Top 10 Pharmaceutical, Healthcare & Life Sciences Headlines from All Regions A panel of FDA advisers voted 6-5 to recommend approval of Medtronic's Amplify, a device used in spinal-fusion surgery. Citing the growing complexities of collaborations between investigators and the private sector, the Department of Health and Human Services (HHS) has proposed new rules for Financial Conflicts of Interest (FCOI). In response to the Centers for Medicare and Medicaid Services’ (CMS’) proposed hospital inpatient rule for FY 2011, lawmakers urged the agency to reconsider payment reductions in a July 12 letter. According to a study by PricewaterhouseCoopers and the National Venture Capital Association, venture capital (VC) investing hit a five-year high in 2006, with $25.5 billion invested. On July 14, 2010, the Department of Health and Human Services ("HHS") issued a Notice of Proposed Rulemaking (the "Proposed Regulations") to modify certain regulations that implement the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"). On July 14, 2010, the Department of Health and Human Services (HHS) published proposed regulations pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH Act). While one published human study has suggested a link between certain nanoparticles and adverse health effects, prudent manufacturers and importers should identify steps to ensure that they are reasonably and effectively minimising the dangers which may be more broadly associated with nanotechnology and nanoparticles. On July 14, 2010, the Department of Health and Human Services (HHS) published a notice of proposed rulemaking (Proposed Rule) to implement modifications to the Health Insurance Portability and Accountability Act's (HIPAA) Privacy, Security and Enforcement Rules. On July 8, 2010, the Department of Health and Human Services (HHS) published proposed modifications to the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security and Enforcement Rules (the Proposed Rules) implementing the Health Information Technology for Economic and Clinical Health Act (HITECH) provisions of the American Recovery and Reinvestment Act of 2009. The Centers for Medicare & Medicaid Services (CMS) recently released various notices and final rules updating 2011 Medicare reimbursement rates for post-acute care providers, including long-term acute care hospitals (LTACHs), inpatient rehabilitation facilities (IRFs), skilled nursing facilities (SNFs), home health agencies (HHAs) and hospices. |