healthy4u: Administrative Procedure Act of 1946

In the FY2014 HHS budget-in-brief document (PDF at <a href="http://www.hhs.gov/budget/fy2014/fy-2014-budget-in-brief.pdf">http://www.hhs.gov/budget/fy2014/fy-2014-budget-in-brief.pdf</a>) on page 115, there's this:<br /><div class="gmail_extra"><br /><br /><div style="margin-left: 40px;"><b>Patient Safety and Health IT Usability</b><br />Patient safety and usability continue to be a focus for<br />ONC. <b>Working with federal partners AHRQ and FDA,</b><b><br />ONC will create the foundation for a patient<br />safety program that will be launched in FY 2014</b><b>called “The Patient Safety Plan”.</b> The Plan seeks<br />to ensure that health IT is safely designed and<br />implemented, medical staff are properly<br />informed and trained to use their health IT<br />systems, and a surveillance system is established<br />to monitor health IT related patient safety events<br />and ensure that unsafe conditions are corrected.</div></div><br />I believe the health IT industry now realizes some form of regulation is inevitable after, for example, revelations from medical malpractice insurers that a significant number of lawsuits involve the effects of health IT (see for instance my post "<b>Malpractice Claims Analysis Confirms Risks in EHRs</b>" at <a href="http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html">http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html</a>).<br /><br />I also believe that industry and its pundits have pushed for the most favorable regulation possible.  This involves pushing for regulation by agencies with the least agency independence as possible, as I bring out below.  <br /><br />HHS along with its member branches FDA, AHRQ and ONC are <b>executive departments</b> of the US government  The legislation that governs the way such departments and agencies may propose and establish regulations is the <b>Administrative Procedure Act of 1946</b> (<a href="http://en.wikipedia.org/wiki/Administrative_Procedure_Act">http://en.wikipedia.org/wiki/Administrative_Procedure_Act</a>).<br /><br />First, it seems the executive branch is attempting to concentrate more power within itself over health IT through proposals like in the FY2014 HHS document.<br /><br />I also point out that that HHS (and its offices such as ONC, FDA etc.) are federal executive departments.  <a href="http://en.wikipedia.org/wiki/United_States_federal_executive_departments" target="_blank">http://en.wikipedia.org/wiki/<wbr></wbr>United_States_federal_<wbr></wbr>executive_departments</a>.  These are <i>not entirely independent of presidential control</i>:<br /><br /><blockquote>"The heads of the federal executive departments, known as secretaries of their respective department, form the traditional Cabinet  of the United States, an executive organ that<b> serves at the disposal of the president </b>and normally act as an advisory body to the presidency."</blockquote><br />In other words, the leaders serve at the pleasure of the President. <br /><br />This is as opposed to the executive department cousin, the federal independent agency, such as the NRC (Nuclear regulatory commission) and NTSB (national transportation safety board) that are independent agencies (<a href="http://en.wikipedia.org/wiki/Independent_agencies_of_the_United_States_government" target="_blank">http://en.wikipedia.org/wiki/<wbr></wbr>Independent_agencies_of_the_<wbr></wbr>United_States_government</a>):<br /><br /><blockquote>Independent agencies of the United States federal government are those agencies that exist outside of the federal executive departments (those headed by a Cabinet secretary). More specifically, the term may be used to describe agencies that,  while constitutionally part of the executive branch, <b>are independent  of presidential control, usually because the president's power to dismiss the agency head or a member is limited.</b></blockquote><br />It is no secret the administration is determined to push as rapid as possible rollout of health IT, come hell or high water, via HITECH, its coming penalties and other measures.  Its predecessor administration was  a bit more genteel and circumspect in this  regard.<br /><br />It is clear to me that, in the current political environment, <b>regulation  by a federal executive agency is minimalist and will likely be politically ineffective, due to fear of its leadership of being dismissed if they upset the upper echelons.   </b><br /><br />I note that Jeffrey Shuren, a physician and attorney, director of FDA CDRH already stated in 2010 that "health IT is a political hot potato" as a reason that FDA "has <span style="font-size: 100%;">largely refrained from enforcing our regulatory requirements</span>."  See my April 2011 post <b>"FDA Decides Regulating Implantable Defibrillator Medical Devices a 'Political Hot Potato'; Demurs"</b> at <a href="http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html">http://hcrenewal.blogspot.com/2011/04/fda-decides-regulating-implantable.html</a> for links to source.<br /><br />I believe it would be better to place the authority for health IT regulation under the aegis of a <i>federal independent agency</i>, whether an existing one or one created for that purpose, so that its leaders are more independent of executive branch control.<br /><br />-----<br /><br />I predict that without meaningful regulation, this is where the health IT industry will find itself in a few years.<br /><blockquote class="tr_bq"><a href="http://www.reuters.com/article/2014/03/11/us-autos-gm-recall-probe-idUSBREA2A1RZ20140311" target="_blank">http://www.reuters.com/<wbr></wbr>article/2014/03/11/us-autos-<wbr></wbr>gm-recall-probe-<wbr></wbr>idUSBREA2A1RZ20140311</a><br /><br />Reuters - <b>Federal prosecutors are examining whether General Motors is  criminally liable for failing to properly disclose problems with some of its vehicles that were linked to 13 deaths and led to a recall last month</b>, according to a source familiar with  the investigation.<br /><br />The New York-based probe is in its early stages, and the source did not elaborate on the legal theory behind the potential criminal liability.<br /><br />.. Federal investigators are reviewing information about how GM handled  reports of problems with ignition switches that first came to light 10 years ago, according to the source.<br /><br />The federal probe by the U.S. attorney in Manhattan adds to a growing list of U.S. authorities examining the recall, which GM announced in February. The National Highway Traffic Safety Administration (NHTSA) previously opened an investigation into whether GM  reacted swiftly enough in its recall.<br /><br /><b>Earlier <span class="aBn" data-term="goog_540420150" tabindex="0"><span class="aQJ">on Tuesday</span></span>,  Reuters reported that a U.S. Senate committee chairman is seeking a hearing on the issue. The U.S. House Energy and Commerce Committee also ordered GM and NHTSA to turn over information about GM's ignition switch  problems.</b><br /><br />The problems in some instances allowed the engine and other components, including front airbags, to turn off while the vehicle was traveling at high speed. More than 1.6 million older vehicles are affected.<br /><br />The failure is believed to be caused when weight on the ignition key, road conditions or some other jarring event causes the ignition switch to move out of the "run" position, turning off the engine and most of the car's electrical components mid-drive, with  sometimes catastrophic results.<br /><br />GM has recommended that owners use only the ignition key with nothing else on the key ring.<br /><br />.. The House committee examining the GM issue, led by Michigan Republican Fred Upton, gave the company and NHTSA until <span class="aBn" data-term="goog_540420151" tabindex="0"><span class="aQJ">March 25</span></span> to turn over information about their responses to consumers' complaints about the problem.<br /><br />The committee has asked GM officials to provide a briefing no later than <span class="aBn" data-term="goog_540420152" tabindex="0"><span class="aQJ">March 18</span></span> on how GM has responded to reports of incidents since 2003 and its interaction with NHTSA since then on problems related to the ignition defect.<br /><br />Upton led the 2000 investigation into Firestone tire failures on Ford Motor Co vehicles, resulting in the TREAD Act that requires automakers to report complaints of defects to the NHTSA.<br /><br /><b>That law also makes it a crime to intentionally mislead the agency about defects that lead to serious accidents.</b><br /><br />... The person familiar with the criminal probe declined to discuss whether prosecutors were considering liability under the TREAD Act.</blockquote><br /> In fact, there is no good reason the health IT sector has been excluded from such actions, through an unprecedented regulatory accommodation this single healthcare sector has enjoyed for decades - namely, that of no true regulation at all.<br /><span class="userContent"> </span> <br /><br /><table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjAREJP0qSqoHqaCCq9y3x81HIJTzS6-HLSU3as_BIzCDOfNAHgX2WAaVEFDLHSYhUMaJFX_l6DHv-RxT00pyP3RJcFQfgbCqBsXJG_-xohfHQYOYO1jqYyqUUObqd3ro9ymPy1cI1ivlXh/s1600/dilbert.jpg" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="150" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjAREJP0qSqoHqaCCq9y3x81HIJTzS6-HLSU3as_BIzCDOfNAHgX2WAaVEFDLHSYhUMaJFX_l6DHv-RxT00pyP3RJcFQfgbCqBsXJG_-xohfHQYOYO1jqYyqUUObqd3ro9ymPy1cI1ivlXh/s1600/dilbert.jpg" width="200" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;"> <br /><div class="MsoNormal">Sure, let's regulate a <s>potentially</s> proven dangerous  healthcare technology, health IT (a glamor child of this administration)  by a federal executive agency that serves "at the disposal" of the President ...  instead of a federal independent agency, with ... uh ...better independence.  Great idea!</div></td></tr></tbody></table><br />-- SS<br /><br /><b>3/12/14 Addendum:</b><br /><br />Note this report of possible delays by the Department of Transportation on disclosure of GM ignition defects, by its National Highway Traffic Safety Administration branch, that caused fatalities and where disclosure could have (and finally now has) resulted in huge legal problems for GM.  GM is a company that was a centerpiece of the administration's economic interventions in recent years:<br /><br /><blockquote class="tr_bq"><b>Did the Obama White House Protect GM? </b><br /><br />Liz Peek<br />The Fiscal Times<br />March 12, 2014</blockquote><blockquote><a href="http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM">http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM</a><br /><br />Did the Obama administration purposefully hide problems with GM cars? Were they panicked that a massive recall of GM products would undermine one of President Obama’s most self-congratulatory campaign themes – that he “saved” Detroit’s auto industry?<br /><br />This is a tale of two car companies: GM, shining star in President Obama’s reelection galaxy, and Toyota, which became political fodder.<br /><br />The House Energy and Commerce Committee announced two days ago that it would undertake an investigation into why it took GM until quite recently to address a decade of complaints about stalling problems with several car models, <b>and why the National Highway Traffic Safety Administration did not demand a recall of the troubled lines earlier on</b>.  <b><span style="color: red;"><i>[Because they were afraid to? - ed.]</i></span></b>  Reports of unexpected stalling in Chevy Cobalts began to trickle in as early as 2003 when 7 incidents were relayed to NHTSA, according to The New York Times ... </blockquote><br />Read the whole article.<br /><br />The Department of Transportation is ... you guessed it ... a <a href="http://en.wikipedia.org/wiki/United_States_federal_executive_departments">federal executive agency</a>, not a federal independent agency.<br /><br />-- SS<br /><br /><br /><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;"><div class="field field-name-field-author-ref field-type-entityreference field-label-hidden"><div class="field-items"><div class="field-item odd"><a href="http://www.thefiscaltimes.com/Authors/P/Liz-Peek" rel="author">Liz Peek</a></div></div></div><span class="field field-name-field-source field-type-taxonomy-term-reference field-label-hidden"><span class="field-items"><span class="field-item odd first last">The Fiscal Times</span></span></span><br /><div class="field field-name-field-release-date field-type-datetime field-label-hidden"><div class="field-items"><div class="field-item odd"><span class="date-display-single">March 12, 2014</span></div></div></div><div class="field field-name-body field-type-text-with-summary field-label-hidden"><div class="field-items"><div class="field-item odd">Did  the Obama administration purposefully hide problems with GM cars? Were  they panicked that a massive recall of GM products would undermine one  of President Obama’s most self-congratulatory campaign themes – that he  “saved” Detroit’s auto industry?<br />This is a tale of two car  companies: GM, shining star in President Obama’s reelection galaxy, and  Toyota, which became political fodder.<br />The House Energy and  Commerce Committee announced two days ago that it would undertake an  investigation into why it took GM until quite recently to address a  decade of complaints about stalling problems with several car models,  and why the National Highway Traffic Safety Administration did not  demand a recall of the troubled lines earlier on.  Reports of unexpected  stalling in Chevy Cobalts began to trickle in as early as 2003 when 7  incidents were relayed to NHTSA, <a href="http://www.nytimes.com/2014/03/09/business/auto-regulators-dismissed-defect-tied-to-13-deaths.html?_r=0">according to The New York Times</a>.</div></div></div>- See more at: http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM#sthash.Ed9FH0ZD.dpuf</div><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;">National Highway Traffic Safety Administrationsuspected of causing many deaths:  "Did the Obama White House Protect GM?", The Fiscal TimesMarch 12, 2014, <a href="http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM">http://www.thefiscaltimes.com/Columns/2014/03/12/Did-Obama-White-House-Protect-GM</a>.Note that the Department of Transportation is ... you guessed it ... a <a href="http://en.wikipedia.org/wiki/United_States_federal_executive_departments">federal executive department</a>.</div><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;">Did the Obama White House Protect GM?</div><div id="stcpDiv" style="left: -1988px; position: absolute; top: -1999px;">Did the Obama White House Protect GM?</div>

Regulation of HIT by federal independent agency vs. federal executive agency / Open criminal probe of GM recall

In the FY2014 HHS budget-in-brief document (PDF at http://www.hhs.gov/budget/fy2014/fy-2014-budget-in-brief.pdf) on page 115, there's this:Patient Safety and Health IT UsabilityPatient safety and usab…

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