Robinson Bradshaw

Category: Health

A Lawyer’s Guide to CRISPR Gene Editing

In October 2018, I chaired a North Carolina Law Review Symposium on the ethical, legal and policy implications of gene editing. The collected papers from the Symposium are about to appear in a special issue of the Review (v. 97, 2019). In that issue, authors from diverse disciplines explore gene editing’s significant implications for law, […]

Possible Stark Law Reform Could Enable Greater Flexibility for Coordinated Care Models

The Centers for Medicare and Medicaid Services (CMS) is once again requesting feedback from health care industry stakeholders in connection with possible future revisions to the federal physician self-referral law (Stark Law). As shown by its recent request for information (RFI), CMS continues to recognize the need for greater flexibility for coordinated care arrangements (such […]

Proposed FDA Precertification Program Streamlines Review Process and Brings SaMD to Market Faster

The U.S. Food & Drug Administration (FDA) recently released an initial working model for its Software Precertification Program. The FDA proposed the precertification program to create a more efficient process for vetting and approving medical software and device developments, specifically for developers of Software as a Medical Device (SaMD). The model should appeal to mobile […]