Data Governance Dilemmas for Research and Clinical Care

Kaplan, B., DeMuro, P.R., Pasquale, F, Talmon, J, Winkelstein, P., American Medical Informatics Association Annual Symposium, Washington, DC, November 2014

3 Pages Posted: 6 Feb 2015 Last revised: 9 Nov 2018

See all articles by Paul DeMuro

Paul DeMuro

Department of Sociobehavioral and Administrative Pharmacy; Oregon Health & Science University

Bonnie Kaplan

Yale University

Frank A. Pasquale

University of Maryland Francis King Carey School of Law; Yale University - Yale Information Society Project

Jan Talmon

Maastricht University

Peter Winkelstein

University at Buffalo

Date Written: September 23, 2014

Abstract

Legal and ethical considerations distinguish between patient care and research. Data collection, protection, privacy, and permissions are governed differently for routine care and research data. Yet, neither patients nor clinicians can so easily separate the two; the distinction is not as clear-cut as it appears. Today’s clinical data becomes tomorrow’s research data. New technologies, medical advances, and the move toward learning health care systems further blur the distinction. Panelists will discuss and debate how the clinical/research distinction holds up in practice, and whether it should (or can be) refined or eliminated. They address dilemmas that informaticians, patients, clinicians, and policy makers face because of the distinction between research and clinical care as it plays out in electronic record keeping, data quality, data storage, data sharing, data linking, and secondary use. The panel considers such timely and controversial issues as: Exactly which aspects of care, and the documentation of that care, are research, and which are clinical, when many may be both? Should consent procedures differ according to whether treatment is considered research? Should patient care be contingent on permission to use care data for research? Are quality assurance, biobanks, or learning systems data clinical data or research data? When is a record review quality improvement and when is it research? What are the benefits and costs of maintaining the status quo and of proposals for change? How do different approaches compare internationally? Panelists and audience will exchange ideas about how they might like to see regulations evolve.

Suggested Citation

DeMuro, Paul and Kaplan, Bonnie and Pasquale, Frank A. and Talmon, Jan and Winkelstein, Peter, Data Governance Dilemmas for Research and Clinical Care (September 23, 2014). Kaplan, B., DeMuro, P.R., Pasquale, F, Talmon, J, Winkelstein, P., American Medical Informatics Association Annual Symposium, Washington, DC, November 2014. Available at SSRN: https://ssrn.com/abstract=2560424

Paul DeMuro

Department of Sociobehavioral and Administrative Pharmacy ( email )

3301 College Avenue
DCRS
Ft. Lauderdale, FL 33314
United States
(954) 745-5224 (Phone)

Oregon Health & Science University

3181 S.W. Sam Jackson Park Rd.
Portland, OR 97201
United States

Bonnie Kaplan (Contact Author)

Yale University ( email )

New Haven, CT 06520
United States

Frank A. Pasquale

University of Maryland Francis King Carey School of Law ( email )

500 West Baltimore Street
Baltimore, MD 21201-1786
United States
410-706-4820 (Phone)
410-706-0407 (Fax)

Yale University - Yale Information Society Project ( email )

127 Wall Street
New Haven, CT 06511
United States

Jan Talmon

Maastricht University

P.O. Box 616
Maastricht, 6200MD
Netherlands

Peter Winkelstein

University at Buffalo

School of Nursing
3435 Main Street
Buffalo, NY 14214
United States

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