Compliance Perspectives

By Adam Turteltaub The Health Care Compliance Association just published the 4th edition of the Research Compliance Professional’s Handbook, and to see what’s new in it we sat down with the editor, Kelly Willenberg (LinkedIn) of Kelly Willenberg & Associates. The Handbook, she explains is there to help both those who attend the HCCA Healthcare Research Compliance Academy and anyone looking for a desktop reference that addresses the fundamentals of research compliance. It addresses topics such as safety, privacy, monitoring, and biosecurity. For this edition each chapter was reviewed thoroughly with any and all necessary updates made, including to the chapter on FDA regulations. In addition, a new chapter was written to address AI. It defines what AI is and why compliance teams need to look at it from a risk management perspective. The chapter also addresses the integration of AI and how therapies are changing. One admonition that she provides for compliance teams is to watch Europe. As with privacy, Euro