Errors in Electronic Health Records: A Growing Source for Medical Malpractice Claims

By

Holly B. Haines and Elie A. Maalouf[1]

March 2018

I. Introduction

In the last ten years, the United States healthcare industry has experienced a largescale shift from paper to electronic health records (EHRs).[2] Ushered in by the Health Information Technology for Economic and Clinical Health Act (HITECH Act), the advent of health information technology[3] (HIT) brought with it the promise of a reduced rate of medical errors, decreased healthcare costs, greater efficiency, and enhanced quality of care and patient safety.[4] EHRs were expected to offer numerous benefits including quicker and better access to patient records, automatic alerts and reminders, and improved communication between providers.[5] A national study conducted in 2011 concluded that 78% of physicians that had adopted EHRs experienced an overall enhancement in patient care.[6] One study found that EHRs are associated with a slight decrease in the number of medical malpractice suits.[7] Other researchers, however, do not consider these encouraging findings to be dispositive and, in recent years, more have reached the opposite conclusion.[8]

While the adoption of EHRs has markedly changed the practice of medicine, “the full potential of [EHRs] has not yet been realized.”[9] As a result of “shortcomings in the design and implementation of HIT systems,” the widespread conversion to EHRs has fallen short of the anticipated benefits and cost-saving projections.[10] Not only have EHRs failed to fully meet expectations with respect to improvements in patient care and lower costs, but the “unintended consequences” of this new technology “often undermine patient safety practices” and may lead to serious injury.[11] Thus, instead of reducing medical errors as intended, the widespread adoption of EHR technology has introduced new medical errors that cause patient harm and jeopardize patient safety.[12]

As health information systems have become widely used, the risk of harm or death associated with errors in EHRs has “increased significantly.”[13] Predictably, the new types of errors and related harm introduced by the slapdash implementation of EHR systems have increasingly contributed to the number of medical malpractice lawsuits in recent years.[14] Multiple studies published in the last several years have identified a minimal, though nevertheless significant, impact that EHR-related errors have had on the rate of medical malpractice claims.[15] The findings revealed that EHR-related claims made up roughly 1% of medical malpractice claims analyzed and suggest that the number of such claims has grown as healthcare providers have progressively transitioned to EHR systems.[16]

II. The Appeal of EHRs: A Brief History

The push to integrate HIT into the American healthcare system began as early as 2004 when President Bush called for the computerization of the health records of all Americans by 2014.[17] The prospect of better care and the estimated annual savings of $78-$81 billion provided the impetus for this national shift to EHRs.[18] At the center of the notion that EHRs can improve healthcare and save money is the concept of interoperabilty—the ability of computer systems to exchange information.[19] The anticipated benefits of interoperable EHR software included facilitating faster and greater access to patients’ medical records; reducing delays and duplicate therapy; enhancing communication between providers, thereby reducing needless treatment; and “enabl[ing] computer-assisted reduction of redundant tests.”[20] In fact, the cost-saving projections associated with EHRs were based on the assumption that interoperative systems would be widely implemented by healthcare providers.[21]

In an effort to stimulate an aggressive transition to EHRs, Congress enacted the HITECH Act in 2009 with the purpose of promoting the adoption and “‘meaningful use’ of EHRs—that is, their use by providers to achieve significant improvements in care.”[22] The HITECH Act incentivizes healthcare providers to implement EHRs through Medicaid and Medicare payments totaling $27 billion through 2019.[23] Furthermore, the Act conditions the incentive payments on improvements in “health care processes and outcomes,” which is accomplished by meeting objectives set by the Secretary of Health and Human Services.[24] Impelled by the incentives of the HITECH act, the vast majority of providers have made the switch to EHRs. As of 2017, 80% of physician office practices and 90% of hospitals have adopted EHRs.[25]

III. The Unintended Consequences of EHRs

Although the use of EHRs has indeed become widespread, modern EHR systems are not interoperable.[26] This inability for EHR systems to communicate with each other impedes the improvements to the quality of care promised by HIT.[27] These shortcomings are in large part due to the federal government’s failure to institute vendor standards for the use of EHRs and its failure to require beta testing to ensure the final product was user-friendly and safe before initiating the rapid adoption of EHRs.[28] Even now, there are no regulatory requirements for EHRs nor is there a government body charged with evaluating EHR effectiveness and safety.[29] Furthermore, The Doctors Company, a medical malpractice insurer, cites the lack of input from physicians and other healthcare professionals in the initial development of EHR software as a major source of the EHR-related errors.[30] The “subsequent workplace experience and concerns [of medical professionals] have been largely ignored” with respect to problems they have encountered with EHRs.[31] Moreover, many vendors of EHR software are reluctant to address the design flaws.[32] Providers, however, have also failed to “reengineer[] existing processes of care” to take full advantage of the new technology.[33] Consequently, a host of hazardous, EHR-related problems have emerged, which generally fall into two categories: system-related and user-related errors.

Flaws in the design of the EHR software are the major source of the system-related errors.[34] For instance, many EHRs utilize drop down menus and templates, which lack sufficient space for documentation, precluding healthcare professionals from taking detailed notes during patient visits.[35] Confusing displays and auto-population (a feature where the software automatically generates data) misinform medical professionals and leads to the transmission of inaccurate information.[36] Additionally, faulty technology may preclude access to imperative information such as radiology studies or lab results, adversely affecting many patients.[37]

In one system-related medical malpractice case, a physician did not have enough space to document all of the patient’s symptoms, which led to the mismanagement of the patient’s condition and resulted in a cardiac event.[38] In a different case, a physician could not access diagnostic imaging within the EHR, which resulted in the delayed diagnosis of lung cancer.  In another system-related malpractice case, a patient’s diagnosis of and treatment for cancer was delayed for years because the EHR system used by the provider referred the physician to outdated imaging.[39]

Among the several user-related issues, copy and paste errors by healthcare professionals have increased in the last ten years and the problem is only getting worse.[40] Copying and pasting text—a common practice among healthcare professionals—from different sections of the health record and medical information from past and current visits “jeopardize[s] the integrity” of the medical record.[41] The misuse of the copy and paste feature clutters the medical records with irrelevant, outdated, and/or potentially inaccurate information, making it difficult for physicians and nurses to sort through and make sense of the record.[42] The overuse of copying and pasting is causing the “‘death’ of the health record narrative.”[43] With so much redundant information muddling health records, healthcare professionals have difficulty discerning a patient’s medical history, which is particularly problematic because a patient’s history is crucial for effective, clinical decision-making.[44] Other user-related errors consist of mistakes due to lack of training and education in the use of the EHR systems.[45]

While copying and pasting may seem harmless, the malpractice claims associated with copy and paste errors indicate otherwise. For example, a patient with a cervical vascular malformation was under the care of a physician who, for four days straight, copied and pasted the same notes while other healthcare providers documented significant changes.[46] By the time the patient underwent surgical treatment, his condition had deteriorated to quadriplegia.[47] In yet another devastating copy and paste-related malpractice suit, a patient died of a pulmonary embolism caused by deep venous thrombosis five days after presenting to his doctor with chest pain and shortness of breath.[48] The physician who attended to the patient performed an incomplete assessment which was evidenced by the fact that the progress note was identical (including spelling errors) to a prior visit’s note, indicating the physician simply copied and pasted the note.[49] As of 2014, mistakes caused by “faulty data entry” or copy and pasting has amounted to roughly $61 million in settlements and legal expenses.[50]

IV. The Upward Trend of EHR-Related Medical Malpractice Lawsuits

As a result of the significant period of time between the occurrence of a medical error and the filing of a malpractice suit, EHR-related claims have only recently surfaced.[51] Notwithstanding the limited data available, The Doctors Company has conducted two studies within its closed claims database analyzing the significance of errors in EHR in medical malpractice actions.[52] The first study revealed 97 EHR-related claims between 2007 and 2014 with only two EHR-related claims between 2007-2010, suggesting that the number of claims has increased as the usage of HIT has become widespread.[53] The second study identified 66 EHR-related claims between July 2014 and December 2016.[54] Although the number of EHR-related claims constitute only 1% of the malpractice claims reported between 2007 and 2013, the number of such claims doubled between 2013 and 2014, further evidencing an upward trend.[55]

In an article published by The Journal of Patient Safety, the authors analyzed the results of a study conducted by CRICO Strategies, a risk management firm, which examined a database of 300,000 medical malpractice cases.[56] The CRICO study confirmed that “adverse events related to [EHRs]… are associated with an appreciable incidence of severe harm and death” and that severe harm “occurs at non negligible rates.”[57] In fact, the degree of harm reported in over 80% of the EHR-related claims was of medium or high severity.[58]  While less than 1% (248 cases) of the malpractice claims analyzed were related to errors in EHRs, these cases represent “the tip of the iceberg” of malpractice cases because the majority of safety-related malpractice rarely result in lawsuits.[59] In other words, the data does not reflect the prevalence of EHR-related errors in medical malpractice claims.

In yet another study, EHR-related claims represented 1.3% of the medical malpractice claims analyzed.[60] The study reaffirmed the findings of the CRICO study regarding the severity of the harm associated with EHR-related claims.[61] While the number of claims may not be significant at this point in time, the costs of EHR-related lawsuits is disproportionally higher than other malpractice claims due to the severity of the harm.[62] Several malpractice suits in which faulty EHRs could not be relied upon have received judgments in excess of $7.5 million.[63] Thus, researchers caution that the impact of EHR-related errors should not be underestimated.[64]

V. Conclusion

Despite the hope that EHRs would save billions of dollars annually, the cost of healthcare has only increased.[65] Given the rising prevalence of EHR-related malpractice claims, plaintiffs’ medical malpractice attorneys should remain vigilant for these issues when determining the merits of a potential case. Although such claims represent the vast minority of malpractice claims, the damages generally associated with EHR-errors are significantly higher than many other malpractice claims. In light of the unwillingness of EHR vendors to address the flaws in their systems, the number of EHR malpractice claims will likely continue to grow. Furthermore, the copying and pasting epidemic adversely affects the practice of law. As EHRs have become inundated with unnecessary information, the sheer number of medical records has increased, driving up the costs associated with retrieving and reviewing these records. Pursuing substantive EHR-related medical malpractice claims is a tangible way to catalyze comprehensive and effective changes in EHR software design as well as to compel health care providers to be more diligent in the use of EHRs. If you have a client with injuries that may have been caused by an EHR system or user error, please call us and we are happy to speak with them. We will work together with you for your client and we honor referral fees.

 

[1] Holly B. Haines and Elie A. Maalouf are attorneys at Abramson, Brown & Dugan in Manchester, New Hampshire. Their firm’s practice focuses on representing plaintiffs in medical malpractice, personal injury, and product liability litigation.

[2] See Mark L. Graber, MD, FACP, et al., Electronic Health Record-Related Events in Medical Malpractice Claims, 00 J. Patient safety 1, 1 (2015) (highlighting “remarkable transition” to electronic health records).

[3] “[H]ealth information technology (HIT) is the overarching term applied to various information and communication technologies used to collect, transmit, display, or store patient data.”  Dean F. Sittig, PhD & Hardeep Singh, MD, MPH, Defining Health Information Technology-related Errors: New Developments Since To Err is Human, 7 Archives Internal Med. 1281, 1281 (2011).

[4] See id. (discussing expectations associated with EHRs); see also Sharona Hoffman & Andy Podgurski, Finding a Cure: The Case for Regulation and Oversight of Electronic Health Record Systems, 22 Harv. J. Law & Tech. 103, 105 (2008) (contending implementation of EHRs could “dramatically reduce” number of medical errors and “promote efficiency, diminish costs, save time, and save lives”).

[5] See Vera Lücia Raposo, Electronic health records: Is it a risk worth taking in healthcare delivery? GMS Health Tech. Assessment (2015), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4677576/pdf/HTA-11-02.pdf (comparing risks and benefits of EHRs); see also Sharona Hoffman & Andy Podgurski, E-Health Hazards: Provider Liability and Electronic Health Record Systems, 24 Berkely Tech. l. J. 1523, 1525-26 (2009) (listing benefits of EHRs).

[6] See Jennifer King et al., Clinical Benefits of Electronic Health Record Use: National Findings, 49 Health Servs. Research 392, 402 (2014) (reporting various clinical benefits of EHRs). 81% of physicians surveyed found that EHRs allowed remote access to patient charts, while 65% reported that the EHRs “alerted them to potential medication errors.” Id.

[7] See, e.g., Mariah A. Quinn et al., The relationship between electronic health records and malpractice claims, Arch Intern Med. (Aug. 13, 2012), https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1203517 (concluding “rate of malpractice claims when EHRs were used was about one-sixth the rate when EHRs were not used).

[8] See Graber, supra note 2, at 1 (stating such findings “remain controversial” considering “many organizations have been dissatisfied” with EHR systems); see also Physicians Use of EHR Systems, Am. Med. Ass’n (2014), http://www.americanehr.com/research/reports/Physicians-Use-of-EHR-Systems-2014.aspx (reporting that more physicians are “dissatisfied or very dissatisfied with their EHR system”).

[9] Graber, supra note 2, (pointing out number of issues that require resolution); see also Penny Greenberg, MS, RN, CPPS & Gretchen Ruoff, MPH, CPHRM, Malpractice Risks Associated with Electronic Health Records, CRICO (June 13, 2017), https://www.rmf.harvard.edu/Clinician-Resources/Article/2017/Malpractice-Risks-Associated-with-Electronic-Health-Records (focusing on concerns raised by unintended consequences of HIT).

[10] Arthur Kellerman & Spencer S. Jones, What it Will Take to Achieve the As-Yet-Unfulfilled Promises of Health Information Technology, 32 Health Affairs 63, 64 (2013) (arguing quality of care only slightly better despite increased use of EHRs).

[11] Sue Bowman, MJ, RHIA, CCS, FAHIMA, Impact of Electronic Health Record Systems on Information Integrity: Quality and Safety Implications, Perspectives in Health mgmt. (Oct. 2013), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3797550/pdf/phim0010-0001c.pdf (calling attention to safety hazards of EHRs); Michael I. Harrison, PhD, Ross Koppel, PhD, Shirly Bar-Lev, PhD, Unintended Consequences of Information Technologies in Health Care—An Interactive Sociotechnical Analysis, 14 J. Am. Med. Informatics Ass’n 542, 542 (2007) (citing a “growing body of research” which reveal many negative consequences of EHRs).

 [12] Milly Dawson, Is Your EHR Harming Your patients? ‘Garbage in garage out’ can pose a risk to patients, MedPage Today (Oct. 15, 2017),

https://www.medpagetoday.com/practicemanagement/informationtechnology/68543 (identifying reduction of medical errors as a “major reason to adopt electronic records”).

[13] Bowman, supra note 11.

[14] See David B. Troxel, MD, Electronic Health Record Closed Claims Study An expert analysis of medical malpractice allegations, The Doctors Co. (Oct. 16, 2017), https://www.thedoctors.com/siteassets/pdfs/risk-management/closed-claims-studies/11220_ccs_ehr_1017_single-page_fr2.pdf [hereinafter Doctors Company Study] (recognizing “rapid implementation” of EHR systems and related errors as “contributing factor[s]” in medical malpractice claims).

[15] See Doctors Company Study, supra note 14, at 7 (assessing professional liability risks arising from EHRs); Graber, supra note 2, at 2 (analyzing medical malpractice claims in which EHRs caused injury); Gabriel Perna, Five EHR-Related Medical Malpractice Limitations, Modern Medicine Network (June 12, 2017), http://www.physicianspractice.com/law-malpractice/five-ehr-related-medical-malpractice-landmines (reporting number of EHR-related claims in study conducted by Constellation, a liability insurer).

[16] See supra note 13 (elaborating on findings of various studies).

[17] See Hoffman & Podgurski, supra note 4, at 106 (describing political enthusiasm for computerized health records); see also Donald W. Simborg, MD, Promoting Electronic Health Record Adoption. Is It the Correct Focus?, 15 J. Am. Med. Informatics Ass’n 127, 127 (2007) (referencing President Bush’s goal for every American to have an EHR); Karoline Kreuser, The Adoption of Electronic Health Records: Benefits and Challenges, 16 Annals of Health Law 317, 318 (2007) (citing President Bush’s proclamation as a driving force behind adoption of EHRs).

[18] See Kreuser, supra note 17, at 318 (citing “desire to improve healthcare” as motivation); Kellerman & Jones, supra note 10, at 63 (explaining Rand Corporation’s projected savings of $81 billion was “enthusiastically embraced”); Jan Walker et al., The Value of Health Care Information Exchange and Interoperability, Health Affairs (Jan. 19, 2005) (estimating net savings of $78 billion if EHRs widely adopted).

[19] See Merriam-Webster Dictionary, https://www.merriam-webster.com/dictionary/interoperability.

[20] Walker et al., supra note 18 (elaborating on benefits of interoperable software); Hoffman & Podgurski, supra note 4, at 112-14.

[21] See Kellerman & Jones, supra note 10, at 64 (highlighting caveat to Rand Corporation’s economic analysis).

[22] David Blumenthal, MD, MPP & Marilyn Tavenner, RN, MHA, The “Meaningful Use” Regulation, 363 New England J. Med. 501, 501 (2010) (outlining purpose of HITECH Act).

[23] See id. (revealing incentive payments totaled $44,000 (through Medicare) and $63,750 (through Medicaid) per clinician).

[24] Id. (providing various “meaningful use” objectives).

[25] See Doctors Company Study, supra note 14.

[26] See Kellerman & Jones, supra note 10, at 64 (explaining that current EHR systems “are not designed to talk to each other”).

[27] See Kellerman & Jones, supra note 10, at 64 (espousing suspicion that HIT vendors oppose interoperability due to lack of progress).

[28] See Doctors Company Study, supra note 14 (taking issue with government’s lack of guidance).

[29] See Doctors Company Study, supra note 14 (noting lack of oversight); Bowman, supra note 11 (disapproving of lack of regulations and policies for vendors and users); Hardeep Singh, MD, MPH, David C. Classen, MD, MS, & Dean F. Sittig, PhD, Creating an Oversight Infrastructure for Electronic Health Record-Related Patient Safety Hazards, 7 J. Patient Safety 169, 172 (2013) (questioning which government agency is charged with EHR oversight and calling for creation of oversight program); See Hoffman & Podgurski, supra note 4, at 107 (stressing need for regulatory oversight).

[30] See Doctors Company Study, supra note 14.

[31] Id.

[32] See Kellerman & Jones, supra note 10, at 65 (finding vendors do not prioritize making their systems user-friendly); see also Susan Kreimer, Avoiding an EHR-related malpractice suit, Med. Econ. (Oct. 25, 2015), http://medicaleconomics.modernmedicine.com/medical-economics/news/avoiding-ehr-related-malpractice-suit.

[33] Kellerman & Jones, supra note 10, at 65 (calling for healthcare providers to adapt their care).

[34] See Graber, supra note 2, at 3 (identifying sources of system related errors).

[35] See Doctors Company Study, supra note 14.

[36] See Bowman, supra note 11 (exposing pitfalls of software design).

[37] See id.

[38] See Greenberg & Ruoff, supra note 9.

[39] See Raposo, supra note 4.

[40] See Bowman, supra note 11 (analyzing impact of copy and paste overuse).

[41] Id.

[42] Id.

[43] Eugenia L. Siegler, MD & Ronald Adleman, MD, Copy and Paste: A Remediable Hazard of Electronic Health Records 122 AM. J. Med. 495, 495 (2009) (addressing loss of medical records’ “narrative function” due to copy and paste overuse).

[44] See Bowman, supra note 11.

[45] See Greenberg & Ruoff, supra note 9.

[46] See Doctors Company Study, supra note 14.

[47] See id.

[48] See id.

[49] See id.

[50] See Debra B. Ruder, Malpractice Claims Analysis Confirms Risks in EHRs, PSQH (February 2014), https://www.psqh.com/analysis/malpractice-claims-analysis-confirms-risks-in-ehrs/.

[51] See David B. Troxel, MD, Analysis of EHR Contributing Factors in Medical Professional Liability Claims, Doctors Co. (2015), https://www.thedoctors.com/the-doctors-advocate/first-quarter-2015/analysis-of-ehr-contributing-factors-in-medical-professional-liability-claims/(estimating it takes 3-4 years from the occurrence of an adverse event to the filing of a lawsuit).

[52] See Doctors Company Study, supra note 14.

[53] See id.

[54] See id.

[55] See id.

[56] See Graber, supra note 2, at 4 (analyzing findings of CRICO study).

[57] Id.

[58] See id.

[59] See id.

[60] See Gabriel Perna, Five EHR-Related Medical Malpractice Landmines Modern Med. Network (June 12, 2017), http://www.physicianspractice.com/law-malpractice/five-ehr-related-medical-malpractice-landmines (reporting on a study conducted by a senior manager at a mutual liability insurer).

[61] See id.

[62] See id.

[63] See Lucas Mearian, Lawyers smell blood in electronic medical records, Computerworld (Apr. 13, 2015), https://www.computerworld.com/article/2909348/lawyers-smell-blood-in-electronic-medical-records.html (rehashing statistics from lecture given by Keith Klein, MD, a physician who has testified in over 350 medical malpractice lawsuits).

[64] See Perna, supra note 60.

[65] See Kellerman & Jones, supra note 10, at 63 (citing rise of healthcare costs from $2 trillion in 2005 to $2.8 trillion in 2013).