News & Analysis as of

Informed Consent

Informed Consent in Pennsylvania – The Supreme Court of Pennsylvania Issues a Wake-Up Call

by McNees Wallace & Nurick LLC on

It has been nearly four months since the Supreme Court of Pennsylvania issued its opinion in the case of Shinal v. Toms. In its opinion, the Court considered the issue of informed consent under Pennsylvania law and issued a...more

The Data Report Episode 17: What the GDPR Means for American Companies

by Bilzin Sumberg on

Module Five: International Law (Part II) In this episode of The Data Report, Litigation attorney Jay Ward expands his discussion on the GDPR, examining what it means for American companies and how thoughtful steps can be...more

Joint Commission Introduces New Accreditation Standards for Telehealth Services

by Foley & Lardner LLP on

The Joint Commission has proposed changes to its accreditation standards to account for direct-to-patient telehealth services. The new standards will apply to Joint Commission-accredited hospitals and ambulatory health care...more

Keeping Pace in Clinical Research: The Common Rule Picks up Speed

by Dickinson Wright on

In recent years, the world of human subjects research has expanded not only with regard to the number of clinical research trials being conducted and the array of drugs and devices being tested, but also with respect to the...more

Do the Waive – FDA Implements Informed Consent Waivers for Minimal Risk Studies

by Hogan Lovells on

On July 25, 2017, FDA issued a guidance document describing under what circumstances IRBs may now approve consent procedures that waive or alter some or all of the elements of informed consent as set forth in FDA’s informed...more

FDA Clarifies Consent Requirements for Certain Minimal Risk Clinical Investigations

by Morgan Lewis on

FDA’s guidance, which permits institutional review boards to waive informed consent for certain clinical investigations, may facilitate valuable personalized medicine research....more

Have You Properly Obtained Informed Consent?

by Burr & Forman on

In June, the Pennsylvania Supreme Court issued a controversial opinion holding that a physician had to have face-to-face interaction with the patient to effectively obtain informed consent. This has raised heightened...more

Obtaining informed consent now requires full disclosure of certain surgical assistants

by McAfee & Taft on

In a previous article titled “Oklahoma Supreme Court broadens scope of state’s informed consent law,” we reported on the Oklahoma Supreme Court’s expansion of the state’s informed consent law as it relates to the requirements...more

FDA Issues Immediately Effective Guidance Allowing Waiver of Informed Consent for Minimal Risk Research

by Ropes & Gray LLP on

The United States Food & Drug Administration (FDA) has issued a guidance document announcing its intention not to object to an IRB’s waiving or altering the informed consent requirements for an FDA-regulated clinical...more

Making Informed Decisions About Informed Consent

by Snell & Wilmer on

Patients have come to expect that they will be actively involved in making decisions about their health care. Informed consent aids patient involvement and provides a process whereby a health care provider discusses a...more

FDA Issues New Guidance on IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

As July comes to an end, the Food and Drug Administration (FDA or agency) has issued a new guidance document for “immediate implementation” entitled “IRB Waiver or Alteration of Informed Consent for Clinical Investigations...more

The Strange Case of the Overly Informed Surgical Consent

by Faegre Baker Daniels on

The Pennsylvania Supreme Court’s cast its June 20 opinion as standing for the proposition that a surgeon can’t delegate his duty of obtaining informed consent to anyone else—his physician assistant in the case at hand. But...more

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

105 Results
|
View per page
Page: of 5
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.