Toward a National Framework for the Secondary Use of Health Data: An American Medical Informatics Association White Paper

Abstract

Secondary use of health data applies personal health information (PHI) for uses outside of direct health care delivery. It includes such activities as analysis, research, quality and safety measurement, public health, payment, provider certification or accreditation, marketing, and other business applications, including strictly commercial activities. Secondary use of health data can enhance health care experiences for individuals, expand knowledge about disease and appropriate treatments, strengthen understanding about effectiveness and efficiency of health care systems, support public health and security goals, and aid businesses in meeting customers' needs. Yet, complex ethical, political, technical, and social issues surround the secondary use of health data. While not new, these issues play increasingly critical and complex roles given current public and private sector activities not only expanding health data volume, but also improving access to data. Lack of coherent policies and standard "good practices" for secondary use of health data impedes efforts to strengthen the U.S. health care system. The nation requires a framework for the secondary use of health data with a robust infrastructure of policies, standards, and best practices. Such a framework can guide and facilitate widespread collection, storage, aggregation, linkage, and transmission of health data. The framework will provide appropriate protections for legitimate secondary use.

Clinical Data Reuse or Secondary Use: Current Status and Potential Future Progress

“…The American Medical Informatics Association has published a white paper listing recommendations for a national framework for the secondary use of clinical data [3]. A similar European initiative proposed recommendations for the trustworthy reuse of health data [52], and Hersh and colleagues published recommendations [53] and caveats for clinical data reuse in comparative effectiveness research [54].…”

“…Among socio-organizational constraints, patient privacy, data ownership, intellectual property, and organizational incentives and policies are the most important. Clinical data reuse for research purposes is inevitably challenged both by legal and ethical considerations, trying to find a balance enabling scientific research within a framework in which the privacy of patients is protected [3,50,51]. Finally, the sale of clinical data remains an unresolved policy issue [3,21,52].…”

“…The benefits of reusing clinical data have been well recognized for decades [3,[18][19][20][21] and a detailed study by PricewaterhouseCoopers explained how reuse could enable improvements of health outcomes and costs [22]. To improve healthcare management and quality, clinical data has already been reused to measure and improve quality [23,24], predict patients length of stay, discharge, readmission, and death [25][26][27][28], and improve infection control [29][30][31].…”

“…Secondary use (or reuse) of clinical data is defined as "non-direct care use of personal health information including but not limited to analysis, research, quality/safety measurement, public health, payment, provider certification or accreditation, and marketing and other business including strictly commercial activities." [3] Reuse of clinical data is essential to fulfill the promises for high quality healthcare, improved healthcare management, reduced healthcare costs, population health management, and effective clinical research. The existing and often biased and underspecified diagnostic and procedure codes assigned for reimbursement and administrative purposes are the easiest to reuse but are insufficient for policymakers, public health officials, funding agencies, scientists, clinicians, citizens, and industry, who need accurate and detailed clinical information, as found in patients' EHRs.…”

Update on Data Reuse in Health Care

“…These barriers include ownership or rights to use data, the appropriateness of methods to analyze the data, the propriety of the question being analyzed, the legal context for the analysis, and even the underlying language of the data. The American Medical Informatics Association and the International Medical Informatics Association have held a series of policy-related meetings to provide a framework for discussion of these complex issues [24][25][26][27].…”