Article by Melissa A. Haendel et al: “It can take many years for evidence generated in research to influence health care guidelines . Meanwhile, the vast data collected during everyday life, particularly during engagement with the health care system, remain largely untapped for public health, precision medicine, postmarket safety, and real-time decision-making. These “real-world data” (RWD) remain fragmented, proprietary, noninteroperable, and inconsistently governed. Although some approaches to RWD have demonstrated value in limited settings, their impact has remained constrained by uneven incentives, voluntary compliance, and the absence of routine auditability of data access and use. To address this, health data should be governed through federated, standards-based, community-driven models that reflect their public benefit, empower patients and communities, and foster public trust and participation. To help achieve these goals, we propose governing health data as essential infrastructure by using public utility models, defined by their public good, distributed stewardship, and public oversight.
Recently, the US Advanced Research Projects Agency for Health (ARPA-H) requested information on economic models that could lower barriers to data access, enable research, and compensate vendors to realize a health data public utility. Existing infrastructure already includes distributed data networks, publicly funded research enclaves, and privately funded platforms, and recent public and private investments have created new entrants that are improving access to health data. We argue, however, that these efforts remain limited by fragmented incentives and governance and must be complemented by reimagining legal, regulatory, and economic policies under a public utility model. Although most challenges and examples described here are drawn from the United States, the underlying lessons and opportunities are globally applicable. In this context, a public utility model addresses persistent barriers to integration, investment, and governance by converting voluntary participation into enforceable obligations, aligning financial incentives with interoperability, and embedding accountability within continuous public oversight…(More)”.
