News & Analysis as of

Informed Consent

Vermont’s New Telemedicine Law Expands Insurance Coverage, Bans Recording

by Foley & Lardner LLP on

Vermont health care providers and patients can now enjoy a revamped, and significantly improved, telehealth commercial insurance coverage law. Vermont Governor Phil Scott signed S. 50 into law on June 7, 2017, expanding...more

FTC Settles Complaint Against Lead Generation Business Selling Consumers’ Sensitive Data

The Federal Trade Commission (FTC) has announced that it has settled its Complaint against operators of the lead generation business Global Media, LLC and its CEO Christopher Kay for $104 million. The judgment has been...more

Pennsylvania Supreme Court Rules that Only Physicians – Not Their Staff – Can Obtain Informed Consent

by Tucker Arensberg, P.C. on

A recent Pennsylvania Supreme Court decision will have a major impact on how physicians across the Commonwealth obtain informed consent from their patients. In Shinal v. Toms, 2017 WL 2655387 (Pa. June 20, 2017), the 4-3...more

Informed Consent Ruling May Affect Your Business

by Steptoe & Johnson PLLC on

In a 4-3 decision, the Supreme Court of Pennsylvania, overturning a Superior Court’s order, ruled that a jury could not consider information provided by the physician’s qualified staff in deciding whether a physician obtained...more

The Doctor Is In – or Better Be to Satisfy PA’s New Informed Consent Requirements

With the increased presence of qualified staff members in a physician’s office and the constant time-pressure on physicians, many patients rely heavily on individuals other than the physician to answer questions about...more

HHS Subjects Human Research to an Updated Common Rule

by Alston & Bird on

The Department of Health and Human Services has taken a step toward harmonizing the complex regulatory requirements for federal human subjects research. Our Health Care Group breaks down the changes to the Common Rule due to...more

Updates to the Common Rule for the Protection of Human Subjects Research

On Sept. 8, 2015, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rule Making (NPRM) to seek input on changes to the Federal Policy for the Protection of Human Subjects, otherwise known as...more

The Lawyers' Lawyer Newsletter - Recent Developments in Risk Management - February 2017

by Hinshaw & Culbertson LLP on

Joint Representation — Conflicts of Interest — Waiver - Foltz v. Columbia Casualty Company, 2016 WL 4734687 (W.D. Ok. 2016) - Risk Management Issue: Can client A's waiver, given with informed consent, permitting...more

Six Key Changes to the Common Rule

by Epstein Becker & Green on

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

Alert: 2016 Round-Up: Key Decisions Affecting Connecticut Health Care Providers

by Pullman & Comley, LLC on

Connecticut state and federal courts faced a number of significant health care issues last year. We have summarized those cases that we think are particularly relevant to Connecticut hospitals, group practices and individual...more

FDA-Approved Labeling Does Not Equal Medical Standard Of Care

by Reed Smith on

We’ve been defending the ability of physicians to engage in off-label use ever since the Bone Screw litigation of the 1990s. Buckman Co. v. Plaintiffs Legal Committee, where the United States Supreme Court affirmed that...more

2016 Round-Up: Key Decisions Affecting Connecticut Health Care Providers

Connecticut state and federal courts faced a number of significant health care issues last year. We have summarized those cases that we think are particularly relevant to Connecticut hospitals, group practices and individual...more

HHS Finalizes Toned-Down Version of Common Rule Overhaul

by McDermott Will & Emery on

The Final Rule published by the US Department of Health and Human Services on January 18, 2017, largely avoids major modifications to the Common Rule. However, it specifically addresses creation of biospecimen and data...more

HHS Issues Final Rule that Substantially Revises the Federal Policy for the Protection of Human Subjects

by King & Spalding on

On January 19, 2017, the Department of Health and Human Services (HHS) and fifteen other Federal departments and agencies published a final rule that extensively revises and modernizes the Federal Policy for the Protection of...more

Welcome to the Future: HHS Releases Final Rule to Modernize Protections for Clinical Trial Participants

by BakerHostetler on

The Federal Policy for the Protection of Human Subjects, or the “Common Rule,” governs the ethical conduct of research involving human subjects and is funded through various federal agencies. On January 19, the U.S....more

CFPB Sues Bank Over Overdraft Sales Pitch

The CFPB’s concern with incentives and overdrafts continues and has resulted in a lawsuit filed against a Minnesota based TCF National Bank. In the lawsuit, the CFPB alleges that TCF National Bank violated the UDAAP...more

CFPB Consent Orders with Consumer Reporting Agencies Focus on Marketing Practices not Credit Reporting

Marketing practices remain at the forefront of CFPB activity as evidenced by two recent consent orders entered into with TransUnion and Equifax. The consent orders combine to require the CRAs to pay more than $17.6 million...more

Better Healthcare Newsletter from Patrick Malone - December 2016

Give a lasting holiday gift of health: Volunteer for a medical research study - That toy the kids whined about for weeks may be broken hours after emerging from the box. The gift card you gave will be frittered away,...more

Nursing Home Mega Rule Finalized: Pre-Dispute Arbitration Agreements Not Permitted

by Murtha Cullina on

In the final rule overhauling skilled nursing facility federal regulations for the first time since 1991, CMS prohibits all arbitration agreements at the time of admission. According to CMS, such pre-dispute agreements are...more

Unlocking the EU General Data Protection Regulation: A practical handbook on the EU's new data protection law: Chapter 8: Consent

by White & Case LLP on

Why does this topic matter to organisations? Processing of personal data is lawful only if, and to the extent that, it is permitted under EU data protection law. Each and every data processing activity requires a lawful...more

Louisiana’s New Telemedicine Law Opens Doors, Removes Barriers

by Foley & Lardner LLP on

Louisiana’s governor signed into law, HB 570, (the “Act”), eliminating a prior requirement that physicians practicing telemedicine maintain an office in Louisiana or contract with in-state providers. The Act also changes the...more

Jackson v. Black Ink Tattoo Studio Inc.: Why Consent Forms for Tattoo Artists Are an Indelibly Good Idea

by Garvey Schubert Barer on

The ability of tattoo artists to protect themselves from negligence lawsuits got a boost from a recent decision of a New York court. The case of Jackson v. Black Ink Tattoo Studio Inc. drew national interest since the...more

The Proposed Common Rule: The Tribe Has Spoken, and They Have Concerns (Part 2)

by BakerHostetler on

On September 28, 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal agencies issued a notice of proposed rulemaking (NPRM) updating federal policy for the Protection of Human Subjects, more...more

Oklahoma Supreme Court broadens scope of state's informed consent law

by McAfee & Taft on

In the late 1970s, a patient named Norma Jo Scott underwent a hysterectomy performed by Dr. Vance Bradford that resulted in problems with incontinence. She sued Dr. Bradford for failing to disclose the risks and available...more

Developing and Implementing an Effective Telemedicine Informed Consent Form

by McDermott Will & Emery on

The search by consumers, payers and providers for more efficient, effective and convenient care delivery models has led to an explosion of technological innovation in the health care sector. This explosion has supported the...more

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