Robinson Bradshaw

Stay in the Know

Privacy and IP Law Affecting Health Care, Research and IT

Newsletter Signup

Stay up to date on privacy news from Robinson Bradshaw

Sign Up
   Filter posts by:    

Some Thoughts on the New Common Rule for Human Subjects Research

On January 18, 2017, in one of its last official acts, the outgoing Obama administration issued a final revised version of the Common Rule—the regulation that governs the treatment of human subjects in all federally funded research. This was the culmination of a process that began in 2011 when the…

Continue reading

Williams v. Athena Motion to Dismiss Hearing—SC Supreme Court May Be Asked to Decide Whether a Diagnostic Laboratory Qualifies as a Healthcare Provider

Foreword by John Conley  Back on May 31, 2016, Contributing Editor Jennifer Wagner wrote a lengthy report on the newly filed case of Williams v. Quest Diagnostics, et al. As Jen recounted, plaintiff Amy Williams sued Athena Diagnostics and its corporate parent, Quest Diagnostics, alleging that Athena negligently misclassified a genetic…

Continue reading

Update on Chadam v. Palo Alto Unified School District

About a year ago we reported on a case involving allegations of genetic discrimination by a school district in California. According to the allegations, in fall 2012 the Palo Alto Unified School District used genetic information regarding cystic fibrosis in deciding to transfer a student away from his neighborhood school…

Continue reading

FTC Muscles in on Health Privacy

In its July 29, 2016 decision in LabMD, Inc., the Federal Trade Commission clearly signaled its intent to get more involved in the regulation of health privacy. Specifically, the case indicates that the agency intends to go well beyond its traditional role of protecting consumers against deception and to begin…

Continue reading

New Federal Trade Secret Act and Its Impact on Life Sciences

On May 11, 2016, a new federal trade secrets law called the Defend Trade Secrets Act (DTSA) took effect. Its primary impact is to allow the victims of trade secret misappropriation to sue in federal court. It also provides some new civil remedies that exceed what is usually available under…

Continue reading

FDA Issues Guidance for Next Generation Sequencing

On July 8, 2016, the FDA issued draft guidance on the subject of next generation sequencing (NGS) activities: (1) “Uses of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases” and (2) “Use of Public Human Genetic Variant Databases to…

Continue reading