February 23, 2021

In 2020, MDIC’s Clinical Diagnostics program launched the ‘Open Hand’ project, a process to pave a path for using IVD Real-World Evidence in regulatory submissions. The goals of this project are to provide a transparent process to evaluate new technology and methods; capture “the how” to share with broader community while staying in the pre-competitive space and protecting proprietary information; create educational modules on application of IVD RWE in the regulatory process; and to capture learnings in peer-reviewed publication. For more information or to participate in this project, please contact diagnostics@mdic.org.