JMIR Publications

ABSTRACT

Background:

Technological advances have radically changed the opportunities for individuals with chronic conditions to practice self-care and co-produce healthcare (co-care) and research. Digital technologies enable patients to perform tasks traditionally carried out by healthcare professionals in a more convenient way, at lower costs, and without compromising quality. There is an urgent need of legal frameworks that promote the sharing of patient-controlled real-world data (RWD) with other stakeholders to promote individual and population health, while respecting data privacy and control. We believe that the conceptualization of distributed patient-controlled RWD as a commons (i.e., a resource that is shared by a group of people) is valuable in the development of such a framework.

Objective:

To describe patient-controlled RWD commons in chronic care management and propose a conceptual model for the sharing of patient-controlled RWD in a way that supports individual and population health, while respecting personal data privacy and control.

Methods:

An action research approach was used to analyze and describe how a mobile patient support system (PSS) has enabled the sharing of patient-controlled RWD with multiple stakeholders across different settings in the context of cystic fibrosis (CF) care in Sweden, in particular to support the orderly introduction and follow-up of a new disease-modifying therapy. Based on the theory of knowledge commons introduced by Hess and Ostrom, we developed a conceptual model that illustrates how the specification of stakeholder groups (arenas) with different property rights can support the development of ethically and legally viable health information exchanges.

Results:

A conceptual model with three arenas for patient-controlled RWD collection, use and sharing was developed: 1) the Patient World Arena, comprising the private sphere of patients and families living with cystic fibrosis; 2) the Clinical Microsystem Arena, comprising the professional sphere at frontline healthcare clinics; 3) the Round Table Arena, comprising multiple stakeholders from different settings. Based on the property rights presented in our model, the patient has control over personal health information and can grant use rights to other stakeholders. The sharing of patient-controlled RWD in the analyzed case has contributed to the implementation of a national system for the orderly introduction and follow-up of new therapies.

Conclusions:

Ethically viable health information exchanges for sharing patient-controlled RWD are pivotal to enable patients, healthcare professionals, healthcare funders, researchers, authorities and industry to co-produce high quality care and manage the introduction and follow up new health-promoting interventions. Our model emphasizes the patient with access to novel health technologies as the core agent to control how personal health information is shared to the benefit of individual and population health.