Medical Research

News & Analysis as of

Health Alert (Australia) - August 31, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpts from Judgments New South Wales (NSW) 28 August 2015 - Smith v Pennington [2015] NSWSC 1168 The Supreme Court gave judgement for the...more

Health Alert (Australia) - August 17, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: New South Wales (NSW) 13 August 2015 - Waller v James [2015] NSWCA 232 The NSW...more

Clinical Trial Data: The New Regime

The European Medicines Agency moves to increase EU clinical trial transparency. The last five years have seen a sea change in the attitude of EU authorities regarding the disclosure of clinical trial results, moving from...more

White House Releases Draft Privacy Principles for the Precision Medicine Initiative

Six months after the Precision Medicine Initiative’s (Initiative’s) debut, the White House has released a working draft of proposed privacy and trust principles (the Principles) to govern future design and development efforts...more

House Passes Medical Innovation Bill That Would Revise HIPAA

On July 10, the U.S. House of Representatives approved the 21st Century Cures Act (the Act), a bill intended to support advancements in medical innovation. The Act includes measures aimed at spurring medical research,...more

21st Century Cures Act – Provisions Relating to Digital Health: Interoperability and Information Blocking

On July 10, 2015, the House of Representatives approved the 21st Century Cures Act (HR 6) (the “bill”) by a vote of 344-77. In addition to increasing medical research funding and expediting the process of making breakthrough...more

House Passes 21st Century Cures Act: What Does it Mean for Clinical Research?

On July 10, 2015, the U.S. House of Representative passed H.R. 6, the 21st Century Cures Act, with strong bipartisan support in a vote of 344-77. As Ropes & Gray has summarized Cures Act provisions related to Medicare and...more

Arnall Golden Gregory Series Explains Provisions in the 21st Century Cures Act

On July 10, 2015, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. The bill is intended to promote drug and device development, support research and expedite patients’ access to new...more

CMS Open Payment Program Data Indicates $6.49 Billion Paid by Manufacturers, GPOs to Physicians and Hospitals in 2014

CMS recently released data collected through the Open Payments Program in accordance with the Affordable Care Act from applicable manufacturers and group purchasing organizations (GPOs) about payments and other transfers that...more

House Easily Passes 21st Century Cures Legislation, Includes Significant FDA Reforms

On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for...more

Also In the News - Data, Privacy, & Security Practice Report - July 2015 #2

FCC Working Group Issues Report On Cybersecurity Best Practices – The June 2015 issue of the Intellectual Property & Technology Law Journal features an article by King & Spalding partner Steven Snyder on a Federal...more

House Passes 21st Century Cures Act

On July 10, 2014, the U.S. House of Representatives overwhelmingly passed legislation intended to speed the approval of drugs and medical devices and increase funding for medical research. The central aim of H.R. 6, the “21st...more

July Congressional Committee Hearings on Health Policy Issues

Congressional committees continue to hold hearings on various health policy topics, including the following: ..A Senate Finance Committee hearing today focused on “Reviewing HealthCare.gov Controls.” ..The House...more

White House Releases Proposed Precision Medicine Initiative Privacy Framework

Earlier this year, President Obama launched a high-profile “Precision Medicine Initiative” (PMI) to develop treatments, diagnostics, and prevention strategies tailored to the individual genetic characteristics of each...more

Health Alert (Australia) - July 6, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: Victoria. 26 June 2015 - Northern Health v Kuipers [2015] VSCA 172 - The Victorian Supreme Court has allowed an appeal...more

HHS Removes Extra Hurdle for Marijuana Research

The process for studying the potential medical benefits of marijuana became more streamlined on Tuesday, when the U.S. Department of Health and Human Services eliminated a controversial requirement for Public Health Service...more

June Xarelto Update – Science Day

Judge Fallon, the federal judge in New Orleans who oversees the MDL coordinated proceedings, held his most recent hearing for all of the pending Xarelto lawsuits on June 10, 2015. At that time, the judge was provided with a...more

Health Alert (Australia) - June 22, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: Victoria. Inquest Into the Death of Baby Chloe Lee Kellett - The Victorian Coroner investigated an infant's death from...more

Health Alert (Australia) - June 15, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: New South Wales. O'Sullivan v Medical Council of New South Wales [2015] NSWCATAD 113 The New South Wales Civil and...more

Technology in Healthcare [Video]

From the 2015 PLUS Medical PL Symposium session “Technology in Healthcare: EHRs & PHI,” moderator Patricia Marzella-Graubert (Swiss Re American Holdings Corporation) and panelist Alexander Grijalva (New York Presbyterian...more

Health Alert (Australia) - June 9, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: Australia. Fair Work Commission Marr v Western Health [2015] FWC 2970 The Fair Work Commission has held that it was...more

Rare Genomics Institute Announces Crowdfunding Initiative for Rare Diseases

Earlier this month, Rare Genomics Institute, an international non-profit that makes cutting edge research technologies of genome sequencing, physicians and scientists around the world accessible to rare disease patients,...more

Law Review Articles That Caught Our Eye

Maybe our motto here at DDLaw should be “we read law review articles so you don’t have to.” Here are a couple of recent ones that looked interesting to us....more

Genes Associated with ALS Identified

One of the promises of the Human Genome Project was that knowledge of the entirety of the human genetic complement would permit researchers to identify genetic bases for diseases that had been intractable to conventional...more

Health Alert (Australia) - May 11, 2015

In This Issue: Judgments, Legislation; and Reports and Publications. Excerpt from Legislation: Commonwealth - 5 May 2015 - Australia New Zealand Food Standards Code — Standard 1.4.2 — Maximum Residue...more

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