Data Sharing That Enables Postapproval Drug and Device Research and Protects Patient Privacy: Best Practice Recommendations

This book chapter evaluates the three HIPAA-compliant pathways for sharing health data in postapproval drug and device research — limited data sets, safe harbor deidentification, and expert determination — and identifies key limitations of each for pharmacoepidemiologic studies. The authors propose best practice recommendations for the underutilized expert determination pathway, including proportional risk thresholds, routine modeling of reidentification attack scenarios, and use of data-use agreements to balance research utility with patient privacy.