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David Vulcano is a well-known leader in the clinical research industry through numerous publications, presentations and contributions. Born and raised in New Orleans, Louisiana, he earned Masters’ degrees in both Social Work and Business Administration. Additional credentials include obtaining the status of Certified IRB Professional (CIP) and Regulatory Affairs Certification (RAC). His current primary employment is as the Responsible Executive for Clinical Research for Hospital Corporation of America (HCA), overseeing the research efforts of over 160 hospitals, over 100 Surgery Centers, various physician practices and affiliated programs across the United States and in London. David is a Past Chair of the Board of Trustees for the Association of Clinical Research Professionals (ACRP) assisting their mission in providing global leadership to promote integrity and excellence in the clinical research profession.
His contributions to the research industry are numerous, with the most recent recognitions including the 2012 Special Recognition Award by the Regulatory Affairs Professional Society, the 2012 Best Practice in Human Subject Protection by the Health Improvement Institute and named one of the Top 100 leaders in the Health IT Community in 2012 by the HealthTech Council (through his leadership to assure the ethical conduct of clinical research with “big data” in healthcare). David has been called to be an expert witness for matters in the clinical trials industry, a judge in the Health Improvement Institute’s Annual Award for Excellence in Human Research Protections and a former Human Subject Protection Program accreditation surveyor for both the National Committee for Quality Assurance (NCQA) and Partners for Human Research Protection (PHRP). His role as Guest Editor for the December 2010 Issue of The Monitor helped earn the 2010 Gold Circle Award for Peer-Reviewed Journal by the American Society Of Association Executives (ASAE). David has been a speaker for most major research-related and other healthcare related associations and organizations on topics related to the clinical trials industry.
On a lighter note, he was the Regulatory Jeopardy! Champion at the DIA in the contest’s first two years (2004 and 2005). He is a member of the Nashville Chapter of the Angel Capital Group where he participates in deal screening, due diligence, entrepreneur mentoring and takes the occasional board seat in startup companies.
Born in New Orleans, he currently lives in Nashville with his wife and 2 children where he involves himself in work, family life as well as other charitable and entrepreneurial opportunities.
HEALTHCARE REFORM’S IMPACT ON THE CLINICAL RESEARCH INDUSTRY
Healthcare reform in the United States is moving forward. With such monumental shifts created by new laws and administrative efforts, there are both intended and unintended consequences to the clinical research industry. This session examines how the changes in overall healthcare initiatives directly or indirectly affect the clinical research in the United States.
REGULATIONS AND ETHICS OF EHR / BIG DATA RESEARCH IN HEALTHCARE
There are research and privacy regulations governing the use of healthcare data for research purposes. Also, what's legal from a federal/state/local level may have ethical issues that need to be addressed. This session provides the caution points but primarily takes a "how can we" approach to these parameters to achieve research goals yet offer optimal protections.
PHYSICIAN PAYMENT SUNSHINE: A RAY OF HOPE OR A DEEPLY FLAWED LAW?
Enacted as part of the Patient Protection and Affordable Care Act, Open Payments (formerly known as the "Physician Payment Sunshine Act") is in full swing and causing quite a stir. This session begins with an overview of the regulations and moves on to discuss the impact on the health care / research industry and what to prepare for.
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