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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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FDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors

Health Law Advisor

Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. On August 15, 2023, the U.S.

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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.

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Healthcare Regulatory Services: Ensuring Compliance & Quality Care

Compliancy Group

The complex nature of healthcare regulations necessitates the need for specialized services to help organizations navigate through this intricate landscape. These services assist healthcare organizations in understanding and implementing various laws and regulations that govern their operations.

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Ivermectin controversy continues

Natalia Mazina

In my blog post “ Risk of dispensing ivermectin ,” I stressed the importance of obtaining informed consent prior to dispensing ivermectin. On the same note, a legal action was filed in Arkansas against a prescriber (among others) for treating patients (inmates) with ivermectin without prior informed consent.

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Important practice-points for pharmacists independently initiating and furnishing Paxlovid

Natalia Mazina

Due to potential side effects and investigational nature of Paxlovid, pharmacists initiating and furnishing Paxlovid should require an informed consent and release signed by their patients taking Paxlovid. This form should notify patients of potential side effects, drug interactions, and other information pertaining to taking Paxlovid.

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Telehealth Anesthesia Billing: A Comprehensive Guide

Medisys Compliance

However, navigating the specific billing practices for telehealth anesthesia services can be complex. Eligible Services for Telehealth Billing The Centers for Medicare & Medicaid Services (CMS) maintains a list of services eligible for telehealth billing. surgery center) during the telehealth visit.