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Informed Consent

Hogan Lovells

FDA Advisory Committee outlines informed consent best practices

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The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed consent practices. Below, we summarize key takeaways from the meeting, including a...more

HaystackID

AI in the Workplace: Best Practices and Worker Well-being

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The transformative role that artificial intelligence (AI) plays in modernizing business operations is undeniably profound, yet it brings with it a maze of ethical and practical considerations. This week, the U.S. Department...more

Kohrman Jackson & Krantz LLP

The FTC’s New "Click-to-Cancel" Rule: Simplifying Subscription Cancellations for Consumers

On October 16, 2024, The Federal Trade Commission (FTC) announced a significant update to its regulations governing negative option programs. This new “click to cancel” rule aims to make it easier for consumers to cancel a...more

Klein Moynihan Turco LLP

FTC Finalizes Subscription Renewal Rulemaking

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On October 16, 2024, the Federal Trade Commission (“FTC”) announced its final rules applicable to recurring subscription plans. According to the FTC, these rules were implemented to make it easier for consumers to stop paying...more

Hinch Newman LLP

FTC Announces Final “Click-to-Cancel” Recurring Subscriptions and Memberships Rule

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On October 16, 2024, the Federal Trade Commission announced a final “click-to-cancel” rule that will require sellers to make it as easy for consumers to cancel their enrollment as it was to sign-up. Most of the final rule’s...more

Dunlap Bennett & Ludwig PLLC

Client-Focused Lawyering: Putting Clients’ Needs First

Regularly, we read from news articles that an entity recently started its own business and entered into a business transaction or agreement with another entity. In response, we sometimes assume such an agreement or...more

Dentons

Yes, No, Maybe? Informed Consent in the Medical Environment

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Informed consent remains critical in healthcare, and over the last several years, there have been multiple updates from agencies and commissions providing clarifications. Most recently in April 2024, Centers for Medicare &...more

Greenbaum, Rowe, Smith & Davis LLP

Hospital Policy for Universal Urine Drug Testing of Pregnant Women Comes Under Scrutiny for Alleged Violations of State Law...

The Attorney General of New Jersey and the Director of the New Jersey Division on Civil Rights jointly commenced a lawsuit against the Virtua Health System and its constituent hospitals alleging that its policy and practices...more

Esquire Deposition Solutions, LLC

Litigators Weigh Need to Disclose AI Use to Clients

Many lawyers today are wrestling with the question of whether they should inform clients that artificial intelligence technologies are being used on their case matters. Ethical advice from state bar regulators has been slowly...more

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

Baker Botts L.L.P.

Lawline Sued under the VPPA

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On August 23, 2024, a proposed class action lawsuit was filed by Kamilah Jolly, against FurtherEd, Inc., doing business as Lawline, which centers on allegations that Lawline violated the Video Privacy Protection Act (VPPA)....more

Dechert LLP

Dechert Cyber Bits - Issue 60

Dechert LLP on

New BIPA Ruling: Dismissal of Claims Against Samsung Over its Face App Data - On July 24, 2024, a federal judge in Illinois dismissed the case GT v. Samsung Electronics America, Inc., in which a putative class of Samsung...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

Amundsen Davis LLC

Put Down Your Phone and Watch Those Texts: New Regulations Impacting Your Outreach to Customers, Clients and Contacts

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The speed, sophistication, and ease of a company’s communications or outreach with and to their customers or clients only continues to get better and better. Just ask your marketing and sales teams about the new technology or...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: June 2024

Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more

Gardner Law

FDA Issues Draft Guidance on Informed Consent for Sponsors, Investigators and Institutional Review Boards (IRBs)

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The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document entitled, Key Information and Facilitating Understanding in Informed Consent. The draft guidance is intended specifically for sponsors,...more

Womble Bond Dickinson

Free, Prior, and Informed Consent & Indigenous Consultation in Mining Development

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This series has surveyed a breadth of permitting reform issues, most recently regarding tribal consultation within the United States. International mineral development permitting in or near areas of indigenous cultural and...more

Vicente LLP

Colorado Natural Medicine Program Draft Rules Released And Public Hearing Scheduled

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On April 18, 2024, the Department of Regulatory Agencies (DORA) presented additional draft rules for Colorado’s regulated natural medicine market to the Natural Medicine Advisory Board, focused on facilitator conduct and...more

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

Holland & Knight LLP

While You Were Sleeping: HHS Releases New Guidance on Sensitive Examinations

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"Informed consent" has been described as "a bedrock principle of healthcare in a free society," and if a "patient is denied the ability to exercise or even consider informed consent, the patient's personal liberty suffers."1...more

Foster Swift Collins & Smith

DHHS Revises and Clarifies Guidelines for Patients’ Informed Consent When Providing Sensitive Medical Care

In recent years, Michigan has been home to two of the largest sexual abuse scandals involving doctors in history: the sexual abuse committed by Larry Nassar while employed by Michigan State University and the sexual abuse...more

King & Spalding

CMS Issues New Guidance Regarding Hospital Requirements for Informed Consent from Patients Undergoing Sensitive Examinations

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On April 1, 2024, CMS released new guidance to reiterate and clarify hospital requirements for informed consent from patients with respect to medical professionals performing sensitive examinations, especially for patients...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

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