In an article published in Annals of Internal Medicine, authors from the NIH Collaboratory describe concerns and solutions regarding data sharing and embedded research. Pragmatic research embedded in health systems uses data from the electronic health record and comes from a fundamentally different context than explanatory trials, which collect research-specific data. Data from embedded research have the potential to do harm if taken out of context or used for comparisons. Therefore, while the authors enthusiastically support data sharing, they also recognize that mandating data sharing may discourage health systems from volunteering to participate in embedded research.
“In an ideal world of transparency regarding healthcare processes and outcomes, health systems would have no expectation of or need for privacy regarding quality of health care delivery. But the current world is not perfect, and unintentional disclosures from participation in embedded research could be far greater than that required for public quality measures. Health systems volunteering to participate in research to improve public health may not be willing to bear the additional risk of misuse of sensitive information.” — Simon et al. Ann Intern Med
The authors use examples from the NIH Collaboratory Demonstration Projects to illustrate potential solutions, and emphasize that data sharing plans for embedded research should be developed in partnership with health system leaders in ways that maximize the amount of data that can be shared while protecting patient privacy and healthcare system interests.