Informed Consent

News & Analysis as of

Colorado Medical Board Adopts New Telehealth Policies

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

Maine Welcomes Telemedicine with New Board Guidelines

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

Colorado Proposes New Telehealth Rules

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

Toward a Grand Unifying Theory of Today’s Tech Trends

As a technology law blogger and co-editor of Socially Aware, I monitor emerging developments in information technology. What’s hot in IT today? Any shortlist would have to include social media, mobile, wearable technology,...more

Facial Recognition Technology: Social Media and Beyond, an Emerging Concern

This week, a major self-regulatory initiative intended to address privacy concerns associated with facial recognition technology hit a significant stumbling block. Nine consumer advocacy groups withdrew from the National...more

New York State DOL Issues Draft Regulations on Payroll Debit Cards

The New York State Department of Labor (“NYSDOL”) recently proposed new regulations governing the payment of employee wages via payroll debit cards – a growing practice among employers. These draft regulations, which are not...more

FCC Finds Fault in User Agreement and Issues Stern Guidance for Telemarketing Calls

June is proving to be a very active month for the US Federal Communications Commission (FCC) in construing the Telephone Consumer Protection Act, including what sorts of consumer interactions are sufficient to meet the...more

Higher Education: New York State to Pass Sexual Misconduct Legislation (6/15)

Recently, Governor Andrew Cuomo announced that he and State Legislative Leaders have reached an agreement regarding new sexual misconduct legislation. It may be recalled that several months ago, the Governor’s office...more

Federal Court Dismisses Accused Student’s Title IX Lawsuit Against Vassar College

Last week, a federal judge in New York (Abrams, J.) dismissed an accused student’s lawsuit against Vassar College alleging that the institution discriminated against him by failing to conduct an equitable investigation into a...more

Washington Healthcare Update

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

FDA Issues Draft Guidance on Use of Electronic Informed Consent in Clinical Trials

On March 9, 2015, the U.S. Food and Drug Administration (FDA) released a draft guidance, Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers, that provides recommendations for clinical...more

Health Update - March 2015

Supporting Informed Decision Making in the Health Insurance Marketplace: A Progress Report - Editor’s note: As Affordable Care Act (ACA) implementation moves forward and the marketplace continues to evolve, there is a...more

Alert: Website Terms and Conditions: A Call for Clarity

The UK House of Commons has highlighted the need for clarity of website terms and conditions in order to allow users to provide their "informed consent" to the terms....more

New FDA Guidance Opens the Door for Electronic Consent Forms That Come with Significant Advantages and Raise Privacy and Secure...

On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...more

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

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

A Review of New York’s Proposed Sexual Violence Legislation – Part I: Consent

As we noted in our last post, we will be taking a closer look at the specific provisions of New York’s proposed sexual violence legislation over the next week or so. With the Governor’s Office urging New York colleges and...more

HK's Christine Helwick Tells the Daily Journal That "Only Yes Means Yes In California Schools"

California has become the first state in the nation to enact a "yes means yes" standard in university disciplinary hearings involving claims of sexual assault, domestic violence, dating violence and stalking. All colleges and...more

Another Blow to Call Recording Class Actions

Back in February, the California Court of Appeal in Hataishi v. First American Home Buyers Protection Corp., 223 Cal. App. 4th 1454 (Feb. 21, 2014), dealt a significant blow to call recording class actions across California. ...more

FDA Updates Manual on Review of INDs Seeking Exception from Informed Consent for Emergency Research under 21 C.F.R. § 50.24

On November 17, 2014, the U.S. Food and Drug Administration (FDA) published a revised version of its internal review procedures and policies for Investigational New Drug applications (INDs) that implicate the exception to the...more

A Quick Summary of New Changes to California Law

Our friends at Legsilative Intent Service (a great resource for digging deep into the history of California legislation) have recently published their list of changes to California law coming in 2015. These legislative...more

Office for Human Research Protections Releases Draft Guidance

On October 24, 2014, the Office for Human Research Protections (OHRP) announced in the Federal Register that it has released, and is seeking comment on, its Draft Guidance on Disclosing Reasonably Foreseeable Risks in...more

Are Browsewrap Agreements Enforceable?

Almost all social media sites contain “Terms of Service” (“TOS”). Are they enforceable against users? It depends on the presentation and the issue....more

FDA Releases Draft Guidance Updating Agency Policies on the Informed Consent Process for Clinical Trials

On July 15, 2014, the U.S. Food and Drug Administration (“FDA”) released draft guidance that provides extensive commentary on FDA’s current thinking regarding the clinical trial informed consent process. Once finalized, this...more

The Evolution of Informed Consent in U.S. Courts [Video]

Learn about the history of how informed consent has been handled by our court system - 202-742-1500. We also invite you to read more about the landmark case, Canterbury v. Spence:...more

Palliative care – navigating the difficult path of informed consent

Medical practitioners are placed in a difficult position when close family members disagree about the treatment that should be provided to a loved one who is no longer capable of making his or her own decisions. ...more

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