• Few Consequences for HIPAA Health Privacy Law's Repeat Offenders

    ProPublica |  Regulators have logged dozens, even hundreds, of complaints against certain health providers for violating federal patient privacy law, but sanctions are imposed only rarely.

    Dec 29, 2015

  • Why Preventing Cancer Is Not the Priority in Drug Development

    New York Times |  The structure of American drug patents and clinical trials skews profit incentives to favor the development of drugs for late stage cancer, even when these drugs provide only very small survival benefits.

    Dec 29, 2015

  • GE Healthcare Prepares for Cloud-Based Management of Medical Imaging

    Clinical Informatics News | With development partner University of Pittsburgh Medical Center, GE Healthcare is preparing to roll out the GE Health Cloud, where medical images can be stored, analyzed, and shared with a suite of in-house and third-party apps.

    Dec 22, 2015

  • UCB Uses Sinequa with Clinical Trial Data

    Clinical Informatics News | UCB has selected the Sinequa Big Data Search & Analytics Platform for use with its clinical trial file share. Using the Sinequa Platform, UCB is able to more effectively find data sets needed to answer questions arising in the lifecycle of drug development.

    Dec 18, 2015

  • Clinical Trials Still Don't Reflect the Diversity of America

    NPR.org |  Clinical trials are too white, with less than 2 percent of cancer studies including enough minority people to provide information that could be useful for health, a study finds.

    Dec 16, 2015

  • PerkinElmer, TIBCO Announce Clinical Data Review Product

    Clinical Informatics News | PerkinElmer announced a new analytics solution yesterday built with TIBCO Spotfire designed to help review teams, biostaticians, data managers, pharmacologists and others overcome clinical data review challenges.

    Dec 15, 2015

  • Federal Law Requiring Disclosure of Clinical Trial Results Is Routinely Flouted

    STAT |  A STAT analysis has found that many of the nation's top research institutions are not reporting clinical trial results as required by law.

    Dec 14, 2015

  • Novo Nordisk, IBM Watson Health to Create ‘Virtual Doctor’

    Wall Street Journal |  Novo Nordisk is teaming up with IBM Watson Health, a division of IBM, to create a "virtual doctor" for diabetes patients that could dispense treatment advice such as insulin dosage.

    Dec 11, 2015

  • Small-Scale Violations of Medical Privacy Often Cause the Most Harm

    ProPublica |  Breaches that expose the health details of just a patient or two are proliferating nationwide. Regulators focus on larger privacy violations and rarely take action on small ones, despite the harm.

    Dec 11, 2015

  • What’s Missing From Your Social Media Clinical Trial Recruitment Strategy

    Clinical Leader |  As social media becomes a permanent fixture in patients' lives and pharmaceutical companies' business strategies, companies are turning to social media to recruit patients. Here's what a social media recruitment strategy should include.

    Dec 9, 2015

  • Bill creating more orphan drugs would cost consumers billions

    STAT |  A 21st Century Cures Act provision allowing more medicines to receive orphan drug status will cost consumers billions of dollars, an analysis says.

    Dec 8, 2015

  • Orphan Drug Approval Process Inefficient, Confusing

    Clinical Informatics News | Last year was the first time that all of the orphan drugs approved by FDA—17 total—took advantage of the Priority Review option. But Priority Review is only one of four options available to developers of orphan compounds for expedited FDA review. In a paper published in September in The Journal of Rare Disorders, authors posit that this indicates that the options are neither fully understood by orphan drug companies nor are not being used optimally by them.

    Dec 7, 2015

  • New Draft Guidance on Best Practices for IND Communications Between Sponsors FDA

    RAPS |  Investigational new drug application (IND) sponsors communicating with the US Food and Drug Administration (FDA) during the various drug development phases now will have a new set of new best practices to consult with prior to their meetings thanks to draft guidance released by FDA on Friday.

    Dec 7, 2015

  • Should DNA donors see their genomic data?

    Nature News & Comment |  Geneticist Charles Danko turned to Twitter this week for help in convincing his IRB at Cornell that he should be allowed to let his study participants download their genetic information

    Dec 4, 2015

  • Sangamo Cleared by FDA to Begin First Gene Editing Clinical Trial

    New Scientist |  Sangamo BioSciences' gene editing therapy for hemophilia B, based on zinc finger nuclease technology, can go forward in the first study of such a therapy in humans.

    Dec 4, 2015