Exploring the sociotechnical intersection of patient safety and electronic health record implementation
Open accessAbstract
OBJECTIVE: The intersection of electronic health records (EHR) and patient safety is complex. To examine the applicability of two previously developed conceptual models comprehensively to understand safety implications of EHR implementation in the English National Health Service (NHS). METHODS: We conducted a secondary analysis of interview data from a 30-month longitudinal, prospective, case study-based evaluation of EHR implementation in 12 NHS hospitals. We used a framework analysis approach to apply conceptual models developed by Sittig and Singh to understand better EHR implementation and use: an eight-dimension sociotechnical model and a three-phase patient safety model (safe technology, safe use of technology, and use of technology to improve safety). RESULTS: The intersection of patient safety and EHR implementation and use was characterized by risks involving technology (hardware and software, clinical content, and human-computer interfaces), the interaction of technology with non-technological factors, and improper or unsafe use of technology. Our data support that patient safety improvement activities as well as patient safety hazards change as an organization evolves from concerns about safe EHR functionality, ensuring safe and appropriate EHR use, to using the EHR itself to provide ongoing surveillance and monitoring of patient safety. DISCUSSION: We demonstrate the face validity of two models for understanding the sociotechnical aspects of safe EHR implementation and the complex interactions of technology within a healthcare system evolving from paper to integrated EHR. CONCLUSIONS: Using sociotechnical models, including those presented in this paper, may be beneficial to help stakeholders understand, synthesize, and anticipate risks at the intersection of patient safety and health information technology.
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- Findingown data§ RESULTS · p. 3
Some dimensions of the sociotechnical model are better represented than others in the dataset, as shown by mappings of phases and dimensions in table 2.
“Some dimensions of the sociotechnical model are better represented than others in the dataset, as demonstrated by the mappings of phases and dimensions in table 2.”
Quote in the paperNot a substantial claim - Findingown data§ Phase two · p. 4
The main theme from the data was that risk arose when the EHR was placed in a clinical context that did not support safe use.
“The prevailing theme from the data was the risk introduced when EHR was placed within a clinical context that did not facilitate safe use.”
Quote in the paperSubstantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
- Findingown data§ RESULTS · p. 3
Most data were mapped to phases one and two of the three-phase model.
“Similarly , most data were mapped to phases one and two of the three-phase model.”
Quote in the paperNot a substantial claim - Findingown data§ Phase two · p. 4
The most frequent dimensions in phase two were workflow and communication, people, human-computer interface, and clinical content.
“The most common dimensions in this phase were workflow and communication, people, human -computer interface, and clinical content.”
Quote in the paperNot a substantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
- Findingown data§ Phase two · p. 5
Clinical content emerged as an area of potential risk.
“clinical content also arose as an area of potential risk.”
Quote in the paperSubstantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
- Findingown data§ DISCUSSION · p. 5
Phase one safety concerns arose most commonly in the hardware and software domains of the sociotechnical model.
“For example, we found, as anticipated, that phase one safety concerns arose most commonly in the hardware and software domains of the sociotechnical model.”
Quote in the paperNot a substantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
- Findingown data§ Phase two · p. 5
Clinical workflow and communication became error prone when the medical record was transitioning from paper to electronic form.
“Finally, as clinical workflow and communication was noted to become error prone when the medical record was in transition from paper to electronic form”
Quote in the paperSubstantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
- Findingown data§ RESULTS · p. 3
In clinical content, most concerns were regarding phase two, in which users experienced difficulties (perceived or actual) with order entry through the EHR.
“Conversely, in clinical content, most concerns were regarding phase two, in which users experienced difficulties (perceived or actual) with order entry through the EHR.”
Quote in the paperNot a substantial claim - Findingown data§ ABSTRACT · p. 1
Patient safety improvement activities and patient safety hazards change as an organization evolves from concerns about safe EHR functionality, ensuring safe and appropriate EHR use, to using the EHR itself to provide ongoing surveillance and monitoring of patient safety.
“Our data support that patient safety improvement activities as well as patient safety hazards change as an organization evolves from concerns about safe EHR functionality, ensuring safe and appropriate EHR use, to using the EHR itself to provide ongoing surveillance and monitoring of patient safety.”
Quote in the paperSubstantial claim- Rests on an assumption: EHR-related safety risks are multifactorial and rarely involve a single contributing factor.
- Rests on an assumption: The absence of explicit patient safety questions in the interviews did not prevent the data from capturing relevant patient safety concerns.
- Rests on an assumption: Interviewees' accounts of patient safety concerns are valid indicators of actual safety risks in EHR implementation.
- Findingown data§ Phase one · p. 3
An example of a phase one safety concern regarding hardware and software was the acknowledgment of an insufficient data center and back-up procedures.
“An example of a phase one safety concern regarding hardware and software was the acknowledgment of an insufficient data center and back-up procedures.”
Quote in the paperNot a substantial claim - Findingown data§ Phase one · p. 3
Within the sociotechnical framework, phase one comments were frequently mapped to hardware and software, clinical content, and human-computer interface domains.
“Within the framework of the sociotechnical model, specific comments were frequently mapped to the domains of hardware and software, clinical content, and human -computer interface.”
Quote in the paperNot a substantial claim - Findingown data§ Phase one · p. 3
A recurring safety concern related to hardware and software was implementation of an EHR without necessary software features to support a clinical workflow that demanded those features.
“A recurring safety concern, also related to hardware and software, was implementation of an EHR without necessary software features to support a clinical workflow that demanded those features.”
Quote in the paperNot a substantial claim - Findingown data§ Phase two · p. 4
In phase two, patient safety is put at risk by unsafe technology use or unsafe workflow changes.
“In this phase patient safety is compromised through unsafe use of technology or unsafe changes in workflow.”
Quote in the paperSubstantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
- Findingown data§ Phase two · p. 4
A phase two concern was the poor integration of computers into clinical encounters where EHR use cannot happen at the same time as care delivery, such as procedural or sterile areas.
“For instance, a phase two concern was the improper integration of computers into clinical encounters in which EHR use cannot occur simultaneously with delivery of care (ie, in procedural or sterile areas).”
Quote in the paperNot a substantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
- Findingown data§ DISCUSSION · p. 5
Phase two concerns were frequently mapped to clinical content and workflow and communication.
“Phase two concerns were frequently mapped to clinical content and workflow and communication.”
Quote in the paperSubstantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
- Findingown data§ Phase two · p. 4
A barrier from the requirement to sign into the EHR led to password sharing and generic password use.
“Another example was the barrier associated with the requirement to sign into the EHR, which resulted in password sharing and generic password use.”
Quote in the paperNot a substantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
- Findingown data§ Phase three · p. 5
Only one interview reflected the ultimate use of technology to monitor and identify safety concerns before patient harm.
“This ultimate use of technology was reflected in only one interview.”
Quote in the paperNot a substantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
- Findingown data§ Phase two · p. 4
Some workflow and communication problems were specific to practice areas where the implemented EHR was thought to be particularly unsuitable.
“Some workflow and communication problems were specific to certain practice areas for which use of the EHR, as implemented, was thought to be particularly ill suited.”
Quote in the paperNot a substantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
- Findingown data§ Phase two · p. 4
Some EHR features, such as copy and paste, were seen as safety risks when used inappropriately.
“Certain EHR features, such as copy and paste, were recognized as safety risks due to inappropriate use.”
Quote in the paperSubstantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
- Premisecitation§ BACKGROUND · p. 2
Sittig and Singh proposed a three-phase model to account for variation in stages of implementation, levels of complexity, and related patient safety concerns within an EHR-enabled healthcare system.
“Therefore, to understand the intersection of EHR and patient safety , Sittig and Singh 27 further proposed a three-phase model to account for the variation in the stages of implementation, levels of complexity, and related patient safety concerns within an EHR-enabled healthcare system.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [27] source
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- Premisecitation§ BACKGROUND · p. 1
Sittig and Singh developed an eight-dimensional sociotechnical model to study the safety and effectiveness of health information technology at all levels of design, development, implementation, use, and evaluation.
“Sittig and Singh 16 17 developed an eightdimensional sociotechnical model to study the safety and effectiveness of HITat all levels of design, development, implementation, use, and evaluation.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites 16 17
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- Premisenone given§ BACKGROUND · p. 2
Improving patient safety within an EHR-enabled healthcare system requires a journey in which sociotechnical infrastructure and functionalities evolve over time.
“Third, improving patient safety within an EHR-enabled healthcare system requires a journey in which the sociotechnical infrastructure and functionalities evolve over time.”
Quote in the paperSubstantial claim - Premisecitation§ BACKGROUND · p. 1
These new workflow processes involve environmental, cultural, or sociopolitical factors.
“These new workflow processes involve different environmental (eg, human interaction with physical devices and their workspace), 24 cultural (eg, role changes of clinicians in the EHR-enabled workflow), 25 or even sociopolitical (eg, clinical power structure) factors. 26”
Quote in the paperSubstantial claim0 of 3 sources checked - Premisecitation§ BACKGROUND · p. 2
A longitudinal sociotechnical evaluation of EHR implementation and adoption in English NHS hospitals was previously conducted.
“Previously, we conducted a longitudinal, sociotechnical evaluation of the implementation and adoption of EHR in English National Health Service (NHS) hospitals. 28 29”
Quote in the paperSubstantial claim0 of 1 sources checked- cites 28 29
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- Premisecitation§ BACKGROUND · p. 1
Increasing adoption of electronic health records has revealed potential safety implications related to EHR design, implementation, and use.
“the increasing adoption of electronic health records (EHR) has revealed potential safety implications related to EHR design, implementation, and use.”
Quote in the paperSubstantial claim0 of 5 sources checked- cites [11] source
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- cites [12] source
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- cites [14] IOM (Institute of Medicine). Health IT and patient safety: building safer systems for safer care. Washington, DC: The National Academies Press, 2012.
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- cites [15] Harrington L Kennerly D Johnson C . Safety issues related to the electronic medical record (EMR): synthesis of the literature from the last decade, 2000–2009. J Healthc Manag 2011;56:31–43. source
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- Interpretationreasoning§ DISCUSSION · p. 5
As an organization evolves, both patient safety improvement activities and hazards evolve from safe functionality and appropriate use toward using the EHR for ongoing surveillance and monitoring of patient safety.
“Our combined model also suggests that as an organization evolves, both patient safety improvement activities and patient safety hazards also evolve from concerns about safe functionality and ensuring safe and appropriate use, to using the EHR itself to provide ongoing surveillance and monitoring of patient safety.”
Quote in the paperSubstantial claim - Interpretationreasoning§ ABSTRACT · p. 1
The study demonstrates the face validity of two models for understanding the sociotechnical aspects of safe EHR implementation and the complex interactions of technology within a healthcare system evolving from paper to integrated EHR.
“We demonstrate the face validity of two models for understanding the sociotechnical aspects of safe EHR implementation and the complex interactions of technology within a healthcare system evolving from paper to integrated EHR.”
Quote in the paperSubstantial claim- Rests on an assumption: EHR-related safety risks are multifactorial and rarely involve a single contributing factor.
- Rests on an assumption: The absence of explicit patient safety questions in the interviews did not prevent the data from capturing relevant patient safety concerns.
- Rests on an assumption: Interviewees' accounts of patient safety concerns are valid indicators of actual safety risks in EHR implementation.
- Interpretationown data§ DISCUSSION · p. 5
The three-phase model was useful for understanding the context of safety risks.
“The three-phase model was useful to understand the context of safety risks given that our sites were still early in their EHR implementation journey”
Quote in the paperSubstantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
- Premiseown data§ DISCUSSION · p. 5
In previous work, the sociotechnical model was applicable in specific clinical contexts such as test results and referral communication.
“For instance, in our previous work, we found this sociotechnical model applicable in specific clinical contexts (eg, test results and referral communication), 43 -48”
Quote in the paperNot a substantial claim0 of 6 sources checked - Premisecitation§ DISCUSSION · p. 5
Other qualitative studies of EHR implementations have mainly focused on implementation barriers, system-wide challenges, or overall benefits and concerns rather than patient safety.
“Other qualitative investigations have analyzed EHR implementations, but primarily focused on barriers to implementation, system-wide challenges, or overall benefits and concerns rather than patient safety . 35 -39”
Quote in the paperSubstantial claim0 of 5 sources checked- cites [35] source
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- cites [36] Greiver M Barnsley J Glazier RH . Implementation of electronic medical records: theory-informed qualitative study. Can Fam Physician 2011;57:e390–7.
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- cites [37] source
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- cites [38] Yoon-Flannery K Zandieh SO Kuperman GJ . A qualitative analysis of an electronic health record (EHR) implementation in an academic ambulatory setting. Inform Prim Care 2008;16:277–84.
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- cites [39] Spetz J Burgess JF Phibbs CS . What determines successful implementation of inpatient information technology systems? Am J Manag Care 2012;18:157–62.
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- Interpretationreasoning§ DISCUSSION · p. 5
In the combined model, the phases differ in sociotechnical scale, function, structure, and temporality.
“In our combined model (figure 1), the phases differ in their ' sociotechnical ' scale, function, structure, and temporality.”
Quote in the paperSubstantial claim - Premisereasoning§ DISCUSSION · p. 5
The model used in this paper covers a broader range of sociotechnical factors, such as workflow and organizational factors, that are more temporally dissociated than the human elements in Magrabi and colleagues' classification.
“By contrast, the model used in this paper encompasses a broader range of sociotechnical factors (eg, workflow and organizational factors) that are more temporally dissociated.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites 40 41
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- Interpretationnone given§ DISCUSSION · p. 5
The eight-dimension model was found to have face validity for understanding and classifying EHR-related safety concerns within their technical, social, or clinical context.
“Furthermore, the eight-dimension model was found to have face validity to understand and classify EHR-related safety concerns within the technical, social, or clinical context in which they occur.”
Quote in the paperSubstantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
- Interpretationreasoning§ DISCUSSION · p. 5
Within each phase, the eight-dimensional sociotechnical model can be used to understand unique safety issues.
“Within each phase, the eightdimensional sociotechnical model can be used to understand unique safety issues.”
Quote in the paperSubstantial claim
- Classified as probably not a substantial claim. 31
- May combine two claims. 20
Probably not a substantial claim: may not pass S3 (load-bearing).
Findingown data§ Data analysis · p. 3Out of 480 interviews conducted in the evaluation, 49 interviews were confirmed to contain patient safety content.
“Out of 480 interviews conducted in the evaluation, AT confirmed 49 interviews in which patient safety content was present.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingown data§ DISCUSSION · p. 5The authors could not identify many activities within phase three of the model.
“Unfortunately, we were unable to identify many activities within phase three of the model.”
Quote in the paperNot a substantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingown data§ Phase three · p. 5One participant reported difficulty in reporting quality measures before EHR implementation and potential advantages of an EHR-enabled healthcare system.
“The participant noted the difficulty in reporting quality measures before EHR implementation and the potential advantages of an EHR-enabled healthcare system.”
Quote in the paperNot a substantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
May combine two claims.
Findingown data§ Phase two · p. 4In one example, pathology specimens were mislabeled and the EHR was understood to increase the risk of patient harm.
“In the example below, pathology specimens were mislabeled and the EHR was understood, in this instance, to increase risk of patient harm.”
Quote in the paperNot a substantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
May combine two claims.
Findingown data§ RESULTS · p. 3In hardware and software, concerns regarding EHR availability were prominent in phase one; data sharing and system-system interface issues were also seen.
“For instance, in hardware and software concerns regarding EHR availability were prominent in phase one; data sharing and system -system interface issues were also seen.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown data§ ABSTRACT · p. 1The intersection of patient safety and EHR implementation and use was characterized by risks involving technology (hardware and software, clinical content, and human-computer interfaces), the interaction of technology with non-technological factors, and improper or unsafe use of technology.
“The intersection of patient safety and EHR implementation and use was characterized by risks involving technology (hardware and software, clinical content, and human -computer interfaces), the interaction of technology with non-technological factors, and improper or unsafe use of technology.”
Quote in the paperSubstantial claim- Rests on an assumption: EHR-related safety risks are multifactorial and rarely involve a single contributing factor.
- Rests on an assumption: The absence of explicit patient safety questions in the interviews did not prevent the data from capturing relevant patient safety concerns.
- Rests on an assumption: Interviewees' accounts of patient safety concerns are valid indicators of actual safety risks in EHR implementation.
Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Findingnone given§ Phase one · p. 3Phase one EHR safety concerns were unique and specific to technology.
“In accordance with the model, phase one EHR safety concerns were unique and specific to technology.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown data§ Phase two · p. 4EHR users in mental health hospitals felt that the effort needed to document in the EHR was potentially unsafe and delayed seeing patients.
“For instance, EHR users in the mental health hospitals felt the effort needed to document in the EHR was not only potentially unsafe, but impeded the ability to see patients in a timely manner.”
Quote in the paperSubstantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
May combine two claims.
Findingown data§ RESULTS · p. 3Table 3 reveals that certain dimensions have heterogeneity while others have more homogeneous concerns expressed.
“This table reveals that certain dimensions have heterogeneity while others have more homogeneous concerns expressed.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Findingreasoning§ DISCUSSION · p. 5Because the sites were still early in their EHR implementation journey, phases one and two were sufficiently represented.
“given that our sites were still early in their EHR implementation journey, and therefore both phases one and two were sufficiently represented.”
Quote in the paperSubstantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
May combine two claims.
Premisecitation§ BACKGROUND · p. 1Technology can introduce new uncertainties and patient safety risks by disrupting established work patterns, creating new risks in practice, and encouraging workarounds.
“research suggests that technology may lead to new uncertainties and risks for patient safety through disrupting established work patterns, creating new risks in practice, and encouraging workarounds.”
Quote in the paperSubstantial claim0 of 8 sources checked- cites [3] 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;11:104–12. source
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Premisecitation§ BACKGROUND · p. 1The sociotechnical intersection of patient safety and EHR conceptualizes the healthcare system as an evolving complex adaptive system in which safety risks often emerge from users' interactions with the EHR that lead to new clinical workflow processes.
“First, this intersection conceptualizes the healthcare system as an evolving, complex adaptive system in which safety risks often emerge from users ' interactions with the EHR that lead to new clinical workflow processes.”
Quote in the paperSubstantial claim0 of 3 sources checkedMay combine two claims.
Premisenone given§ BACKGROUND · p. 1EHR-related safety risks are not solely technological; they may involve EHR users and workflows, organizational aspects, and governing rules and regulations.
“These risks are not related solely to the technological features of the EHR but may involve EHR users and their workflows, aspects of the organizations in which they function, and the rules and regulations that govern or oversee their activities.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim. May combine two claims.
Study design and conductnone given§ Data collection · p. 2Participating hospitals were purposefully selected according to projected implementation timelines and included a range of hospital types (teaching, non-teaching, acute care, mental health) to allow comparisons.
“Participating hospitals were purposefully selected according to their projected implementation timelines and included a range of hospital types (ie, teaching, non-teaching, acute care, and mental health) to allow comparisons.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
Premisecitation§ BACKGROUND · p. 1Efforts to improve EHR-related patient safety depend on identifying underlying risks and appreciating contributing areas of vulnerability.
“Efforts to improve EHR-related patient safety rely on identification of underlying risks as well as an appreciation of contributing areas of vulnerability”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [23] source
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Premisecitation§ Data analysis · p. 3Framework analysis is a qualitative research method that has pre-set aims but accommodates new themes from the data.
“The data were then analyzed using a framework analysis approach, a qualitative research method that has pre-set aims but accommodates new themes from the data. 32”
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Premisecitation§ BACKGROUND · p. 2The second phase addresses unsafe or inappropriate use of technology and unsafe changes in overall workflow that emerge due to technology use.
“The second phase addresses unsafe or inappropriate use of technology as well as unsafe changes in the overall workflow that emerge due to technology use.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [27] source
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Study design and conductnone given§ Data collection · p. 3The six interviewers did not explicitly ask interviewees questions regarding patient safety.
“The six interviewers did not explicitly ask interviewees questions regarding patient safety.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Premisenone given§ BACKGROUND · p. 2The eight-dimensional sociotechnical model does not itself convey how it fits into the continuum of health information technology safety that includes safe transition from paper to fully integrated EHR.
“The sociotechnical model does not itself convey how it fits into the continuum of HIT safety that includes safe transition from paper to fully integrated EHR.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductreasoning§ Data analysis · p. 3Interrater reliability was not assessed because the study aimed to explore themes of patient safety and EHR implementation, not to perform rigorous classification with the two models.
“Interrater reliability was not assessed as the aim of the study was to explore themes of patient safety and EHR implementation (mapping and interpretation), not rigorous classification with the two models.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Premisecitation§ BACKGROUND · p. 1The eight-dimensional model comprises interdependent domains: hardware and software; clinical content; human-computer interface; people; workflow and communication; internal organization policies, procedures, and culture; external rules, regulations, and pressures; and system measurement and monitoring.
“The model ' s dimensions represent interdependent domains of an EHR-enabled healthcare system: hardware and software; clinical content; human -computer interface; people; workflow and communication; internal organization policies, procedures, and culture; external rules, regulations, and pressures; system measurement and monitoring (figure 1).”
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Premisenone given§ BACKGROUND · p. 1Patient safety risks associated with EHR may vary along the EHR adoption and implementation timeline.
“patient safety risks associated with EHR may vary along the EHR adoption and implementation timeline.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisecitation§ BACKGROUND · p. 2The third phase addresses use of technology proactively to identify and monitor potential safety concerns before patient harm occurs.
“The third phase addresses use of technology proactively to identify and monitor potential safety concerns before harm occurs to the patient.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [27] source
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Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Premisecitation§ BACKGROUND · p. 2The first phase of the three-phase model concerns safety events unique and specific to technology (unsafe technology), which often emerge early in implementation.
“The first phase is concerned with safety events that are unique and specific to technology (ie, unsafe technology), which often emerge early in the process of implementation.”
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Premisecitation§ BACKGROUND · p. 2The boundaries between the three phases may not always be distinct.
“While the boundaries between the phases may not always be distinct”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [27] source
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Premisecitation§ BACKGROUND · p. 2That prior study demonstrated the importance of considering the sociotechnical context of EHR implementation, but the UK investigators did not apply a formal framework to assess patient safety until now.
“That study demonstrated the importance of considering the sociotechnical context of EHR implementation, although the UK investigators did not apply a formal framework to assess patient safety until now. 30”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [30] source
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Study design and conductnone given§ Data analysis · p. 3The analysis was performed iteratively until consensus was obtained among the reviewers.
“This analysis was performed iteratively until consensus was obtained among the reviewers.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Interpretationnone given§ DISCUSSION · p. 5Combining the sociotechnical model with the three-phase model allows EHR safety to be viewed from a systems engineering perspective.
“The combination of the sociotechnical model with the three-phase model allows us to view EHR safety from a systems engineering perspective.”
Quote in the paperSubstantial claimMay combine two claims.
Premisecitation§ DISCUSSION · p. 5There is growing recognition that EHR use can introduce unintended risks and that efforts are needed to ensure safe EHR design and implementation.
“However, there is increasing acknowledgement that the use of EHR could introduce unintended risks, and simultaneous efforts are needed to establish safe EHR design and implementation. 14”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [14] IOM (Institute of Medicine). Health IT and patient safety: building safer systems for safer care. Washington, DC: The National Academies Press, 2012.
Not checked in the free run.
May combine two claims.
Study design and conductreasoning§ DISCUSSION · p. 6The study's limitations include the interview protocol's lack of specificity to patient safety issues and the inability to assess impact on patient safety.
“The limitations of this study include the interview protocol ' s lack of specificity to patient safety issues and the inability to assess impact on patient safety .”
Quote in the paperSubstantial claimMay combine two claims.
Interpretationreasoning§ DISCUSSION · p. 5In phase one, the sociotechnical scale of the problem is more isolated and contained, while in later phases the scale increases to include users and the physical environment in phase two and potentially the entire organization in phase three.
“In other words, in phase one, we view the sociotechnical scale of the problem to be much more isolated and contained, while in the latter phases, the scale increases significantly: including users and the physical environment in phase two and, potentially , the entire organization in phase three.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Interpretationnone given§ Phase one · p. 4The complexity of vendors' software and business models may influence future use.
“Complexity of software and business models of vendors may affect future use”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
Interpretationreasoning§ CONCLUSION · p. 6Using practical conceptual models to examine the intersection of HIT and patient safety can move the EHR-enabled healthcare system toward improving patient safety.
“Examining the intersection of HIT and patient safety with practical conceptual models can advance the EHR-enabled healthcare system towards the goal of improving patient safety.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
Interpretationnone given§ DISCUSSION · p. 6Despite differences in EHR software, cultures, and healthcare delivery methods, the authors believe the usefulness of their analysis lies in the potential ability of the two models to identify EHR-related safety concerns and priorities to address them.
“but despite different EHR software, cultures, and methods of healthcare delivery, we believe the usefulness of our analysis is the potential ability of the two models to identify EHR-related safety concerns and priorities to address them.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductreasoning§ DISCUSSION · p. 6Although the concerns of those involved during implementation appeared appropriate, no additional effort was made to validate them.
“Although the concerns of those involved during implementation appeared appropriate, no additional effort was made to validate these concerns.”
Quote in the paperNot a substantial claimMay combine two claims.
Study design and conductnone given§ DISCUSSION · p. 6The interviewers focused broadly on EHR implementation and did not intentionally seek detailed responses about patient safety.
“The interviewers broadly focused on EHR implementation and did not intentionally seek detailed responses about patient safety .”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S2 (checkable).
Interpretationreasoning§ CONCLUSION · p. 6The sociotechnical approach, along with other existing frameworks, may help stakeholders understand, synthesize, and anticipate risks across the continuum of HIT safety, including the transition from paper to integrated EHR.
“Our sociotechnical approach, along with other existing frameworks, may be beneficial to help stakeholders understand, synthesize, and anticipate risks within the continuum of HIT safety that includes safe transition from paper to integrated EHR.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based).
Interpretationnone given§ DISCUSSION · p. 5A piecemeal, reactive approach to finding and correcting EHR-related safety issues is unlikely to be efficient or effective.
“As with other patient safety issues, a piecemeal, reactive approach to identifying and correcting EHR-related safety issues is unlikely to be efficient or effective.”
Quote in the paperNot a substantial claimMay combine two claims.
Premisecitation§ DISCUSSION · p. 5The Institute of Medicine adapted the sociotechnical model in its report on HIT safety, but without the detailed technology dimensions the authors consider essential for appreciating EHR use nuances.
“Our sociotechnical model was adapted by the Institute of Medicine in their report on HIT safety albeit without the detailed technology dimensions that we believe are essential to appreciate the nuances involved with EHR use. 14”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [14] IOM (Institute of Medicine). Health IT and patient safety: building safer systems for safer care. Washington, DC: The National Academies Press, 2012.
Not checked in the free run.
May combine two claims.
Study design and conductreasoning§ DISCUSSION · p. 6Although safety concerns arose in several interviews, the interviews did not necessarily elicit the full range of potential EHR-related safety concerns.
“While safety concerns arose in several interviews, the interviews did not necessarily elicit the full range of potential EHR-related safety concerns.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone given§ DISCUSSION · p. 6The case study design may have reduced the generalizability of the findings.
“The case study design may have reduced the generalizability of the findings”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone given§ DISCUSSION · p. 5A strength of this qualitative analysis was the large scale of the EHR implementation and evaluation, which involved simultaneous interviews.
“The strengths of this qualitative analysis include the large scale of the EHR implementation and evaluation involving simultaneous interviews.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductreasoning§ DISCUSSION · p. 6Because this was a secondary analysis of previously collected data, safety-related interview data could have been overlooked during the original UK investigators' initial review, since data collection did not anticipate this use.
“As this was a secondary analysis of previously collected data, interview data regarding safety potentially could have been overlooked during the initial review by the original UK investigators because the data collection did not anticipate this use.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based).
Interpretationnone given§ CONCLUSION · p. 6The combined use of the two models has face validity for facilitating understanding of the sociotechnical aspects of safe EHR implementation and the complex interactions of technology within the evolving healthcare system.
“W e demonstrated how the combined use of two models has face validity to facilitate understanding of the sociotechnical aspects of safe EHR implementation and the complex interactions of technology within the evolving healthcare system.”
Quote in the paperNot a substantial claim- Rests on an assumption: The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
- Rests on an assumption: The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
Probably not a substantial claim: may not pass S2 (checkable), S4 (based). May combine two claims.
Interpretationnone given§ CONCLUSION · p. 6Safe technology and safe use of technology are necessary for efforts to improve and monitor patient safety.
“' Safe technology ' and ' safe use of technology ' are necessary for efforts to improve and monitor patient safety; for example, phase three of the EHR-enabled healthcare system.”
Quote in the paperNot a substantial claim
The paper relies on this without support.
EHR-related safety risks are multifactorial and rarely involve a single contributing factor.
“Second, these safety risks are multifactorial and rarely involve a single contributing factor.”
The paper relies on this without support.
The absence of explicit patient safety questions in the interviews did not prevent the data from capturing relevant patient safety concerns.
“The six interviewers did not explicitly ask interviewees questions regarding patient safety.”
The paper relies on this without support.
Interviewees' accounts of patient safety concerns are valid indicators of actual safety risks in EHR implementation.
“AT confirmed 49 interviews in which patient safety content was present.”
The paper relies on this without support.
The safety concerns spontaneously reported by participants are valid indicators of actual EHR-related patient safety risks.
“Although the concerns of those involved during implementation appeared appropriate, no additional effort was made to validate these concerns.”
The paper relies on this without support.
Before this analysis, there was no formal model for studying patient safety issues with EHR implementation.
“but until this analysis, a formal model to study patient safety issues with EHR implementation was lacking”
The paper relies on this without support.
The interview data from the original study are adequate to identify the range of EHR-related safety concerns despite the protocol not being specific to patient safety.
“The limitations of this study include the interview protocol ' s lack of specificity to patient safety issues and the inability to assess impact on patient safety .”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Conceptual frameworks or models have been developed to incorporate the breadth of technical and non-technical factors into the analysis of EHR safety and effectiveness.
“In addition, conceptual frameworks or models have been developed to incorporate the breadth of technical and non-technical factors into the analysis of EHR safety and effectiveness.21 25 27 32 33”
From An analysis of electronic health record-related patient safety concerns (2014) · cites this paper as [21]
Rapid adoption of electronic health records has revealed potential safety concerns related to EHR design, implementation, and use.
“In particular, rapid adoption of electronic health records (EHRs) has revealed potential safety concerns related to EHR design, implementation, and use.12 17–21”
From An analysis of electronic health record-related patient safety concerns (2014) · cites this paper as [21]
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- IOM (Institute of Medicine). Health IT and patient safety: building safer systems for safer care. Washington, DC: The National Academies Press, 2012.
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BackgroundDalal, A. K., Fuller, T. E., Garabedian, P., Ergai, A., Balint, C., Bates, D. W., & Benneyan, J. C. (2019) · Journal of the American Medical Informatics Association · doi:10.1093/jamia/ocz002 · Cited by 58 · see citing works
“The safety failings of healthcare systems often are attributed to difficulty introducing new initiatives, many which leverage health IT, in sociotechnically complex settings.(8,9) For hospital safety and quality improvement initiatives to achieve their intended goals, interdisciplinary teams must assess and measure or…”
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“The sociotechnical framework has also been used to classify patient safety events [21-23].”
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“Inclusion keywords (94) ADC, Administrative billing system, Alert, Alert fatigue, Anesthesia monitor, Apnea monitor, Arterial monitor, Atlas monitor, Automated, Automated dispensing cabinet, Barcoding, Bar-coding, Blood pressure monitor, Central monitor, Clinical documentation system, Communication device, Communicati…”
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“Likewise, in the US the move to consider safety across all hospitals continues apace (Meeks et al. 2014).”
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“Although an agreed upon definition of HIT safety hazards is lacking, there has been tremendous interest in better understanding these hazards to reduce patient harm [4–7].”
BackgroundA Sociotechnical Approach to Electronic Health Record Related Safety
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“…there is a growing collection of research studies that have applied the Sittig and Singh [24] sociotechnical model in analyzing safety concerns [27,67-69], no literature was identified where this framework was incorporated into experiential learning activities or embedded into clinical…”
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“The findings in this study are supported by research by Meeks et al (2014) which states that the meeting point between patient safety and EHR implementation is the use of technology including hardware and software, clinical content and human-computer interface.”
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Electronic Health Record and Patient Safety
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Madeo, A. C., Marable, J., Kukhareva, P., Kohlmann, W. K., Bradshaw, R. L., Maxwell, W. F., Martin, C., Davis-Rivera, L., Ahsan, M. D., Borsato, E. P., et al. (2026) · BMC Health Services Research · doi:10.1186/s12913-026-14723-8
“Meeks et al. (2014) found that some dimensions of their socio-technical model were better represented than others in their data, which is like our results: neither all ELICIT software levels, nor all levels of outcomes/long-term satisfaction assessments were uniformly represented [53].”
- Authors
- Meeks, D. W., Takian, A., Sittig, D. F., Singh, H., & Barber, N.
- Affiliations
- Michael E. DeBakey VA Medical Center (US)
- Brunel University of London (GB)
- Memorial Hermann (US)
- UCL School of Pharmacy (GB)
- Corresponding author
- Meeks, Derek W
- Venue
- Journal of the American Medical Informatics Association
- Publisher
- Oxford University Press (OUP)
- Published
- 2014-02
- Volume
- 21
- Issue
- e1
- Pages
- e28-e34
- ISSN
- 1067-5027 (ISSN-L)
- 1527-974X
- PMC
- PMC3957388
- OpenAlex
- W2098001923
- Semantic Scholar
- 6172490b4f92d89f512f0ad6e4ec8e452d89176c
- Cited by
- 91
- References
- 52
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 3 · 2023: 6 · 2022: 4 · 2021: 6 · 2020: 6 · 2019: 11 · 2018: 17 · 2017: 8 · 2016: 12 · 2015: 5 · 2014: 6
- FWCI
- 13.28
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of the American Medical Informatics Association (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Public Health Service (T32HP10031)
- Topics
- Health Sciences › Health Professions › Health Information Management › Electronic Health Records Systems
- Health Sciences › Health Professions › Emergency Medical Services › Patient Safety and Medication Errors
- Health Sciences › Medicine › Emergency Medicine › Hospital Admissions and Outcomes
- Keywords
- electronic health records, patient safety, EHR implementation, socio-technical model, health information technology, patient safety surveillance, human-machine interaction, National Health Service
- MeSH terms
- Attitude of Health Personnel, Attitude to Computers, United Kingdom, Health Plan Implementation, Hospital Information Systems, Humans, Longitudinal Studies, Models, Theoretical, Organizational Innovation, Software, State Medicine, Electronic Health Records, Patient Safety
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