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. 2020 Jan 13;4(3):e10211.
doi: 10.1002/lrh2.10211. eCollection 2020 Jul.

Learning health care systems: Highly needed but challenging

Roel H P Wouters  1 , Rieke van der Graaf  1 , Emile E Voest  2 , Annelien L Bredenoord  1
Affiliations

Learning health care systems: Highly needed but challenging

Roel H P Wouters et al. Learn Health Syst. .

Abstract

Background: Learning health care systems (LHSs) have the potential to transform health care. However, this transformation process faces significant challenges.

Materials and methods: Based on proposals and early examples of LHSs in the literature and conceptual analysis of the LHS mission, we provide four models with distinct organizational and ethical implications that may facilitate the transformation.

Results: An LHS could be developed in the following ways: by taking away practical impediments that prevent patients and professionals from engaging in scientific research (model 1: optimization LHS); by routinely analyzing observational data from electronic health records and other sources (model 2: comprehensive data LHS); by making clinical decisions based on the outcomes of the aforementioned data analyses and directly evaluating the outcomes in order to continuously improve decision-making (model 3: real-time LHS); or by embedding clinical trials into routine care delivery (model 4: full LHS).

Conclusions: Each model has different ethical implications for consent and oversight. Also, the four-model approach shows that reorganizing a health care center into an LHS is not an all-or-nothing decision. Rather, it is a choice from a menu of possibilities. Instead of discussing the advantages and disadvantages of the LHS menu in its entirety, the medical community should focus on the designs and ethical aspects of each of the separate options.

Keywords: health policy; informed consent; learning health care system; learning health system; research ethics.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
A schematic overview of comprehensive data, real‐time and full LHSs
See this image and copyright information in PMC

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