JMIR Publications

ABSTRACT

Background:

A Learning Healthcare System (LHS) approach may be considered one of the most promising ways to enable implementation of clinical improvements based on newly generated scientific knowledge for key areas of unmet need. For example, for the group of pregnant and lactating people, for whom there is still a poor evidence base for medication safety and efficacy. Combining unique data sources across Europe in an LHS could help clarify how medications impact pregnancy outcomes and lactation exposures. These unique data sources, also called Data Access Providers (DAPs), typically have volumes of routine (health) data in their organizations and they often have valuable expertise for handling such vast amounts of data. Furthermore, it is expected of these DAPs to handle data in an ethical way and to respect ethical principles such as transparency, trustworthiness, responsibility, and community engagement. Although there are greater expectations on DAPs to think about the ethical use of data, it does not necessarily mean that they have a dedicated governance structure to safeguard these principles or that they feel a moral actor in an LHS. Moreover, these organizations may also have different reasons for collaborating.

Objective:

In this paper, we aimed to explore the views of people working for/as DAP who participate in a public-private partnership.

Methods:

By means of a qualitative interview design, we interviewed 14 people who participate in the Innovative Medicine Initiative (IMI) ConcePTION project, which aims to build an LHS for pregnant and lactating people. The pseudonymized transcripts were analysed thematically.

Results:

The respondents typically viewed the collaboration as an opportunity for many reasons beyond the goal of creating knowledge on the safety of medication used during pregnancy and lactation. The opportunities included collaborating with and learning from other experts, stimulating scientific research, presenting the database, and securing financial support. Respondents have different interpretations of responsibility in the context of data intensive research in a public-private network. Respondents explained that resources (financial and other), scientific output, motivation, agreements regarding the participation of the pharmaceutical industry, trust, and transparency are important conditions for participating and committing to the ConcePTION LHS. Respondents also discussed the challenges for an LHS, such as the limitations to (real-world) data analyses and governance procedures.

Conclusions:

Our respondents want to contribute to an LHS for pregnant and lactating people and while they acknowledge their role and responsibility, their focus was primarily on their work and contribution to the project rather than safeguarding ethical data handling and data ownership.The results of our interviews describe underline the importance of a transparent governance structure and they provide stepping-stones for the development of a sustainable learning healthcare system.