• New Rules for Clinical Trials in China

    Outsourcing Pharma | The Chinese government implemented additional regulations last month for clinical trials and the hospitals that conduct them. The new measures--Administrative Measures for the Clinical Study Projects of Medical Institutions--supplement current research regulations

    Nov 10, 2014

  • EHR Audits to Increase Next Year

    Healthcare IT News | The Office of the Inspector General will focus on EHR fraud in 2015, the office's work plan reveals, which means more EHR audits for groups who have received EHR incentive payments from CMS and their business associates.

    Nov 7, 2014

  • Foundation Medicine's Data Experiment to Prove Clinical Utility

    Clinical Informatics News | Foundation Medicine highlighted several recent industry wins yesterday including a data partnership that it hopes will further prove the business case for the company’s two cancer diagnostic panel.

    Nov 6, 2014

  • The Dangers of Early Detection

    New York Times | In South Korea, aggressive screening for thyroid cancer has increased diagnoses fifteen-fold in just twenty years — illustrating the hidden risks and costs of seemingly benign early detection programs.

    Nov 6, 2014

  • October Clinical News and Product Briefs

    Clinical Informatics News | News and product releases from around the industry, including Geisinger Health System's 100,000 patient sequencing initiative, and IBM's Watson supercomputer at the Cleveland Clinic.

    Nov 4, 2014

  • Mobile Health at the Global Pediatric Innovation Summit

    Clinical Informatics News | At Boston Children's Hospital's second annual Global Pediatric Innovation Summit, a panel discussion on mobile and digital health took an optimistic, even futurist stance to the promise of technology, but also stressed the role of changing the culture of care providers in implementing real improvements.

    Nov 3, 2014

  • Shredding Paper, Saving Cash: Going Digital with a Cloud-Based eTMF

    Clinical Informatics News | Contributed Commentary | Adopting an electronic trial master file for collaborative clinical trials will be increasingly important for maintaining regulatory compliance in a cost-effective and timely manner — but also requires careful thinking about standard frameworks for use across trial stakeholders.

    Oct 30, 2014

  • Should Wealthy Patients Buy Their Own Clinical Trials?

    Mosaic Science | Author Alexander Masters delves into the legal and ethical obstacles to a plan for funding high-risk, rare-indication clinical trials: let the ultra-rich suffering from rare diseases fund trials that they or their loved ones can participate in.

    Oct 29, 2014

  • The Case Against Surrogate Endpoints

    MedPage Today | John Fauber and Elbert Chu examine the pharmaceutical industry's growing reliance on surrogate endpoints, like "progression-free survival," to gain approval of new drugs.

    Oct 27, 2014

  • ClinGen Opens Patient Portal for Genomic Health Information

    Clinical Informatics News Brief | The NIH-funded consortium ClinGen has partnered with Geisinger Health System to launch GenomeConnect, an online portal where patients who have undergone genetic testing can share their health histories anonymously with researchers and other, similar patients.

    Oct 24, 2014

  • Digital Signatures and Identities Fuel Collaboration

    Clinical Informatics News | As the biopharmaceutical industry turns to large, multimember collaborations through the cloud, digital signatures are becoming an essential security and authentication measure, creating a need for new global standards.

    Oct 23, 2014

  • Review Board Shares Insight Into GSK's Trial Transparency Program

    Clinical Informatics News | With patient-level data from over 1200 clinical trials at nine pharma companies now available through the GlaxoSmithKline-founded data sharing portal, the review board tasked with approving data access for researchers has published its initial thoughts on the system.

    Oct 21, 2014

  • Foundation Medicine Wins Insurance Coverage at Priority Health

    Clinical Informatics News | Foundation Medicine, provider of the FoundationOne tests for cancer mutations, has announced an agreement with Michigan-based insurer Priority Health to cover both of the company's flagship tests.

    Oct 17, 2014

  • Investigating Physician Satisfaction with EHRs

    Medical Economics | A survey of physicians finds that, despite widely aired concerns that electronic health records are interfering with clinical practice, a slight majority feel their patient care has benefited from implementing an electronic records system.

    Oct 16, 2014