The Association of Corporate Counsel (ACC) is the world's largest organization serving the professional and business interests of attorneys who practice in the legal departments of corporations, associations, nonprofits and other private-sector organizations around the globe.
Collaborate with your peers across legal and regulatory disciplines to develop a compliant strategy for a healthcare technology product launch before your time runs out! Communicate to identify issues, assess and mitigate risks, complete tasks, and solve a variety of complications while remaining compliant. Boost your skills in communication, project management, issue spotting, and advising on matters such as intellectual property, access to data, and privacy laws that affect the company's products and services as well as advising them on compliance with regulations governing technology products - all within an impending deadline.
Collaborate with your peers across legal and regulatory disciplines to develop a compliant strategy for a healthcare technology product launch before your time runs out! Communicate to identify issues, assess and mitigate risks, complete tasks, and solve a variety of complications while remaining compliant. Boost your skills in communication, project management, issue spotting, and advising on matters such as intellectual property, access to data, and privacy laws that affect the company's products and services as well as advising them on compliance with regulations governing technology products - all within an impending deadline.
This program will offer a straightforward assessment, from a range of perspectives from those on the front lines, of what enforcers are focusing on and what it means for you. Topics covered will include civil, criminal and administrative updates to healthcare fraud litigation and investigations.
This program will offer a straightforward assessment, from a range of perspectives from those on the front lines, of what enforcers are focusing on and what it means for you. Topics covered will include civil, criminal and administrative updates to healthcare fraud litigation and investigations.
The Food and Drug Administration has long taken the position that while an off-label use of pharmaceuticals and medical devices is legal, off-label marketing or promotion is not legal. However, recent jurisprudence calls into question whether merely marketing a product for an off-label use is sufficient to satisfy the requirement of making a “false statement” under the False Claims Act (FCA). In this presentation, we will outline the elements of the FCA and the Anti-Kickback Statute (AKS), and discuss case law and agency guidance regarding whether off-label marketing or promotion truly puts healthcare companies at risk of violating the FCA and AKS.