Letter To U.S. Senators and Representatives Who've Sought HHS Input On EHR Problems

Several members of Congress have written HHS demanding meetings on health IT issues such as upcoding, test overutilization, misuse of incentive programs, and other factors as <a href="http://ihealthtran.com/wordpress/2012/10/senate-republicans-send-letter-to-sebelius-with-concerns-over-meaningful-use/" target="_blank">here</a>.<br /><br />However, what was largely left out was the issue of safety.<br /><br />I've written this letter to the congresspeople who've written to HHS secretary Sebelius (PDF available <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/EHR_congress_letter_oct24_2012_final.doc" target="_blank">at this link</a>):<br /><br /><blockquote class="tr_bq"><div class="MsoNormal"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">October 24, 2012</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">To:</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Sens. Coburn, Burr, Roberts and Thune</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Reps. Ellmers, Camp, Herger, Upton and Pitts</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">United States</span><span style="font-family: Arial; font-size: 10.0pt;"> Congress</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Washington</span><span style="font-family: Arial; font-size: 10.0pt;">, DC</span><span style="font-family: Arial; font-size: 10.0pt;"></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Re:<span style="mso-spacerun: yes;">  </span>HITECH and healthcare information technology</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Dear Senators and Representatives,</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">I applaud your recent inquiries to HHS regarding critical issues related to healthcare information technology (EHRs, physician order entry, decision supporting systems, etc.)  Issues such as the possible role of these systems in upcoding and Medicare overbilling, test overutilization, abuse of incentives, etc. must be addressed.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">However, you did not address an issue probably more important to the public, indeed to us all as patients – that of health information technology <i style="mso-bidi-font-style: normal;">safety.</i></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Congress must be made aware that health IT exists in two forms:  <b style="mso-bidi-font-weight: normal;">good health IT </b>and<b style="mso-bidi-font-weight: normal;"> bad health IT</b>.  <span style="mso-bidi-font-weight: bold;">Bad health IT reduces safety, creates close calls, injures, kills, raises costs, and sacrifices information privacy and confidentiality, among other ill effects</span>.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Congress must also be made aware that unfortunately due to systemic impediments to free flow of information about health IT systems and lack of FDA or other independent industry regulation, bad health IT is rarely removed from the marketplace or fixed.  </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">FDA and its director of the Center for Devices and Radiological Health (CDRH), Jeffrey Shuren MD JD, testified to HHS in Feb. 2010 that “under the Federal, Food, Drug, and Cosmetic Act, health information technology software is a medical device”, but that FDA has “largely refrained from enforcing our regulatory requirements with respect to HIT devices.”  </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">To clarify about the two types of health IT:</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><b><span style="font-family: Arial; font-size: 10.0pt;">Good Health IT</span></b><span style="font-family: Arial; font-size: 10.0pt;"> provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes. </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><b><span style="font-family: Arial; font-size: 10.0pt;">Bad Health IT </span></b><span style="font-family: Arial; font-size: 10.0pt;">is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">The Agency for Healthcare Research and Quality (AHRQ) recently reported that the highest prevalence of medical technology safety issues was related to EHR systems.<span style="mso-spacerun: yes;">  </span>Even worse, there is a lack of reporting transparency. Harms are known of, but the magnitude admittedly unknown due to systematic impediments to reporting transparency, collection and analysis, as noted by FDA in a 2010 internal memo and IOM itself in its 2012 report on health IT safety.  This is unprecedented in modern medicine, violates patient’s rights, and under no circumstances should be considered acceptable.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">I personally know of adverse patient outcomes including death related to bad health IT that are unreported (even in a state that mandates reporting of medical incidents and serious events), as do numerous colleagues.<span style="mso-spacerun: yes;">  </span></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">The Institute of Medicine has just released a Discussion Paper written by experts in health information technology entitled “<b>Comparative User Experiences of Health IT Products: How User Experiences Would Be Reported and Used"  </b>(<a href="http://www.iom.edu/Global/Perspectives/2012/%7E/media/Files/Perspectives-Files/2012/Discussion-Papers/comparative-user-experiences.pdf" target="_blank">http://www.iom.edu/Global/Perspectives/2012/~/media/Files/Perspectives-Files/2012/Discussion-Papers/comparative-user-experiences.pdf</a>). The recommendations in this paper need to be put into place, and Congressional awareness of the issues and official inquiry as to when this will happen is essential.  </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">This paper’s recommendations will not happen without the oversight of Congress.  As stated in the paper itself, “Some medical and IT leaders have invested their reputations, and their organization’s time and money, in the software [implementation] program; complaints that expose large problems may not be appreciated or carried forward.” </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Some claim safeguards are already in place in the form of HHS certification of health IT.  </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Unfortunately, the HHS health IT certification guidelines do not have sufficient depth nor the correct focus to distinguish between bad health IT and good health IT.  Certification for MU does not look at real-world testing for safety, reliability and usability, for instance, under real loads, in actual clinical settings, and is not very thorough.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">On the other hand,  NASA, the pharmaceutical industry (via FDA's regulation of pharmaceutical research and manufacturing IT) and others dependent on mission-critical software have rigorous validation procedures to check for such factors, e.g., NASA’s "<a href="http://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20040014965_2004000657.pdf" target="_blank">Certification Processes for Safety-Critical andMission-Critical Aerospace Software</a>" that includes rigorous testing to distinguish bad IT from good IT, and remediate or abandon the former.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">p. 6-7:  In order to meet most regulatory guidelines, developers <span style="mso-bidi-font-weight: bold;">must build a safety case</span> as a means of documenting the safety justification of a system. The safety case is a <span style="mso-bidi-font-weight: bold;">record of all safety activities</span> associated with a system throughout its life. Items contained in a safety case include the following:<br /><br />• Description of the system/software<br />• Evidence of <span style="mso-bidi-font-weight: bold;">competence of personnel</span>involved in development of safety-critical software and any safety activity<br />• Specification of <span style="mso-bidi-font-weight: bold;">safety requirements</span><br />• Results of <span style="mso-bidi-font-weight: bold;">hazard and risk analysis</span><br />• Details of <span style="mso-bidi-font-weight: bold;">risk reduction</span>techniques employed<br />• Results of design analysis showing that the <span style="mso-bidi-font-weight: bold;">system design</span> <span style="mso-bidi-font-weight: bold;">meets all required safety targets</span><br />• <span style="mso-bidi-font-weight: bold;">Verification and validation strategy</span><br />• Results of <span style="mso-bidi-font-weight: bold;">all verification and validation activities</span><br />• Records of<span style="mso-bidi-font-weight: bold;"> safety reviews</span><br />• Records of <span style="mso-bidi-font-weight: bold;">any incidents which occur throughout the life of the system</span><br />• Records of all changes to the system and<span style="mso-bidi-font-weight: bold;"> justification of its continued safety</span></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">These processes need to be put in place regarding healthcare IT as well, but will take much time and regulatory push on the industry to occur.  In the absence of truly rigorous testing, though, transparency is essential.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">The aforementioned IOM Discussion Paper outlines the creation of a nationwide post-marketing surveillance process and transparency on health IT usability problems, safety issues, billing fraud promotion, etc. is essential.  It recommends:</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">“Flight simulator”-like, thorough laboratory evaluation of test scenarios;</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">Point-of-use reporting by doctors and nurses on their experiences;</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">Third party–administered doctor and nurse surveys about their experiences with EHR systems;</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">Direct clinician-to-public reporting; and</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">A formalized system of hazards reporting from EHR systems.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">These measures are essential if the technology is to achieve the benefits of which it is theoretically capable, but not presently achieving despite the hundreds of billions of dollars being spent.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">In conclusion, I ask you to add to your inquiries the subject of health information technology safety.  That includes the need for HHS to develop a robust, transparent national reporting system for safety problems created by the technology, and a system to ensure that bad health IT is either fixed in a timely manner or removed from the marketplace.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Sincerely,</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Scot Silverstein, MD</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">-----------------------------------------------------------------</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Scot M. Silverstein, MD</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Adjunct faculty in Healthcare Informatics and IT (Sept. 2007-present)</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Assistant Professor of Healthcare Informatics and IT, and Director, Institute for Healthcare Informatics (2005-7)</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Drexel</span><span style="font-family: Arial; font-size: 10.0pt;"> University</span><span style="font-family: Arial; font-size: 10.0pt;"></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">College</span><span style="font-family: Arial; font-size: 10.0pt;"> of Information Science</span><span style="font-family: Arial; font-size: 10.0pt;"> and Technology</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">3141 Chestnut St.</span><span style="font-family: Arial; font-size: 10.0pt;">, Philadelphia, PA 19104-2875</span><span style="font-family: Arial; font-size: 10.0pt;"></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Email:<span style="mso-spacerun: yes;">  </span>sms88 AT drexel DOT edu </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Bio:<span style="mso-spacerun: yes;">  </span><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm">http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm</a> </span></div></blockquote><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;"></span></div><br /><br />I hope this letter has some beneficial effect.<br /><br />-- SS

Letter To U.S. Senators and Representatives Who've Sought HHS Input On EHR Problems

Several members of Congress have written HHS demanding meetings on health IT issues such as upcoding, test overutilization, misuse of incent...

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