On March 15, 2016, in response to an epidemic of opioid overdose deaths, the Centers for Disease Control and Prevention (CDC) issued guidance intended to assist primary care providers in prescribing opioid medications for chronic pain (pain lasting greater than
Our newly released guide shares the top ten things to know about tapping into China’s medical devices industry. The guide provides an overview of the regulatory regime for medical devices in China and the top issues that foreign investors and manufacturers should consider when entering the China market.
As we reported last August, U.S. District Judge Paul Engelmayer ruled that Amarin Pharma has a First Amendment right to truthfully promote its prescription drug Vascepa for off-label uses. August 10, 2015, article. Shortly afterward, Amarin and the government entered settlement talks. August 31, 2015 update. We are now able to report that on March 8, 2016, the parties entered into a proposed Settlement Agreement resolving all causes of action in Amarin’s suit against the FDA.
On February 29, 2016, an Alberta woman suffering from amynotrophic lateral sclerolsis (“ALS”), became the first person in Canada to obtain a physician-assisted death.
Four days prior to her death, Ms. S applied to the Alberta Court of the Queen’s
On March 1, 2016, the U.S. Food and Drug Administration (FDA) issued guidance on screening donors of human cells, tissues, and cellular and tissue-based products for risk of evidence of infection with Zika virus. The FDA’s guidance identifies Zika virus as a relevant communicable disease agent or disease (RCDAD) and provides recommendations for reducing the risk of transmission of Zika virus by human cells, tissues, and cellular and tissue-based products.
In a report released on February 26, 2016, the federal government announced that it recovered $2.4 billion through its Health Care Fraud and Abuse Control Program (HCFAC) during FY 2015. The $2.4 billion is almost $1 billion lower than the recovery of $3.3 billion in FY 2014. Over the last three years, the return on investment (ROI) for the HCFAC program is $6.10 returned for every $1.00 expended. Qui tam litigation accounted for $452 million of the recovery by the federal government.
In its recent decision in Burquitlam Care Society v Fraser Health Authority, 2015 BCSC 1343, the British Columbia Supreme Court may have expanded the potential use of the common law duty to act honestly as a means for contracting
The U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) recently published two guidance documents to aid organizations in complying with HIPAA.
The HIPAA Security Rule Crosswalk to NIST Cybersecurity Framework (the “Crosswalk”), developed in