I am thrilled to share some great news! The 8th Annual Health Law Regulatory and Compliance Competition was held this past weekend at The University of Maryland Francis King Carey School of Law. This competition challenges students to navigate a complex series of health care transactions and practices that necessitate regulatory and compliance sanctions and oversight. MHSL’s team, comprised of Rachel Foss, Jane Blaney, and Michael Dixon, took 2nd place!…
December 2018 Issue Now Available
Given that this is our last issue of 2018, we decided to focus on several important topics that never seem to get enough airtime. Therefore, we are featuring articles on privacy, including the new California Consumer Protection Act and other state legislation, controlled substances, including the new SUPPORT Act that was enacted in October, and the risks of global regulatory approvals. Also, as is typical this time of year, we…
Season’s Greetings from Whitelaw Compliance Group
Whitelaw Compliance Group Presents at the 19th Annual Pharmaceutical & Medical Device Conference
On Thursday, November 8th, Dr. Seth Whitelaw will be joining a distinguished panel of experts for an interactive discussion on the evolution of the compliance office from “Compliance 1.0 to 3.0”. The commercial compliance profession is now over 25 years old. While the demands have changed as the commercial model has become more complex, many of the concerns have stayed the same. Will Compliance 3.0 require a different kind of…
Open Payments 2.0 – Big Changes Are Forecast
Key Messages Tucked into the latest opioid law are changes to the Sunshine Act. Beginning in 2022, drug and device companies now must report transfers of value to advance practice nurses and physician assistants. CMS also awarded a contract to analyze Open Payments data over the next five years. All drug and device should review both their Sunshine Act systems AND their reported payments BEFORE CMS comes knocking at the…