Food and Drug Administration (FDA)

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Mobile Health Technology: It's A Phone, It's An App, It's A…Medical Device?

Molly R. Berkery and Jed A. Roher | The National Law Review | August 18, 2016

As mobile health technology has proliferated, federal regulatory authorities have taken notice. In particular, over the last five years the U.S. Food and Drug Administration (FDA) has been honing its approach to mobile apps and has released a series of documents that provide helpful guidelines to developers of healthtech apps. In particular, the FDA sorts mobile apps into three buckets...

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Mobile Health: What Should Be Regulated And What Not?

Eric Wicklund | Healthcare IT News | July 27, 2012

With the mHealth industry anxiously awaiting the U.S. Food and Drug Administration's final draft of guidelines for mobile medical apps (expected by this fall), the talk at that particular panel discussion focused on what should be regulated and what shouldn't. Bakul Patel, a policy adviser for the FDA's Center for Devices and Radiological Health, pointed out that the market is flooded with apps – many of them harmless, but some of them potentially dangerous and in need of regulation.

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More Hospitals Are Ditching Antibiotics In The Meat They Serve

Eliza Barclay | NPR | January 12, 2016

Concern about the livestock industry's overuse of antibiotics has led a number of health care institutions to start choosing meat from animals raised without antibiotics whenever they can. According to Practice Greenhealth, a nonprofit that's helping the health care industry on this issue, more than 400 U.S. hospitals are working toward a goal of making 20 percent of their meat purchases "antibiotic-free." And around a dozen hospitals have already switched the majority of their chicken purchases to "antibiotic-free." And around a dozen hospitals have already switched the majority of their chicken purchases to antibiotic-free.

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Mortal Coils: Why We Must Stop Tolerating Failing Health Tech

Today, data are scattered across thousands of database tables within any single electronic medical record (EMR) system, but also across dozens of other systems that hold pharmacy data, imaging data, insurance data, laboratory data, etc. Pretty much none of it is available on demand in any given clinical setting. The inevitable result of this disconnected galaxy of data "black holes" is mistakes, or if not outright mistakes, well-intentioned missteps based on lack of background data within the acute-care setting.

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Mostashari Assures Patient Safety Plan Sooner than 12 Months

Mary Mosquera | Government Health IT | November 9, 2011

Dr. Farzad Mostashari, the national health IT coordinator, said that agencies in the Health and Human Services Department will work closely to craft a surveillance and action plan to keep patients safer through health IT, and it will be done sooner than called for by the Institute of Medicine. Read More »

Mostashari Says ONC Using Every Lever To Advance Exchange

Diana Manos | Government Health IT | March 21, 2013

Today in the third of three hearings held by subcommittees of the House Energy and Commerce Committee, Farzad Mostashari, MD, national coordinator for health IT reassured a congressional panel that health IT interoperability will take some dramatic leaps forward within the next two years. Read More »

National Medical Device Registries Task Force Recommends Partnerships to Build National System for Medical Devices

Press Release | Weill Cornell Medical College | August 24, 2015

The federal government and stakeholders interested in device innovation and evaluation should support the creation of a comprehensive partnership on medical devices to monitor the products' performance after they become commercially available, a Food and Drug Administration-initiated and independent national group of experts is recommending in a report. The recommendations call for a master network of data in each clinical area where devices are used. Information on medical devices does exist — in registries, electronic health records (EHR) and claims data — but the disparate locations make it difficult for regulators, doctors and patients to understand and use it efficiently. Yet millions of patients undergo surgery each year and require some type of medical device during the procedure.

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New Evidence That Sugar Is Harming Our Hearts

Alice G. Walton | Forbes | February 3, 2014

If the torrent of studies suggesting that sugar is bad for our health wasn’t quite enough, new research again suggests that added dietary sugar increases the risk of death from heart disease. Read More »

New Recall Management Tool Matches Alerts Directly to Hospitals' Equipment Inventory Data

Press Release | ECRI Institute | May 23, 2016

The faster a hospital responds to a product safety alert or recall, the safer its patients are. But with dozens of alerts and recalls issued every week by FDA, manufacturers, and other organizations, how can busy hospital staff quickly see which ones have the potential to affect their own patients?Today, ECRI Institute announces the release of Automatch™ for Equipment, the newest enhancement to its Alerts Tracker™ automated recall management solution used by hospitals and health systems worldwide...

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NIH Launches Database Of Liver Injury-Linked Drugs

Anthony Brino | Government Health IT | October 15, 2012

The National Institutes of Health (NIH) has launched a database of pharmaceutical drugs associated with liver damage. Read More »

NIH Showcases Informatics Researchers As New Open Source Ventures Launch

Anthony Brino | Government Health IT | November 9, 2012

After the National Institutes of Health grew interested in bioinformatics, following breakthroughts in the 1990s, the National Centers for Biomedical Computing were created with the goal of advancing the field by a few leaps and bounds, because IT systems hadn’t quite caught up to molecular biology. Read More »

NIH Unveils Precision Medicine, Genomics, Big Data Analytics Plan

Jennifer Bresnick | HealthIT Analytics | September 21, 2015

The National Institutes of Health (NIH) has published a detailed framework outlining its vision for the development of its Precision Medicine Initiative, a wide-ranging research program that hopes to integrate healthcare big data analytics, advances in genomics, and targeted therapies into real-world clinical applications...

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NSFW: Apple, iOS 8 Health, And The Gordian Knot Of Healthcare Bureaucracy

Peter Cohen | iMore | August 2, 2014

This year I've spent a lot of time in doctor's offices and I see what a giant mess the electronic health records (EHR) industry really is. And I don't think Apple's going to solve the problems facing the American healthcare industry...

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Nurses Warn Epic EHR Causes Serious Disruptions to Safe Patient Care at East Bay Hospitals

Press Release | California Nurses Association | July 11, 2013

Introduction of a new electronic medical records system at Sutter corporation East Bay hospitals has produced multiple problems with safe care delivery that has put patients at risk, charged the California Nurses Association today...In over 100 reports submitted by RNs at Alta Bates Summit Medical Center facilities in Berkeley and Oakland, nurses cited a variety of serious problems with the new system, known as Epic. The reports are in union forms RNs submit to management documenting assignments they believe to be unsafe. Read More »

NY Attorney General Confirms Real-Life Conspiracy Among Drug Companies

J.D. Heyes | Natural News | February 21, 2014

The office of the New York Attorney General and the American units of Ranbaxy Laboratories Ltd. and Teva Pharmaceutical Industries Ltd. have come to terms on a settlement involving claims that an agreement between the two Big Pharma companies restricted competition unlawfully. Read More »