Linking Unique Identifiers (UDIs) to Insurance Claims: A Pilot Demonstration [Methods Study], Massachusetts and Pennsylvania, 2016-2021 (ICPSR 39635)
Medical devices, such as pacemakers or stents, can help diagnose, treat, or prevent health problems. Companies that make medical devices label them with unique device identifiers, or UDIs. UDIs contain data about a device, such as the make, model, and expiration date. Healthcare providers can scan UDIs when they use the devices and record UDI data in patients' health records.
Right now, UDI data can only be accessed by the health systems that use the devices. Having the UDI data in insurance claim forms, instead of only in patients' health records, would mean that researchers could look at data over time and across health systems. They could then use these data to help monitor devices for safety or study questions like how well devices are working.
In this study, the research team created ways to send UDI data from health systems to insurance claims forms.
Research Ethics in Patient-Centered Outcomes Research (PCOR) [Methods Study], United States, 2015-2019 (ICPSR 39567)
Patient-centered outcomes research, or PCOR, is a type of research that focuses on patient values and needs. PCOR includes patients in many parts of the research process, including helping to plan and conduct the study. Institutional Review Boards, or IRBs, oversee research studies to make sure patients participating in a study are protected from harm. But current IRB guidance may not address ethical issues that arise when patients are involved in other roles.
In this study, the research team created recommendations to guide IRB oversight of PCOR studies.