Posted by Admin | 12:54 PM

Our latest example of the interchangeability of top insiders within corporate health care and the government agencies that are supposed to r...

Labels: CMS, corporatism, DHHS, FDA, Johnson and Johnson, revolving doors

Posted by Admin | 6:54 AM

From http://www.healthit.gov/policy-researchers-implementers/federal-advisory-committees-facas/fdasia : The Food and Drug Administration Saf...

Labels: David Bates, ECRI Deep Dive Study, FDA, FDASIA Health IT Policy Committee Workgroup, healthcare IT dangers, healthcare IT deaths, healthcare IT defects, healthcare IT risk, ONC, premarket approval

Posted by Admin | 4:42 AM

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

Labels: David Bates, FDA, FDA Safety Innovation Act work group, health IT extremism, healthcare IT regulation, healthcare IT risk, Joseph Conn, Modern Healthcare, postmarketing sureveillance, premarket approval

Posted by Admin | 12:39 PM

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

Labels: conflicts of interest, FDA, health care corruption, Mylan, revolving doors, Teva, US Department of Justice

Posted by Admin | 9:03 AM

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

Labels: Abington Memorial Hospital, Bloomberg News, ecri institute, FDA, healthcare IT risk, IOM Committee on Patient Safety and Health Information Technology, Jodi Daniel, Jordan Robertson, ONC, prior restraint

Posted by Admin | 11:40 AM

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...

Labels: adulterated drugs, adverse effects, crime, Daiichi Sankyo, FDA, manufacturing problems, outsourcing, Ranbaxy

Posted by Admin | 5:55 AM

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...

Labels: FDA, healthcare IT risks, HIMSS, IOM, IOM Committee on Patient Safety and Health Information Technology, John Casillas, medical ethics

Posted by Admin | 4:16 PM

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

Labels: CDER, FDA, regulatory capture, retalation, whistle-blowers

Posted by Admin | 9:02 AM

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

Labels: FDA, FDA recall, healthcare IT risk, Philips Medical, Philips Xcelera Connect

Posted by Admin | 6:09 PM

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

Labels: FDA, FDA Office of Science and Engineering Laboratories, healthcare IT dangers, medical devices, sale of known defective software, software glitch

Posted by Admin | 1:27 PM

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...

Labels: electronic medical records, FDA, healthcare IT certification, healthcare IT regulation, healthcare IT safety, ONC, ONC ATCB, Wall Street Journal