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While the U.S. Department of Justice (DOJ) continues to prioritize its investigation of fraud and misconduct within the clinical research space, the Office of Research Integrity in the U.S. Department of Health and Human Services recently released its Final Rule on regulations governing Public Health Service Policies on Research Misconduct, which takes effect January 1, 2025. Clearly, the role of compliance in clinical research is a critical area of focus, and one with the potential for significant consequences if overlooked or minimized.
Recent DOJ enforcement actions include:
- The conviction of two biotech CEOs for making false and misleading statements about the application and U.S. Food and Drug Administration approval status of an investigational HIV and COVID-19 treatment with the goal of inflating their company’s stock value. (“Two Biotech CEOs Convicted in Securities Fraud Scheme”)
- The sentencing of a medical clinic owner to 71 months in prison for falsifying and fabricating clinical trial data around a potential new CDAD drug. (“Florida Medical Clinic Owner and Pharmacy Technician Sentenced to Prison in Clinical Trial Fraud Scheme”)
With constantly evolving laws, technological advances, and enforcement priorities, it’s more important than ever that clinical research professionals stay up to date with developments in the compliance industry. But how do you add compliance education to your already full plate?
To get the latest insights on a broad spectrum of topics, from understanding the evolution of artificial intelligence (AI) and decentralized clinical trials (DCTs) to keeping up with updates to critical regulations such as the False Claims Act (FCA), Health Care Compliance Association (HCCA) invites you to join us for our 29th Annual Compliance Institute, April 28–May 1.
This year’s Compliance Institute features more than 100 educational sessions across 14 unique learning tracks, as well as the valuable opportunity to connect with an expected 1,500 healthcare professionals from a wide variety of organizations and roles, with whom you can share knowledge, experiences, and insights.
The conference highlights 14 unique topic tracks:
- Auditing and Monitoring
- Behavioral Health
- Case Studies
- Compliance Law
- Discussion Group (in-person attendees only)
- General Compliance/Hot Topics
- Investigations
- Physician Compliance
- Post-Acute Care
- Privacy and Security
- Professional Skills
- Risk Management
- Technology and Innovation
- Telehealth
Educational sessions will cover many emerging and important healthcare compliance topics, including:
Decentralized Clinical Trials (DCTs): Are They Here to Stay? A Compliance Perspective
Ashaben Sharma, Research Compliance Quality Auditor II, H. Lee Moffitt Cancer Center and Research Institute, Inc.
What Every Compliance Officer Needs to Know: Data and Analytics Governance in the Era of Artificial Intelligence
Mark Neu, Chief Compliance Officer, Renown Health; Justin Coran, Chief Analytics Officer, Renown Health
Discovering, Investigating, and Resolving Stark Issues, Including Alternatives to Repayment or Self-Disclosure
Aaron Narva, CEO, Conflixis; Robert Wade, Partner, Nelson Mullins
For a look at the full selection of educational sessions, view the agenda.
The city of Las Vegas will provide an iconic backdrop for the 2025 Compliance Institute, and we encourage you to join us there for the full conference experience, featuring access to all educational sessions, face-to-face networking, in-person connections with solution providers, and onsite receptions, volunteer opportunities, and more.
For those unable to travel, a virtual attendance option is available beginning April 29, with access to a majority of sessions, live-streamed directly from Las Vegas.
An early bird registration discount is available for those who register now, and a discounted room block at ARIA Resort & Casino, the conference site, is open for booking.
About HCCA®
Established in 1996, Health Care Compliance Association® supports healthcare compliance professionals as part of the overarching mission of SCCE & HCCA, a member-based professional association with more than 19,000 members in more than 100 countries. SCCE & HCCA is dedicated to enabling the lasting success and integrity of organizations worldwide by promoting high standards in compliance and ethics programs, nurturing a community of compliance practitioners, and offering knowledge-rich educational opportunities. Learn more about HCCA
