Food and Drug Administration (FDA)

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OSEHRA 2018: Perspecta Sponsors Open Source EHR Summit

Press Release | OSEHRA | June 7, 2018

OSEHRA is delighted to welcome Perspecta as the Conference Sponsor for our 7th Annual Open Source Summit, to be held this July 18 – 20, 2018. Officially launched less than a week ago on June 1st, Perspecta was formed through a merger of the U.S. Public Sector Business of DXC Technology with Vencore Holding Corporation and KeyPoint Government Solutions. Those of you who follow the industry know that DXC Technology was the result of a massive merger of Computer Sciences Corporation (CSC) and HP Enterprise Services (which also included EDS). So, while the name is new, Perspecta will bring a wealth of experience (and yes, perspective!) to this year’s event.

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Other Resource 530 Chefs Call On White House To End Antibiotic Overuse On Industrial Farms

Staff Writer | Pew | September 27, 2013

This week, The Pew Charitable Trusts delivered a letter signed by 530 chefs (PDF) to Sam Kass, executive director of Let’s Move! and senior policy advisor for nutrition at the White House, urging the Obama administration to finalize policies to preserve the effectiveness of antibiotics and to protect people from resistant superbugs. Read More »

Out With the Old...Wait, Not in Health Care

The last company still manufacturing VCRs announced it has ceased their production. VCRs had a good run, most households had one, but their time has passed.  Meanwhile, the stethoscope is celebrating its 200th birthday, and is still virtually the universal symbol for health care professionals. There has got to be a moral in there somewhere. VCRs revolutionized our TV viewing experience. We could record television shows to not only watch programs at our own convenience, but we could also fast forward through commercials! We could watch the movies we wanted, when we wanted to, in the comfort of our own homes. Video rental outlets popped up everywhere, from boutique neighborhood stores to wildly successful chains like Blockbuster...

Overview of Major eClinical Trends and Clinical Research

Clinical research is well on its way to transforming its paper-driven model to an all things electronic format. During the past year, the clinical trial industry has made considerable progress in adopting technology as a way to streamline data collection, transmission, and monitoring. This article focuses on the top eClinical trends of 2015 and beyond. Among the latest developments- adoption rates are higher for electronic data capture (EDC), electronic source data (eSource), and eClinical integration, as the focus is now on capturing real-time data as a continuous stream. These trends are partially the result of high-tech devices, sensors and wearables entering the clinical trial industry, as well as the FDA embracing technology and opening up a dialogue with experts on how to best channel this revolution in order to advance clinical research.

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Pandemics Are the Mother of Invention

Many believe that the Allies won WWII in large part because of how industry in the U.S. geared up to produce fantastic amounts of weapons and other war materials. It took some time for businesses to retool and get production lines flowing, during which the Axis powers made frightening advances, but once they did it was only a matter of time until the Allies would prevail. Similarly, COVID-19 is making scary inroads around the world, while businesses are still gearing up to produce the number of ventilators, personal protective equipment (PPE), tests, and other badly needed supplies. COVID-19 is currently outnumbering these efforts, but eventually we'll get the necessary equipment in the needed amounts. Eventually. What intrigues me, though, is how people are innovating, inventing new solutions to the shortages we face. I want to highlight a few of these:

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Panel Emphasizes Safety in Digitization of Health Records

Steve Lohr | New York Times | November 8, 2011

Poorly designed, hard-to-use computerized health records are a threat to patient safety, and an independent agency should be set up to investigate injuries and deaths linked to health information technology, according to a federal study released Tuesday. Read More »

Personal Connected Health Alliance To Bring mHealth Worldwide

Jennifer Bresnick | EHR Intelligence | April 23, 2014

The Personal Connected Health Alliance (PCHA), a collaboration between HIMSS, Continua Health Alliance, and the mHealth Summit, officially launched this week with a mission to bring wearable health tracking devices, mHealth apps, mobile sensors, and other personal technologies to as wide an audience of patient-consumers as possible.  The Alliance hopes to promote the adoption, standardization, and necessary regulation of mHealth technologies, while empowering individuals to take charge of their own health.

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Pharmaceutical And IT Communities Collaborate On OASIS Clinical Trial Data Standard For Content Management Systems

Press Release | OASIS | March 20, 2014

The pharmaceutical community, health care organizations, and software providers are coming together at the OASIS open standards consortium to define a machine-readable content classification standard for the interoperable exchange of clinical trial data via content management systems. The work of the new OASIS Electronic Trial Master File (eTMF) Standard Technical Committee will promote interoperability across diverse computing platforms and cloud networks within the clinical trials community.

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Practical Approaches for Handling Drug Shortages

Ka Yiu Carmen Lam, Vaiyapuri Subramaniam and Vincent Calabrese | Pharmacy Practice News | December 1, 2011

According to the FDA, the number of drug shortages has nearly tripled over the last 6 years—jumping from 61 drug products in 2005 to 178 in 2010 and more than 200 in 2011.Such drug shortages, caused by a variety of factors...adversely affect drug therapy regimens, patient care, and health system finances. Read More »

PrecisionFDA: A Community Approach For Submitting & Evaluating Diagnostic Tests

DNAnexus has been awarded a research and development contract by the FDA’s Office of Health Informatics to build precisionFDA, an open source platform for community sharing of genomic information. precisionFDA is a new approach for evaluating bioinformatics workflows, and is an integral part of FDA’s work in better understanding diagnostic tests that incorporate next-generation sequencing (NGS) technologies. As a component of the White House’s Precision Medicine Initiative, precisionFDA’s streamlined approach to evaluating NGS-based diagnostics and creation of reference datasets will build a community around best-practices resources and democratize the submission process to the FDA.

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Re-Examining The FDA Antibiotics Decision: Banning Growth Promoters Won’t Be Enough

Maryn McKenna | Wired | December 27, 2013

In my first take on the news of the FDA finalizing its request to agriculture to stop using growth-promoter antibiotics, I promised to come back for a more thoughtful reaction. And then this happened, and this happened, and the holidays happened, and, well, it’s been a busy few weeks. Read More »

Report: FDA Documents Show Decade Of Unsuccessful Attempts To Control Farm Antibiotics

Maryn McKenna | Wired | January 28, 2014

A nonprofit group that has been using the courts to pressure the Food and Drug Administration into exerting more control over farm antibiotic overuse has done a deep review of FDA documents prised loose through Freedom of Information Act requests — and concludes that by allowing the drugs to remain on the market as formulated, the agency isn’t meeting its own internal safety standards. Read More »

Rise Of Superbugs Threatens Antibiotic Crisis

Ian Sample | The Guardian | January 24, 2013

Lethal drug-resistant organisms mean threat must be listed on register of civil emergencies, says chief medical officer Read More »

Robotic Surgery Opens Up

Larry Greenemeier | Scientific American | February 11, 2014

If the open-source approach to building robot surgeons can cut costs and improve performance, patients will increasingly find them at the other end of the scalpel Read More »

Save the Dates! National Health Code-A-Thon Calendar

Aman Bhandari and Steven Randazzo | Health 2.0 | September 25, 2012

The Department of Health and Human Services is interested in the development of innovative applications and solving critical social and health problems, and to help you optimize the opportunity you have to solve some of the most critical health issues this country faces we have developed HealthData.gov... Read More »