21st Century Cures Act

Currently, when orders are placed in Epic® and associated to a research study, the subsequent results are NOT released to the participant’s MyChart account.  The 21st Century Cures Act regulates how to share information with patients including research results. The law has provisions for holding results if the release would reveal the results of the study, hence we need the insight of the research team confirming the need to hold or release research results. 

What is changing?

On January 25th, 2023, UF Health will begin automatically releasing research-related results to participants’ MyChart accounts, unless doing so could affect the outcome of the study.  This change will not release research-related results retroactively.

What should I do if these releases will affect the outcome of my study?

When study-related results/information for a stigmatizing or blinded research study should not be released to a patient or other parties, the Epic® IT team can add a restriction type and a duration to the study record in Epic thus suppressing the sharing of information.  This ensures information that could affect the outcome of an in-progress research study is not included in any results releases or releases of information to patients and external parties.

Action Needed

A REDCap survey was sent to study teams (either study coordinators or principal investigator) where they could indicate whether their study should or should not allow the release of research-related results/information. This will assist us in appropriately configuring your study record in Epic. If your study team has not responded to the survey or you have further questions, please email scrogm@shands.ufl.edu. Please note that after January 25th, 2023, all results for patients enrolled in research studies will be released if the study team has not opted out.