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Can Electronic Health Records Be Saved?

Published online by Cambridge University Press:  01 January 2021

Craig Konnoth  and
Gabriel Scheffler
Craig Konnoth
Affiliation:
University of Colorado Law School
Gabriel Scheffler
Affiliation:
University of Miami School of Law
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American Journal of Law & Medicine , Volume 46 , Issue 1 , March 2020 , pp. 7 - 19
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Copyright © American Society of Law, Medicine and Ethics and Boston University 2020

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References

1 See, e.g., President George W. Bush, A New Generation of American Innovation, The White House, 7–10 (2004) https://www.cepal.org/iyd/noticias/pais/6/31456/EEUU_doc_1.pdf [https://perma.cc/8XVE-NLQZ].

2 See Sharona Hoffman, Electronic Health Records And Medical Big Data: Law And Policy 16-23 (2016) (outlining the potential benefits of EHR systems).

3 See generally Institute of Medicine, The Computer-Based Patient Record: An Essential Technology for Health care 58–62 (Richard S. Dick et. al eds., rev. ed. 1997) (outlining several types of problems with paper health records).

4 See infra Part II.A.

5 David Wahlberg, Flint Doctor Used Epic Systems Records to Expose Lead Crisis, Wisconsin State Journal (Jan. 30, 2016), https://madison.com/wsj/news/local/health-med-fit/flint-doctor-used-epic-systems-records-to-expose-lead-crisis/article_ef462592-f27b-5ed0-a2ff-33232902ab74.html [https://perma.cc/2M39-ZR72].

6 Former Physician at Rikers Island Exposes Health Risks of Incarceration, NPR Fresh Air (March 18, 2019), https://www.npr.org/transcripts/704424675 [https://perma.cc/P3CR-LM5R]. See also U.S. Department of Justice, CRIPA Investigation of the New York City Department of Correction Jails on Rikers Island (Aug. 4, 2014).

7 See Fred Schulte & Erika Fry, Death By 1,000 Clicks: Where Electronic Health Records Went Wrong, Kaiser Health News (Mar. 18, 2019), https://khn.org/news/death-by-a-thousand-clicks/ [https://perma.cc/2FMN-W9CG] (“David Blumenthal, who, as Obama's national coordinator for health information technology, was one of the architects of the EHR initiative, acknowledged to KHN and Fortune that electronic health records ‘have not fulfilled their potential. I think few would argue they have.’”).

8 See Hoffman, Electronic Health Records And Medical Big Data, supra note 2, at 35-37; Lin, Sunny C., Jha, Ashish K., & Adler-Milstein, Julia, Electronic Health Records Associated with Lower Hospital Mortality After Systems Have Time to Mature, 7 Health Aff. 1128 (2018)CrossRefGoogle Scholar.

9 See, e.g., Schulte & Fry, supra note 7; Ratwani, Raj. M. et al., Identifying Electronic Health Record Usability and Safety Challenges in Pediatric Settings, 37 Health Aff. 1752 (2018)CrossRefGoogle ScholarPubMed (analyzing 9,000 patient safety reports and finding that over one-third of them had an EHR usability issue that contributed to a medication error).

10 Atul Gawande, Why Doctors Hate Their Computers, The New Yorker (Nov. 12, 2018), https://www.newyorker.com/magazine/2018/11/12/why-doctors-hate-their-computers. See also Tai-Seale, Ming et al., Electronic Health Record Logs Indicate That Physicians Split Time Evenly Between Seeing Patients and Desktop Medicine, 36 Health Aff. 655 (2017)CrossRefGoogle ScholarPubMed (finding that primary care providers are spending at least as much time on their computers as interacting with patients).

11 Sarah Kliff, Obama's Surprising Answer on Which Part of Obamacare Has Disappointed Him The Most, Vox (Jan. 9, 2017), https://www.vox.com/2017/1/9/14211778/obama-electronic-medical-records [https://perma.cc/K2MS-4RPS].

12 See Hoffman, Sharona & Podgursky, Andy, E-Health Hazards: Provider Liability and Electronic Health Record Systems, 24 Berkeley Tech. L. J. 1523, 1531 (2009)Google Scholar (citing Biomedical Informatics: Computer Applications in Health Care and Biomedicine 952 (Edward H. Shortliffe & James J. Cimino eds., 2006)) (“Interoperability’ means the ability of two or more systems to exchange data and to operate in a coordinated fashion.”).

13 See Hoffman, Electronic Health Records And Medical Big Data, supra note 2, at 18; Janet Marchibroda, Health Policy Brief: Interoperability, Health Aff. (Aug. 11, 2014), https://www.healthaffairs.org/do/10.1377/hpb20140811.761828/full/ [https://perma.cc/Q644-43SQ].

14 Hoffman, Electronic Health Records And Medical Big Data, supra note 2, at 18.

15 Id.

16 Hoffman, Sharona & Podgurski, Andy, Finding a Cure: The Case for Regulation and Oversight of Electronic Health Record Systems, 22 Harv. J. L. & Tech. 103, 113 (2008)Google Scholar.

17 Marchibroda, supra note 13, at 2.

18 Terry, Nicolas P., Anticipating Stage Two: Assessing the Development of Meaningful Use and EMR Deployment, 21 Ann. Health L. 103, 111 (2012)Google Scholar.

19 Marchibroda, supra note 13, at 4 (“The primary barrier to electronic information sharing is the lack of a ‘business case.’”).

20 Id.

21 Hoffman & Podgurski, Finding a Cure, supra note 16, at 153-154.

22 Savage, Lucia, Gaynor, Martin & Adler-Milstein, Julia, Digital Health Data and Information Sharing: A New Frontier for Health Care Competition?, 82 Antitrust L.J. 593, 605 (2019)Google Scholar.

23 Id. at 605–06.

24 Id. at 611; Julia Adler-Milstein, Moving Past the EHR Interoperability Blame Game, New. Eng. J. Med. Catalyst (July 18, 2017). Of course, clinicians stand to benefit from interoperability to the extent that it improves their ability to care for patients and reduces their workload. See id. (“[P]roviders have professional norms and mission statements that should motivate them to pursue interoperability (or at least not actively interfere with it) to benefit their patients.”). See also Jeffrey Bendix, Doctors Sound Off About EHR Shortcomings, Medical Economics (Oct. 17, 2019), https://www.medicaleconomics.com/ehr/doctors-sound-about-ehr-shortcomings [https://perma.cc/G8PJ-SMMY] (listing lack of interoperability as one of physicians' primary complaints about EHRs systems).

25 Savage et al., supra note 22, at 612.

26 Off. of the Nat’l Coordinator for Health Info. Tech., Report on Health Information Blocking 11 (2015) [hereinafter ONC Report].

27 Joel C. White, Administrative delays threaten the promise of the 21st Century Cures Act, StatNews (Sept. 8, 2018), https://www.statnews.com/2018/09/08/21st-century-cures-act-administrative-delays/ [https://perma.cc/Z4TH-HDM2]. See also ONC Report, supra note 26, at 15.

28 Adler-Milstein, Julia & Pfeifer, Eric, Information Blocking: Is It Occurring and What Policy Strategies Can Address It?, 95 Milbank Quarterly 117, 118 (2017)CrossRefGoogle Scholar.

29 See, e.g., ONC Report, supra note 26, at 24–25; Hoffman, Electronic Health Records And Medical Big Data, supra note 2, at 55.

30 Hoffman & Podgurski, Finding a Cure, supra note 16, at 152–53.

31 Id. at 152.

32 Ben Moscovitch, Testimony before the United States Senate Committee on Health, Education, Labor, & Pensions, Pew Trusts 8–9 (March 26, 2019), https://www.pewtrusts.org/-/media/assets/2019/03/ben-moscovitch-help-written-testimony-326.pdf [https://perma.cc/RN74-XP7Y].

33 Mello, Michelle M. et al., Legal Barriers to the Growth of Health Information Exchange—Boulders or Pebbles?, 96 Milbank Q. 110, 111 (2018)CrossRefGoogle ScholarPubMed.

34 Id. at 120–22.

35 Id. at 125–28.

36 Id. at 117–18.

37 Id. at 118. See also Off. of the Nat’l Coordinator for Health Info. Tech., & U.S. Dep’t of Health and Human Services Off. for Civil Rights, Permitted Uses and Disclosures: Exchange for Treatment (2016), https://www.healthit.gov/sites/default/files/exchange_treatment.pdf [https://perma.cc/7KNG-PANR].

38 Mello et al., supra note 33, at 110–11, 118–20.

39 See Lin, Sunny C. et al., Technology, Incentives, or Both? Factors Related to Level of Hospital Health Information Exchange, 53 Health Servs. Res. 3285, 3302-03 (2018)Google ScholarPubMed (finding that both technological capabilities and incentives were associated with greater health information exchange).

40 See Savage et al., supra note 22, at 612.

41 Mello et al., supra note 33, at 118–19.

42 Lin et al., supra note 39 (finding that both technological capabilities and incentives were associated with greater health information exchange).

43 See Savage et. al, supra note 22, at 599.

44 See Achieving the Promise of Health Information Technology: What Can Providers and the U.S. Department of Health and Human Services Do to Improve the Electronic Health Record User Experience? Before the S. Comm. on Health, Educ., Labor, and Pensions, 114th Cong. 2, 3 (2017), https://www.govinfo.gov/content/pkg/CHRG-114shrg95269/pdf/CHRG-114shrg95269.pdf [https://perma.cc/XE97-GNHS].

45 Terry, Nicolas P., Meaningful Adoption: What We Know or Think We Know about the Financing, Effectiveness, Quality, and Safety of Electronic Medical Records, 34 J. Legal Med. 7, 10 (2013)CrossRefGoogle ScholarPubMed.

46 Health Information Technology for Economic and Clinical Health Act, Pub. L. No. 111-5, 123 Stat. 226 (2009) [hereinafter “HITECH Act”]; Savage et al., supra note 22, at 594.

47 Savage et al., supra note 22, at 599.

48 HITECH Act, supra note 46, at § 3004 (b)(1).

49 JaWanna Henry, Yuriy Pylypchuk, Talisha Searcy, & Vaishali Patel, Office of Nat’l Coordinator for Health Info. Tech., ONC Data Brief No. 35, Adoption of Electronic Health Record Systems among U.S. Non-Federal Acute Care Hospitals: 2008-2015 3 (2016), https://www.healthit.gov/sites/default/files/briefs/2015_hospital_adoption_db_v17.pdf [https://perma.cc/M826-RWAU]

50 Office-based Physician Electronic Health Record Adoption, Office of Nat’l Coordinator for Health Info. Tech, https://dashboard.healthit.gov/quickstats/pages/physician-ehr-adoption-trends.php [https://perma.cc/H2CH-BL85].

51 See Adler-Milstein, Julia & Jha, Ashish, HITECH Act Drove Large Gains in Hospital Electronic Health Record Adoption, 36 Health Aff. 1416, 1416 (2017)CrossRefGoogle ScholarPubMed.

52 Adler-Milstein, supra note 24.

53 See, e.g., Hoffman, Electronic Health Records And Medical Big Data, supra note 2, at 55; Savage et al., supra note 22, at 612.

54 Jay Holmgren, A., Patel, Vaishali, & Adler-Milstein, Julia, Progress in Interoperability: Measuring US Hospitals' Engagement in Sharing Patient Data, 36 Health Aff. 1820, 1820 (2017)CrossRefGoogle ScholarPubMed.

55 See Schulte & Fry, supra note 7.

56 Niam Yaraghi, Where HITECH's $28 Billion of Investment Has Gone, Brookings (March 5, 2015), https://www.brookings.edu/blog/techtank/2015/03/05/where-hitechs-28-billion-of-investment-has-gone [https://perma.cc/8648-HFR4]; Schulte & Fry, supra note 7; Sarah Kliff, The Fax of Life: Why American Medicine Still Runs on Fax Machines, Vox (Jan. 12, 2018), https://www.vox.com/health-care/2017/10/30/16228054/american-medical-system-fax-machines-why [https://perma.cc/92JF-QV65] (“Obama officials believed competing health systems would volunteer to share patient data. They now admit that was naive.”).

57 Kliff, Obama's Surprising Answer, supra note 11.

58 Medicare Access and CHIP Reauthorization Act of 2015, Pub. L. No. 114-10 § 106(b)(2)(B).

59 Explore Measures, Quality Payment Program, https://qpp.cms.gov/mips/explore-measures/promoting-interoperability?py=2018#measures [https://perma.cc/PXJ5-4RDS].

60 Scott Mace, MACRA's Information Blocking Threat May Be Toothless, Health Leaders Media (Nov. 22, 2016), https://www.healthleadersmedia.com/innovation/macras-information-blocking-threat-maybe-toothless [https://perma.cc/5X59-ZTNC].

61 Savage et al., supra note 22, at 613 (noting that to achieve top marks in the “advancing care information” domain, a physician needed only exchange a summary of care record with one other physician).

62 Medicare Payment Advisory Comm’n, Report to the Congress: Medicare Payment Policy 449 (Mar. 2018).

63 Achieving the Promise of Health Information Technology: What Can Providers and the U.S. Department of Health and Human Services Do to Improve the Electronic Health Record User Experience? Before the S. Comm. on Health, Educ., Labor and Pensions, 114th Cong. 2 (2017) (statement of Sen. Bill Cassidy) (describing the lack of interoperability and information blocking as “inexcusable”). See also id. at 3 (statement of Sen. Sheldon Whitehouse) (stating “very much respect my Republican colleague's concerns about the usability of EHRs and remaining barriers to the interoperation of different EHR systems. There is a lot of frustration to go around.”).

64 Office of the Nat’l Coordinator for Health Info. Tech., Trusted Exchange Framework and Common Agreement (TEFCA) Draft 2, at 4 (2019) [hereinafter TEFCA (2019)].

65 Adler-Milstein & Pfeifer, supra note 28, at 131.

66 21st Century Cures Act, Pub. L. No. 114-255, § 4004, 130 Stat. 1033, 1177-78 (2016).

67 Id.

68 Id. at § 4002.

69 Don Rucker, Achieving the Interoperability Promise of 21 st Century Cures, Health Aff. Blog (June 19, 2018), https://www.healthaffairs.org/do/10.1377/hblog20180618.138568/full/ [https://perma.cc/9BDR-K2RR].

70 PEW Charitable Trusts, Electronic Tools Can Strengthen Health Care Data Access (Sept. 2018), https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2018/09/electronic-tools-can-strengthen-health-care-data-access-sharing [https://perma.cc/KC4S-YTVF].

71 21st Century Cures Act § 4002(a).

72 Id. at § 4003(b).

73 Id. at § 4004(a)(3) (emphasis added).

74 See Lye, Carolyn T., Forman, Howard P., Daniel, Jodi G. & Krumholz, Harlan M., The 21st Century Cures Act and Electronic Health Records One Year Later: Will Patients See the Benefits?, 25 J. Am. Med. Informatics Ass’n. 1218, 1220 (2018)Google ScholarPubMed.

75 Press Release, U.S. Department of Health & Human Services, HHS Proposes New Rules to Improve the Interoperability of Electronic Health Information (Feb. 11, 2019), https://www.hhs.gov/about/news/2019/02/11/hhs-proposes-new-rules-improve-interoperability-electronic-health-information.html [https://perma.cc/ZQ46-UNYS]. This article does not discuss the final versions of the rules, which were released after the article was finalized for publication. See Press Release, U.S. Department of Health & Human Services, HHS Finalizes Historic Rules to Provide Patients More Control of Their Health Data (March 9, 2020), https://www.hhs.gov/about/news/2020/03/09/hhs-finalizes-historic-rules-to-provide-patients-more-control-of-their-health-data.html.

76 21st Century Cures Act § 4004(a)(3) (emphasis added).

77 21st Century Cures Act, 84 Fed. Reg. 7424, 7523 (March 4, 2019) (codified at 45 C.F.R. pt. 170 and 171).

78 Id. at 7469.

79 Protection and Affordable Care Act, 84 Fed. Reg. 7610, 7616 (March 4, 2019) (codified at 45 C.F.R. pt. 156).

80 Id. at 7625.

81 Id.; 21st Century Cures Act, 84 Fed. Reg. 7424, 7427 (March 4, 2019) (codified at 45 C.F.R. pt. 170 and 171).

82 21st Century Cures Act, 84 Fed. Reg. 7424, 7482.

83 Id. at 7440–41.

84 Protection and Affordable Care Act, 84 Fed. Reg. at 7610, 7617–18.

85 Id. at 7634.

86 Id. at 7640.

87 Id. at 7642.

88 Id. at 7650.

89 TEFCA 2019, supra note 65, at 4.

90 Id.

91 Id.

92 Id. at 5.

93 Id. at 8.

94 See generally id.

95 Implementing the 21st Century Cures Act: Making Electronic Health Information Available to Patients and Providers: Hearing Before the S. Comm. on Health, Educ. Labor & Pensions, 116th Cong. 2 (2020) (testimony of Lucia C. Savage, Chief Privacy & Regulatory Officer, Omada Health, Inc.), https://www.help.senate.gov/imo/media/doc/Savage2.pdf [https://perma.cc/ZDW4-MJNV].

96 See, e.g., Webb Yackee, Jason & Webb Yackee, Susan, A Bias Towards Business? Assessing Interest Group Influence on the U.S. Bureaucracy, 68 J. Pol. 128, 135 (2006)Google Scholar (examining interest group participation in over 30 regulations and finding that find “[w]hen business commenters are united in their desire to see less regulation in a final rule … they will receive less regulation over 90% of the time”).

97 Press Release, Ashley Thompson, Am. Hosp. Ass'n Senior Vice President for Pub. Policy Analysis & Dev., AHA Statement on Proposed Electronic Health Information Rule (Feb. 11, 2019), https://www.aha.org/press-releases/2019-02-12-aha-statement-proposed-electronic-health-information-rule [https://perma.cc/X7V5-PXF3].

98 Mike Miliard, AHIP Says Proposed Interoperability Rules Push Payers Too Far, Too Fast, Healthcare IT News (Mar. 27, 2019, 12:59 PM), https://www.healthcareitnews.com/news/ahip-says-proposed-interoperability-rules-push-payers-too-far-too-fast [https://perma.cc/HM5L-ZXHV].

99 Jennifer Bresnick, CMS Sparks Mixed Reactions with Interoperability, Data Blocking Rules, Health IT Analytic (Feb. 15, 2019) https://healthitanalytics.com/features/cms-sparks-mixed-reactions-with-interoperability-data-blocking-rules [https://perma.cc/MN45-BY7G].

100 See generally Becker, Gary S., Crime and Punishment: An Economic Approach, 76 J. Pol. Econ. 169 (1968)CrossRefGoogle Scholar.

101 See, e.g., Fine and Punishment, Economist (July 21, 2012), https://www.economist.com/finance-and-economics/2012/07/21/fine-and-punishment [https://perma.cc/CG4T-DEZM].

102 Protection and Affordable Care Act, 84 Fed. Reg. at 7610, 7614 (March 4, 2019) (codified at 45 C.F.R. pt. 156).

103 Id. In June 2019, the House of Representatives voted to repeal this prohibition, but as of August 2019, the bill's fate in the Senate is uncertain. Susannah Luthi & Jessica Kim Cohen, House Votes to Overturn Ban on National Patient Identifier, Modern Healthcare (June 13, 2019), https://www.modernhealthcare.com/politics-policy/house-votes-overturn-ban-national-patient-identifier [https://perma.cc/4GHK-H723].

104 Protection and Affordable Care Act, 84 Fed. Reg. at 7610, 7614-7615.

105 Id. at 7615.

106 Id.

107 ONC Report, supra note 26; Centers for Medicare & Medicaid Services, 84 Fed. Reg. 7615 (March 4, 2019).

108 See supra note 30 and accompanying text.

109 Fast Healthcare Interoperability Resources, https://www.hl7.org/fhir/overview.html [https://perma.cc/KZJ6-JHSQ].

110 Electronic Tools Can Strengthen Health Care Data Access, Sharing, The Pew Charitable Trusts (Sept. 19, 2018), https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2018/09/electronic-tools-can-strengthen-health-care-data-access-sharing [https://perma.cc/UWM4-K69B].

111 Hearings before the Comm. on Health, Education, Labor & Pensions (2019) (statement of Ben Moscovitch, Project Director of Health Information Technology, The Pew Charitable Trusts); Electronic Tools Can Strengthen Health Care Data Access, Sharing, The Pew Charitable Trusts (Sept. 19, 2018), https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2018/09/electronic-tools-can-strengthen-health-care-data-access-sharing [https://perma.cc/2T42-AWDM].