The Ethics of the Learning Health System

The future of health care will almost certainly involve the proliferation of learning health systems (LHS), in which patient data, collected at the point of care, are regularly analyzed to improve care delivery. LHS activity tends to blur the distinctions between research, treatment, and quality improvement, raising important ethical questions regarding proper oversight.

An article posted on the Health Affairs Blog explores these ethical challenges inherent in LHS activity. One of the primary questions is how institutional review boards (IRBs) should handle oversight of the LHS. IRBs will have to determine when LHS activities are exempt from review and when informed consent can be waived, decisions usually determined on the basis of whether the proposed activity is considered research or treatment. The article describes a paradigm shift, put forth by a team led by Hopkins inHealth affiliates Nancy Kass and Ruth Faden*, that suggests IRB decisions should instead be guided by whether LHS activity involves high or low risk to patients. The article doubts whether this new paradigm is necessary; alternatively, they propose the creation of IRBs with specialized expertise in LHS activities and communication with patients about the importance of “systematic learning.”

Regardless of which approach the health care research community selects to manage oversight of the LHS, it is clear that a consensus needs to be reached soon to facilitate the rapid learning and care improvement anticipated from LHS activity.

*Click here to learn more about inHealth’s patient consent research. 

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