When sponsored CDS is a crime …
Today, The Department of Justice issued an announcement that was “the first ever criminal action against an EHR vendor.”
Criminal action
The core of the criminal action was something inevitable: the tension between better health and better profit. Here’s what I saw … all of which caused me to be not-so-surprised today when the news broke.
In 2008 I was the CMIO at Allscripts. Much of my work was focused on how our customers could use our products to improve the health of our patients. We implemented clinical practice guidelines in the software as a way to help clinical teams and patients mak...
Source: Docnotes - January 28, 2020 Category: Primary Care Authors: Jacob Tags: Uncategorized Source Type: blogs
23andMe ’s Pharmacogenetic Test Approved by FDA
The FDA has just approved 23andMe’s Personal Genomic Service (PGS) Pharmacogenetic Reports. This marks the first direct-to-consumer test for pharmacogenetics of enzyme variants that may affect the way patients break down medications. Consumers collect their saliva into 23andMe’s testing kit, mail it to the company’s labs, and then receive the results via an online portal. The approved pharmacogenetic assessment system looks for 33 variants of common enzymes that affect medication metabolism, including CYP2C19, CYP2C9, CYP3A5, UGT1A1, DPYD, TPMT, SLCO1B1, and CYP2D6. The full list of variants can be found ...
Source: Medgadget - November 1, 2018 Category: Medical Devices Authors: Ben Ouyang Tags: Diagnostics Genetics News Source Type: blogs
Industry, Academic, Foundation and Government Alliances Continue in Early 2013
As promised, we are continuing to provide coverage of newly announced or recently discovered collaborations between industry, academia, and other entities to highlight the importance of such relationships in furthering medical progress and improving patient care.
Michael J. Fox Foundation and Parkinson’s
A recent opinion article published in Nature Medicine discussed how “Money without collaboration won’t bring cures.” The piece, written by Todd B. Sherer, chief executive officer of The Michael J. Fox Foundation for Parkinson's Research, maintained that “It's up to stakeholders at every stage of therape...
Source: Policy and Medicine - February 15, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
2012: Banner Year for New Drugs
Fueled by new cancer therapeutics, last year the annual new molecular and biological entity approval count from the U.S. Food and Drug Administration (FDA) saw its highest year since 1997. One-third of the novel products approved by the FDA’s Center for Drug Evaluation and Research (CDER) are used to treat cancers of the blood, breast, colon, prostate, skin and thyroid.
As part of the U.S. Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER) promotes and protects the health of Americans by assuring that all prescription and over-the-counter drugs are safe and effective. The CDE...
Source: Highlight HEALTH - February 13, 2013 Category: Medical Scientists Authors: Walter Jessen, Ph.D. Source Type: blogs
