article thumbnail

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”).

article thumbnail

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]

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.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.

article thumbnail

AI’s Ability to Manipulate Decision Making Requires a Moratorium on Its Use in Obtaining Consent for Biomedical Research

Bill of Health

The federal government’s commitment to assuring that participants in human subject research provide fully informed consent dates back to the U.S The World Health Organization supports this ban and in particular describes it as making informed consent impossible in the health care setting.

article thumbnail

New Portable MRI Revolutionizing Brain Research Demands Ethical and Legal Innovation

Bill of Health

Working with an interdisciplinary expert Working Group supported by the NIH BRAIN Initiative Neuroethics program, our newly published article in the Journal of Law and the Biosciences (JLB) provides the first consensus guidance for addressing ethical, legal, and policy challenges in field-based neuroimaging research with highly portable MRI.

article thumbnail

Bringing eConsent to the Intensive Care Unit

Healthcare IT Today

The following is a guest article by Karen Maduschke, Sr. Director & General Manager, Patient Consent at IQVIA. The Challenge of Informed Consent in the ICU. Still, obtaining informed consent to participate in a clinical trial in these scenarios can be challenging. Enter eConsent. The Power of eConsent .

article thumbnail

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.

HIPAA 52