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New HHS guidance on informed consent impacts GIs

In both inpatient and outpatient hospital settings, written informed consent is now required prior to rectal examinations.
Hands of medical doctor on paperwork
Hands of medical doctor on paperwork

On April 1, 2024, the U.S. Department of Health and Human Services (HHS) released new guidance which requires hospitals to obtain informed consent from patients before practitioners, or medical or other students, perform important surgical tasks or sensitive or invasive procedures or examinations, including rectal examinations.

What does this mean?

Hospitals must set clear guidelines to ensure providers and trainees first obtain and document properly executed informed consent from patients before performing sensitive examinations in all circumstances. Documentation must be recorded in the patient’s medical record.

Which patients does this apply to?

It applies to invasive procedures or examinations performed on hospital inpatients and outpatients. CMS emphasizes the particular importance of a patient’s informed consent to services to be provided while the patient is under anesthesia, inclusive of being made aware of who will be conducting the examination or procedure and its nature and purpose, and their right to refuse consent for sensitive examinations conducted for teaching purposes.

What should gastroenterologists do?

If you practice in a hospital inpatient or outpatient department, ask your hospital administration what changes they plan to make to the informed consent process that may impact rectal examinations performed under sedation and while the patient is awake in a hospital setting and hospital-based outpatient clinics.

See the following resources for more information:

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