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CMS Releases New Guidance Regarding Informed Consent for Sensitive Exams

Hall Render

Department of Health and Human Services (“HHS”), through the Centers for Medicare & Medicaid Services (“CMS”) released a memorandum to state survey agency directors highlighting revisions and clarification to the Hospital Interpretive Guidelines for Informed Consent (the “Guidance”).

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Comply with Privacy Rights to Avoid Unconsented Intimate Exams

AIHC

Written by Gabriella Neff, RHIA, CHA, CHC, CHRC, CHPC This past year, in 2024, revisions were made to clarify hospital guidelines related to informed consent specifically addressing UIEs (unconsented intimate exams) to patients while under anesthesia. OCR recently issued an FAQ focusing on this right. [6]

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FDA Finalizes Its Informed Consent Guidance for IRBs, Clinical Investigators and Sponsors

Hall Render

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. Informed consent includes the following basic elements: Description of clinical investigation.

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HIPAA Consent Form: An Essential Tool in Preserving Patient Privacy

Compliancy Group

The Health Insurance Portability and Accountability Act (HIPAA) compliance patient consent form is essential for properly using and disclosing protected health information (PHI). Failure to get informed consent can have dire consequences for your organization.

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Managing Healthcare Compliance in Colorado

MedTrainer

Colorado, like other states in the United States, has its own set of regulations and requirements that make managing healthcare compliance in Colorado tricky. To effectively manage compliance, healthcare organizations must establish a robust system for monitoring and interpreting these changes and swiftly implement necessary adjustments.

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Your Healthcare Compliance Due Diligence Checklist

Compliancy Group

In today’s complex healthcare landscape, compliance is crucial. A healthcare compliance due diligence checklist is one essential tool that can help organizations in their quest for compliance. What is a Healthcare Compliance Due Diligence Checklist? What is a Healthcare Compliance Due Diligence Checklist?

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Corporate Compliance Training: Mistakes and How To Avoid Them

MedTrainer

Corporate compliance training helps healthcare organizations balance the need to provide top-notch care with adhering to a plethora of regulations. What Is Corporate Compliance Training? What Is the Difference Between Corporate Compliance Training and Regulatory Compliance Training?