Informed Consent

News & Analysis as of

Safe Harbor Invalidated – What’s Next on the Chopping Block?

As I reported earlier today, the Court of Justice of the EU (ECJ) has declared Safe Harbor invalid. The full decision is now available online in English (other languages also available at by searching on...more

EU Top Court’s Safe Harbor Decision Invalidates Safe Harbor and Sends Facebook Case Back to Irish Data Protection Authority

The initial reports of the ECJ’s decision in the Schrems Safe Harbor case (C-362/14) indicate that the Court of Justice of the EU has declared Safe Harbor invalid and sent the case back to the Irish Data Protection Authority...more

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

ECJ Advocate General’s Safe Harbor Opinion Points Towards Imminent End of Safe Harbor As We Know It

Does your company rely on Safe Harbor to transfer personal data from Europe to the US? If so, it’s time to think about alternatives to Safe Harbor – and fast....more

HHS Releases Notice of Proposed Rulemaking Updating Rules for Human Subjects Research

On September 2, 2015, HHS issued the long-awaited Notice of Proposed Rulemaking (NPRM) on revisions to the rules governing federally-funded research involving individuals, commonly referred to as the Common Rule (Subpart A of...more

HHS Releases Highly Anticipated Proposal to Modernize U.S. Human Subjects Research Protections

In a notice of proposed rulemaking (NPRM) released September 2, 2015, the U.S. Department of Health and Human Services (HHS), through the Office for Human Research Protections (OHRP) and 15 other federal departments and...more

Anything in the New Clinical Trial Rules of Interest to Product Liability? Not Really.

An inter-agency taskforce is proposing a comprehensive overhaul of “Federal Policy for the Protection of Human Subjects” in today’s issue of the Federal Register (comments close on 12/7/2015). See 80 Fed. Reg. 53933 (Sept....more

Drastic Changes Proposed for Clinical Research Rules

The U.S. Department of Health and Human Services (“HHS”) and fifteen other Federal Departments and Agencies have announced a proposal to update the Federal Policy for the Protection of Human Subjects known as the “Common...more

HHS Proposes Major Overhaul of the Common Rule

On September 8, 2015, the Department of Health and Human Services proposed significant revisions to the Federal Policy for the Protection of Human Subjects (“Common Rule”), the set of federal regulations governing the conduct...more

Blog: “Common Rule” Overhaul Proposed – Intended to Modernize Human Research Subject Protections

On September 2, 2015, sixteen federal agencies and departments jointly issued a Notice of Proposed Rulemaking (“the NPRM”), designed to “modernize, strengthen, and make more effective” the so-called “Common Rule”. The Common...more

AGs Reach $1 Million Settlement With Online Marketer of Pimsleur Language Courses

The Attorney General offices from the states of New York, Pennsylvania and Washington entered into a $1 million settlement with Internet Order LLC, doing business as, over its use of ‘negative option’...more

Agencies Release Proposed Overhaul of the Common Rule

On September 2, 2015, sixteen federal departments and agencies, including the US Department of Health and Human Services (HHS) released a proposed rule to modernize regulations governing human research subjects under the...more

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

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