HHS: Patient consent required before conducting sensitive exams

Key takeaways:

• HHS responded to reports of trainees examining patients under anesthesia without their consent.
• The guidance requires teaching hospitals and schools to obtain patient consent to conduct sensitive exams.

The HHS has released guidance regarding the requirement for hospitals to obtain informed patient consent before performing sensitive examinations.

According to a letter to teaching hospitals and medical schools, patients under anesthesia were subjected to sensitive and intimate examinations, such as pelvic, breast, prostate or rectal examinations, without giving proper informed consent as part of medical students’ courses of study and training. Informed consent includes the right to refuse consent for sensitive examinations conducted for teaching purposes and the right to refuse consent to any previously unagreed examinations while under anesthesia, according to the letter.

Through the CMS, the new guidance from the HHS highlights that surveyors must ensure that hospitals’ patient informed consent policy and process, as well as its informed consent forms, contain elements and information that allow patients or their representatives to make fully informed health care decisions.

“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,” HHS Secretary Xavier Becerra, CMS Administrator Chiquita Brooks-LaSure, and Melanie Fontes Rainer, director of the Office for Civil Rights at HHS, said in the release. “Informed consent is the law and essential to maintaining trust in the patient-provider relationship and respecting patients’ autonomy. We welcome the opportunity to work with providers to promote compliance with existing federal laws and plan to hold a webinar regarding this requirement soon.”

Reference:

• Revisions and Clarifications to Hospital Interpretive Guidelines for Informed Consent. www.cms.gov/medicare/health-safety-standards/quality-safety-oversight-general-information/policy-memos-states/revisions-and-clarifications-hospital-interpretive-guidelines-informed-consent. Published April 1, 2024. Accessed April 1, 2024.