By Michelle Meyer This is the second post in Bill of Health‘s symposium on the Law, Ethics, and Science of Re-Identification Demonstrations. We’ll have more contributions throughout the week, and extending at least into early next week. Background on the symposium is here. You can call up all of the symposium contributions by clicking here…
By Michelle Meyer This is the first post in Bill of Health‘s symposium on the Law, Ethics, and Science of Re-Identification Demonstrations. We’ll have more contributions throughout the week. Background on the symposium is here. You can call up all of the symposium contributions by clicking here (or by clicking on the “Re-Identification Symposium” category…
By The Petrie-Flom Center
By Michelle Meyer Over the course of the last fifteen or so years, the belief that “de-identification” of personally identifiable information preserves the anonymity of those individuals has been repeatedly called up short by scholars and journalists. It would be difficult to overstate the importance, for privacy law and policy, of the early work of…
By Elizabeth Pike and Kayte Spector-Bagdady [Posted on behalf of Elizabeth Pike and Kayte Spector-Bagdady from the Presidential Commission for the Study of Bioethical Issues – and cross-posted here.] In the most recent issue of the Hastings Center Report, Drs. Amy Gutmann and James Wagner of the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission), contributed to the lively…
By The Petrie-Flom Center
By Michelle Meyer [This is off-the-cuff live blogging, so apologies for any errors, typos, etc] Day two of PFC’s FDA in the 21st Century conference begins with a morning plenary by the very fabulous Alta Charo, of the University of Wisconsin Law School, who is speaking on “Integrating Speed and Safety.” Today Alta is presenting what…
By I. Glenn Cohen [This is off-the-cuff live blogging, so apologies for any errors, typos, etc] Panel 1: FDA in a Changing World: Lewis Grossman, Ted Ruger, Barbara Evans, moderated by Holly Fernandez Lynch Lewis Grossman, FDA in the Age of the Empowered Consumer Begins his analysis by comparing a hypothetical consumer in 1960 and…
The New England Journal of Medicine has two new commentaries out on the SUPPORT study and arguing that OHRP has things all wrong – in a dangerous way. From the editors: “[OHRP’s] response is disappointing, because it does not take into account either the extent of clinical equipoise at the time the study was initiated…
By Holly Fernandez Lynch On Monday, the World Medical Association opened a 2-month public consultation on proposed revisions to the Declaration of Helsinki. The Declaration was most recently revised in 2008, and according to the WMA, the current round of proposed changes is intended “to provide for more protection for vulnerable groups and all participants by…
