TAG ARCHIVES FOR big data

13
Jun2019

In April, the Food and Drug Administration (FDA) issued a discussion paper, "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD).” The paper represents FDA’s response to the growing number of medical device manufacturers who are utilizing artificial intelligence and machine learning technologies to continuously improve their products. On June 3, PRIM&R submitted comments in response to the discussion paper, thanking the FDA for their consideration of the public health implications of the use of these technologies, but also cautioning that any new regulatory approach in this area must address the protection of individuals whose personal information and data are being used in the creation and ongoing testing of these technologies. Read more

3
Jun2019

data-rich networked information technologies are unique in that they represent people’s lives and activities, bridge multiple dimensions of a person’s life, and are often collected, aggregated, exchanged, and mined without them knowing. We call this data “pervasive data,” and the increased scale, scope, speed, and depth of pervasive data available to researchers require that we confront the ethical frameworks that guide such research activities. Read more

5
Apr2018

At PRIM&R’s 2017 SBER conference, I had the opportunity to sit in on the excellent didactic session, “Certificates of Confidentiality (CoCs) and National Institute of Justice (NIJ) Privacy Certificates,” given by Petrice Brown-Longenecker, PhD, CIP (Extramural Human Research Protection Officer, NIH); Elonna Ekweani, JD (Public Health Analyst, NIH); Mary Ramirez, MA, CIP (Assistant Director, Health Sciences and Behavioral Sciences IRB, University of Michigan); and Leslie E. Wolf, JD, MPH (Professor; Director, Center for Law, Health, and Society, Georgia State University College of Law). Read more

24
Aug2017

On March 1, 2017, PRIM&R held a day-long Ethics of Data Access, Use, and Sharing for Human Subjects Research Workshop in partnership with the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (MRCT Center). I am pleased to announce that the proceedings and other information from the day are now available on PRIM&R’s website. Read more

24
Feb2017

This week’s Research Ethics Roundup highlights the argument for treating medical data donations like organ donations, bioethicists’ suggestions for how to lower drug costs, how Australian animal researchers are using unpiloted drones, and the US Department of Agriculture (USDA)’s decision to re-publish a portion of the Animal Welfare Act records that they previously removed. Read more