[04/16/24]
Posted on April 16, 2024 in Health Law News
Published by: Hall Render
On April 1, 2024, the U.S. 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”). The Guidance clarifies informed consent requirements for the performance of... READ MORE
Tags: cms, Hospital Interpretive Guidelines for Informed Consent, informed consent, Sensitive Exams
[10/05/23]
Posted on October 5, 2023 in Health Law News
Published by: Hall Render
On August 15, 2023, the U.S. 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Guidance for IRBs, Clinical Investigators, and Sponsors” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. The Final Guidance reflects the FDA’s recommendations on informed consent and the regulatory requirements in place to... READ MORE
Tags: Clinical Investigators, FDA, informed consent, U.S. Food and Drug Administration
[08/16/11]
Posted on August 16, 2011 in Long-Term Care, Home Health & Hospice
Written by: Selby, Todd J.
On July 29, 2011, CMS issued the following guidance for the use of video cameras in ICFs/MR: To ensure that clients’ rights are protected, the use of video cameras in the ICF/MR must be reviewed, approved and monitored by the Specially Constituted Committee (SCC) of the facility as constituted per 42 CFR 483.440(f)(3)(i-iii). If... READ MORE
Tags: 42 cfr, bufford, cameras, certification, client, cms, guidance, hall render, icf/mr, informed consent, jent, letter, long term care, provider, regulations, selby, survey, transmittal, video
