healthy4u: Rep. Marsha Blackburn

Proof positive of government incompetence and recklessness in information technology - H.R.3303 - Bipartisan call for exemption of health IT from the FD&C Act

Here's proof positive of government incompetence and recklessness in information technology. A new proposed bill that would exempt health IT from the Food, Drug & Cosmetic Act and FDA regulation. Rep. Marsha Blackburn (R-TN) calls for exemption of healthcare software from FDA regulation with bipartisan co-sponsorship from Reps. Gene Green (D-TX), Phil Gingrey, M.D. (R-GA), Diana DeGette (D-CO), Greg Walden (R-OR) and G.K. Butterfield (D-NC). H.R.3303 - SOFTWARE Act of 2013 - referred to House Energy & Commerce on 10/22/2013 <a href="http://beta.congress.gov/bill/113th/house-bill/3303/text">http://beta.congress.gov/bill/113th/house-bill/3303/text</a> This remarkable and unprecedented regulatory accommodation is based on nebulous, speculative and largely imaginary grounds that translate to - just because:   <blockquote class="tr_bq">... (c) Sense of Congress.--It is the sense of the Congress that--             (1) clinical software and health software (as defined in         section 201(tt) of the Federal Food, Drug, and Cosmetic Act, as         added by subsection (a)) [can]--                     (A) advance the goals of enhanced patient safety                 and continued innovation;                     (B) hold much promise to lower costs and improve                 the health of patients; and                     (C) can improve the quality and efficacy of health                 care provider services </blockquote> This is despite known defects and harms in-the-now (e.g., ECRI Deep Dive Study with 8 injuries and 3 possible deaths in 9 weeks from 171 health IT 'mishaps', voluntarily reported in just 36 hospitals,<a href="https://www.ecri.org/EmailResources/PSRQ/ECRI_Institute_PSO_Deep%20Dive_HIT_TOC.pdf"> https://www.ecri.org/EmailResources/PSRQ/ECRI_Institute_PSO_Deep%20Dive_HIT_TOC.pdf</a>; Emergency Department EHR dangers as at <a href="http://hcrenewal.blogspot.com/2013/10/quality-and-safety-implications-of.html">http://hcrenewal.blogspot.com/2013/10/quality-and-safety-implications-of.html</a>; innumerable "glitches" that can kill, <a href="http://hcrenewal.blogspot.com/search/label/glitch">http://hcrenewal.blogspot.com/search/label/glitch</a> and <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html">http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html</a>; baby deaths, <a href="http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html">http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html</a> etc.) Instead this group of intrepid Cybernetic Crusaders, to whom your life is valuable (as a guinea pig, it seems) call for -- <blockquote class="tr_bq">"the President and the Congress [to] work together to develop and enact legislation that establishes a risk-based regulatory framework for such clinical software."</blockquote> With the Obamacare/Obamaware debacle still in progress ... (see "Drudge Report, Oct. 10, 2013, 9 AM EST: All that needs to be said about government, computing and healthcare" at <a href="http://hcrenewal.blogspot.com/2013/10/drudge-report-oct-10-2013-9-am-est-all.html">http://hcrenewal.blogspot.com/2013/10/drudge-report-oct-10-2013-9-am-est-all.html</a>) ... All I can say is: REALLY? -- SS p.s. perhaps I should have entitled this post "Look, Ma, No Regulation!" (See <a href="http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html">http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html</a>.) -- SS

Proof positive of government incompetence and recklessness in information technology - H.R.3303 - Bipartisan call for exemption of health IT from the FD&C Act

Here's proof positive of government incompetence and recklessness in information technology. A new proposed bill that would exempt healt...

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