Written patient consent required for sensitive exams, HHS guidance says

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The US Department of Health and Human Services issued new guidance on Monday clarifying that hospitals must obtain written consent for sensitive exams, such as pelvic, breast or prostate exams – especially if patients will be under anesthesia during the exam.

Top officials from HHS, Centers for Medicare and Medicaid Services and the Office for Civil Rights sent a letter on Monday advising teaching hospitals and medical schools of the new guidance and condemning the practice of performing sensitive exams on anesthetized patients without informed consent.

“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,” the letter says. “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 new guidance comes as public scrutiny of this traditional practice has grown. Studies from US medical schools show that it is common practice for students to perform sensitive examinations on anesthetized patients without informed consent. Patient advocates, doctors and medical students have expressed concerns about this practice and the level of consent obtained, the letter said.

“While CMS recognizes that these patient exams are often conducted as part of the vital skills clinical students must obtain during their training and education, we also firmly believe that patients have the right to make informed decisions on the healthcare services they receive,” the letter says.

The new guidance clarifies that written consent must be obtained when any doctor, student, or other health care practitioner performs an invasive exam or procedure for educational purposes. It also emphasizes that informed consent procedures must comply with hospital policies as well as state and federal laws as a condition of participating in Medicare and Medicaid programs.

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

Additionally, the Office for Civil Rights is working to ensure that policies and practices related to sensitive examinations do not discriminate against patients based on sex, race, nationality, age and disability. They are also investigating complaints that patients’ health information was disclosed to medical trainees in violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, the letter says.

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