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CMS Finalizes The Increasing Organ Transplant Access Model

The Increasing Organ Transplant Access Model ("IOTA Model") introduces mandatory financial incentives and penalties for selected kidney transplant hospitals....more

FDA Final Rule: IRB Waiver of Informed Consent for Minimal-Risk Investigations

The Food and Drug Administration ("FDA") expands informed consent exceptions with a final rule permitting institutional review board ("IRB") waiver or alteration of elements for certain FDA-regulated minimal-risk clinical...more

OIG and CMS Modify AKS Safe Harbor and Stark Law Exception for EHR Donations

The Situation: In light of the now widespread adoption of electronic health records ("EHR") technology, the U.S. Department of Health and Human Services Office of Inspector General ("OIG") and Centers for Medicare & Medicaid...more

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