Meaningful adoption: What we know or think we know about the financing, effectiveness, quality, and safety of electronic medical records

Journal of Legal Medicine

Volumn 34, Issue 1, 2013, Pages 7-42

  Terry, Nicolas P ^a  

^a Indiana University School of Law Indianapolis   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ATTITUDE TO COMPUTERS; COMPUTER SECURITY; ECONOMICS; ELECTRONIC MEDICAL RECORD; HEALTH CARE POLICY; HEALTH CARE QUALITY; HUMAN; MASS COMMUNICATION; MEDICAL INFORMATICS; UNITED STATES; ARTICLE;

AMERICAN RECOVERY AND REINVESTMENT ACT; ATTITUDE TO COMPUTERS; COMPUTER SECURITY; DIFFUSION OF INNOVATION; ELECTRONIC HEALTH RECORDS; HEALTH POLICY; HUMANS; MEDICAL INFORMATICS; QUALITY ASSURANCE, HEALTH CARE; UNITED STATES;

EID: 84876128907     PISSN: 01947648     EISSN: 1521057X     Source Type: Journal    
DOI: 10.1080/01947648.2013.768143     Document Type: Article

References (215)

1. Jerome Groopman & Pamela Hartzband, Obama's $80 Billion Exaggeration, Wall St. J., Mar. 12, 2009, http://online.wsj.com/article/ SB123681586452302125.html
2. Press Release, U.S. Dep't of Health and Human Servs., Obama Administration Takes New Steps to Encourage Doctors and HospitalstoUse Health Information Technology toLower Costs, Improve Quality, Create Jobs (Nov. 30, 2011), available at http://www.hhs.gov/news/press/2011pres/11/20111130a. html
3. Barry R. Furrow, Adverse Events and Patient Injury: Coupling Detection, Disclosure, and Compensation, 46 New Eng. L. Rev. 437 (2012)
4. Leslie Pickering Francis, The Physician-Patient Relationship and a National Health Information Network, 38 J.L. Med. & Ethics 36 (2010)
5. Laura Ashpole, Health Information Technology: Building the Foundation for the Reconstruction of Health Care Delivery, 20 Annals Health L. 32 (2011)
6. Susan R. Gering, Electronic Health Records: How to Avoid Digital Disaster, 16 Mich. St. U.J. Med. & L. 297 (2012)
7. Sharona Hoffman & Andy Podgurski, Improving Health Care Outcomes through Personalized Comparisons of Treatment Effectiveness Based on Electronic Health Records, 39 J.L. Med. & Ethics 425 (2011)
8. Nicolas P. Terry, Certification and Meaningful Use: Reframing Adoption of Electronic Health Records as a Quality Imperative, 8 Ind. Health L. Rev. 43 (2011)
9. Nicolas Terry, To HIPAA, a Son: Assessing the Technical, Conceptual, and Legal Frameworks for Patient Safety Information, 12 Widener L. Rev. 134 (2006)
10. Steve Lohr, The "Miracle" of Digital Health Records, 50 Years Ago, N.Y. Times, Feb. 17, 2012, http://bits.blogs.nytimes.com/2012/02/17/the- miracle-of-digital-health-records-50-years-ago/
11. Lawrence L. Weed, Medical Records That Guide and Teach, 278 New Eng. J. Med. 593 (1968), available at http://imed.stanford.edu/curriculum/session17/ content/NEJM%20-%20Medical%20 record%20 that%20guide%20and%20teach%20(Weed%20- %201968).pdf
12. Regenstrief Inst., Inc., INPC History, Indiana Network for Patient Care, http://www.regenstrief.org/medinformatics/inpc/history-1
13. J. Michael Fitzmaurice et al., Three Decades of Research on Computer Applications in Health Care: Medical Informatics Support at the Agency for Healthcare Research and Quality, 9 J. Am. Med. Informatics Ass'n 144, 144 (2002), http://www.ncbi.nlm.nih.gov/pmc/articles/PMC344572/pdf/0090144.pdf
14. See Comm. on Improving the Patient Record Div. of Health Care Serv., Inst. Med. (Richard S. Dick et al. eds., revised ed. 2007)
15. Richard Hillestad et al., Can Electronic Medical Record Systems Transform Health Care? Potential Health Benefits, Savings, and Costs, 24 Health Affairs 1103, 1103 (2005)
16. Comm. on Quality of Health Care in Am., Inst. of Med., Crossing the Quality Chasm: A New Health System for the 21st Century (1st ed. 2001)
17. Comm. on Quality of Health Care in Am., Inst. of Med., To Err Is Human: Building A Safer Health System (Linda T. Kohn et al. eds., 2000)
18. Comm. on Quality of Health Care, supra note 10, at 16
19. George W. Bush, Addressing Vanderbilt University Medical Center, President Discusses Transforming Health Care for Americans with HealthIT (May 27, 2004), available at http://georgewbush-whitehouse. archives.gov/news/ releases/2004/05/20040527-5.html
20. Newt Gingrich, Preface to the First Edition, Ctr. for Health Transformation, Paper Kills (David Merritt ed., 1st ed. 2007)
21. Hillestad et al., supra note 9, at 1107 ("Achieving savings at the upper end of the range will be limited by the degree of transformation that accompanies HIT")
22. See, e.g., Jerome Groopman & Pamela Hartzband, Mindful Medicine: Critical Thinking Leads to Right Diagnosis, ACP Internist (2008), http://www.acpinternist.org/archives/2008/01/groopman.htm
23. Rainu Kaushal et al., The Costs of a National Health Information Network, 143 Annals Internal Med. 165, 165 (2005)
24. Robert H. Miller et al., The Value of Electronic Health Records in Solo or Small Group Practices, 24 Health Affairs 1127, 1130 (2005), http://content.healthaffairs.org/cgi/reprint/24/5/1127
25. See Ctrs. for Medicare & Medicaid Servs., Pub. No. 903695, Medicare Electronic Health Record Incentive Program for Eligible Professionals (2010), available at http://www.cms.gov/Outreach-and-Education/Medicare-Learning- Network-MLN/MLNProducts/Downloads/CMS eHR Tip Sheet.pdf
26. See, e.g., Janet M. Coffman et al., On the Road to Meaningful Use of EHRs: A Survey of California Physicians 6 (2012), available at http://www.chcf.org/?/media/MEDIA%20LIBRARY%20Files/PDF/R/ PDF%20RoadMeaningfulUseEHRsPhysicians.pdf
27. David Blumenthal & Marilyn Tavenner, The "Meaningful Use" Regulation for Electronic Health Records, 363 New Eng. J. Med. 501 (2010), available at http://www.nejm.org/doi/full/10.1056/NEJMp1006114
28. See, e.g., Jeffrey A. Linder et al., Method of Electronic Health Record Documentation and Quality of Primary Care, J. Am. Med. Informatics Ass'n, May 19, 2012, available at doi:10.1136/amiajnl-2011-000788
29. Press Release, Accenture, Doctors Agree on Top Healthcare IT Benefits, but Generational Divide Exists, According to Accenture Eight-Country Survey (Jan. 10, 2012), available at http://newsroom. accenture.com/article display.cfm?article id=5370
30. Deloitte Ctr. for Healthcare Solutions,Physician Perspectives About Health Information Technology 1, 3 (2012), http://www.deloitte.com/assets/Dcom- UnitedStates/Local%20Assets/Documents/Health%20Reform%20Issues%20Briefs/us chs PhysicianPerspectivesAboutHIT 021612.pdf
31. Cf. Randall Stross, Advice for the Ill, and Points for the Doctors, N.Y. Times, Feb. 4, 2012, http://www. nytimes.com/2012/02/05/business/on-healthtap- advice-for-you-and-points-for-doctors.html?r=1&
32. Michael C. Christensen & Dahlia Remler, Information and Communications Technology in U.S. Health Care: Why Is Adoption So Slow and Is Slower Better?, 34 J. Health Politics, Pol'y & L. 1011, 1014-15 (Dec. 2009)
33. Cf. Paul G. Shekelle, Agency for Healthcare Research and Quality, Evidence Report/Technology Assessment: Costs and Benefits of Health Information Technology 132 (2006), available at http://www.ahrq.gov/downloads/pub/evidence/ pdf/hitsyscosts/hitsys.pdf
34. Christensen & Remler, supra note 30, at 1011
35. Cf. Coffman et al., supra note 22, at 14 (reporting that a survey of Californian physicians found that 99% of Kaiser physicians and 93% of VA or military physicians had access to an EMR and that those were generally capable of more comprehensive use/tasks)
36. Health Information Technology: HHS Is Continuing Efforts to Define a National Strategy, Hearing before the Subcomm
37. Federal Workforce and Agency Organization of the H. Comm. on Government Reform, 109th Cong. 16 (2006) (Statement of David A. Powner, Dir. Information Tech. Mgmt. Issues), available at http://www.gao.gov/assets/120/113041.pdf
38. Joseph Conn, Brailer's Firm to Invest $700 Million from CalPERS, Modern Healthcare (June 6, 2007), http://www.modernhealthcare.com/article/ 20070606/INFO/70606006
39. Zach Brennan, Funding Issues Add to Doubts about Future of Health IT Office, iHealthBeat (Sept. 20, 2007), http://www.ihealthbeat.org/Features/2007/ Funding-Issues-Add-To-Doubts-About-Future-of-Health-IT-Office.aspx
40. See generally Nicolas P. Terry, Personal Health Records: Directing More Costs and Risks to Consumers?, 1 Drexel L. Rev. 216 (2009)
41. Ashish K. Jha et al., Use of Electronic Health Records in U.S. Hospitals, 360 New Eng. J. Med. 1628 (2009)
42. See generally Roger Taylor et al., Promoting Health Information Technology: Is There a Case for More-Aggressive Government Action?, 24 Health Affairs 1234 (2005)
43. J.D. Kleinke, Dot-Gov: Market Failure and the Creation of a National Health Information Technology System, 24 Health Affairs 1246, 1257-58 (2005)
44. American Recovery and Reinvestment Act of 2009, H.R. 1, 11th Cong. § 3005 (2009), available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi? dbname=111 cong bills&docid=f:h1enr.pdf
45. Centers for Medicaid and Medicare Services, EHR Incentive Programs (Aug. 27, 2012), https://www. cms.gov/Regulations-and-Guidance/Legislation/ EHRIncentivePrograms/index.html?redirect=/EHR IncentivePrograms/
46. Office of the Nat'l Coordinator for Health Info. Technology, ONC Initiatives, U.S. Dep't of Health & Human Servs. (Dec. 7, 2011), http://healthit.hhs.gov/portal/server.pt/community/healthit hhs gov onc initiatives/1497
47. David Blumenthal, Launching HITECH, 362 New Eng. J. Med. 382 (2010)
48. PwC Health Research Inst., Rock and a Hard Place 2 (Apr. 2009), http://www.pwc.com/us/en/healthcare/publications/rock-and-a-hard-place.jhtml
49. See generally Centers for Medicaid and Medicare Services, Medicare and Medicaid EHR Incentive Programs Basics (Aug. 27, 2012), https://www.cms.gov/ Regulations-and-Guidance/Legislation/EHRIncentivePrograms/Basics.html
50. See generally Rock and a Hard Place, supra note 45, at 3, http://www.pwc.com/us/en/healthcare/publications/rock-and-a-hard-place.jhtml
51. Jaime Oh, Lawmakers Introduce Bill That Would Increase Meaningful Use Incentive Payments for Multi-Campus Hospitals, Becker's Hosp. Rev. (Jul. 14, 2011), http://www.beckershospitalreview.com/healthcare-information-technology/ lawmakers-introdu ce-bill-that-would-increase-meaningful-use-incentive-payments- for-multi-campus-hospitals.html
52. Centers for Medicaid and Medicare Services, Registration & Attestation (Aug. 23, 2012), http://www.cms.gov/Regulations-and-Guidance/ Legislation/EHRIncentivePrograms/RegistrationandAttestation.html
53. McKinsey on Business Technology, 20 McKinsey & Co. 28 (Nov. 20, 2010), http://www.ortechsystems. com/pdfs/MRreformingHospitalsITinvestment.pdf
54. Medicare Electronic Health Record Incentive Program for Eligible Professionals (Nov. 2012), https://www.cms.gov/Outreach-and-Education/Medicare- Learning-Network-MLN/MLNProducts/downloads/CMS eHR Tip Sheet.pdf
55. CMS Medicare and Medicaid HER Incentive Programs Milestone Timeline (Aug. 27, 2012), https://www.cms.gov/Regulations-and-Guidance/Legislation/ EHRIncentivePrograms/Downloads/EHRIncentProgtimeline508V1.pdf
56. Hannah Fishman, A Discussion with National Health Information Technology Coordinator David Blu-menthal, Burness Comm'n (Apr. 20, 2010), http://www.burnesscommunications.com/burness-effect/2010/4/20/ discussion-national-health-information-technology-coordinator-david-blument
57. Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 75 Fed. Reg. 44,590, 44,600 (July 28, 2010) (to be codified at 45 C.F.R. pt. 170), available at http://www.gpo.gov/fdsys/pkg/FR-2010-07-28/pdf/ 2010-17210.pdf
58. Medicare and Medicaid Programs, Electronic Health Record Incentive Program, Final Rule, 75 Fed. Reg. 44,314, 44,321 (July 28, 2010) (to be codified at 45 C.F.R. pts 412, 413, 422), available at http://www.gpo.gov/fdsys/pkg/FR- 2010-07-28/pdf/2010-17207.pdf
59. Terry, Certification, supra note 3, at 51
60. See Final Rule, supra note 64, at 44,314, 44,370 (Table 2: "Stage 1 Meaningful Use Objectives and Associated Measures Sorted by Core and Menu Set")
61. See Blumenthal, supra note 45; see also Terry, Certification, supra note 3, at 51
62. Terry, Certification, supra note 3, at 51
63. C.F.R. § 495.6(e)(2) (i) (2012). Terry, Certification, supra note 3, at 53-54
64. "Meaningful Use " Requirements Seen as Compliance Challenge, Despite High Hospital EHR Adoption Rates, Says KPMG Poll, PR Newswire (Apr. 24, 2012), http://www.prnewswire.com/news-releases/meaningful-use-requirements-seen- as-compliance-challenge-despite-high-hospital-ehr-adoption-rat es-says-kpmg-poll-148662355.html. Id
65. Centers for Medicare & Medicaid Services, Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 2, 77 Fed. Reg. 53,967 (Sept. 4, 2012) (to be codified at 42 C.F.R. parts 412, 413, and 495), available at http://www.gpo.gov/fdsys/pkg/FR-2012-09-04/pdf/2012-21050. pdf. ™ 77 Fed. Reg. at 53,970
66. See generally Centers for Medicare & Medicaid Services, Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 2, 77 Fed. Reg. 53,967
67. Fed. Reg. at 53,970 (16 core objectives and 2 out of 6 menu objectives for hospitals)
68. See generally Jane Metzger, Moving Ahead with Stage 2 of Meaningful Use, CSC's Global Institute for Emerging Healthcare Practices (May 2012), http://assets1.csc.com/health services/downloads/CSC Moving Ahead with Stage 2 of Meaningful Use.pdf
69. Robert Kocher & Bryan Roberts, Meaningful Use of Health IT Stage 2: The Broader Meaning, Health Affairs, Mar. 15, 2012, http://healthaffairs.org/ blog/2012/03/15/meaningful-use-of-health-it-stage-2-the-broader-meaning/
70. See generally Nicolas P. Terry, Anticipating Stage Two: Assessing the Development of Meaningful Use and EMR Deployment, 21 Annals Health L. 103 (2012)
71. See Medicare and Medicaid Programs, Electronic Health Record Incentive Program-Stage2, Proposed Rule, 77 Fed. Reg. 13,698 (Mar. 7, 2012) (to be codified at 45 C.F.R. pts 412, 413, 495), available at http://www.gpo.gov/fdsys/ pkg/FR-2012-03-07/pdf/2012-4443.pdf
72. John Reichard, Washington Health Policy Week in Review: Debate Heating Up over CMS Payments for Health IT, The Commonwealth Fund (May 2, 2012), http://www.commonwealthfund.org/Newsletters/Washington-Health-Policy-in-Review/ 2012/May/May-7-2012/Debate-Heating-Up-Over-CMS-Payments-for-Health-IT.aspx
73. Jeff Byers, Five Societies Blast CMS with Meaningful Use Opinions, Health Imaging (May 8, 2012), http://www.healthimaging.com/index.php?option=com articles&view=article&id=33934:five-socie ties-blast-cms-with- meaningful-use-opinions
74. Diana Manos, Negative Reaction to Stage 2: Docs Face Measures "Outside Their Control," Healthcare IT News (Aug. 30, 2012), http://www.healthcareitnews.com/news/negative-reaction-mu2-docs-face-measures- outside-their-control
75. David Blumenthal, EHR Adoption Set to Soar, The Office of the Nat'l Coordinator Health Info. Tech. (Jan. 13, 2011), http://healthit.hhs.gov/portal/ server.pt?open=512&mode=2&objID=3357
76. David J. Brailer, David Brailer and Farzad Mostashari: Two National Health IT Czars Compare Notes, 31 Health Affairs 475, 476 (2012)
77. NPRM for Stage 2 of Meaningful Use Available, Health Data Management (Apr. 11, 2012), http://www.healthdatamanagement.com/news/EHR-meaningful-use- Stage-2-details-44055-1.html
78. See, e.g., Catherine M. DesRoches et al., Electronic Health Records in Ambulatory Care-A National Survey of Physicians, 359 New Eng. J. Med. 50 (2008)
79. Albert Boonstra & Manda Broekhuis, Barriers to the Acceptance of Electronic Medical Records by Physicians from Systematic Review to Taxonomy and Interventions, BMC Health Serv. Res. 12 (2010), http://www.biomedcentral.com/ content/pdf/1472-6963-10-231.pdf
80. "Meaningful Use," supra note 76
81. AthenaHealth 2012 Physician Sentiment Index, Q6 (June 12, 2012), http://www.athenahealth.com/PSI/meaningful-use-incentives.php
82. Coffman et al., supra note 22, at 14 (noting that 99% of Kaiser physicians had access to an EMR)
83. The State of Health Information Technology in California, California Healthcare Foundation, May 2011, http://www.chcf.org/publications/2011/05/ health-information-technology-california
84. Coffman et al., supra note 22, at 9
85. Stuart Wright, Memorandum Report: Use of Electronic Health Record Systems in 2011 among Medicare Physicians Providing Evaluation and Management Services OEI-04-10-00184, at 7, http://oig.hhs.gov/oei/reports/oei-04-10-00184.pdf
86. Dustin Charles et al., The Office of the Nat'l Coordinator for Health Info. Tech., ONC Data Brief (Feb. 2012), http://www.healthit.gov/media/pdf/ONC Data Brief AHA 2011.pdf
87. Ctrs. Medicare & Medicaid Servs., April 2012 EHR Incentive Program (Apr. 2012), http://www. cms.gov/Regulations-and-Guidance/Legislation/ EHRIncentivePrograms/downloads/Monthly Paym ent Registration Report Updated.pdf
88. Bipartisan Policy Center Task Force on Delivery System Reform and Health IT, Transforming Healthcare: The Role of Health IT. 1, 21 (Jan. 2012), http://bipartisanpolicy.org/sites/default/files/Transforming%20Health%20Care.pdf
89. Dav i d Charles et al., Electronic Health Record Systems and Intent to Attest to Meaningful Non-Federal Acute Care Hospitals in the United States: 2008-2011, at 2 (Feb. 2012), available at http://www.healthit.gov/media/pdf/ONC Data Brief AHA 2011.pdf
90. AthenaHealth, supra note 111, at Q21-22
91. U.S. Dep't Health & Human Servs., News Release, More Than 100,000 Health Care Providers Paid for Using Electronic Health Records (June 19, 2012), available at http://www.hhs.gov/news/press/2012pres/06/20120619a.html
92. Josh Israel & Kimberly Leonard, Health Info. Tech.: Incentives May Not Always Serve Intended Purpose, Center for Public Integrity (Oct. 12, 2011), http://www.iwatchnews.org/2011/10/12/6934/health-information-technology- incentives-may-not-always-serve-intended-purpose
93. Joseph Conn, EHR Incentive Payments Top $5 Billion, Modern Healthcare (June 4, 2012), http://www.modernhealthcare.com/article/20120604/ NEWS/306049987#ixzz1yGmZNNKi?trk=tynt
94. Christensen & Remler, supra note 30, at 1022-25
95. Coffman et al., supra note 22, at 10
96. IVANS, 2012 Healthcare Provider Survey 4, 14 (Feb. 2012), available at http://www.ivans.com/assets/208.pdf
97. See Genevieve Douglas, Providers Share Experiences Achieving Meaningful Use, but Challenges Remain, Bloomberg BNA, Oct. 12, 2011, available at http://www.bna.com/providers-share-experiences-n12884903856
98. See generally David Houle & Jonathon Fleece, Why One-Third of Hospitals Will Close by 2020, Policy (Mar. 14 2012), available at http://www.kevinmd.com/blog/2012/03/onethird-hospitals-close-2020. html
99. GAO, First Year of CMS's Incentive Programs Shows Opportunities to Improve Processes to Verify Providers Met Requirements, GAO-12-481, Apr. 30, 2012, http://gao.gov/assets/600/590538.pdf
100. See Ken Terry, AthenaHealth CEO Says Meaningful Use Needs Performance Data, Information-Week (Oct. 10, 2011), http://www.informationweek.com/news/ healthcare/policy/231900421 (quoting Jonathan Bush, CEO of AthenaHealth)
101. Stage 2 Meaningful Use Final Rule Expected by Beginning of September, CMS Official Says, Bloomberg BNA, Aug. 15, 2012, http://www.bna.com/stage- meaningful-final-n12884911198/
102. IVANS, supra note 128, at 3
103. See generally Nat'l Council Cmty. Behavioral Healthcare, HIT Adoption and Readiness for Meaningful Use in Community Behavioral Health (June 2012), available at http://www.thenationalcouncil. org/galleries/business- practice%20files/HIT%20Survey%20Full%20 Report.pdf
104. Larry Wolf et al., Hospitals Ineligible for Federal Meaningful-Use Incentives Have Dismally Low Rates of Adoption of Electronic Health Records, 31 Health Affairs 505, 505-13 (2012)
105. Blumenthal & Tavenner, supra note 23, at 501
106. See, e.g., Elnahal et al., Electronic Health Record Functions Differ Between Best and Worst Hospitals, 17(4) Am. J. Managed Care 121, 121-47 (2011)
107. Catherine M. DesRoches et al., Small, Nonteaching, and Rural Hospitals Continue to Be Slow in Adopting Electronic Health Record Systems, 31 Health Affairs 1092, 1097 (2012)
108. U.S. Gov't Accountability Office, Electronic Health Records: Number and Characteristics of Providers Awarded Medicare Incentive Payments for 2011, GAO-12-778R, at 5 (July 26, 2012), available at http://www.gao.gov/assets/600/ 593078.pdf
109. Sandra L. Decker et al., Physicians in Nonprimary Care and Small Practices and Those Age 55 and Older Lag in Adopting Electronic Health Record Systems, 31 Health Affairs 1108, 1108 (2012)
110. see Coffman et al., supra note 22, at 14 (reporting similar findings among California physicians).
111. Decker et al., supra note 114, at 1111
112. David Raths, MU Work Group to Make Initial Stage 3 Recommendations in August, Healthcare Informatics, July 5, 2012, http://www.healthcare-informatics. com/article/mu-work-group-make-initial-stage-3-recommendations-august?WA MAILING LEVEL CODE=&spMailingID= 39427252&spUserID= MzYzODM1ODI2MAS2&spJobID=149569313&spReportId=MTQ5NTY5 MzEzS0
113. Health Information Technology for Economic and Clinical Health Act, 42 U.S.C. § 17921(5) (2006 & Supp. IV 2010)
114. Peter Garrett & Joshua Seidman, EMR vs. EHR-What Is the Difference?, HealthIT Buzz, Jan. 4, 2011, http://www.healthit.gov/buzz-blog/electronic- health-and-medical-records/emr-vs-ehr-difference/
115. Id.; see also Dave Garets & Mike Davis, Electronic Medical Records vs. Electronic Health Records: Yes, There Is a Difference, HIMSS Analytics (2006), http://www.himssanalytics.org/docs/WP EMR EHR.pdf (discussing early concepts)
116. See Prashila Dullabh et al., White Paper: Measurement of the Utilization of an Installed EHR, U.S. Dep't Health & Human Servs., (2009) (discussing various approaches to assessing the functionality of records technologies), http://aspe.hhs.gov/sp/reports/2009/ehrutil/index.shtml
117. What Is Clinical Decision Support?, HIMSS, http://www.himss.org/asp/ topics clinicaldecision.asp
118. See generally Sharon Silow-Carroll et al., Using Electronic Health Records to Improve Quality and Efficiency: The Experiences of Leading Hospitals, 17 Commonwealth Fund 1 (July 2, 2012), available at http://www. commonwealthfund.org/?/media/Files/Publications/Issue%20Brief/2012/Jul/1608 SilowCarroll using EHRs improve quality.pdf (detailing comprehensive EMR implementation in nine hospitals)
119. See Chun-Ju Hsiao et al., Preliminary Estimates of Electronic Medical Record Use by Office-Based Physicians: United States, 2008, Nat i o na l Center for Health Statistics (2008), http://www.cdc.gov/nchs/data/hestat/physicians08/ physicians08.pdf
120. Charles et al., supra note 117
121. See supra notes 127-34 and accompanying text
122. See supra notes 86-92 and accompanying text; see also Letter from AMA et al. to Marilyn B. Tavenner (May 7, 2012), available at http://www.ama-assn.org/ resources/doc/washington/ehr-stage-2-certification-sign-on-letter-07may2012.pdf
123. See Karen C. Nanji et al., Errors Associated with Outpatient Computerized Prescribing Systems, 18 J. Am. Med. Informatics Ass'n 767 (2011)
124. See Johanna I. Westbrook et al., Effects of Two Commercial Electronic Prescribing Systems on Prescribing Error Rates in Hospital In-Patients: A before and after Study, 9 PLoS Medicine 1 (Jan. 31, 2012), available at http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed. 1001164
125. See Jesse C. Crosson et al., Typical Electronic Health Record Use in Primary Care Practices and the Quality of Diabetes Care, 10 Annals Fam. Med. 221 (May/June 2012)
126. Daria O'Reilly et al., Cost-Effectiveness of a Shared Computerized Decision Support System for Diabetes Linked to Electronic Medical Records, 19 J. Am. Med. Informatics Ass'n 341 (2012) (showing only marginal improvement in trial involving treatment of diabetes type 2)
127. Max J. Romano & Randall S. Stafford, Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality, 171 Archives Int. Med. 897, 901 (2011)
128. Melinda Beeuwkes Buntin et al., The Benefits of Health Information Technology: A Review of the Recent Literature Shows Predominantly Positive Results, 30 Health Affairs 464, 464 (2011)
129. Ajit Appari et al., Meaningful Use of Electronic Health Record Systems and Process Quality of Care: Evidence from a Panel Data Analysis of U.S. Acute-Care Hospitals, Health Services Research, July 20, 2012, http://onlinelibrary.wiley.com.proxy.lib.siu.edu/doi/10.1111/j.1475-6773.2012. 01448.x/pdf
130. Danny McCormick, Giving Office-Based Physicians Electronic Access to Patients' Prior Imaging and Lab Results Did Not Deter Ordering of Tests, 31 Health Affairs 488, 493 (2012)
131. Farzad Mostashari, Recent Study: Get the Facts, HealthITBuzz (Mar. 6, 2012), http://www.healthit. gov/buzz-blog/meaningful-use/study-facts/
132. Janet Marchibroda, Does Health IT Reduce Costs or Not?, Bipartisan Policy Ctr. Blog (Mar. 14, 2012), http://www.bipartisanpolicy.org/blog/2012/03/does- health-it-reduce-costs-or-not
133. See generally Timothy Mullaney, This Man Wants to Heal Healthcare, Bloomberg Businessweek, Oct. 30, 2005, http://www.businessweek.com/magazine/ content/05 44/b3957113.htm
134. See, e.g., Nationwide Health Information Network, Health IT, http://healthit.hhs.gov/portal/server.pt/community/healthit hhs gov nhin exchange/1407
135. Robert H. Miller, Satisfying Patient-Consumer Principles for Health Information Exchange: Evidence from California Case Studies, 31 Health Affairs 537 (2012)
136. See President's Counsel Advisors Sci.&Tech., Report to the President Realizing the Full Potential of Health Information Technology to Improve Healthcare for Americans: The Path Forward (2010)
137. Metadata Standards to Support Nationwide Electronic Health Information Exchange, 76 Fed. Reg. 48,769, 48,776 (Aug. 9, 2011)
138. See generally Direct Project, Office of the National Coordinator for Health Information Technology (Aug. 2, 2012), http://healthit.hhs.gov/portal/ server.pt/community/healthit hhs gov direct project/3338
139. Brett Andriesen, Bright Spots of the Direct Project Adoption, HealthITBuzz (June 18, 2012), http://www.healthit.gov/buzz-blog/state-hie/the- direct-project-adoption/
140. See generally Transforming Health Care: The Role of IT, Bipartisian Policy Center, Jan. 27, 2012, http://www.bipartisanpolicy.org/news/multimedia/ 2012/02/transforming-health-care-role-health-it
141. Nicolas P. Terry & Leslie P. Francis, Ensuring the Privacy and Confidentiality of Electronic Health Records, 2007 U. Ill. L. Rev. 681, 683
142. Coffman et al., supra note 22, at 13 (reporting that a survey of California physicians found only 35% "very satisfied" with their EMRs and 38% "somewhat satisfied")
143. AthenaHealth, supra note 111, at Q11, Q17
144. See, e.g., Katherine Rourke, Why Hospitals Can't Talk EMRs with Doctors, Hospital EMR & EHR, Sept. 1, 2011, http://www.hospitalemrandehr.com/2011/09/ 01/why-hospitals-cant-talk-emrs-with-doctors/
145. AthenaHealth, supra note 111, at Q15
146. Mary Mosquera, ONC Improves Usability of Online Certified EHRs List, Government HealthIT (June 25, 2012), http://www.govhealthit.com/news/onc- improves-usability-online-certified-ehrs-list?topic= 08
147. Joseph Conn, Few EHR Vendors Dominate Payments, Modern Healthcare.com (Jan. 13, 2012), http://www.modernhealthcare.com/article/20120113/NEWS/301139989
148. Wright, supra note 116, at 8
149. Sarita Harbour, What Is a Vendor Lock-In?, Houston Chron., http://smallbusiness.chron.com/vendor-lockin-33663.html
150. See, e.g., John Lynn, Meaningful Use Provides Hospital EHR Vendor Lock In, Hospital EMR & EHR (Apr. 10, 2012), http://www.hospitalemrandehr.com/ 2012/04/10/meaningful-use-provides-hospital-ehr-vendor-lock-in/
151. Joel Schectman, For Hospital CIOs, Mergers Complicate Move to Electronic Records, CIO J., June 13, 2012, http://blogs.wsj.com/cio/2012/06/13/for- hospital-cios-mergers-complicate-move-to-electronic-records/
152. Not What the Doctor Ordered: Barriers to Health IT for Small Medical Practices: Hearing before the H. Subcomm. on Health Care and Technology, 112th Cong. 18-20 (2011) (statement of Sasha Kramer, M.D.), http://www.gpo.gov/fdsys/ pkg/CHRG112hhrg68062/html/CHRG112hhrg68062.htm
153. Statement by the American Medical Association, Health IT Policy Committee Certification/Adoption Workgroup 1 (Apr. 21, 2011), http://healthit.hhs.gov/ portal/server.pt/directory/april 21%2C 2011 cawg/18327?DirMode=1
154. Written testimony of Christine A. Sinsky before Certification/Adoption Workgroup Usability Panel 2 (Apr. 21, 2011), http://healthit.hhs.gov/portal/ server.pt?open=space&name=Dir&id=cached& psname=Dir&psid= 1&in hi userid=10741&cached=true&control=DirRepost&rangeFrom= 21& rangeTo=25&subfolderID=18327&DirMode=1
155. Atul Gawande, The Checklist Manifesto: How to Get Things Right 22 (2009)
156. See, e.g., Kirk Johannesen, Columbus Hospital Blames Electronic Records for Rising ER Waits, Indianapolis Sta r , Aug. 8, 2012 http://www.indystar.com/ article/20120808/NEWS/120808018/Columbus-hospital-blames-electronic-records- rising-ER-waits (reporting doubling of patients' lengths of stay in a hospital emergency department during transition to EMR)
157. M. Susan Ridgely & Michael D. Greenberg, Too Many Alerts, Too Much Liability: Sorting through the Malpractice Implications of Drug-Drug Interaction Clinical Decision Support, 5 St. Louis U. J. Health L. & Pol'y 257, 259 (2011-2012)
158. Alissa L. Russ et al., Prescribers' Interactions with Medication Alerts at the Point of Prescribing: A Multi-Method, in Situ Investigation of the Human-Computer Interaction, 81 Int'l J. Med. Informatics 232, 240 (2012)
159. Kenny Goldberg, iHealthBeat Special Report: Health Care Industry Struggle with Usability of Electronic Health Record Systems, iHealthBeat, June 13, 2012, http://origin.eastbaymedia.com/? advisoryboard/podcast media/ iHBSpecialReportTranscript061312.pdf
160. Evaluating the Usability of Electronic Health Record (EHR) Systems, 77 Fed. Reg. 8,217 (Feb. 14, 2012), http://www.gpo.gov/fdsys/pkg/FR-2012-02-14/ html/2012-3415.htm
161. Lowry et al., Technical Evaluation, Testing and Validation of the Usability of Electronic Health Records, Nat 'l Inst. of Sci. and Tech. Interagency Rep. 7804 (Feb. 21, 2012), http://www.nist.gov/customcf/get pdf.cfm? pub id=909701
162. Eric Topol,The Creative Destruction of Medicine:How the Digital Revolution Will Create Better Health Care 150 (2012)
163. Harris Meyer, Scribes Are Doctors' Tech Support, L.A. Times, Sept. 6, 2010, http://articles.latimes. com/2010/sep/06/health/la-he-medical-scribes- 20100906
164. Human Resources (CAMCAH/Critical Access Hospitals): Use of Unlicensed Persons Acting as Scribes, The Joint Commission (July 12, 2012), http://www.jointcommission.org/standards information/jcfaqdetails.aspx? StandardsFAQChapterId=19&StandardsFAQId=426
165. Mariah A. Quinn et al., The Relationship between Electronic Health Records and Malpractice Claims, 172 Archives Int. Med. 1187, 1188 (2012)
166. Harrington et al., Safety Issues Related to the Electronic Medical Record (EMR): Synthesis of the Literature from the Last Decade, 2000-2009, 56 J. Healthcare Mgmt. 31, 32 (2011)
167. See, e.g., Joel Schectman, Philips Recalls Flawed Patient Data System, Wall St. J., July 20, 2012, http://blogs.wsj.com/cio/2012/07/20/philips-recalls- flawed-patient-data-system/
168. HIT Pol'y Comm. Adoption/Certification Workgroup, Testimony of Dr. Jeffrey Shuren, Director of FDA's Center for Devices and Radiological Health 2 (Feb. 25, 2010), available at http://healthit. hhs.gov/portal/server.pt/gateway/ PTARGS 0 11673 910717 0 0 18/3Shuren Testimony022510.pdf
169. Inst. Med., Health IT and Patient Safety: Building Safer Systems for Better Care 2 (2012), available at http://iom.edu/Reports/2011/Health-IT-and- Patient-Safety-Building-Safer-Systems-for-Better-Care.aspx
170. DesRoches et al., supra note 106, at 57
171. HIT Pol'y Comm., supra note 202, at 2
172. Harrington et al., supra note 200, at 31-43
173. See generally Fred Schulte & Emma Schwartz, Electronic Medical Record Shift: Signs of Harm Emerge as Doctors Move from Paper, Huffington Post, May 25, 2011, http://www.huffingtonpost.com/2010/04/20/electronic-medical-record n 545441.html
174. Sharona Hoffman & Andy Podgurski, Finding a Cure: The Case for Regulation and Oversight of Electronic Health Record Systems, 22 Harv. J.L. & Tech. 103, 126-40 (2008)
175. HIT Pol'y Comm., supra note 202, at 3
176. Fred Schulte & Emma Schwartz, FDA Considers Regulating Safety of Electronic Health Systems, Huff-ington Post, May 25, 2011, http://www. huffingtonpost.com/2010/02/23/fda-considers-regulating n 474137.html
177. Neil Versel, FDA, ONC Clash over EMR Safety Issues, Fierce EMR (Aug. 5, 2010), http://www.fierceemr.com/story/fda-onc-clash-over-emr-safety-issues/2010- 08-05
178. Milt Freudenheim, Panel Set to Study Safety of Electronic Patient Data, N.Y. Times, Dec. 13, 2010, http://www. nytimes.com/2010/12/14/business/ 14records.html? r=0
179. Mary Mosquera, HHS Panel Endorses Patient Safety Database, Government HealthIT (Apr. 22, 2010), http://www.govhealthit.com/news/hhs-panel-endorses- patient-safety-database
180. Inst. Med., supra note 203, at 3
181. Farzad Mostashari, Improving Patient Safety through Health IT, Health It Buzz, Nov. 8, 2011, http://www.healthit.gov/buzz-blog/electronic-health-and- medical-records/patient-safety-healthit/
182. Letter from Renee L. Ellmers, Chairwoman, U.S. H.R. Comm. Small Bus., to Kathleen Sebelius, Sec'y, U.S. Dep't Health & Human Servs. (June 2, 2012), available at http://smbiz.house.gov/UploadedFiles/Sebelius Health IT IOM report followup 6 12 12.pdf
183. Inst. Med., supra note 203, at 197
184. HIT Pol'y Comm., supra 202, at 2
185. David Raths, Report from PharmEHR Summit: Will FDA Regulate EHRs?, Healthcare Informatics, Apr. 8, 2011, available at http://www.healthcare- informatics.com/article/report-pharmehr-summit-will-fda-regulate-ehrs (quoting Dr. Shuren)
186. Note that the agency recently reclassified so-called Medical Device Data Systems (basically conduit, storage, or display components) to Class 1. Medical Devices, Medical Device Data Systems, 76 Fed. Reg. 8,637, 8638 (Feb. 15, 2011)
187. 21 U.S.C. § 360c (2012)
188. see generally U.S. Food and Drug Admin., Overview of Device Regulation (Aug. 31, 2009), available at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/Overview/default.htm
189. Inst. Med, supra note 203, at 3 (emphasis in original)
190. U.S. Food and Drug Admin., Draft Guidance for Industry and Food and Drug Administration Sta f f-Mobile Medical Applications 7 (July 21, 2011), available at http://www.fda.gov/medicaldevices/deviceregulationandguidance/ guidancedocuments/ucm263280.htm
191. Raths, supra note 217 (quoting Dr. Shuren)
192. See generally Nicolas P. Terry, When the Machine That Goes "Ping" Causes Harm: Default Torts Rules and Technologically-Mediated Health Care Injuries, 46 St. Louis U.L.J. 37 (2002)
193. see also Thomas v. United States, 660 F. Supp. 216, 218 (D.D.C. 1987)
194. See, e.g., Sharona Hoffman & Andy Podgurski, E-Health Hazards: Provider Liability and Electronic Health Record Systems, 24 Berkeley Tech. L.J. 1523, 1533-52 (2009)
195. John Halamka, Order Interrupted by Text: Multitasking Mishap, Web M&M, Dec. 2011, available at http://webmm.ahrq.gov/case.aspx?caseID=257
196. Adelman et al., Understanding and Preventing Wrong-Patient Electronic Orders: A Randomized Controlled Trial, J. Am. Med. Informatics Ass'n 1-6 (June 29, 2012)
197. Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 45 C.F.R. 170 (2010)
198. Medicare and Medicaid Programs, Electronic Health Record Incentive Program, 42 C.F.R. 412, 413, 422, & 495 (2012)
199. Spencer S. Jones et al., Guide to Reducing Unintended Consequences of Electronic Health Records, Agency for Healthcare Res. & Quality (Aug. 2011), available at http://www.ucguide. org/index.html
200. See generally Howard Melvis, Electronic Medical Records: Liability Is Lurking, AAOS Now, July 2010, available at http://www.aaos.org/news/aaosnow/ jul10/managing5.asp
201. See supra text accompanying notes 218-223
202. See, e.g., Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)
203. See, e.g., Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)
204. See Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012)
205. Food and Drug Administration Safety and Innovation Act of 2012, Pub. L. No. 112-144, § 618, 126 Stat. 993, 1063 (2012)
206. Bonnie Darves, EHR Vendor Contract Controversy Persists, iHealthBeat, May 7, 2012, http://www.ihealthbeat.org/features/2012/ehr-vendor-contract- controversy-persists.aspx?utm source=feed burner&utm medium=feed&utm campaign=Feed%3A+Ihealthbeat%2FBusinessAndFinance+%28 iHB+- +Business+and+Finance%29#ixzz1us UUlPW3
207. Kenneth W. Goodman et al., Challenges in Ethics, Safety, Best Practices, and Oversight Regarding HIT Vendors, Their Customers, and Patients: A Report of an AMIA Special Task Force, 18 J. Am. Med. Informatics Ass'n 77, 77-78 (2011), available at http://jamia.bmj.com/content/18/1/77.full.pdf+html
208. Inst. Med., Health IT and Pat i e n t Safety: Building Safer Systems for Better Care 2 (2011), available at http://www.iom.edu/?/media/Files/ Report%20Files/2011/Health-IT/HealthITandPatientSafetyreportbrieffinal new.pdf
209. Ross Koppel & David Kreda, Health Care Information Technology Vendors' "Hold Harmless" Clause, 301 J.A.M.A. 1276, 1278 (2009)
210. E.g., Wired for Health Care Quality Act, S. 1693, 110th Cong. (2007)
211. See HIMSS Analytics Stage 7 Award-Paperless and Proud of It!, HIMSS Analytics (2012), http://www.himssanalytics.org/hc providers/stage7Award.asp
212. Molly Merrill, Survey Reveals Docs' Perceptions of EHRs as Potential Buyers, Users, Healthcare IT News (Aug. 8, 2011), http://www.healthcareitnews. com/news/survey-reveals-docs-perceptions-ehrs-potential-buyers-users
213. Emily Walker, Health IT Break Sought for Docs in Small Practices, MedPage Today (May 2, 2012), http://www.medpagetoday.com/PracticeManagement/ InformationTechnology/32473
214. KPMG, Accelerating Innovation: The Power of the Crowd 2 (2012), available at http://www.kpmg. com/Global/en/IssuesAndInsights/ArticlesPublications/ accelerating-innovation/Documents/ehealth-implementation.pdf
215. Diana Manos, Mostashari: "Keep Our Eyes on the Prize," HealthcareIT News, Apr. 26, 2012, http://www.healthcareitnews.com/news/ mostashari-keep-our-eyes-prize.