U.S. EPA Acting Administrator Andrew Wheeler signed a new hazardous waste pharmaceutical rule on December 8, 2018. This rule will impose significant new obligations on certain health care providers, including pharmacies and long-term care providers, as well as forward and all reverse distributors of pharmaceuticals. This new rule represents a noteworthy change from EPA’s previous policy position that pharmaceuticals in the reverse distribution chain were not “discarded” under RCRA for purposes of the waste designation until an affirmative decision was made to treat them as “waste” and discard them.
The U.S. District Court for the District of Columbia has set aside the most significant portions of the U.S. Department of Labor's (DOL) regulations on Association Health Plans (AHPs). The court's ruling invalidates regulatory provisions that sought to broaden the groups of employers that could be treated as if they were a single employer, allowing them to establish health plans that did not need to meet certain Affordable Care Act (ACA) requirements.
The FDA announced proposing new amendments to key regulations regarding mammography facilities that would require these entities “to tell women more about how dense breast tissue can affect their health and increase their cancer risk.” These changes not only enhance regulatory requirements but likely foreshadow increasing enforcement and communications from the FDA with regard to mammography services.
Due to severe Measles outbreak, an emergency was declared in Rockland County on March 27 and in New York City on April 9. Following this, new guidelines have been issued to combat the outbreak. One of the main highlights of these guidelines include exclusion of infected people from indoor as well as outdoor public places for a period of 21 days.
According to results of a large observational cohort study, children with mother's having a history of Gestational Diabetes are at two times more risk of developing Type 1 DM by 22 years of age. This study stresses upon the need for evaluating every child with positive history of Gestational Diabetes in mother showing suspected symptoms of Diabetes.
According to findings of a study published in JACC: Cardiovascular Interventions, patients with less physical activity or those who lead sedentary lifestyles have a higher risk of mortality and functional decline post TAVR procedures. The researchers further added that whether one can prevent these complications by advising exercise routine to such patients still needs to be investigated.
According to reports published in the journal Stem Cell Reports, insulin-like growth factor II gene in adult stem cell provides key support for the existence of stem cells in the intestine. The researchers added that these genes show unregulated self-renewal and proliferation which may contribute to colorectal cancers.
According to research published in Radiology, a “research roadmap" has been developed on helping researchers use artificial intelligence (AI) algorithms. The researchers added that the blueprint will provide for professional societies, funding agencies, research labs, and everyone else working in the field.
The U.S. Supreme Court cast aside pharmaceutical company Allergan Plc’s unorthodox bid to shield patents from a federal administrative court’s review by transferring them to a Native American tribe. The justices left in place a lower court ruling upholding the authority of a U.S. Patent and Trademark Office tribunal to decide the validity of patents covering Allergan’s dry eye drug Restasis, refusing to hear the company’s appeal.
The U.S. Department of Health and Human Services (HHS) recently proposed two new rules designed to increase patient and provider access to health records. The proposed rules will support seamless and secure access, exchange, and use of electronic health information. CMS and ONC proposed complementary rules facilitating patient access to and the flow of health information.