【作者单位】in Washington, DC. Prior to joining PCORI, she served as1 Program officer for the Clinical Effectiveness and Decision Science program at the Patient-Centered Outcomes Research Instituteconsultant to the Institute of Medicine Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs and asPCORImember of research teams at the Johns Hopkins School of Medicine 2 Senior program officer for the Leadership Consortium forValue and Science-Driven Health System at the National Academy of Medicine in Washington, DC
【摘 要】 A learning health system provides opportunities to leverage data generated in the course of standard clinical care to improve clinical practice. One such opportunity includes a clinical decision support structure that would allow clinicians to query ... 更多 >> A learning health system provides opportunities to leverage data generated in the course of standard clinical care to improve clinical practice. One such opportunity includes a clinical decision support structure that would allow clinicians to query electronic health records (EHRs) such that responses from the EHRs could inform treatment recommendations. We argue that though using a clinical decision support system does not necessarily constitute a research activity subject to the Common Rule, it requires more ethical and regulatory oversight than activities of clinical practice are generally subjected to. In particular, we argue that the development and use of clinical decision support systems should be governed by a framework that (1) articulates appropriate conditions for their use, (2) includes processes for monitoring data quality and developing and validating algorithms, and (3) sufficiently protects patients\' data. << 收起
