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Department of Justice (DOJ) officials have made it clear in the last few years that investigation and enforcement of clinical research misconduct is an increasing priority. Investigations can occur in a variety of areas, from misuse of funds to the falsification of data and failure to disclose ties to foreign governments.
Recent DOJ enforcement indictments and charges include:
- Three Florida medical clinic owners for fabricating clinical trial data by enrolling ineligible subjects in the trial, falsifying laboratory results and medical records, and falsely representing subjects were taking the study drug (United States v. Montalvo Villa, et al.)
- A biotech company CEO for disseminating misleading information about the efficacy of a particular drug (DOJ: “Former InterMune CEO Sentenced for False & Misleading Statements Related to Pulmonary Fibrosis Drug’s Clinical Tests”)
- A New York researcher who misused grant funds for personal travel and entertainment purposes (United States ex rel. English v. Parsons-Kietikko, et al.)
- Several researchers who failed to disclose relationships with Chinese universities on their grant applications (United States v. Mingqing Xiao)
Clearly, there are a multitude of regulations that impact clinical research, and it’s vital to stay up to date on the latest industry developments.
To get the latest information and insights on a broad spectrum of topics, Health Care Compliance Association® (HCCA®) invites you to join us for our 28th Annual Compliance Institute, April 14–17. 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.
General sessions at this year’s Compliance Institute will cover many emerging and important healthcare compliance topics:
Health and Human Services-Office of the Inspector General Enforcement and Compliance Update
Robert K. DeConti, Chief Counsel to the Inspector General, HHS-OIG
An Update on the Office for Civil Rights’ 2024 Priorities
Melanie Fontes Rainer, Director of The Office for Civil Rights, Department of Health and Human Services
AI in Healthcare
Brett Short, Chief Compliance Officer, University of Kentucky
Christine Moundas, Partner, Co-Lead – Digital Health Initiative, Ropes & Gray
John Nash, Associate Professor, Educational Leadership Studies, University of Kentucky
Sherrine Eid, Global Head of Real-World Evidence and Epidemiology, SAS
The Art of Collaboration
Charles Esten, Singer/Songwriter and Actor
Educational sessions are categorized into 14 topic tracks:
- Auditing & Monitoring
- Behavioral Health
- Case Studies
- Compliance Law
- Discussion Group
- General Compliance/Hot Topics
- Investigations
- Physician Compliance
- Post-Acute Care
- Privacy & Security
- Professional Skills
- Risk Management
- Technology & Innovation
- Telehealth
For a look at the full selection of educational sessions, view the agenda.
The city of Nashville, Tenn., will provide a vibrant backdrop for the 2024 Compliance Institute, and we’re excited to not only provide you with first-class education and networking, but also encourage you to take full advantage of the in-person conference experience and discover Nashville’s charm.
For those unable to travel, a virtual attendance option is available April 15–17, with access to more than 50 live-streamed sessions. Those who attend the virtual conference option can network with an anticipated 1,000 virtual attendees. Save your spot today – Learn more and sign up.
About HCCA
Established in 1996, Health Care Compliance Association® (HCCA®) 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 and ethics practitioners, and offering knowledge-rich educational opportunities. Additionally, we offer professional certification through the Compliance Certification Board (CCB®), an independent body which recognizes individuals with competence in the practice of compliance and ethics.
