HHS Issues Guidance to Teaching Hospitals and Medical Schools on Informed Consent Requirements

Posted by Steve Alder

The Department of Health and Human Services (HHS) has written to the nation’s teaching hospitals and medical schools to clarify the requirement to obtain informed consent from patients before they are subjected to sensitive examinations, especially on patients under anesthesia.

HHS Secretary Xavier Becerra, Office for Civil Rights Director Melanie Fontes Rainer, and CMS administrator Chiquita Brooks-LaSure explained in the letter that they are aware of media reports and medical and scientific literature that indicate that as part of the training of medical students, patients are subjected to sensitive and intimate examinations – including pelvic, breast, prostate, or rectal examinations – while under anesthesia, when proper informed consent has not been obtained from the patients.

The letter stresses that it is vital for hospitals and medical schools to obtain and document informed consent before examinations are performed and that informed consent is required in all circumstances. Patients have the right to refuse to have sensitive examinations performed for teaching purposes and can refuse to consent to previously unagreed examinations while under anesthesia. The CMS has issued new guidance that clarifies the requirements of the Hospital Conditions of Participation with respect to the CMS’s revision of its hospital interpretive guidance about informed consent.

OCR has also stressed that under the HIPAA Privacy Rule, patients have the right to restrict who can access their PHI, including in situations where they may be unconscious while having a medical procedure performed. OCR has provided a Q&A that explains this HIPAA Privacy Rule right with respect to examinations by medical students while under anesthesia, and subsequent examinations when the covered entity has agreed to restrict disclosures of PHI.

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OSHA Issues Final Rule on Employee Representation During OSHA Inspections

Posted by Steve Alder

The Occupational Safety and Health Administration (OSHA) has issued a final rule that confirms that employees are entitled to representation during OSHA inspections, and employee representatives do not have to be employees.

The Occupational Safety and Health (OSH) Act gives employees and employers the right to authorize a representative to accompany OSHA personnel during workplace inspections. The final rule clarifies that workers may authorize another employee to serve as a representative or they may select a non-employee, and if the latter is chosen, the individual must be reasonably necessary to the conduct of an effective and thorough inspection. For instance, the non-employee must have the skills, knowledge, or experience, such as knowledge or experience with hazards or conditions in the workplace or similar workplaces, or language or communication skills. There are no specific qualifications required for employer representatives nor for employee representatives who are employees of the employer.

The update stems from a 2017 court ruling where the court acknowledged that the OSH Act does not limit who can serve as an employee representative and the clarification will help OSHA conduct more effective inspections. The final rule takes effect on May 31, 2024. Up to that date, current regulations apply, which means that OSHA inspectors have the discretion to decide whether a third party can participate in the inspection.

“Worker involvement in the inspection process is essential for thorough and effective inspections and making workplaces safer,” said OSHA Assistant Secretary Doug Parker. “The Occupational Safety and Health Act gives employers and employees equal opportunity for choosing representation during the OSHA inspection process, and this rule returns us to the fair, balanced approach Congress intended.”

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