AIHC
NOVEMBER 12, 2024
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]
Bill of Health
JUNE 7, 2024
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.
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Hall Render
APRIL 16, 2024
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”).
Bill of Health
JULY 14, 2023
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.
Hall Render
OCTOBER 5, 2023
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Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014.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.
Healthcare IT Today
AUGUST 9, 2022
The following is a guest article by Natalie C. The use of AI is revolutionizing the delivery of healthcare, but its use comes with significant ethical challenges that cannot be ignored, the most important of which involve bias and informed consent. . Oehlers, Associate Attorney and Carly C.
Healthcare IT Today
SEPTEMBER 1, 2022
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 .
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