Medical Technology Compliance: FDA, AKS, FCA and Other Regulatory Requirements
Mitigating Medical Device and Healthcare Technology Risks
Recording of a 90-minute CLE webinar with Q&A
This CLE course will provide guidance to counsel in the medical technology industry on the regulatory compliance risks facing the industry and on implementing the optimal compliance program. The panel will discuss the pitfalls to avoid as well as healthcare fraud issues facing the industry.
- Unique risk profile for medical technology companies
- Evolving regulatory landscape
- Ever-increasing compliance requirements
- Safety, security and reliability
- Managing data
- Unique operational considerations for medical technology companies
- Tips on implementing a “right sized” compliance program
- “Toolkit” for fighting healthcare fraud
- Anti-Kickback Statute
- False Claims Act
- Open Payments/Sunshine Act
- “Whistleblower” suits
- Core components of effective compliance program
- Key questions to consider
The panel will review these and other key issues:
- What are the unique risks facing medical technology and device companies?
- What are the key pitfalls to avoid when implementing compliance programs?
- What steps should counsel take to ensure compliance with FCA and AKS?
Jana Gerken, J.D.
Co-Founder and Chief Legal Strategist
Kinetic Compliance Solutions
Ms. Gerken develops and executes legal strategies that strike the right balance between risk and reward to help her... | Read More
Ms. Gerken develops and executes legal strategies that strike the right balance between risk and reward to help her clients gain a competitive edge while remaining compliant. She partners with clients in translating complex legal challenges into pragmatic business solutions. Prior to co-founding Kinetic Compliance Solutions, she was the General Counsel for GE Healthcare’s five-billion-dollar diagnostic imaging businesses (Detection & Guidance Solutions (DGS), Molecular Imaging & Computed Tomography (MICT), and Magnetic Resonance (MR)).Close
Ethan E. Rii
Mr. Rii focuses his practice on healthcare transactions and regulatory matters surrounding mergers and acquisitions,... | Read More
Mr. Rii focuses his practice on healthcare transactions and regulatory matters surrounding mergers and acquisitions, corporate restructurings and joint ventures for hospitals, health systems, multispecialty and large physician practices, specialty and ancillary care providers, managed care organizations, private equity firms and financial institutions investing in the healthcare space. He counsels clients on healthcare compliance issues, including fraud and abuse and related matters, such as physician referral and anti-kickback regulations.Close