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HHS tells hospitals to get patient consent before invasive exams

Hospitals must obtain informed consent from patients before allowing physicians to conduct sensitive and invasive examinations, such as pelvic and prostate, particularly if the patients are under anesthesia, the Department of Health and Human Services (HHS) said Monday.

In new guidance and in a letter sent to teaching hospitals, HHS Secretary Xavier Becerra and other officials said they were acting based on “increasing concerns” about the absence of informed patient consent in educational settings.

“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,” HHS said in the letter.

“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.

A New York Times investigation in 2020 found that hospitals and physicians, including medical students in training, aren’t required to obtain explicit consent from patients before conducting pelvic exams. In some cases, the investigation found the exams were only done for teaching purposes and weren’t medically necessary.

HHS in the guidance specified that 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.

Privacy laws give individuals the right to restrict who has access to their protected health information, including in scenarios where they may be unconscious during a medical procedure, HHS said.

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

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