Abstract
Learning healthcare systems have recently emerged as a strategy to continuously use experiences and outcomes of clinical care for research purposes in precision medicine. Although it is known that learning healthcare transitions in general raise important ethical challenges, the ethical ramifications of such transitions in the specific context of precision medicine have not extensively been discussed. Here, we describe three levers that institutions can pull to advance learning healthcare systems in precision medicine: (1) changing testing of individual variability (such as genes); (2) changing prescription of treatments on the basis of (genomic) test results; and/or (3) changing the handling of data that link variability and treatment to clinical outcomes. Subsequently, we evaluate how patients can be affected if one of these levers are pulled: (1) patients are tested for different or more factors than before the transformation, (2) patients receive different treatments than before the transformation and/or (3) patients’ data obtained through clinical care are used, or used more extensively, for research purposes. Based on an analysis of the aforementioned mechanisms and how these potentially affect patients, we analyze why learning healthcare systems in precision medicine need a different ethical approach and discuss crucial points to consider regarding this approach.
Highlights
The first way in which patients can be affected by an Learning Healthcare Systems (LHSs) transformation in precision medicine relates to the type and scope of testing that patients receive in clinical care
To protect patients from risks and to honor widely acknowledged standards of autonomous decision-making in genetics, careful additional procedures need to be put in place to navigate LHSs in precision medicine
The challenges related to precision medicine LHSs may well exceed the challenges posed by earlier examples of LHS reform described in the literature
Summary
Ethicists who came out in favor of learning healthcare transformation have responded to these concerns by pointing out that this transformation can be used as an impetus for revising the incumbent ethical framework They have posited that learning health care is an opportunity to overcome (unjustified) discrepancies between protections for research participants and patients. In line with the initial 2007 report on the LHS by the US Institute of Medicine, many previous contributors to the debate have focused on comparative effectiveness research involving standard-of-care interventions (e.g., various antihypertensives that are prescribed interchangeably) [1,15] It is not self-evident that these previously published ethical evaluations of the LHS are applicable to LHSs in precision medicine, which is a rapidly evolving and relatively new field. Precision medicine is obviously much broader, yet genomics is a key driver of many precision medicine innovations and has been acknowledged as a central feature of LHS transformation in precision medicine [16,17,18]
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