Robinson Bradshaw

Topic: health data

EU Adopts New Privacy Shield for Data Transfers to U.S.

Back in April, we reported on some new developments in European Union law that have implications for the life sciences industry. One of these developments was in the privacy area—the final approval of the EU’s new General Data Protection Regulation (GDPR). The GDPR will have enormous significance for medical research and practice, since it will […]

Cleveland Clinic Pathologist Urges Contract Solution for Return of Genomic Data

The Cleveland Clinic’s Roger Klein responds to my previous GLR post: The Office of Civil Rights’ interpretation of the requirements of 45 CFR § 164 could pose problems for clinical laboratories and the professionals who practice within them. Although the issue of providing benign variants for a single gene, at least prospectively, would be straightforward, […]

UNC Geneticist Comments on Testing Laboratories’ Duty to Return Genomic Data to Patients

UNC’s Karen Weck responds to my previous GLR post: I agree in principle that patients have the right to access their genomic data; however, in practice it is much more complicated (as things often are). Giving a patient his/her raw sequencing data would be meaningless – it is the interpretation of the clinical significance of […]

mHealth on the Horizon: Federal Agencies Paint Regulatory Landscape with Broad Brushstrokes

For years, and with increasing frequency, health care and information technology companies have touted the potential of mobile medical and health applications and technologies to improve the quality and delivery of health care through the use of technology. While the future of mobile health (frequently referred to as “mHealth”) is undoubtedly filled with promise, the […]