US Health Department Mandates Written Consent for Sensitive Medical Procedures

The Health and Human Services Department of the U.S.
The Health and Human Services Department of the U.S. Credit | Shutterstock

United States: The Health and Human Services Department of the U.S. sent the letter yesterday, specifically instructing the facilities of teaching hospitals and medical schools across the country to obtain written consent from patients at least 24 hours in advance before delivering sensitive procedures like pelvic and prostate exams.

Ensuring Patient Rights

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.

HHS issued a new rule that clarifies a longstanding policy that states hospitals are not permitted to bill for their services unless they get written, informed consent from the patient.

“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 still, that hasn’t always been going on.

Addressing Past Failures

The New York Times unveiled that such operations as gynecological and routine pelvic exams as well as full medical histories of women were taken by different hospitals, doctors, and fellows in training in 2020, even without the necessary consent and when the patient was completely under anesthesia. Often the tests were carried out only for the purpose of classroom teaching.

“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.”