Robinson Bradshaw

Category: Regulation

The Strictest Data Privacy Law in the United States

On June 28, 2018, California’s Senate and Assembly unanimously approved the California Consumer Privacy Act of 2018 (CCPA), which will take effect Jan. 1, 2020, and will become the strictest data privacy law in the United States. The CCPA seeks to be far-reaching, both in terms of the companies affected and the content to be […]

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 […]