By Leslie Francis Cross-post from HealthLawProf Blog The President’s Council of Advisors on Science and Technology (PCAST) has issued a report intended to be a technological complement to the recent White House report on big data. This PCAST report, however, is far more than a technological analysis—although as a description of technological developments it is wonderfully accessible, clear…
By The Petrie-Flom Center The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to announce an upcoming collaborative academic symposium: Emerging Issues and New Frontiers for FDA Regulation Monday, October 20,…
By The Petrie-Flom Center The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to announce an upcoming collaborative academic symposium: Emerging Issues and New Frontiers for FDA Regulation Monday, October 20, 2014 Washington, DC We are currently seeking…
By Timo Minssen Following the approval of the European Parliament (EP) earlier last month, the Council of the European Union (the Council) adopted on 14 April 2014 a “Regulation on clinical trials on medicinal products for human use” repealing Directive 2001/20/EC. As described in a press-release, the new law: “aims to remedy the shortcomings of…
By Timo Minssen Three weeks ago I blogged about my recent review of “Pharmaceutical Innovation, Competition and Patent Law – a Trilateral Perspective” (Edward Elgar 2013). The full review, which is forthcoming in a spring issue of European Competition Law Review (Sweet Maxwell), is now available at SSRN: https://ssrn.com/abstract=2396804.
By Timo Minssen I am pleased to announce that we have today published the following paper: Minssen, Timo and Wested, Jakob Blak, Standardization, IPRs and Open Innovation in Synthetic Biology (February 14, 2014). Available at SSRN. This brief book contribution stems from a presentation given at the 2013 conference “Innovation, Competition, Collaboration” at Bucerius Law School, Hamburg, Germany. It…
By Nicolas Terry I recently posted this draft on SSRN. Feedback much appreciated. Here is the abstract: Fragmentation and lack of coordination remain as some of the most intractable problems facing health care. Attention has often alighted on the promise of Health care Information Technology not least because IT has had such positive impact on…
By Michael S. Young On December 12, a bipartisan bill entitled the Excellence in Diagnostic Imaging Utilization Act of 2013 (HR 3705) was introduced in the House of Representatives which would require clinicians to use electronic clinical decision support tools (CDS) before ordering advanced diagnostic imaging tests for Medicare patients. Structured around appropriate use criteria developed by…
By Nicolas Terry The political ripples from the poorly managed exchange roll-out likely will endure through at least one election cycle. Maybe, late night comedians will run out of material sooner. While criticism and inquiry are appropriate given the foreseeable nature of the problem (some months ago at SEALS even I was moved to highlight the…
By Michael Young It is estimated that 500,000 patients are discharged from U.S. hospitals against the recommendations of medical staff each year. This category of discharges, dubbed discharges against medical advice (DAMA), encompasses cases in which patients request to be discharged in spite of countervailing medical counsel to remain hospitalized. Despite safeguards that exist to ensure that…
