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Privacy & Data

Data Sharing and Reuse for Learning in Health Care is Doable – Really!

Building a health care system that helps keep people healthy and effectively treats them when they get sick, at a cost we can all afford, requires the capability – and a willingness – to learn rapidly from “big” data. This comes from sharing the clinical data that is generated through day-to-day patient encounters in the health care system, and optimizing reuse of clinical data is key to achieving a reformed health care system. Yet all of this triggers numerous legal and ethical challenges related to data stewardship and governance.

For some, these challenges have proven to be insurmountable barriers to reuse of data for “learning” purposes. But others – through diligence and careful navigation of applicable rules, ethical norms, and different operating cultures – have managed to build successful “learning” health care data networks. Our paper, Pathways to Success for Multi-Site Clinical Data Research, which was published last week in the open-access journal eGEMs (Generating Evidence & Methods to improve patient outcomes), tells the story of nine such initiatives.

Gleaned through in-depth phone interviews and in-person discussions, the paper describes the strategies deployed by each initiative to overcome resistance and satisfy ethical and legal requirements on research and quality improvement uses of health information. Although each initiative has its own story, there were some common strategies deployed by many: capitalizing on pre-existing relationships with trusted partners; starting slowly and expanding over time; developing legal and policy documents with sufficient participant input; exchanging de-identified rather than personally identifiable data; and structuring governance bodies carefully and with effective representation.

The experiences of these nine initiatives demonstrate that re-use of clinical data frequently is not easy – but it is also not impossible. Our hope is that reading about the experiences of successful initiatives where data-sharing is occurring in privacy-protective, legally compliant ways will serve as validation and inspiration for a broad array of entities, yet in particular those who are smaller, less-experienced and less-resourced, yet who also aspire to contribute to the learning health care system.

The paper, which was commissioned by the Electronic Data Methods (EDM) Forum, does not attempt to catalogue the full spectrum of governance issues that could potentially surface in the course of multi-site research. Rather, its goal is to provide a snapshot in time of the data-sharing challenges and navigation strategies utilized by these particular initiatives.

It also provides a foundation and framing for a broader community resource on governance – a “governance toolkit” – that is intended to create a virtual space for the further discussion and sharing of promising practices. Hosted and curated by the EDM Forum, the site has already collected a number of shareable resources that can be adapted by individual sites and initiatives. This toolkit is intended to endure beyond the shelf-life of any one paper or study, serving as a living resource to support the ever-evolving learning health system.