The Department of Health and Human Services (HHS), on September 14, 2011, announced proposed changes to regulations that implement the Clinical Laboratory Improvement Amendments (CLIA) and the Health Insurance Portability and Accountability Act (HIPAA). These proposed changes would broaden patient access to laboratory test reports and preempt current Pennsylvania law on this topic.
In a ruling issued yesterday in Goudy-Bachman v. United States, United States District Court judge Christopher Conner held that the individual mandate provision of the Affordable Care Act — or “Obamacare” or “Obamneycare” depending on your political persuasion — is unconstitutional. Judge Conner’s ruling adds to the myriad cases percolating through various federal courts on the trial and appellate levels throughout the country.
On September 7, 2011, the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) announced draft guidance on exculpatory language in informed consent for human subject research. The current regulatory guidance on this point was issued in November 1996. This newly issued draft guidance will ultimately supersede the 1996 guidance on what constitutes exculpatory language that is inappropriate to include in informed consent for human subject research.