Yesterday, the FDA issued a news release highly supportive of the clinical, regulatory, and financial value of RegenMed Circle Datasets.

Circle Datasets need no IRB or other outside validation beyond this clearly stated FDA policy.  They deliver exactly what the FDA is looking for: fit-for-purpose structure, correlated outcomes, statistical significance, and data provenance in the context of practice-of-medicine hypotheses and corresponding data.  To this are added clear ownership rights and compliant monetization opportunities for contributing physicians.