As biopharma and med-tech companies grapple with restrictive data privacy laws in the EU and China while trying to meet the demand for greater diversity reflective of the U.S. population, there’s been more of an interest in conducting clinical trials in the U.S., Stacy Amin, a partner at Morrison & Foerster LLP, told BioWorld.
As biopharma and med-tech companies grapple with restrictive data privacy laws in the EU and China while trying to meet the demand for greater diversity reflective of the U.S. population, there’s been more of an interest in conducting clinical trials in the U.S., Stacy Amin, a partner at Morrison & Foerster LLP, told BioWorld.
The U.S. Federal Trade Commission (FTC) has been moving aggressively on privacy issues in connection with health data in the past two years, but the agency has issued an advisory of sorts to collectors of these data points. The FTC said July 11 that it intends to crack down on violators in an effort to protect data privacy.
As a growing roster of nations moves to protect individual genomic and other health data in the name of privacy under the General Data Protection Regulation in the EU and similar laws elsewhere, chief aggregators of such data, drug developers, are struggling.
As a growing roster of nations moves to protect individual genomic and other health data in the name of privacy under the General Data Protection Regulation in the EU and similar laws elsewhere, chief aggregators of such data, drug developers, are struggling.
South Korea plans to create a bio data dam, a step toward generating the necessary industrial ecosystem in the country’s bid to become one of the top seven players in the global medical device market by 2025.
A data-blocking rule set to go into effect in the U.S. April 5 could make it easier for sponsors to get the real-world data they need to demonstrate postmarket evidence of the safety and efficacy of their drugs and devices and to develop future products.
DUBLIN – The ongoing legal uncertainty surrounding the transfer of data from European research institutions or companies to international partners shows little sign of resolution, despite the urgency of the COVID-19 pandemic, which has engendered an extraordinary collaborative response from the global scientific community.
