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Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

A War on Patients: Panel Says EHRs Should Not Be Vetted Before Marketing and Deployment

thumbnail "First, do harm - it's a learning experience, and injured or dead patients are just a bump in the road, anyway" - the apparent...

Health Care Revolving Door Roundup

thumbnail Increasingly, the regulatory and law enforcement functions of the US government in the health care sphere seem to be blending with the manag...

Is ONC's definition of "Significant EHR Risk" when body bags start to accumulate on the steps of the Capitol?

thumbnail In a June 25, 2013 Bloomberg News article " Digital Health Records’ Risks Emerge as Deaths Blamed on Systems " by technology repor...

Six Years Later, Ranbaxy - Oops, Daiichi Sankyo - Pleads Guilty to Adulteration, Pays $500 Million

thumbnail It only took until 2013, but the US Food and Drug Administration finally secured guilty pleas and fines.  The basics are in an Associated Pr...

HIMSS Senior Vice President on Medical Ethics: Ignore Health IT Downsides for the Greater Good

thumbnail The Health Information Management Systems Society ( HIMSS ) is the large health IT vendor trade group in the U.S.  At a Sept. 21, 2012 HIMSS...

Old Mystery Solved? Former FDA Reviewer Speaks Out About Intimidation, Retaliation and Marginalizing of Safety

thumbnail At my Dec. 2005 post " Report: Life Science Manufacturers Adapt to Industry Transition " I wrote: ... The recognition of a gap in ...

Health IT FDA Recall: Philips Xcelera Connect - Incomplete Information Arriving From Other Systems

thumbnail Another health IT FDA recall notice, this time on middleware, an interface engine that routes data: Week of July 11 Product description:   P...

FDA: Software Failures Responsible for 24% Of All Medical Device Recalls

thumbnail At " FDA: Software Failures Responsible for 24% Of All Medical Device Recalls " via Kapersky Labs, a software security company, it...

WSJ "There's a Medical App for That—Or Not" - Misinformation on Health IT Safety Regulation?

thumbnail There's a health IT meme that just won't die (patients may, but not the meme). It's the meme that health IT "certification...

Doctors and EHRs: Reframing the "Modernists v. Luddites" Canard to The Accurate "Ardent Technophiles vs. Pragmatists" Reality

thumbnail One manner by which Healthcare's core values are usurped is via distortions and slander about physicians and other clinicians. At "...