HHS releases new guidance on informed consent

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The Department of Health and Human Services and the Centers for Medicare and Medicaid Services have released new guidance to reiterate and provide clarity regarding hospital requirements for informed consent from patients as it relates to medical professionals performing sensitive examinations – particularly on patients under anesthesia.

HHS cited media reports and medical and scientific literature highlighting instances in which, 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 exam.

In the departments’ view, it’s important that hospitals set clear guidelines to ensure providers and trainees performing these exams first obtain and document informed consent from patients before performing sensitive examinations.  

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 not agreed to exams to treatment while under anesthesia.


The Office for Civil Rights investigates complaints alleging that patients’ protected health information was used or disclosed to medical trainees in violation of the Health Insurance Portability and Accountability Act of 1996 Privacy Rule.

The HIPAA Privacy Rule safeguards protected health information (PHI) from impermissible use and disclosure and further gives individuals the right to restrict who has access to their PHI, including in scenarios where they may be unconscious during a medical procedure. OCR recently issued a Frequently Asked Questions document explaining this right.

OCR also enforces federal civil rights laws, such as Section 1557 of the Affordable Care Act, which prohibits discrimination on the basis of sex, race, national origin, age and disability.

“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,” wrote HHS Secretary Xavier Becerra. “Informed consent is the law and essential to maintaining trust in the patient-provider relationship and respecting patients’ autonomy.”


About a year ago OCR settled with MedEvolve for $350,000 over potential HIPAA violations regarding a data breach in which a server containing protected health information was left unsecured and accessible over the internet.

The potential violations in this case include the lack of an analysis to determine risks and vulnerabilities to electronic protected health information across the organization and the failure to enter into a business associate agreement with a subcontractor, said OCR.

Jeff Lagasse is editor of Healthcare Finance News.
Email: [email protected]
Healthcare Finance News is a HIMSS Media publication.


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