Medical Research

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Medical Research Fraud And HHS's Office Of Research Integrity: Watching The Watchdog

Even for those who carefully follow legal developments in the health care fraud arena, the Department of Health and Human Service’s Office of Research Integrity (“ORI”) is an agency that rarely appears on the radar. According...more

Medical Journal Studies on the Health Effects of E-Cigarettes May Help Local Governments

Evidence continues to drift out of the scientific community as to the health effects of e-cigarettes. The latest, a study by the Journal of Adolescent Health as reported by Stephanie M. Lee on SFGate.com. ...more

Council of the European Union and European Parliament Agree on Proposal for New Clinical Trials Regulation

When Approved by the European Parliament, the Regulation Will Have the Force of Law in All EU Member States and Repeal the Current Clinical Trial Directive - On December 20, 2013, the General Secretariat released the...more

China Releases Vaccine Good Clinical Practices

On October 31, 2013, The China Food and Drug Administration (“CFDA”) promulgated a regulation titled Guiding Principles for the Quality Management of Clinical Studies on Vaccines (“Vaccine GCP”), with immediate effect. The...more

OIG Not Asleep at the Switch: Reviews Polysomnography Services from 2011

The OIG recently released its review of polysomnography services (sleep studies) provided in both hospital-based outpatient settings and non-hospital settings. Medicare pays for sleep studies to diagnose obstructive sleep...more

St. Jude's Hospital Sues Novartis over Research Tool Patents

Lest anyone think that Myriad Genetics is the only patentee asserting rights in patents having claims to isolated DNA molecules or other biological molecules, St. Jude's Children's Research Hospital, Inc. has sued Novartis...more

OIG Releases Report on Questionable Billing for Sleep Studies; CMS to Take Action

The Office of the Inspector General (OIG) released a report earlier this month on Medicare spending on polysomnography (sleep studies to diagnose and guide treatment for conditions such as sleep apnea), which indicated that...more

Update on WARF Stem Cell Patent Challenge

As reported in my July 8, 2013 post, Consumer Watchdog (formerly known as The Foundation for Taxpayer and Consumer Rights) and the Public Patent Foundation (collectively “CW”) asked the Federal Circuit to determine if in...more

2013-2014: Evolving Challenges for Value-Priced LDTs

Introduction - In 2004, the Genomic Health Oncotype DX breast cancer molecular test was launched and within five years had substantially changed the standard of care for patients with early breast cancers. How has the...more

Study Advances Personalized Medicine for Newborns

Earlier this year, the American Academy of Pediatrics (AAP) and the American College of Medical Genetics and Genomics (ACMG) issued recommendations and proposed best practices for genetic testing and screening of infants and...more

FTC Complaint Against Medical Laboratory Signals Agency’s Continued Intent to Assert Authority in Data-Security-Breach Actions

In taking action against medical laboratory LabMD, the U.S. Federal Trade Commission demonstrated its continued intent to assert authority through the Federal Trade Commission Act in data-security-breach actions. On August...more

Authors of Genome Medicine Article Form Genetic Testing Company

In a paper published in March in the journal Genome Medicine, Dr. Jeffrey Rosenfeld of the University of Medicine & Dentistry of New Jersey and Dr. Christopher Mason of Cornell University contended that due to the...more

Northwestern University Settles Cancer Research False Claims Act Lawsuit

On July 30, 2013, the United States Attorney’s Office for the Northern District of Illinois announced that Northwestern University entered a settlement agreement to pay the United States $2.9 million to settle False Claims...more

NCI Researchers Generate Largest Database of Cancer-specific Genetic Variations

Last month, the American Association for Cancer Research (AACR) announced that researchers at the National Cancer Institute (NCI) had generated a data set of cancer-specific genetic variations, which the researchers were...more

Clinical Progress in Regenerative Medicine

Two separate clinical initiatives were recently announced that support the therapeutic use of regenerative medicine. The first utilzing induced pluripotent stem cells and the second, a state-wide network in support of...more

Proposed Medicare Cuts Would Significantly Impact Independent Laboratories

Last week, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule setting forth revisions to payment policies under the Medicare Physician Fee Schedule (MPFS) and other revisions to Medicare Part B for...more

China Strengthens Oversight of Human Subjects Research

On July 15, 2013, China National Health and Family Planning Commission (the “Commission”) published the draft Administrative Measures on Medical Research Involving Human Subjects (the “Draft Measures”) and is seeking public...more

Other Transactional Authority: A Nontraditional Tool for Partnering with the Federal Government

Last week, the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (“BARDA”) announced that it has used “other transactional authority” to enter into a novel, comprehensive...more

Controversial U.S. Medical Study Raises Informed Consent Questions

The recent controversy surrounding a study of newborn babies in universities across the United States demonstrates the importance of compliance with human subject protection regulations in medical research....more

White House Unveils BRAIN Initiative

Last week, President Obama announced a new research initiative designed to advance our understanding of the human brain. It is hoped that the new initiative, dubbed the BRAIN (Brain Research through Advancing Innovative...more

Research Initiatives Hope To Unlock Complexity Of Brain Injuries

Traumatic brain injuries can manifest themselves in a vast array of symptoms. Victims can be made to struggle with any combinations of memory difficulties, motor difficulties, personality changes and emotional struggles....more

Time to Take Advantage of HIPAA Omnibus Rule's "Good News": Fundraising, Research, and Student Immunization Records

The Omnibus Rule went into effect on March 26, 2013. While covered entities and business associates have until Sept. 23, 2013, to comply with new restrictions and obligations, they can take advantage of the rule’s benefits...more

Sharing an Umbrella

Big Pharma and academia cement big deals in the quest for bigger prizes - With the patents of many highly profitable blockbuster drugs expiring over the course of a few years, the search is on for new drugs to fill...more

New from Abroad: Broadening of UK Bolar Defence

Originally published in WP Thompson & Co. on March 4, 2013. On 26 February 2013, the UK government announced a proposed change to the Patents Act to exempt clinical and field trials, as well as "health technology...more

Physician Payment Sunshine Rule is Finalized

The Final Rule implementing the Physician Payment Sunshine Act was announced on February 1st and published in the Federal Register on February 8th. The Final Rule establishes procedures for drug and device manufacturers to...more

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