News & Analysis as of

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

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FDA Issues Draft Guidance on Informed Consent for Sponsors, Investigators and Institutional Review Boards (IRBs)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

King & Spalding on

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

Stevens & Lee on

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

Lowenstein Sandler LLP

SEC Settlements Highlight Governing Document Amendment Considerations for Private Funds

Limited partnership agreements and similar documents that govern private funds are often amended over the course of a fund’s life cycle. For example, many funds may be currently going through the amendment process in...more

Benesch

HHS and FDA Release Updated Guidance on Informed Consent

Benesch on

On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) unveiled a preliminary guidance document named Enhancing...more

Sheppard Mullin Richter & Hampton LLP

Time to Refresh? FDA Issues Draft Guidance on Key Information and Informed Consent

Earlier this month, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance, “Key Information and Facilitating Understanding in Informed Consent”, with notable implications for clinical trial sponsors,...more

McDermott Will & Emery

HHS and FDA Seek Comments on Informed Consent Draft Guidance

McDermott Will & Emery on

On March 1, 2024, the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the US Food & Drug Administration (FDA) released a draft guidance document entitled Key Information and...more

Foley & Lardner LLP

Clinical Research: FDA Issues Draft Guidance on Informed Consent

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The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more

Hogan Lovells

FDA and OHRP publish draft guidance on facilitating understanding in informed consent

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As part of its broader efforts to improve the informed consent process for prospective study participants, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) in the Department of...more

Segal McCambridge

The Illinois State Legislature Set to Take up BIPA Reform

Segal McCambridge on

Recently, the Illinois General Assembly have restarted efforts to amend the Biometric Information Privacy Act of 2008 (“the Act”). On January 31, 2024, Senator Bill Cunningham introduced S.B. 2979 ostensibly to answer the...more

WilmerHale

Recent Enforcement Actions Signal FTC Focus on Protecting Location Data

WilmerHale on

On January 9, 2024, the Federal Trade Commission (FTC) issued its first ever prohibition on the use, sale and disclosure of sensitive location data against X- Mode Social and Outlogic (“X-Mode”), a location data broker. Only...more

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