Discussion: Health Hazards Articles Summary & Reply

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Case Western Reserve University School of Law Scholarly Commons Faculty Publications 2009 E-Health Hazards: Provider Liability and Electronic Health Record Systems Sharona Hoffman Case Western Reserve University School of Law, [email protected] Andy Podgurski Case Western University, [email protected] Follow this and additional works at: https://scholarlycommons.law.case.edu/faculty_publications Part of the Health Law and Policy Commons Repository Citation Hoffman, Sharona and Podgurski, Andy, “E-Health Hazards: Provider Liability and Electronic Health Record Systems” (2009). Faculty Publications. 2. https://scholarlycommons.law.case.edu/faculty_publications/2 This Article is brought to you for free and open access by Case Western Reserve University School of Law Scholarly Commons. It has been accepted for inclusion in Faculty Publications by an authorized administrator of Case Western Reserve University School of Law Scholarly Commons. 1523-1582 HOFFMAN WEB E-HEALTH HAZARDS: PROVIDER LIABILITY AND ELECTRONIC HEALTH RECORD SYSTEMS Sharona Hoffman† & Andy Podgurski †† ABSTRACT In the foreseeable future, electronic health record (EHR) systems are likely to become a fixture in medical settings. The potential benefits of computerization could be substantial, but EHR systems also give rise to new liability risks for health care providers that have received little attention in the legal literature. This Article features a first of its kind, comprehensive analysis of the liability risks associated with use of this complex and important technology. In addition, it develops recommendations to address these liability concerns. Appropriate measures include federal regulations designed to ensure the quality and safety of EHR systems along with agency guidance and well crafted clinical practice guidelines for EHR system users. In formulating its recommendations, the Article proposes a novel, uniform process for developing authoritative clinical practice guidelines and explores how EHR technology itself can enable experts to gather evidence of best practices. Discussion: Health Hazards Articles Summary & Reply. The authors argue that without thoughtful interventions and sound guidance from government and medical organizations, this promising technology may encumber rather than support clinicians and may hinder rather than promote health outcome improvements. TABLE OF CONTENTS I. INTRODUCTION …………………………………………………………………………………. 1524 II. EHR SYSTEM ATTRIBUTES……………………………………………………………. 1530 III. LIABILITY CONCERNS ………………………………………………………………….. 1533 A. MEDICAL MALPRACTICE CLAIMSNorthwestern University HSA 516 E Health Hazards Articles Summary & Reply ………………………………………………….. 1533 © 2009 Sharona Hoffman and Andy Podgurski. † Professor of Law and Bioethics, Co-Director of Law-Medicine Center, Case Western Reserve University School of Law; B.A., Wellesley College; J.D., Harvard Law School; LL.M. in Health Law, University of Houston. †† Professor of Electrical Engineering and Computer Science, Case Western Reserve University. B.S., M.S., Ph.D., University of Massachusetts. The authors wish to thank Jessica Berg, Henry Bloom, Shawneequa Callier, David Hyman, Richard Krueck, Maxwell J. Mehlman, Cassandra Robertson, and Robert Strassfeld for valuable comments on drafts of this paper. We are also grateful for the very skillful research assistance of Michael Hill. 1523-1582 HOFFMAN WEB 1524 BERKELEY TECHNOLOGY LAW JOURNAL [Vol. 24:4 1. B. C. Liability of Health Care Entities: Corporate Negligence and Vicarious Liability ……………………………………………………………….. 1535 2. Clinician Liability ……………………………………………………………………. 1537 a) Physician Time Constraints and Information Overload ………………………………………………………………… 1537 b) Reliance on Others‘ Diagnosis and Treatment Decisions………………………………………………………………… 1542 c) Input Errors ………………………………………………………………. 1544 d) The Challenges of Decision Support …………………………. 1545 e) Responsiveness to Electronic Communication ………….. 1549 f) Patient Access to PHRs ……………………………………………… 1551 g) Product Defects…………………………………………………………. 1552 PRIVACY BREACHES ………………………………………………………………………. 1555 1. Security Threats and Regulation ………………………………………………….. 1555 2. Potential Litigation …………………………………………………………………… 1558 DISCIPLINARY ACTION BY STATE MEDICAL BOARDS AND CRIMINAL PROSECUTION ……………………………………………………………. 1561 IV. ADDRESSING LIABILITY RISKS: STRATEGIES AND RECOMMENDATIONS …………………………………………………………………… 1562 A. ACHIEVING QUALITY CONTROL …………………………………………………… 1563 1. Government Regulations…………………………………………………………….. 1563 2. Agency Guidance ……………………………………………………………………… 1567 B. ESTABLISHING THE STANDARD OF CARE ……………………………………… 1568 1. Regulations, Agency Guidance, and Certification as Evidence of Standard of Care ………………………………………………………………….. 1569 2. Clinical Practice Guidelines ………………………………………………………… 1570 a) What are CPGs? ………………………………………………………… 1570 b) A Critique of CPGs …………………………………………………… 1571 c) The Opportunity Presented by an Emerging Technology …………………………………………………………….. 1572 d) A Proposed Approach for CPG Development …………. 1574 3. Audit Trails, User Problem Reports, and the Collection of Data about EHR System Use ………………………………………………………… 1576 V. CONCLUSION ……………………………………………………………………………………… 1579 I. INTRODUCTION The American Recovery and Reinvestment Act of 2009 (ARRA),1 better known as President Obama‘s stimulus legislation, was enacted to rescue an 1. American Recovery and Reinvestment Act of 2009, Pub. L. No. 111-5, 123 Stat. 115 (2009). 1523-1582 HOFFMAN WEB 2009] E-HEALTH HAZARDS 1525 ailing economy in early 2009.2 One of its many goals was ?to increase economic efficiency by spurring technological advances in science and health.?3 To that end, ARRA dedicated nineteen billion dollars to the promotion of health information technology.4 The ARRA‘s goal is to computerize all Americans‘ health records by 2014.5 Currently, only a small minority of health care practices use electronic health record (EHR) systems, including perhaps seventeen percent of doctors and ten percent of hospitals.6 In order to comply with this mandate and avoid penalties for non-compliance,Northwestern University HSA 516 E Health Hazards Articles Summary & Reply Discussion: Health Hazards Articles Summary & Reply. 7 health care providers will need to increase their rate of EHR system adoption dramatically. Comprehensive EHR systems will have a pervasive influence on medical care and serve multiple functions beyond storing medical files. They electronically transmit diagnostic test images and results, laboratory reports, and radiologic images and reports to physicians so that these can be quickly reviewed and shared with patients.8 The systems feature computerized provider-order entry (CPOE), which allows providers to send electronic orders, such as those for laboratory tests and medications, to appropriate parties.9 They also feature decision support tools, among which are clinical guidelines, clinical reminders, drug-allergy and drug interaction alerts, and drug-dose support.10 EHR systems may also provide a secure messaging feature to help physicians communicate with patients confidentially.11 Ideally, EHR systems should be interoperable and thus be able to automatically 2. Id. at § 3 (stating that the purpose of the Act is ?to preserve and create jobs and promote economic recovery? and ?to assist those most impacted by the recession?). 3. Id. § 3(a)(3). 4. David Blumenthal, Stimulating the Adoption of Health Information Technology, 360 NEW ENG. J. MED. 1477 (2009). 5. American Recovery and Reinvestment Act § 3001(c)(3)(A)(ii). 6. Id. (noting that these figures represent practices using basic systems, not necessarily sophisticated or comprehensive systems); Catherine M. DesRoches et al., Electronic Health Records in Ambulatory Care: A National Survey of Physicians, 359 NEW ENG. J. MED. 50, 54 (2008); Ashish K. Jha et al., Use of Electronic Health Records in U.S. Hospitals, 360 NEW ENG. J. MED. 1628, 1631 (2009). 7. Blumenthal, supra note 4, at 1477–78 (noting that ?[p]hysicians who are not using EHRs systems meaningfully will lose 1% of their Medicare fees in 2015, then 2% in 2016, and 3% in 2017?). 8. Jha et al., supra note 6, at 1632. 9. Id. 10. Id. 11. Catherine Chen et al., The Kaiser Permanente Electronic Health Record: Transforming And Streamlining Modalities of Care, 28 HEALTH AFF. 323, 325 (2009) (describing the secure messaging system implemented by Kaiser Permanente Hawaii in September 2005). 1523-1582 HOFFMAN WEB 1526 BERKELEY TECHNOLOGY LAW JOURNAL [Vol. 24:4 incorporate records and process information from EHR systems developed by different vendors.12 The potential benefits of computerization are considerable.13 In short, EHR systems can facilitate access to patients‘ medical records, improve the quality of care and the accuracy of treatment decisions, achieve cost savings, and promote clinical research.14 Some health care providers with EHR systems already report better outcomes, fewer complications, lower costs, and fewer malpractice claim payments.15 Without discounting any of these potential benefits, this Article focuses on the risks of EHR systems and on liability concerns associated with their use. Discussion: Health Hazards Articles Summary & Reply It argues that despite the promise of this technology, the implementation of EHR systems must proceed with both caution and appropriate government oversight. In recent years, more than a few startling EHR-related stories have surfaced. For example, software glitches in the U.S. Department of Veterans Health Administration‘s EHR system exposed veterans to excessive, 12. BIOMEDICAL INFORMATICS: COMPUTER APPLICATIONS IN HEALTH CARE AND BIOMEDICINE 952 (Edward H. Shortliffe & James J. Cimino eds., 2006) [hereinafter BIOMEDICAL INFORMATICS] (explaining that interoperable systems can communicate with each other, exchange data, and operate seamlessly and in a coordinated fashion across organizations). 13. We have discussed them extensively in prior work. See Sharona Hoffman & Andy Podgurski, Finding A Cure: The Case for Regulation and Oversight of Electronic Health Record Systems, 22 HARV. J.L. & TECH. 103, 112–19 (2008) (discussing the benefits of EHR systems). 14. Id.; see also Richard J. Baron et al., Electronic Health Records: Just Around the Corner? Or Over the Cliff? 143 ANNALS INTERNAL MED. 222, 225–26 (2005) (discussing the benefits of an EHR system in a small practice); Stephen T. Parente & Jeffrey S. McCullough, Health Information Technology And Patient Safety: Evidence From Panel Data, 28 HEALTH AFF. 357, 357– 58 (2009) (utilizing four years of inpatient data from Medicare patients and finding that EHRs have ?a small, positive effect on patient safety?); Julie Weed, If All Doctors Had More Time to Listen, N.Y. TIMES, June 7, 2009, at BU1 (praising EHR systems and arguing that they save physicians time and money). But see Yong Y. Han et al., Unexpected Increased Mortality After Implementation of a Commercially Sold Computerized Physician Order Entry System, 116 PEDIATRICS 1506, 1510–12 (2005) (noting that the mortality rate among children increased from 2.80% to 6.57% after computerized physician order entry implementation and asserting that further evaluation of this evolving technology is needed). 15. Ruben Amarasingham et al., Clinical Information Technologies and Inpatient Outcomes, 169 ARCH. INTERN. MED 108, 111–12 (2009) (reporting on a survey that involved 167,233 patients at 41 urban Texas hospitals); Anunta Virapongse et al., Electronic Health Records and Malpractice Claims in Office Practice, 168 ARCH. Northwestern University HSA 516 E Health Hazards Articles Summary & Reply INTERN. MED. 2362, 2365 (2008) (presenting a survey of 1,345 Massachusetts physicians and stating that although the study‘s results were inconclusive, they suggest that ?physicians with EHRs appear less likely to have paid malpractice claims?). But see Steve Lohr, Little Benefit Seen, So Far, in Electronic Patient Records, N.Y. TIMES, Nov. 16, 2009, at B3 (reporting on research that revealed that EHR systems have ?not yet had a real impact on the quality or cost of health care?). 1523-1582 HOFFMAN WEB 2009] E-HEALTH HAZARDS 1527 potentially life-threatening dosages of the blood-thinner heparin.16 In a different incident, a hospital pharmacy‘s computer program generated erroneous medication order lists, leading to the delivery of the wrong drugs to patients in many wards.17 A May 2009 article featured the alarming title ? ?Nearly Killed‘ by E-Records Data Model? and described the distressing experience of a patient in an intensive care unit with an EHR system that did not allow doctors and nurses to access critical medical information or obtain medication from the pharmacy in a timely fashion.18 The liability risks of EHR systems, however, have received little attention in the legal literature. Along with the potential to enhance health outcomes, this new technology may bring novel responsibilities, burdens, and complexities for medical practices. Historically, medical innovations, such as anesthetics and x-rays, have generated increased tort litigation as patients quickly came to expect better care while physicians struggled to perfect their use of challenging technologies.19 The same phenomenon may well occur with EHR systems. This Article details specific liability risks associated with EHR systems and explores strategies to alleviate liability concerns.20 For the sake of simplicity, we use the terms EHR and EHR systems to designate electronic health records and the systems in which they operate. We mean the term EHR to be synonymous with what others call the electronic medical record (EMR).21 16. Hope Yen, BlueCross BlueShield Association, Veterans Exposed to Incorrect Drug Doses, (Jan. 13, 2009), http://www.bcbs.com/news/national/veterans-exposed-toincorrect-drug-doses.html. 17. Richard I. Cook & Michael F. O‘Connor, Thinking About Accidents and Systems, in IMPROVING MEDICATION SAFETY 80, 80–82 (Kasey Thompson & Henri R. Manasse eds., 2005) (explaining that the problem was rooted in a backup tape that was incomplete and corrupted). 18. Tony Collins, “Nearly Killed” by E-Records Data Model, COMPUTERWEEKLY.COM, (May 21, 2009), http://www.computerweekly.com/Articles/2009/05/21/236128/nearlykilled-by-e-records-data-model.htm. 19. James C. Mohr, American Medical Malpractice Litigation in Historical Perspective, 283 J. AM. MED. ASS‘N 1731, 1733–34 (2000); Mark F. Grady, Why Are People Negligent? Technology, Nondurable Precautions, and the Medical Malpractice Explosion, 82 NW. U. L. REV. 293, 297–301, 314–15 (1988) (explaining that many ?believe that new technology adds to the number of negligence claims? and analyzing the reasons for this phenomenon). 20. See infra Part IV. 21. There is confusion in the literature about the terms EHR and EMR. For example, the HITECH Act defines an EHR as ?an electronic record of health-related information on an individual that is created, gathered, managed, and consulted by authorized health care clinicians and staff.? American Recovery and Reinvestment Act of 2009, Pub. L. No. 111-5, 123 Stat. 115 (2009) (to be codified at 42 U.S.C. § 17921(5)). However, one commentator notes that the HITECH Act‘s definition of EHR is ?confusingly . . . one that is generally associated with an EMR.? Nicolas P. Terry, Personal Health Records: Directing More Costs and 1523-1582 HOFFMAN WEB 1528 BERKELEY TECHNOLOGY LAW JOURNAL [Vol. 24:4 With their wealth of capabilities, EHR systems are likely to raise the public‘s expectations concerning clinicians‘ performance and to affect the standard of care to which clinicians are held for medical malpractice purposes.Northwestern University HSA 516 E Health Hazards Articles Summary & Reply 22 The systems make unprecedented volumes of information available to physicians.23 With computers connecting them to a local, regional, and perhaps even national health information network,24 doctors could have access to every detail of the patient‘s medical history from birth until the present time and be expected to consider all relevant information in their treatment decisions. EHR systems also provide doctors with sophisticated decision support tools,25 which will raise the public‘s expectations concerning the quality of medical treatments. More common use of e-mail and secure messaging for patient-doctor communication and improved access to clinical data through personal health records26 may further increase patient demands and expectations. Physicians who have more complete records and better decision support and communication tools, but who do not have the time or skill to assimilate the unprecedented amount of available data and to optimize their use of technology, may face medical malpractice claims that would have never emerged in the past.27 Clinicians who mishandle EHR systems and thereby cause injury to patients could also in rare cases face disciplinary action initiated by state licensing boards and even criminal prosecution.28 Health care organizations such as hospitals may likewise face reaccreditation challenges and lawsuits based on vicarious liability and other negligence theories.29 Risks to Consumers?, 1 DREXEL L. REV. 216, 257 (2009). 22. See infra notes 69–79 and accompanying text for a discussion of medical malpractice and the standard of care. 23. Jha et al., supra note 6, at 1633 (discussing the various capabilities of comprehensive EHR systems). 24. American Recovery and Reinvestment Act § 3002(b)(1) (articulating the goal of establishing a ?nationwide health information technology infrastructure that permits the electronic exchange and use of health information?). 25. Jonathan A. Handler et al., Computerized Physician Order Entry and Online Decision Support, 11 ACAD. EMERGENCY MED. 1135, 1135–36 (2004). 26. See Paul C. Tang et al., Personal Health Records: Definitions, Benefits, and Strategies for Overcoming Barriers to Adoption, 13 J. AM. MED. INFORMATICS ASS‘N 121, 121 (2006) (explaining that personal health records provide a ?repository for patient data,? provide capabilities that ?assist patients in managing chronic conditions,? and generally allow individuals to be more active in their own health care). 27. See infra Section III.A.2. 28. See infra Section III.C. 29. See infra Sections III.A.1 & III.C. 1523-1582 HOFFMAN WEB 2009] E-HEALTH HAZARDS 1529 In addition, computerization and electronic distribution of private health information could lead to privacy breach claims. Electronic data is vulnerable to improper disclosure through hacking, laptop theft, inadvertent disclosure, or deliberate leaks.30 Once electronic information is accessed by unauthorized personnel, it can be rapidly distributed to a worldwide audience through the Internet, potentially causing humiliation, ruining careers, or causing other serious harms.31 This Article prov … Get a 10 % discount on an order above $ 100 Use the following coupon code : NURSING10