Secondary Logo

Journal Logo

Perspectives

Commercial Interests in Continuing Medical Education: Where Do Electronic Health Record Vendors Fit?

Rubinstein, Pesha F. MPH, CHCP; Middleton, Blackford MD, MPH, MSc; Goodman, Kenneth W. PhD; Lehmann, Christoph U. MD

Author Information
doi: 10.1097/ACM.0000000000003190
  • Free

Abstract

Throughout their careers, physicians must acquire new knowledge based on ongoing research and discovery to provide patients with the best diagnostic and treatment methods. To ensure that physicians continue this practice of lifelong learning, most states in the United States have mandatory continuing medical education (CME) requirements for physicians to obtain or maintain licensure. The Accreditation Council for Continuing Medical Education (ACCME) oversees CME activities and accredits the organizations that provide this learning to physicians.

The ACCME and Commercial Interests

The ACCME criteria restrict accredited CME providers to organizations that are independent of commercial interests and promote advances in health care, rather than those that have proprietary or commercial interests.1 Pharmaceutical and medical device companies may be commercial supporters of CME activities, but they are barred by the ACCME’s Standards for Commercial Support from influencing CME activities, including the educational needs assessment, objectives, content, selection of persons in control of the content, educational methodology, and evaluation. Despite these prohibitions, commercial spending on CME for physicians and other health care professionals reached a peak of $1.2 billion in 2007 before dropping to $659 million in 2013. Since then, spending has increased steadily to nearly $740 million in 2017, when commercial support accounted for 28% of all CME funding.2

To prevent undue influence by commercial interests, commercial funding from pharmaceutical and medical device companies for CME events is granted to ACCME-accredited organizations (e.g., medical education companies, academic organizations, health and hospital systems, physician member organizations) that then apply that support to offset their CME activity costs. Working through accredited CME providers ensures that the content reaching health care professionals is unbiased and that any conflicts of interest due to the event planners’ or speakers’ relevant financial relationships with commercial interests have been successfully resolved.

The ACCME rules prohibiting the accreditation of “commercial interest[s]” state that commercial interests “cannot be accredited providers and cannot be joint providers.”3 The ACCME defines a “commercial interest” as “any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.”3 According to ACCME President Graham McMahon, the “guiding principle behind the definition is that [the ACCME rules are meant to] prohibit organizations that might use CME to market products or services they produce to doctors who then would prescribe or use those products or services on patients inappropriately.”4

The Effects of Commercially Funded CME on Physicians’ Behaviors

There is concerning evidence that completing a pharmaceutical company-supported CME activity, even when the event is run by an ACCME-accredited provider, alters physicians’ prescribing behaviors, which might not be in the best interest of patients, payers, and society.5 Commercial support for CME events affects presentation content,6 with the drug of the company supporting the event often being preferentially highlighted.7 Similar to direct interactions between physicians and pharmaceutical sales representatives, which have been shown to alter prescribing and formulary requests,8 commercially supported CME events lead to physicians increasing their prescribing of the drugs produced by the companies supporting the events more than their prescribing of other drugs in the same class.7 Physicians who accepted commercial funding to attend symposia were more likely to generate more formulary addition requests for the drugs produced by the companies funding the symposia.9 According to a 2001 article, most residents reported that pharmaceutical companies’ marketing efforts did not influence their prescribing, but only 16% believed the same of their peers.10 Physicians receiving compensation from medical device manufacturers frequently did not disclose this information when publishing on related topics.11

With mounting public concern about physician–industry relationships,12,13 the ACCME in 2007 redefined “commercial interest[s]” to include companies involved in “marketing” health care goods or services consumed by, or used on, patients.3 They also created a structured self-assessment so companies could determine if they were commercial interests under the new definition.14

The U.S. Senate Finance Committee’s 2007 report “Use of Educational Grants by Pharmaceutical Manufacturers” had a significant impact on commercial funding for CME activities, with pharmaceutical companies assiduously separating their grant-making processes and departments from their marketing divisions.15 Updates to the ACCME accreditation criteria in 2006 and 2016 were associated with decreases in perceptions of bias in commercially supported CME activities.16,17

Electronic Health Record Vendors as Commercial Interests

While focusing on preventing pharmaceutical and medical device companies from becoming CME providers, the ACCME has accredited other commercial entities that produce and market products and services that could be used inappropriately on patients. These entities are electronic health record (EHR) vendors. The EHR industry is a $31.5 billion per year business,18 and the interaction of physicians and EHR vendors is highly consequential for physicians themselves, patients, payers, and society. The U.S. Department of Health and Human Services Office of the National Coordinator (ONC) for Health Information Technology reported that EHRs are used by 86% of office-based physicians and that 4 of every 5 clinics has adopted an ONC-certified EHR system.19

Even though the 21st Century Cures Act excluded EHR systems from the Food and Drug Administration’s (FDA’s) oversight, they should be considered medical devices similar to pacemakers, insulin pumps, and CT scanners, which are all under the purview of the FDA. No other commercial device or technology is used more often by physicians and other health care professionals than EHRs. In addition, EHR vendors meet the definition of a commercial interest, namely they are entities that produce, market, resell, or distribute health care goods or services that are consumed by, or used on, patients. Not only is the care of patients influenced by how EHRs are designed and implemented, but patients and their caregivers also interact with EHRs directly through patient portals.20 Therefore, there are compelling ethical reasons for EHR vendors to be considered commercial entities that are ineligible for ACCME accreditation.

The Need for Unbiased EHR Education

EHRs have led to novel unintended challenges as well as patient safety issues in clinical care.21–23 Although health information technology (IT) has the potential to improve patient safety, especially once the technology has matured,24,25 it also may jeopardize patient–physician communication26 and the safe provision of care and may lead to physician burnout.27–29 EHR vendors’ efforts to encourage the correct use of their products can counter these challenges. However, known publication bias for positive studies of EHRs30 and the “hold harmless” and nondisclosure clauses in vendor contracts, which prevent physicians from disclosing flaws in these systems,31,32 combined with marketing focused on improving vendors’ profits, can result in poor purchasing and upgrade decisions by physicians, which may adversely affect patients.

The use of EHRs and their embedded decision-support systems have led to ethical challenges related to the range of appropriate uses and users, skill degradation, and interoperability, which may further diminish the utility of vendor-specific education.33 Because of the inherent risk in using EHRs, as with recognized medical devices, the education of the physician workforce that implements and maintains these systems, including those in the new clinical informatics subspecialty,34,35 must be as sound, comprehensive, and free from influence by commercial interests as possible.

The Effects of EHR Vendor-Funded CME on Physicians’ Behaviors

Vendor gifts

EHR vendors with large market shares36 currently hold and sponsor multiday CME events. These events are attended by thousands of health care professionals and offer nicely furnished surroundings (frequently on vendor campuses) and gifts in the form of free food and drink, entertainment, and social programs that are designed to provide levity and amusement. From these vendors, attendees receive greatly discounted (or free) CME credits, which they need to maintain their license to practice medicine. Attendees also receive other gifts, which have been shown to alter their neuropsychological responses,37 generate reciprocity,38 and modify their behavior unbeknownst to them.39

To describe the potential effects of EHR vendor gifts, we replaced “drug companies” with “EHR vendors” in the following key quote from a seminal New England Journal of Medicine article:

The relationships between [EHR vendors] and doctors would be of little interest if they did not have potential consequences for patients, doctors, and the larger society. Explicitly or implicitly, much of the debate about these relationships revolves around the question of whether [EHR vendors] influence physicians’ behavior and, if they do, whether the results are, on balance, positive or negative for the quality and cost of health care and for the profession of medicine itself.12

Information bias

Similar to pharmaceutical companies’ “expert” dinner meetings,40 which are now prohibited by the pharmaceutical industry’s own code of conduct41 and the federal Anti-Kickback Statute,42 EHR vendor-sponsored CME events focus exclusively on and highlight preferentially one EHR product and its benefits and by design do not discuss or even mention solutions or products by competitors. Because every EHR system has intrinsic limitations, attendees are not adequately trained on alternate ways to solve problems. Variations in EHR system functionalities and layouts can be a source of data bias.43 Vendors might tell the truth about their product, but they provide an incomplete version of the known knowledge in the field, which is another form of information bias. Instead of learning best clinical informatics practices44 and challenging the vendor to improve its product, attendees are presented with only the vendor’s worldview, which may result in their suboptimal or inappropriate use of EHR products or services on patients.

Former president and chief executive officer of the American Medical Informatics Association Douglas Fridsma explained:

To prevent harm to patients, clinicians need fundamental training in how to collect, analyse, and use health data—training that is not tied to a specific technology. Without that foundation, … we are faced with the educational equivalent of drug companies teaching medical students the mechanics of how to write a prescription for their products, without teaching them essential pathophysiology, pharmacology, and microbiology to make them safe and effective prescription writers. We need to move beyond the basic mechanics of how to use information technology and teach health providers the underlying science of health information.45

Anchoring

At the CME events they sponsor, EHR vendors only present solutions that are specific to their systems and, in theory, prevent attendees from considering associated products (analytics, messaging, interoperability, consumer interfaces, web portals, other integration activities, etc.). This may lead attendees to “anchor” in the EHR system of the event sponsor. Many EHR vendors are already known to provide very little corporate social responsibility information.46 They also like their customers to wait until they develop and introduce additional proprietary services and technologies to the market, rather than have clients adopt solutions from other companies that are already available. In addition, they divert customers’ attention from their competitors’ solutions, which might improve care immediately and might very well replace their product in the future. EHR vendors focus physicians’ attention on future enhancements to their systems so physicians may miss opportunities to implement available solutions that are more congruent with the needs of their patients, organizations, and the community.

In itself, EHR vendors educating and training physicians to better use their systems is not concerning. This kind of education could lead to better patient care. In fact, the ACCME has defined specific scenarios in which employees of ACCME-defined commercial interests are permitted to control the content of certified CME events, for example, a technician “teach[ing] the safe and proper use of medical devices.”47 However, education provided directly by an EHR vendor does not meet the stringent requirements for unbiased CME.

Patient care

Is the accreditation of EHR vendors as CME providers a problem? We believe the answer is yes, because vendors focus their CME events solely on their own content and products rather than the full scope of the health IT available. Clinical informatics is a board-certified medical specialty, and the ACCME’s clinical content validation rules for all specialties demand that “all the recommendations involving clinical medicine in a CME activity must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients.”48 Omitting substantial portions of that evidence is not acceptable.

In addition, potential reciprocation or “quid pro quo” by attendees to the EHR vendors that sponsor a CME event is similar to the altered medication prescribing practices of attendees of pharmaceutical industry-sponsored events. As the purchase of health IT, such as an EHR system, is a large project involving many groups and individuals in a health care system, some have argued that no single attendee of a vendor-sponsored CME event alone can affect the purchasing of an EHR system or the subsequent care of patients. Unfortunately, this is not the whole story. First, EHR vendor-sponsored CME events may include tens or even hundreds of attendees from a single institution, thereby vendors do have the power to influence institutional decisions. Chief medical informatics officers49 and other physicians who attend vendor-sponsored CME events are in a position to make important purchasing and update/improvement decisions that ultimately affect patient care. The potential need for them to reciprocate for the gifts they receive from EHR vendors that are CME providers could prejudice their decisions to the detriment of patient care. Further, there is the risk that published evaluations of vendor products by these attendees may become more favorable or their conflicts (like receiving CME from the EHR vendor) may not be properly disclosed, as has been the case with attendees of medical device company-sponsored CME events.13

As with medical devices, EHR systems require “interaction between physicians and industry that is considerably more intimate than that in pharmaceutical development.”50 Though physician–industry partnerships can have desirable outcomes, they must be fully transparent and not overlook flaws that jeopardize patient care. The ideal patient–physician relationship places the best interests of patients over those of physicians, even as they pertain to health IT, which may not be possible if physicians are influenced by the vendors that sponsor their CME activities.51

Unmanaged conflicts of interest are most concerning during the purchase of an EHR system. Such purchases require large investments in products that will be used for decades. However, health IT is constantly changing, and systems are always in need of new features, modules, and modifications. EHR systems are upgraded, replaced, and modified, even while they are in use in patient care. Thus, physicians often have to make important decisions about vendor partners, products, consultants, and overall strategy that directly affect patients. They cannot get too close or become indebted to vendors. Patients need physicians to critically analyze EHR system modifications, demand improvements, and modify the deployment of health IT to meet their needs and to protect them from potentially poor or self-interested vendor decisions.

Unlike the airline industry, which is heavily regulated and tightly overseen by the Federal Aviation Administration, EHR vendors, whose systems contain the sensitive data of hundreds of millions of people, have limited government supervision, as the 21st Century Cures Act excluded EHR systems from the FDA’s oversight of medical devices.52 This leaves only limited product certification by nongovernmental, ONC-authorized testing and certification bodies.

Conclusions and Recommendations

We applaud the American Board of Preventive Medicine’s (ABPM’s) past practice of declining EHR vendors’ requests for Lifelong Learning and Self-Assessment (LLSA) credits for their sponsored CME events. This practice has led health care professionals to instead attend conferences offered by independent ACCME-accredited CME providers, such as the American Medical Informatics Association. At these events, optimal and differential clinical informatics solutions are presented and discussed without focusing on any specific EHR system or vendor. However, the ABPM’s recent combining of LLSA credits and CME credits into a single CME requirement for physicians board certified in clinical informatics53 poses the risk that a physician may now earn all her or his CME credits through one EHR vendor.

EHR vendor-provided CME events are potentially biased, and they pose a risk to patient care and safety. We call on the ACCME to recognize EHR vendors as commercial interests and to remove them from the list of eligible CME providers. EHR vendors that want to support unbiased CME events should follow the same process that was developed for other commercial interests, such as pharmaceutical and medical device manufacturers.

References

1. Accreditation Council for Continuing Medical Education. Accreditation rules. https://www.accme.org/accreditation-rules. Accessed January 8, 2020.
2. Accreditation Council for Continuing Medical Education. ACCME publications: Annual data reports. http://www.accme.org/publications/annual-data-reports. Accessed January 8, 2020.
3. Accreditation Council for Continuing Medical Education. Definition of a commercial interest. https://www.accme.org/accreditation-rules/policies/definition-commercial-interest. Accessed January 15, 2020.
4. McMahon G. Personal communication with Douglas Fridsma., January 4, 2018.
5. Wazana A. Physicians and the pharmaceutical industry: Is a gift ever just a gift? JAMA. 2000;283:373–380
6. Schofferman J. Industry-funded continuing medical education: The potential for bias. Pain Med. 2015;16:1252–1253
7. Bowman MA, Pearle DL. Changes in drug prescribing patterns related to commercial company funding of continuing medical education. J Contin Educ Health Prof. 1988;8:13–20
8. Fickweiler F, Fickweiler W, Urbach E. Interactions between physicians and the pharmaceutical industry generally and sales representatives specifically and their association with physicians’ attitudes and prescribing habits: A systematic review. BMJ Open. 2017;7:e016408
9. Chren MM, Landefeld CS. Physicians’ behavior and their interactions with drug companies. A controlled study of physicians who requested additions to a hospital drug formulary. JAMA. 1994;271:684–689
10. Steinman MA, Shlipak MG, McPhee SJ. Of principles and pens: Attitudes and practices of medicine housestaff toward pharmaceutical industry promotions. Am J Med. 2001;110:551–557
11. Ziai K, Pigazzi A, Smith BR, et al. Association of compensation from the surgical and medical device industry to physicians and self-declared conflict of interest. JAMA Surg. 2018;153:997–1002
12. Blumenthal D. Doctors and drug companies. N Engl J Med. 2004;351:1885–1890
13. Coyle SL; Ethics and Human Rights Committee, American College of Physicians-American Society of Internal Medicine. Physician-industry relations. Part 1: Individual physicians. Ann Intern Med. 2002;136:396–402
14. Accreditation Council for Continuing Medical Education. FAQ search. How can I determine if my organization is a commercial interest? https://www.accme.org/faq/how-can-i-determine-if-my-organization-commercial-interest. Accessed January 8, 2020.
15. Committee on Finance. United States Senate. Use of Educational Grants by Pharmaceutical Manufacturers. 2007.Washington, DC: U.S. Government Printing Office;
16. Kawczak S, Carey W, Lopez R, Jackman D. The effect of industry support on participants’ perceptions of bias in continuing medical education. Acad Med. 2010;85:80–84
17. Cervero RM, Gaines JK. The impact of CME on physician performance and patient health outcomes: An updated synthesis of systematic reviews. J Contin Educ Health Prof. 2015;35:131–138
18. Kalorama Information. EHR: Over 30 Billion-Dollar Market and Growing. https://www.prnewswire.com/news-releases/ehr-over-30-billion-dollar-market-and-growing-300695179.html. Published August 14, 2018. Accessed January 8, 2020
19. Department of Health and Human Services. Office of the National Coordinator for Health Information Technology. Health IT Dashboard. Office-based physician electronic health record adoption. https://dashboard.healthit.gov/quickstats/pages/physician-ehr-adoption-trends.php. Published 2017. Accessed January 8, 2020.
20. Ali SB, Romero J, Morrison K, Hafeez B, Ancker JS. Focus section health IT usability: Applying a task-technology fit model to adapt an electronic patient portal for patient work. Appl Clin Inform. 2018;9:174–184
21. Ash JS, Berg M, Coiera E. Some unintended consequences of information technology in health care: The nature of patient care information system-related errors. J Am Med Inform Assoc. 2004;11:104–112
22. Campbell EM, Sittig DF, Ash JS, Guappone KP, Dykstra RH. Types of unintended consequences related to computerized provider order entry. J Am Med Inform Assoc. 2006;13:547–556
23. Sittig DF, Wright A, Ash J, Singh H. New unintended adverse consequences of electronic health records. Yearb Med Inform. 20167–12
24. Lin SC, Jha AK, Adler-Milstein J. Electronic health records associated with lower hospital mortality after systems have time to mature. Health Aff (Millwood). 2018;37:1128–1135
25. Campanella P, Lovato E, Marone C, et al. The impact of electronic health records on healthcare quality: A systematic review and meta-analysis. Eur J Public Health. 2016;26:60–64
26. Alkureishi MA, Lee WW, Lyons M, et al. Impact of electronic medical record use on the patient-doctor relationship and communication: A systematic review. J Gen Intern Med. 2016;31:548–560
27. Nebeker JR, Hoffman JM, Weir CR, Bennett CL, Hurdle JF. High rates of adverse drug events in a highly computerized hospital. Arch Intern Med. 2005;165:1111–1116
28. Kim MO, Coiera E, Magrabi F. Problems with health information technology and their effects on care delivery and patient outcomes: A systematic review. J Am Med Inform Assoc. 2017;24:246–250
29. Melnick ER, Dyrbye LN, Sinsky CA, et al. The association between perceived electronic health record usability and professional burnout among US physicians. Mayo Clin Proc. 2019;pii:S0025-6196(19)30836-30835
30. Vawdrey DK, Hripcsak G. Publication bias in clinical trials of electronic health records. J Biomed Inform. 2013;46:139–141
31. Koppel R. Uses of the legal system that attenuate patient safety. 68 DePaul L Rev. https://via.library.depaul.edu/law-review/vol68/iss2/6. Published 2019. Accessed January 8, 2020
32. Koppel R, Kreda D. Health care information technology vendors’ “hold harmless” clause: Implications for patients and clinicians. JAMA. 2009;301:1276–1278
33. Goodman KEthics, Medicine, and Information Technology: Intelligent Machines and the Transformation of Health Care. 2016.Cambridge, UK: Cambridge University Press;
34. Lehmann CU, Gundlapalli AV, Williamson JJ, et al. Five years of clinical informatics board certification for physicians in the United States of America. Yearb Med Inform. 2018;27:237–242
35. Detmer DE, Munger BS, Lehmann CU. Clinical informatics board certification: History, current status, and predicted impact on the clinical informatics workforce. Appl Clin Inform. 2010;1:11–18
36. Koppel R, Lehmann CU. Implications of an emerging EHR monoculture for hospitals and healthcare systems. J Am Med Inform Assoc. 2015;22:465–471
37. Harvey AH, Kirk U, Denfield GH, Montague PR. Monetary favors and their influence on neural responses and revealed preference. J Neurosci. 2010;30:9597–9602
38. Pokorny AM, Gittins CB. Dangerous liaisons: Doctors-in-training and the pharmaceutical industry. Intern Med J. 2015;45:1085–1088
39. Katz D, Caplan AL, Merz JF. All gifts large and small: Toward an understanding of the ethics of pharmaceutical industry gift-giving. Am J Bioeth. 2003;3:39–46
40. Essi DF. Mixing dinner and drugs—Is it ethically contraindicated? AMA J Ethics. 2015;17:787–795
41. Pharmaceutical Research and Manufacturers of America. Code on interactions with healthcare professionals. http://phrma-docs.phrma.org/sites/default/files/pdf/phrma_marketing_code_2008.pdf. Revised July 2008. Accessed January 8, 2020
42. Department of Health and Human Services. Office of the Inspector General. Comparison of the Anti-Kickback Statute and Stark Law. https://oig.hhs.gov/compliance/provider-compliance-training/files/starkandakscharthandout508.pdf. Accessed January 8, 2020.
43. Verheij RA, Curcin V, Delaney BC, McGilchrist MM. Possible sources of bias in primary care electronic health record data use and reuse. J Med Internet Res. 2018;20:e185
44. Safran C, Shabot MM, Munger BS, et al. AMIA Board of Directors. Program requirements for fellowship education in the subspecialty of clinical informatics. J Am Med Inform Assoc. 2009;16:158–166
45. Fridsma DB. Health informatics: A required skill for 21st century clinicians. BMJ. 2018;362:k3043
46. Jackson BR. Social responsibility practices of EHR vendors: An analysis of disclosures in annual corporate reports and websites. AMIA Annu Symp Proc. 2018;2018:609–615
47. Accreditation Council for Continuing Medical Education. FAQ search. Are there any circumstances when employees of ACCME-defined commercial interests can be in a position to control the content of accredited CME? https://www.accme.org/faq/are-there-any-circumstances-when-employees-accme-defined-commercial-interests-can-be-position. Accessed January 8, 2020.
48. Accreditation Council for Continuing Medical Education. CME clinical content validation. https://www.accme.org/accreditation-rules/policies/cme-clinical-content-validation. Accessed January 14, 2020.
49. Kannry J, Sengstack P, Thyvalikakath TP, et al. The Chief Clinical Informatics Officer (CCIO): AMIA task force report on CCIO knowledge, education, and skillset requirements. Appl Clin Inform. 2016;7:143–176
50. LaViolette PA. Medical devices and conflict of interest: Unique issues and an industry code to address them. Cleve Clin J Med. 2007;74suppl 2S26–S28
51. Institute of Medicine.. Conflict of Interest and Medical Innovation: Ensuring Integrity While Facilitating Innovation in Medical Research: Workshop Summary. 2014.Washington, DC: National Academies Press;
52. Department of Health and Human Services. Food and Drug Administration. Medical devices; medical device data systems final rule. https://www.govinfo.gov/content/pkg/FR-2011-02-15/pdf/2011-3321.pdf. Published 2011. Accessed January 8, 2020
53. American Board of Preventive Medicine. ABPM Increases Flexibility for Diplomates by Combining Lifelong Learning and Self-Assessment Requirement into a Single Continuing Medical Education Requirement. https://www.theabpm.org/2019/08/30/abpm-increases-flexibility-for-diplomates-by-combining-lifelong-learning-and-self-assessment-requirement-into-a-single-continuing-medical-education-requirement. Published 2019. Accessed January 23, 2020
Copyright © 2020 by the Association of American Medical Colleges