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Life Sciences › Informed Consent › Healthcare

Verrill

Don’t Wait – CMS Expects Hospitals to Take Action on Informed Consent for Certain Exams and Procedures

Verrill on

Hospitals should not delay in reviewing and revising their surgical informed consent forms and policies. On April 1, 2024, the Centers for Medicare & Medicaid Services (“CMS”) issued new guidance regarding informed consent...more

Epstein Becker & Green

Updated Requirements for Informed Consent: HHS Issues New Guidance on Sensitive Exams

Epstein Becker & Green on

On April 1, 2024, the U.S. Department of Health and Human Services (“HHS”) released new guidance which requires hospitals to obtain informed consent from patients before practitioners, or medical or other students, perform...more

Quarles & Brady LLP

What Does Wisconsin Medical Examining Board’s New Chaperone Rule Mean for Hospitals?  Not Much.

Quarles & Brady LLP on

The new rules about chaperones for physicians in private practice (not hospitals or hospital-employed physicians) go into effect October 1, 2023. The rule is promulgated by the Medical Examining Board (MEB), which does not...more

McDermott Will & Emery

FDA Issues Final Guidance on Informed Consent in Clinical Investigations

McDermott Will & Emery on

On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more

Epstein Becker & Green

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

Epstein Becker & Green on

On August 15, 2023, the U.S. 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 This update follows FDA’s draft guidance, which was issued in July...more

Nelson Mullins Riley & Scarborough LLP

FDA Publishes Informed Consent Final Guidance for Drug and Medical Device Clinical Investigations

Nelson Mullins Riley & Scarborough LLP on

The U.S. Food and Drug Administration (FDA or the Agency) has issued the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final Guidance). The...more

Nelson Mullins Riley & Scarborough LLP

FDA Finalizes Informed Consent Guidance for Drug and Medical Device Clinical Investigations

Nelson Mullins Riley & Scarborough LLP on

On August 15, the U.S. Food and Drug Administration (FDA or the Agency) published the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final...more

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