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Introduction: Critical for advancing a Learning Health System (LHS) in the U.S., a regulatory safe harbor for deidentified data reduces barriers to learning from care at scale while minimizing privacy risks. We examine deidentified data policy as a mechanism for synthesizing the ethical obligations underlying clinical care and human subjects research for an LHS which conceptually and practically integrates care and research, blurring the roles of patient and subject., Methods: First, we discuss respect for persons vis-a-vis the systemic secondary use of data and tissue collected in the fiduciary context of clinical care. We argue that, without traditional informed consent or duty to benefit the individual, deidentification may allow secondary use to supersede the primary purpose of care. Next, we consider the effectiveness of deidentification for minimizing harms via privacy protection and maximizing benefits via promoting learning and translational care. We find that deidentification is unable to fully protect privacy given the vastness of health data and current technology, yet it imposes limitations to learning and barriers for efficient translation. After that, we evaluate the impact of deidentification on distributive justice within an LHS ethical framework in which patients are obligated to contribute to learning and the system has a duty to translate knowledge into better care. Such a system may permit exacerbation of health disparities as it accelerates learning without mechanisms to ensure that individuals' contributions and benefits are fair and balanced., Results: We find that, despite its established advantages, system-wide use of deidentification may be suboptimal for signaling respect, protecting privacy or promoting learning, and satisfying requirements of justice for patients and subjects., Conclusions: Finally, we highlight ethical, socioeconomic, technological and legal challenges and next steps, including a critical appreciation for novel approaches to realize an LHS that maximizes efficient, effective learning and just translation without the compromises of deidentification., Competing Interests: The authors declare no conflicts of interest., (© 2022 The Authors. Learning Health Systems published by Wiley Periodicals LLC on behalf of University of Michigan.)

Background: Although people who smoke cigarettes are overrepresented among hospital inpatients, few are connected with smoking cessation treatment during their hospitalization. Training, accountability for medication use, and monitoring of all patients position pharmacists well to deliver cessation interventions to all hospitalized patients who smoke. Methods: A large Midwestern University hospital implemented a pharmacist-led smoking cessation intervention. A delegation protocol for hospital pharmacy inpatients who smoked cigarettes gave hospital pharmacists the authority to order nicotine replacement therapy (NRT) during hospitalization and upon discharge, and for referral to the Wisconsin Tobacco Quit Line (WTQL) at discharge. Eligible patients received the smoking cessation intervention unless they actively refused (ie, "opt-out"). The program was pilot tested in phases, with pharmacist feedback between phases, and then implemented hospital-wide. Interviews, surveys, and informal mechanisms identified ways to improve implementation and workflows. Results: Feedback from pharmacists led to changes that improved workflow, training and patient education materials, and enhanced adoption and reach. Refining implementation strategies across pilot phases increased the percentage of eligible smokers offered pharmacist-delivered cessation support from 37% to 76%, prescribed NRT from 2% to 44%, and referred to the WTQL from 3% to 32%. Conclusion: Hospitalizations provide an ideal opportunity for patients to make a tobacco quit attempt, and pharmacists can capitalize on this opportunity by integrating smoking cessation treatment into existing inpatient medication reconciliation workflows. Pharmacist-led implementation strategies developed in this study may be applicable in other inpatient settings., Competing Interests: Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2021.)