A new study by Consortium collaborator Kingshuk Sinha illustrates troubling lags in the recall of flawed medical devices. In the paper, Prof. Sinha, a professor in the University of Minnesota's Carlson School, "applied digital analytics to millions of medical device product reports and recall records" to reveal what Sinha calls "under-reaction bias," according to the Minneapolis Star Tribune. The article details efforts by the Food and Drug Administration to use data-mining to improve surveillance of health technology. However, despite robust evidence that problem devices can have significant negative health effects, such adverse-event reports aren't consistently sought or entered into the federal tracking system, known as MAUDE. Prof. Sinha was one of the presenters in the recent Deinard Memorial Lecture on Law & Medicine, How Patients Are Creating Medicine’s Future, during which he shared Big Data and supply chain perspectives on health improvement; a video of that event can be viewed here.
This innovative 3-year project, based cooperatively at the University of Minnesota and Vanderbilt University, has convened a national Working Group of top legal and scientific experts to analyze current federal and state law and regulation on translational genomics and to generate consensus guidance on what the law should be. The project team will build a searchable online database of relevant law and an annotated bibliography for free public access, systematically collect and analyze a range of stakeholder inputs, convene a national public conference, and publish analyses and recommendations to help shape the law to support genomic medicine.