By Dan Vorhaus [Cross-posted from Genomics Law Report] Three days of hearings by a House of Representatives committee concluded yesterday with a pledge from an FDA official to finalize long-awaited guidance on the regulation of mobile medical applications “in coming weeks“; at the latest by the end of the FDA’s fiscal year (i.e., September 30th). The hearings,…
By Adriana Benedict Today, Professor Glenn Cohen announced on this blog that he, in conjunction with two others, filed an amicus brief in AMP v. USPTO (Myriad), a case concerning Myriad’s patents on isolated DNA and cDNA. In a paper I have been writing on the natural phenomenon doctrine as applied to biotechnology patents, I…
By: Katie Booth The looming sequester will have a significant impact on health care, including cuts to Medicare, FDA, CDC, NIH, and Affordable Care Act programs. Budget cuts could slow down the drug approval process, impede the tracking of infectious diseases, and lead to layoffs for hundreds of thousands of workers in the health care…
By Adriana Benedict In December, I wrote a blog post noting that access to biomedical research is critical not only for informed patient care, but also for the sustainable development of pharmaceutical R&D responsive to local needs, especially in developing countries. In recent years, open access issues have taken on an increasingly important role in…
By Adriana Lee Benedict In a couple days, petitioners in AMP v. USPTO will be filing their brief on the merits following the Supreme Court’s grant of certiorari in late November. For many, the Supreme Court’s ruling in this case will provide a long-awaited answer to the question of whether or not isolated DNA is…
By Casey Thomson The flu, gun control, and legal action against the FDA – all amongst our Twitter feeds this past week. Read on for more: Frank Pasquale (@FrankPasquale) retweeted a link to the FDA’s current legal trouble concerning their failure to disclose antibiotic resistance data. The Government Accountability Project (GAP) is accusing…
By Casey Thomson This week’s Twitter Round-Up features an “American Idol-style” selection of research grant winners, the problems facing children in Syria attempting to be vaccinated, and a review of where we stand with current patient health information privacy and security. Michelle Meyer (@MichelleNMeyer) retweeted an article about a newly emerging landmark case in…
By Dan Vorhaus and Phil Ross (cross-posted from Genomics Law Report) For years, and with increasing frequency, health care and information technology companies have touted the potential of mobile medical and health applications and technologies to improve the quality and delivery of health care through the use of technology. While the future of mobile health (frequently…
By Casey Thomson From policy adoption at the federal level to debate over the health concerns of political figures, this week’s round-up focuses largely on the news for bioethics and health law in the realm of politics. Dan Vorhaus (@genomicslawyer) posted a feature on the history of gene patent litigation and implications for next-generation sequencing technologies.…
By Nicolas Terry Today the Office of the Inspector General (OIG) in the Department of Health and Human Services released a report, here, that is decidedly critical of CMS and ONC oversight of the Electronic Health Record (EHR) subsidy program. Over the last couple of years there have been growing criticisms of the Meaningful Use program and…
