The US Department of Health and Human Services (HHS) has released new guidelines through the Centers for Medicare & Medicaid Services about hospital requirements for informed consent.1
Takeaways
- The US Department of Health and Human Services emphasizes the importance of hospitals establishing clear guidelines for obtaining informed consent before sensitive medical examinations, including under anesthesia.
- Patients have the right to refuse sensitive examinations for teaching purposes and those not previously agreed upon while under anesthesia, enhancing their control over their medical care.
- Properly executed informed consent forms, reflecting the patient's participation in care planning, are essential before any procedure, except in emergencies, ensuring transparency and legal compliance.
- The Health Insurance Portability and Accountability Act of 1996 safeguards patients' protected health information, granting them control over who can access their data, reinforcing confidentiality and privacy in medical settings.
- Aligning with medical organizations' recommendations and state laws, these guidelines are crucial for upholding patient trust and preventing discrimination, as monitored by the Office for Civil Rights.
Recently, media reports have highlighted cases where patients receive sensitive examinations while under anesthesia without proper informed consent. These include breast, prostate, pelvic, and rectal examinations.
According to the HHS, it is vital for hospitals to set clear guidelines to obtain informed consent before providers or trainees conduct the examinations. Informed consent should be obtained and documented in all circumstances and includes the right to refuse sensitive examinations for teaching purposes and to refuse consent for prior unagreed examinations while under anesthesia.
The patient consent process should be reflected in an informed consent form. A properly executed informed consent form should be completed before any type of procedure except those specified for emergency situations in a hospital’s informed consent policy.
In the guidance, the HHS stated the right to make informed decisions, “includes the patient's or the patient’s representative’s participation in the development of his/her plan of care, including providing consent to, or refusal of, medical or surgical interventions, and in planning for care after discharge from the hospital.”2
This involves providing adequate information to the patient or their representative that will allow them to make informed decisions. Provided information should include the patient’s health status, diagnosis, and prognosis. This information should be ensured through an established process.
Additional information in a consent form should include the name of the hospital where treatment will occur, specific procedure or treatment name, practitioner name, statement that the procedure will be explained to the patient or their legal representative, signature of the patient or patient’s representative, and date and time of signature. The form should also follow applicable State law about its content.
The guidance also noted that protected health information (PHI) is protected from impermissible use and disclosure by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).1 The HIPAA also gives patients the right to restrict who has access to their PHI.
These new guidelines fit with the standard of care recommended by many medical organizations, as well as state laws requiring explicit protections. This is vital for maintaining patient trust. The Office for Civil Rights will work to ensure these policies do not discriminate against patients.
References
- Biden-Harris administration announces new guidance on informed consent. US Department of Health and Human Services. April 1, 2024. Accessed April 1, 2024.
- Revisions and clarifications to Hospital Interpretive Guidelines for Informed Consent. Centers for Medicare & Medicaid Services. April 1, 2024. Accessed April 1, 2024. https://www.cms.gov/files/document/qso-24-10-hospitals.pdf
