Barbarians at the Gate: Consumer-Driven Health Data Commons and the Transformation of Citizen Science

Abstract

This article introduces consumer-driven health information commons, which are institutional arrangements to empower groups of consenting individuals to collaborate to assemble powerful, large-scale health data resources for use in scientific research, on terms the group members themselves would set through collective self-governance processes. Many of the grand scientific challenges of the 21st-century require access to big data resources that are both deeply descriptive (in the sense of containing detailed personal health, genomic, environmental, and lifestyle information about each individual) and inclusive (in the sense of supplying such data for many — sometimes, hundreds of millions — of individuals). These grand challenges include President Obama’s Precision Medicine and Brain Initiatives, the Vice President’s Cancer Moonshot, efforts by the National Institutes of Health and the Food and Drug Administration to clarify the clinical significance of genetic variants and to make modern diagnostics safe and effective, and attempts to create a “learning health care system” that harnesses healthcare data to improve patient care. Without big data resources, these efforts will fail.

Current research and privacy regulations, which were designed for clinical research and for small-data studies of the past, cannot support creation of the vast data resources that 21st-century science needs. These regulations enshrine data-holders (hospitals, insurers, and other entities that store people’s data) as the prime movers in assembling large-scale data resources for scientific use and rely on mechanisms — such as de-identification of data and waivers of individual consent — that are unworkable going forward. They shower individuals with unwanted, paternalistic protections — such as barriers to access to their own research results — while denying them a voice in what will be done with their data.

The barbarians — the people whose data scientific researchers wish to study — are at the gate demanding our right of democratic data self-governance. The atomistic vision of individual autonomy enshrined in 20th-century bioethics ultimately disempowered the very patients and research subjects it sought to protect, empowering them to make decisions as individuals, but only as individuals, and lacking a roadmap for collective action. Individuals acting alone are strong, but never as strong as individuals acting together. This article draws on the natural resource commons theory associated with Elinor Ostrom to propose an alternative approach that places consumers — patients, research subjects, and persons who track their health using mobile and wearable sensor devices — at the center of efforts to assemble large-scale data resources of the people, by the people, and for the people, who would themselves control the terms of use through collective self-governance processes.

Keywords: precision medicine, citizen science, data commons, privacy, interoperable health data resources