News & Analysis as of

Healthcare Informed Consent

Health Care Compliance Association (HCCA)

Federation of State Medical Boards weighs in on ethical use of AI in clinical practice

Though responsible and ethical use of artificial intelligence (AI) has been a hot topic for the past few years, there has not yet been significant adoption of laws or regulations aimed specifically at regulating the use of AI...more

Health Care Compliance Association (HCCA)

Overlapping surgeries: Time for a compliance checkup?

Overlapping surgeries is a practice that has been used for many years by healthcare providers (such as hospitals and surgical centers). This practice generally refers to situations where one lead attending surgeon is...more

Holland & Hart LLP

Idaho's New Parental Consent Law: FAQs

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Idaho’s new parental consent law took effect July 1, 2024. Under the new law: “[A]n individual shall not furnish a health care service or solicit to furnish a health care service to a minor child without obtaining the...more

Verrill

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

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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

McCarter & English, LLP

New Informed Consent Guidance and Pharmacy Immunity

New guidance released by the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) on April 1, 2024, clarified that hospitals will not be eligible for Medicare or Medicaid...more

Stevens & Lee

New CMS Informed Consent Guidance for Sensitive Examinations of Unconscious Patients

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On April 1, 2024, the U.S. Department of Health and Human Services (“HHS”), through the Centers for Medicare & Medicaid Services (“CMS”), Center for Clinical Standards and Quality/Quality, Safety & Oversight Group, issued new...more

Epstein Becker & Green

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

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.

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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

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

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

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

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

Holland & Hart LLP

The Idaho Medical Consent Act: Recent Amendments

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The Idaho legislature has amended Idaho’s Medical Consent Act. The redlined changes are shown here. Effective July 1, 2023, the rules for medical consents in Idaho are as follows: 1. Need for Informed Consent. As a...more

Holland & Hart - Health Law Blog

Idaho’s New Virtual Care [Telehealth] Access Act

Idaho’s new Virtual Care Access Act (the “Act”) amends Idaho’s existing law to make it easier to render telehealth in Idaho effective July 1, 2023. The requirements of the new Act are summarized below....more

Pullman & Comley - Connecticut Health Law

Significant 2022 Connecticut Health Law Cases

Significant health care cases of 2022 included a surprise billing unfair trade practices case, a class action recognizing a patient’s constitutionally protected interest in their inpatient classification and a ruling...more

White and Williams LLP

PA Supreme Court Confirms Risk/Complication Evidence Is Admissible for Standard of Care and Causation in Med Mal Cases

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In a win for healthcare providers, the Pennsylvania Supreme Court confirmed in Mitchell v. Shikora that evidence of the risks and complications of a surgical procedure may be admissible in a medical negligence case that does...more

Snell & Wilmer

Colorado Medical Board Adopts New Telehealth Policies

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On August 20, 2015, the Colorado Medical Board (the Board) adopted Policy 40-27, which sets forth important new guidelines for providers delivering healthcare services via telehealth technologies, including the ability to...more

Foley & Lardner LLP

Maine Welcomes Telemedicine with New Board Guidelines

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The Maine Board of Licensure in Medicine enacted new guidelines governing the practice of telemedicine and the use of technology to deliver health care services. Effective June 2014, Maine’s guidelines expand upon prior Board...more

Foley & Lardner LLP

Colorado Proposes New Telehealth Rules

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The Colorado Medical Board proposed updated draft guidelines for the delivery of healthcare services via telehealth, as well as remote prescribing for new patients. Recognizing that “using telehealth technologies in the...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: CMS Releases Three Documents on Biosimilar Reimbursement... SCOTUS: Agencies, Not State Courts, in Charge of Medicaid Rate Setting... HHS OIG and Treasury IG Release Report on ACA’s Advanced Premium Tax Credits....more

Cozen O'Connor

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

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The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more

Patrick Malone & Associates P.C. | DC Injury...

What patients misunderstand about their right of informed consent

Many patients misunderstand what "informed consent" is all about. They often believe it's about signing a form ahead of surgery that acts as a waiver against any rights they may have for legal recourse if the surgery goes...more

Pullman & Comley, LLC

Peer Review/Medical Staff Concerns in Telemedicine Practice

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Originally published in American Health Lawyers Association's MedStaff News - November 2012. Much ink has been spilled over the last several years concerning the growth of telemedicine. Taking advantage of high-tech...more

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