Privacy and Security Research Scenario Initiative and Legal Analysis and Ethics Framework Development project

This project addresses how health information derived from a wide variety of data sources can be used for patient-centered outcomes research (PCOR) and comparative effectiveness research (CER), consistent with ethical principles and legal and regulatory requirements related to patient consent, privacy, and autonomy. The first phase of our project will focus on developing research data use scenarios through collaboration with PCOR researchers, patients, providers, health IT technologists, privacy experts, and legal experts. The research data use scenarios will be distilled into use cases that outline the legal, policy, and ethical requirements. The use cases will be carefully constructed to include the actors, pre-conditions, post-conditions, goals, workflow, tension points, etc. related to each issue. The second phase will focus on developing the aforementioned framework that addresses the legal and regulatory requirements and ethical principles governing the use of health information for PCOR and CER. The two phases will utilize an online project collaboration space, which will facilitate the sharing of project documents so that the work of each phase will inform the other.