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How Rare Disease Communities' Participation in Data Trust Governance Builds Trust & Drives Research

By: Samantha C. Smith

Data sharing plays an increasingly prominent role in society, but it remains a necessary component of rare disease research. Because rare diseases are—as the name indicates— rare, researchers have only a small number of patients from whom to collect data, and the expense of cross-border data sharing to increase research data is significant. Nevertheless, the rise of artificial intelligence and precision medicine increases the need for usable rare disease data. Current legislation and regulations aimed at addressing rare diseases fall short in addressing these data sharing needs for rare disease research. While the European Union (EU) has invested in rare disease data sharing more than most of the world, its programs are fragmented and limited to the rare disease community.

Simultaneously, data is becoming increasingly viewed as a necessary component of a competitive economy, driving interest in data sharing platforms and initiatives, including the EU’s new Trusted Secure Data Sharing Space (TRUSTS) initiative. Perhaps the most promising instrument for data sharing is the data trust, but it suffers from an undefined and uncertain legal structure. This Note suggests that the rare disease community should embrace these broader data sharing initiatives in order to ensure the representation of rare disease data in these data sets and to harness the power of large-scale data sharing. Simultaneously, data trusts should look to rare disease communities for representation in their governance structures in order to establish the patient-centricity and public trust necessary for data trusts to thrive in an uncertain legal environment.


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