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
http://beta.congress.gov/bill/113th/house-bill/3303/text
This remarkable and unprecedented regulatory accommodation is based on nebulous, speculative and largely imaginary grounds that translate to - just because:
... (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
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, https://www.ecri.org/EmailResources/PSRQ/ECRI_Institute_PSO_Deep%20Dive_HIT_TOC.pdf; Emergency Department EHR dangers as at http://hcrenewal.blogspot.com/2013/10/quality-and-safety-implications-of.html; innumerable "glitches" that can kill, http://hcrenewal.blogspot.com/search/label/glitch and http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html; baby deaths, http://hcrenewal.blogspot.com/2011/06/babys-death-spotlights-safety-risks.html etc.)
Instead this group of intrepid Cybernetic Crusaders, to whom your life is valuable (as a guinea pig, it seems) call for --
"the President and the Congress [to] work together to develop and enact legislation that establishes a risk-based regulatory framework for such clinical software."
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 http://hcrenewal.blogspot.com/2013/10/drudge-report-oct-10-2013-9-am-est-all.html) ...
All I can say is:
REALLY?
-- SS
p.s. perhaps I should have entitled this post "Look, Ma, No Regulation!" (See http://hcrenewal.blogspot.com/2011/06/my-mother-passed-away.html.)
-- SS
