Robinson Bradshaw

Author: Jennifer Hutchens

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 […]

Comment on ACB v. Thompson Medical

In a recent conversation with John Conley about his April 25 post on the ACB v. Thompson Medical ruling by the Court of Appeal of Singapore, I made a couple of points, and he asked me to write them up to briefly comment on the topic for the Genomics Law Report. First, the real damage caused […]

Removing the Cables: New FCC Rule Paves Way for Utilization of Wireless Medical Technology

Amit Bhagwandass is a rising third-year student at University of North Carolina School of Law. New rules adopted by the Federal Communications Commission (FCC) have an appreciable impact on the way that hospitals, nursing homes and other inpatient and outpatient health care providers will monitor their patients in the future. The new FCC rules enable […]

Don’t Forget About State Law: Michigan Decision Reminds Health Care Providers of HIPAA Preemption Issue

Phillip C. Ross is a summer associate at Robinson, Bradshaw & Hinson, P.A. and a rising third-year student at Wake Forest University School of Law. Many health care providers and other individuals and entities who deal with sensitive patient information may assume that if they comply with the Health Insurance Portability and Accountability Act (“HIPAA”), they […]