to consent, should be given the same opportunity to participate in that education that they would be given if they were awake and fully clothed,” Ashley Weitz, who underwent an unauthorized pelvic exam while she was under sedation in an emergency room, told the Times. “We can only expect to have better trust in medicine when both patients and providers can expect a standard of care that prioritizes patient consent.”

More information

The U.S. Department of Health and Human Services has more on patient privacy under HIPAA (Health Insurance Portability and Accountability Act).

SOURCES: U.S. Department of Health and Human Services, letter, April 1, 2024; New York Times

Source: HealthDay