Perceptions of hospital electronic health record (EHR) training, support, and patient safety by staff position and tenure.

BACKGROUND: Hospitals rely on their electronic health record (EHR) systems to assist with the provision of safe, high quality, and efficient health care. However, EHR systems have been found to disrupt clinical workflows and may lead to unintended consequences associated with patient safety and health care professionals' perceptions of and burden with EHR usability and interoperability. This study sought to explore the differences in staff perceptions of the usability and safety of their hospital EHR system by staff position and tenure. METHODS: We used data from the AHRQ Surveys on Patient Safety Culture® (SOPS®) Hospital Survey Version 1.0 Database and the SOPS Health Information Technology Patient Safety Supplemental Items ("Health IT item set") collected from 44 hospitals and 8,880 staff in 2017. We used regression modeling to examine perceptions of EHR system training, EHR support & communication, EHR-related workflow, satisfaction with the EHR system, and the frequency of EHR-related patient safety and quality issues by staff position and tenure, while controlling for hospital ownership type and bed-size. RESULTS: In comparison to RNs, pharmacists had significantly lower (unfavorable) scores for EHR system training (regression coefficient = -0.07; p = 0.047), and physicians, hospital management, and the IT staff were significantly more likely to report high frequency of inaccurate EHR information (ORs = 2.03, 1.34, 1.72, respectively). Compared to staff with 11 or more years of hospital tenure, new staff (less than 1 year at the hospital) had significantly lower scores for EHR system training, but higher scores for EHR support & communication (p < 0.0001). Dissatisfaction of the EHR system was highest among physicians and among staff with 11 or more years tenure at the hospital. CONCLUSIONS: There were significant differences in the Health IT item set's results across staff positions and hospital tenure. Hospitals can implement the SOPS Health IT Patient Safety Supplemental Items as a valuable tool for identifying incongruity in the perceptions of EHR usability and satisfaction across staff groups to inform targeted investment in EHR system training and support.

Patient Portals Fail to Collect Structured Information About Who Else is Involved in a Person's Care.

The US health care delivery system does not systematically engage or support family or friend care partners. Meanwhile, the uptake and familiarity of portals to personal health information are increasing among patients. Technology innovations, such as shared access to the portal, use separate identity credentials to differentiate between patients and care partners. Although not well-known, or commonly used, shared access allows patients to identify who they do and do not want to be involved in their care. However, the processes for patients to grant shared access to portals are often limited or so onerous that interested patients and care partners often circumvent the process entirely. As a result, the vast majority of care partners resort to accessing portals using a patient's identity credentials-a "do-it-yourself" solution in conflict with a health systems' legal responsibility to protect patient privacy and autonomy. The personal narratives in this viewpoint (shared by permission) elaborate on quantitative studies and provide first-person snapshots of challenges faced by patients and families as they attempt to gain or grant shared access during crucial moments in their lives. As digital modalities increase patient roles in health care interactions, so does the importance of making shared access work for all stakeholders involved-patients, clinicians, and care partners. Electronic health record vendors must recognize that both patients and care partners are important users of their products, and health care organizations must acknowledge and support the critical contributions of care partners as distinct from patients.

CancelRx case study: implications for clinic and community pharmacy work systems.

BACKGROUND: Medication prescribing and discontinuation processes are complex and involve the patient, numerous health care professionals, organizations, health information technology (IT). CancelRx is a health IT that automatically communicates medication discontinuations from the clinic electronic health record to the community pharmacy dispensing platform, theoretically improving communication. CancelRx was implemented across a Midwest academic health system in October 2017. The health system also operates 15 outpatient community pharmacies. OBJECTIVE: The goal of this qualitative study was to describe how both the clinic and community pharmacy work systems change and interact over time regarding medication discontinuations, before and after CancelRx implantation. APPROACH: Medical Assistants (n = 9), Community Pharmacists (n = 12), and Pharmacy Administrators (n = 3), employed by the health system were interviewed across 3-time periods between 2017 and 2018- 3-months prior to CancelRx implementation, 3-months after CancelRx implementation, and 9-months after CancelRx implementation. Interviews were audio recorded, transcribed, and conducted a hybrid analysis with deductive content analysis following the Systems Engineering Initiative for Patient Safety (SEIPS) framework and inductive analysis to capture additional codes and themes. KEY RESULTS: CancelRx changed the medication discontinuation process at both clinics and community pharmacies. In the clinics, the workflows and medication discontinuation tasks changed over time while MA roles and clinic staff communication practices remained variable. In the pharmacy, CancelRx automated and streamlined how medication discontinuation messages were received and processed, but also increased workload for the pharmacists and introduced new errors. CONCLUSIONS: This study utilizes a systems approach to assess disparate systems within a patient network. Future studies may consider health IT implications for systems that are not in the same health system as well as assessing the role of implementation decisions on health IT use and dissemination.

Persuading Patients Using Rhetoric to Improve Artificial Intelligence Adoption: Experimental Study.

BACKGROUND: Artificial intelligence (AI) can transform health care processes with its increasing ability to translate complex structured and unstructured data into actionable clinical decisions. Although it has been established that AI is much more efficient than a clinician, the adoption rate has been slower in health care. Prior studies have pointed out that the lack of trust in AI, privacy concerns, degrees of customer innovativeness, and perceived novelty value influence AI adoption. With the promotion of AI products to patients, the role of rhetoric in influencing these factors has received scant attention. OBJECTIVE: The main objective of this study was to examine whether communication strategies (ethos, pathos, and logos) are more successful in overcoming factors that hinder AI product adoption among patients. METHODS: We conducted experiments in which we manipulated the communication strategy (ethos, pathos, and logos) in promotional ads for an AI product. We collected responses from 150 participants using Amazon Mechanical Turk. Participants were randomly exposed to a specific rhetoric-based advertisement during the experiments. RESULTS: Our results indicate that using communication strategies to promote an AI product affects users' trust, customer innovativeness, and perceived novelty value, leading to improved product adoption. Pathos-laden promotions improve AI product adoption by nudging users' trust (n=52; ß=.532; P<.001) and perceived novelty value of the product (n=52; ß=.517; P=.001). Similarly, ethos-laden promotions improve AI product adoption by nudging customer innovativeness (n=50; ß=.465; P<.001). In addition, logos-laden promotions improve AI product adoption by alleviating trust issues (n=48; ß=.657; P<.001). CONCLUSIONS: Promoting AI products to patients using rhetoric-based advertisements can help overcome factors that hinder AI adoption by assuaging user concerns about using a new AI agent in their care process.

Patient Perspectives and Preferences for Consent in the Digital Health Context: State-of-the-art Literature Review.

BACKGROUND: The increasing integration of digital health tools into care may result in a greater flow of personal health information (PHI) between patients and providers. Although privacy legislation governs how entities may collect, use, or share PHI, such legislation has not kept pace with digital health innovations, resulting in a lack of guidance on implementing meaningful consent. Understanding patient perspectives when implementing meaningful consent is critical to ensure that it meets their needs. Consent for research in the context of digital health is limited. OBJECTIVE: This state-of-the-art review aimed to understand the current state of research as it relates to patient perspectives on digital health consent. Its objectives were to explore what is known about the patient perspective and experience with digital health consent and provide recommendations on designing and implementing digital health consent based on the findings. METHODS: A structured literature search was developed and deployed in 4 electronic databases-MEDLINE, IEEE Xplore, Scopus, and Web of Science-for articles published after January 2010. The initial literature search was conducted in March 2021 and updated in March 2022. Articles were eligible for inclusion if they discussed electronic consent or consent, focused on the patient perspective or preference, and were related to digital health or digital PHI. Data were extracted using an extraction template and analyzed using qualitative content analysis. RESULTS: In total, 75 articles were included for analysis. Most studies were published within the last 5 years (58/75, 77%) and conducted in a clinical care context (33/75, 44%) and in the United States (48/75, 64%). Most studies aimed to understand participants' willingness to share PHI (25/75, 33%) and participants' perceived usability and comprehension of an electronic consent notice (25/75, 33%). More than half (40/75, 53%) of the studies did not describe the type of consent model used. The broad open consent model was the most explored (11/75, 15%). Of the 75 studies, 68 (91%) found that participants were willing to provide consent; however, their consent behaviors and preferences were context-dependent. Common patient consent requirements included clear and digestible information detailing who can access PHI, for what purpose their PHI will be used, and how privacy will be ensured. CONCLUSIONS: There is growing interest in understanding the patient perspective on digital health consent in the context of providing clinical care. There is evidence suggesting that many patients are willing to consent for various purposes, especially when there is greater transparency on how the PHI is used and oversight mechanisms are in place. Providing this transparency is critical for fostering trust in digital health tools and the innovative uses of data to optimize health and system outcomes.

Perceptions of chief clinical information officers on the state of electronic health records systems interoperability in NHS England: a qualitative interview study.

BACKGROUND: In the era of electronic health records (EHR), the ability to share clinical data is a key facilitator of healthcare delivery. Since the introduction of EHRs, this aspect has been extensively studied from the perspective of healthcare providers. Less often explored are the day-to-day challenges surrounding the procurement, deployment, maintenance, and use of interoperable EHR systems, from the perspective of healthcare administrators, such as chief clinical information officers (CCIOs). OBJECTIVE: Our study aims to capture the perceptions of CCIOs on the current state of EHR interoperability in the NHS, its impact on patient safety, the perceived facilitators and barriers to improving EHR interoperability, and what the future of EHR development in the NHS may entail. METHODS: Semi-structured interviews were conducted between November 2020 - October 2021. Convenience sampling was employed to recruit NHS England CCIOs. Interviews were digitally recorded and transcribed verbatim. A thematic analysis was performed by two independent researchers to identify emerging themes. RESULTS: Fifteen CCIOs participated in the study. Participants reported that limited EHR interoperability contributed to the inability to easily access and transfer data into a unified source, thus resulting in data fragmentation. The resulting lack of clarity on patients' health status negatively impacts patient safety through suboptimal care coordination, duplication of efforts, and more defensive practice. Facilitators to improving interoperability included the recognition of the need by clinicians, patient expectations, and the inherent centralised nature of the NHS. Barriers included systems usability difficulties, and institutional, data management, and financial-related challenges. Looking ahead, participants acknowledged that realising that vision across the NHS would require a renewed focus on mandating data standards, user-centred design, greater patient involvement, and encouraging inter-organisational collaboration. CONCLUSION: Tackling poor interoperability will require solutions both at the technical level and in the wider policy context. This will involve demanding interoperability functionalities from the outset in procurement contracts, fostering greater inter-organisation cooperation on implementation strategies, and encouraging systems vendors to prioritise interoperability in their products. Only by comprehensively addressing these challenges would the full potential promised by the use of fully interoperable EHRs be realised.

The 21st Century Cures Act and Multiuser Electronic Health Record Access: Potential Pitfalls of Information Release.

Although the Office of The National Coordinator for Health Information Technology's (ONC) Information Blocking Provision in the Cures Act Final Rule is an important step forward in providing patients free and unfettered access to their electronic health information (EHI), in the contexts of multiuser electronic health record (EHR) access and proxy access, concerns on the potential for harm in adolescent care contexts exist. We describe how the provision could erode patients' (both adolescent and older patients alike) trust and willingness to seek care. The rule's preventing harm exception does not apply to situations where the patient is a minor and the health care provider wishes to restrict a parent's or guardian's access to the minor's EHI to avoid violating the minor's confidentiality and potentially harming patient-clinician trust. This may violate previously developed government principles in the design and implementation of EHRs for pediatric care. Creating legally acceptable workarounds by means such as duplicate "shadow charting" will be burdensome (and prohibitive) for health care providers. Under the privacy exception, patients have the opportunity to request information to not be shared; however, depending on institutional practices, providers and patients may have limited awareness of this exception. Notably, the privacy exception states that providers cannot "improperly encourage or induce a patient's request to block information." Fearing being found in violation of the information blocking provisions, providers may feel that they are unable to guide patients navigating the release of their EHI in the multiuser or proxy access setting. ONC should provide more detailed guidance on their website and targeted outreach to providers and their specialty organizations that care for adolescents and other individuals affected by the Cures Act, and researchers should carefully monitor charting habits in these multiuser or proxy access situations.

Associations Between Patient-Provider Secure Message Content and Patients' Health Care Visits.

Background:Between-visit communications can play a vital role in improving intermediate patient outcomes such as access to care and satisfaction. Secure messaging is a growing modality for these communications, but research is limited about the influence of message content on those intermediate outcomes. We examined associations between secure message content and patients' number of health care visits.Methods:Our study included 2,111 adult patients with hypertension and/or diabetes and 18,309 patient- and staff-generated messages. We estimated incident rate ratios (IRRs) for associations between taxonomic codes assigned to message content, and the number of office, emergency department, and inpatient visits.Results:Patients who initiated message threads in 2017 had higher numbers of outpatient visits (p < 0.001) compared with patients who did not initiate threads. Among patients who initiated threads, we identified an inverse relationship between outpatient visits and preventive care scheduling requests (IRR = 0.92; 95% confidence interval [CI]: 0.86-0.98) and requests for appointments for new conditions (IRR = 0.95; 95% CI: 0.92-0.99). Patients with higher proportions of request denials or more follow-up appointment requests had more emergency department visits compared with patients who received or sent other content (IRR = 1.18; 95% CI: 1.03-1.34 and IRR = 1.14; 95% CI: 1.07-1.23, respectively). We identified a positive association between outpatient visits and the proportion of threads that lacked a clinic response (IRR = 1.02; 95% CI: 1.00-1.03).Discussion:We report on the first analyses to examine associations between message content and health care visits.Conclusions:Our findings are relevant to understanding how to better use secure messaging to support patients and their care.

Behavioral Intentions to Use Patient Portals to Disclose HIV and Other Sexually Transmitted Infection Testing Histories with Sexual Partners Among U.S. Sexual Minority Men.

Disclosure of HIV and other sexually transmitted infection (HIV/STI) testing history to sexual partners is low among gay, bisexual, and other U.S. sexual minority men (SMM). Patient portals (PP) could increase HIV/STI testing history disclosure. This study estimated the predictive validity of the Enhancing Dyadic Communication (EDC) latent construct for perceived behavioral intentions to use PP for HIV/STI test disclosures. A randomized subset of SMM completed the Patient Portal Sexual Health Instrument as part of the 2018 American Men's Internet Survey. Multivariable logistic regression models estimated associations between EDC and intentions to use PP for test disclosures. Among a sample of 1,509 SMM aged 15 to 77 years, EDC was associated with intentions to use PP to disclose test history with main partners (aOR 2.17; 95% CI 1.90 to 2.47) and non-main partners (aOR 2.39; 95%CI 2.07 to 2.76). Assessing EDC could be useful in clinical settings for interventions encouraging patients to communicate with partners about testing.

RESUMEN: La divulgación del historial de pruebas del VIH y otras infecciones de transmisión sexual (VIH / ITS) a las parejas sexuales es baja entre los homosexuales, bisexuales y otros hombres de minorías sexuales (SMM) de EE. UU. Los portales de pacientes (PP) podrían aumentar la divulgación del historial de pruebas de VIH / ITS. Este estudio estimó la validez predictiva del constructo latente Mejora de la comunicación diádica (EDC) para las intenciones conductuales percibidas de usar PP para las revelaciones de pruebas de VIH / ITS. Un subconjunto aleatorio de SMM completó el Instrumento de salud sexual del portal para pacientes como parte de la Encuesta de Internet de hombres estadounidenses de 2018. Los modelos de regresión logística multivariable estimaron asociaciones entre EDC e intenciones de usar PP para divulgaciones de pruebas. Entre una muestra de 1.509 SMM de entre 15 y 77 años, la EDC se asoció con las intenciones de utilizar PP para revelar el historial de pruebas con los socios principales (ORa = 2,17; IC del 95% = 1,90 a 2,47) y socios no principales (ORa = 2,39; IC del 95% = 2,07 a 2,76). La evaluación de EDC podría ser útil en entornos clínicos para intervenciones que alienten a los pacientes a comunicarse con sus socios sobre las pruebas.

What matters when exploring fidelity when using health IT to reduce disparities?

BACKGROUND: Implementation of evidence-based interventions often involves strategies to engage diverse populations while also attempting to maintain external validity. When using health IT tools to deliver patient-centered health messages, systems-level requirements are often at odds with 'on-the ground' tailoring approaches for patient-centered care or ensuring equity among linguistically diverse populations. METHODS: We conducted a fidelity and acceptability-focused evaluation of the STAR MAMA Program, a 5-month bilingual (English and Spanish) intervention for reducing diabetes risk factors among 181 post-partum women with recent gestational diabetes. The study's purpose was to explore fidelity to pre-determined 'core' (e.g. systems integration) and 'modifiable' equity components (e.g. health coaching responsiveness, and variation by language) using an adapted implementation fidelity framework. Participant-level surveys, systems-level databases of message delivery, call completion, and coaching notes were included. RESULTS: 96.6% of participants are Latina and 80.9% were born outside the US. Among those receiving the STAR MAMA intervention; 55 received the calls in Spanish (61%) and 35 English (39%). 90% (n = 81) completed ≥ one week. Initially, systems errors were common, and increased triggers for health coach call-backs. Although Spanish speakers had more triggers over the intervention period, the difference was not statistically significant. Of the calls triggering a health coach follow-up, attempts were made for 85.4% (n = 152) of the English call triggers and for 80.0% (n = 279) of the Spanish call triggers (NS). Of attempted calls, health coaching calls were complete for 55.6% (n = 85) of English-language call triggers and for 56.6% of Spanish-language call triggers (NS). Some differences in acceptability were noted by language, with Spanish-speakers reporting higher satisfaction with prevention content (p = < 0.01) and English-speakers reporting health coaches were less considerate of their time (p = 0.03). CONCLUSIONS: By exploring fidelity by language-specific factors, we identified important differences in some but not all equity indicators, with early systems errors quicky remedied and high overall engagement and acceptability. Practice implications include: (1) establishing criteria for languge-equity in interventions, (2) planning for systems level errors so as to reduce their impact between language groups and over time; and (3) examining the impact of engagement with language-concordant interventions on outcomes, including acceptability. Trial Registration National Clinical Trials registration number: CT02240420 Registered September 15, 2014. ClinicalTrials.gov.

Secure Messaging with Physicians by Proxies for Patients with Diabetes: Findings from the ECLIPPSE Study.

BACKGROUND: Little is known about patients who have caregiver proxies communicate with healthcare providers via portal secure messaging (SM). Since proxy portal use is often informal (e.g., sharing patient accounts), novel methods are needed to estimate the prevalence of proxy-authored SMs. OBJECTIVE: (1) Develop an algorithm to identify proxy-authored SMs, (2) apply this algorithm to estimate predicted proxy SM (PPSM) prevalence among patients with diabetes, and (3) explore patient characteristics associated with having PPSMs. DESIGN: Retrospective cohort study. PARTICIPANTS: We examined 9856 patients from Diabetes Study of Northern California (DISTANCE) who sent ≥ 1 English-language SM to their primary care physician between July 1, 2006, and Dec. 31, 2015. MAIN MEASURES: Using computational linguistics, we developed ProxyID, an algorithm that identifies phrases frequently found in registered proxy SMs. ProxyID was validated against blinded expert categorization of proxy status among an SM sample, then applied to identify PPSM prevalence across patients. We examined patients' sociodemographic and clinical characteristics according to PPSM penetrance, "none" (0%), "low" (≥ 0-50%), and "high" (≥ 50-100%). KEY RESULTS: Only 2.3% of patients had ≥ 1 registered proxy-authored SM. ProxyID demonstrated moderate agreement with expert classification (Κ = 0.58); 45.7% of patients had PPSMs (40.2% low and 5.5% high). Patients with high percent PPSMs were older than those with low percent and no PPSMs (66.5 vs 57.4 vs 56.2 years, p < 0.001) had higher rates of limited English proficiency (16.1% vs 3.2% vs 3.5%, p < 0.05), lower self-reported health literacy (3.83 vs 4.43 vs 4.44, p < 0.001), and more comorbidities (Charlson index 3.78 vs 2.35 vs 2.18, p < 0.001). CONCLUSIONS: Among patients with diabetes, informal proxy SM use is more common than registered use and prevalent among socially and medically vulnerable patients. Future research should explore whether proxy portal use improves patient and/or caregiver outcomes and consider policies that integrate caregivers in portal communication.

Visit Planning Using a Waiting Room Health IT Tool: The Aligning Patients and Providers Randomized Controlled Trial.

PURPOSE: Time during primary care visits is limited. We tested the hypothesis that a waiting room health information technology (IT) tool to help patients identify and voice their top visit priorities would lead to better visit interactions and improved quality of care. METHODS: We designed a waiting room tool, the Visit Planner, to guide adult patients through the process of identifying their top priorities for their visit and effectively expressing these priorities to their clinician. We tested this tool in a cluster-randomized controlled trial with usual care as the control. Eligible patients had at least 1 clinical care gap (eg, overdue for cancer screening, suboptimal chronic disease risk factor control, or medication nonadherence). RESULTS: The study (conducted March 31, 2016 through December 31, 2017) included 750 English- or Spanish-speaking patients. Compared with usual care patients, intervention patients more often reported "definitely" preparing questions for their doctor (59.5% vs 45.1%, P <.001) and "definitely" expressing their top concerns at the beginning of the visit (91.3% vs 83.3%, P = .005). Patients in both arms reported high levels of satisfaction with their care (86.8% vs 89.9%, P = .20). With 6 months of follow-up, prevalence of clinical care gaps was reduced by a similar amount in each study arm. CONCLUSIONS: A simple waiting room-based tool significantly improved visit communication. Patients using the Visit Planner were more prepared and more likely to begin the visit by communicating their top priorities. These changes did not, however, lead to further reduction in aggregate clinical care gaps beyond the improvements seen in the usual care arm.

A socio-technical systems approach to the use of health IT for patient reported outcomes: Patient and healthcare provider perspectives.

BACKGROUND: Patient-Reported Outcomes (PROs) can be used to inform the clinical management of individuals, including patient self-management, care planning, and goal setting. Despite a rapid proliferation of technology to collect and integrate PROs in clinical care, uptake by patients and healthcare providers remains sub optimal. A consideration of systems factors to understand these challenges is needed. OBJECTIVES: To apply the socio-technical systems (STS) model as a framework for understanding the usability and functional requirements of patients collecting PRO data using applications (apps), and of healthcare providers using these data at the point of care in ambulatory settings. METHODS: With questions guided by the STS model, semi-structured interviews were conducted with eighteen patients and nine healthcare providers to elicit feedback about facilitators and barriers to successful use of PRO apps and PRO data in ambulatory settings. Patient participants were selected to fit into two categories: older, low utilizers of technology with less than a bachelor's degree, and younger higher utilizers of technology with at least a bachelor's degree. Participants were from primary and specialty care practices. Data were analyzed inductively to identify emergent themes. RESULTS: Younger patients were only interested in using a PRO app if they had an active health issue to track. The nine older patients preferred passive means of data collection if they were to track a health issue, and preferred direct contact with their healthcare provider and using office visits to share information. All patients desired optimal usability and emphasized bidirectional communication in an app that is transparent about privacy. All nine healthcare providers agreed that PRO data would be most useful and relevant if key patient populations were targeted based on the specific measure. In this case the healthcare providers noted potentially optimal utility of collecting physical function PRO data for patients 65 and older. Access to the data was highlighted by each healthcare provider stating that these data would be most useful if they were seamlessly integrated into the electronic health record. DISCUSSION: Several emergent themes were identified under the five selected dimensions of the STS model (clinical content, human computer interface, hardware and software computing infrastructure, people, and workflow and communication). Findings highlighted the continued need for innovative methods to obtain more rapid cycle, continuous feedback to identify system factors impacting use of these technologies. CONCLUSION: The STS model provides a comprehensive framework that can be applied to collect patient and healthcare provider feedback to better guide the design and implementation of new health information technology.

Review and Comparison of Electronic Patient-Facing Family Health History Tools.

Family health history (FHx) is one of the most important pieces of information available to help genetic counselors and other clinicians identify risk and prevent disease. Unfortunately, the collection of FHx from patients is often too time consuming to be done during a clinical visit. Fortunately, there are many electronic FHx tools designed to help patients gather and organize their own FHx information prior to a clinic visit. We conducted a review and analysis of electronic FHx tools to better understand what tools are available, to compare and contrast to each other, to highlight features of various tools, and to provide a foundation for future evaluation and comparisons across FHx tools. Through our analysis, we included and abstracted 17 patient-facing electronic FHx tools and explored these tools around four axes: organization information, family history collection and display, clinical data collected, and clinical workflow integration. We found a large number of differences among FHx tools, with no two the same. This paper provides a useful review for health care providers, researchers, and patient advocates interested in understanding the differences among the available patient-facing electronic FHx tools.

Rethinking the Meaning of Cloud Computing for Health Care: A Taxonomic Perspective and Future Research Directions.

BACKGROUND: Cloud computing is an innovative paradigm that provides users with on-demand access to a shared pool of configurable computing resources such as servers, storage, and applications. Researchers claim that information technology (IT) services delivered via the cloud computing paradigm (ie, cloud computing services) provide major benefits for health care. However, due to a mismatch between our conceptual understanding of cloud computing for health care and the actual phenomenon in practice, the meaningful use of it for the health care industry cannot always be ensured. Although some studies have tried to conceptualize cloud computing or interpret this phenomenon for health care settings, they have mainly relied on its interpretation in a common context or have been heavily based on a general understanding of traditional health IT artifacts, leading to an insufficient or unspecific conceptual understanding of cloud computing for health care. OBJECTIVE: We aim to generate insights into the concept of cloud computing for health IT research. We propose a taxonomy that can serve as a fundamental mechanism for organizing knowledge about cloud computing services in health care organizations to gain a deepened, specific understanding of cloud computing in health care. With the taxonomy, we focus on conceptualizing the relevant properties of cloud computing for service delivery to health care organizations and highlighting their specific meanings for health care. METHODS: We employed a 2-stage approach in developing a taxonomy of cloud computing services for health care organizations. We conducted a structured literature review and 24 semistructured expert interviews in stage 1, drawing on data from theory and practice. In stage 2, we applied a systematic approach and relied on data from stage 1 to develop and evaluate the taxonomy using 14 iterations. RESULTS: Our taxonomy is composed of 8 dimensions and 28 characteristics that are relevant for cloud computing services in health care organizations. By applying the taxonomy to classify existing cloud computing services identified from the literature and expert interviews, which also serves as a part of the taxonomy, we identified 7 specificities of cloud computing in health care. These specificities challenge what we have learned about cloud computing in general contexts or in traditional health IT from the previous literature. The summarized specificities suggest research opportunities and exemplary research questions for future health IT research on cloud computing. CONCLUSIONS: By relying on perspectives from a taxonomy for cloud computing services for health care organizations, this study provides a solid conceptual cornerstone for cloud computing in health care. Moreover, the identified specificities of cloud computing and the related future research opportunities will serve as a valuable roadmap to facilitate more research into cloud computing in health care.

Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health.

Policy Points: Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial. No studies of medical devices and software assess the impact on patient safety of the FDA's current regulatory safeguards and new legislative changes to those standards. Our analysis quantifies the impact of software problems in regulated medical devices and indicates that current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market. New legislative changes will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients. CONTEXT: Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. To understand which policies might best protect patients, we examined the impact of the US Food and Drug Administration's (FDA's) regulatory safeguards on software-related technologies in recent years and the implications for newly passed legislative changes in regulatory policy. METHODS: Using FDA databases, we identified all medical devices that were recalled from 2011 through 2015 primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall of electronic medical records to determine the manufacturer, device classification, submission type, number of units, and product details. FINDINGS: A total of 627 software devices (1.4 million units) were subject to recalls, with 12 of these devices (190,596 units) subject to the highest-risk recalls. Eleven of the devices recalled as high risk had entered the market through the FDA review process that does not require evidence of safety or effectiveness, and one device was completely exempt from regulatory review. The largest high-risk recall categories were anesthesiology and general hospital, with one each in cardiovascular and neurology. Five electronic medical record systems (9,347 units) were recalled for software defects classified as posing a moderate risk to patient safety. CONCLUSIONS: Software problems in medical devices are not rare and have the potential to negatively influence medical care. Premarket regulation has not captured all the software issues that could harm patients, evidenced by the potentially large number of patients exposed to software products later subject to high-risk and moderate-risk recalls. Provisions of the 21st Century Cures Act that became law in late 2016 will reduce safeguards further. Absent stronger regulations and implementation to create robust risk assessment and adverse event reporting, physicians and their patients are likely to be at risk from medical errors caused by software-related problems in medical devices.

Impact of an electronic handoff documentation tool on team shared mental models in pediatric critical care.

OBJECTIVE: To examine the impact of the implementation of an electronic handoff tool (the Handoff Tool) on shared mental models (SMM) within patient care teams as measured by content overlap and discrepancies in verbal handoff presentations given by different clinicians caring for the same patient. MATERIALS AND METHODS: Researchers observed, recorded, and transcribed verbal handoffs given by different members of patient care teams in a pediatric intensive care unit. The transcripts were qualitatively coded and analyzed for content overlap scores and the number of discrepancies in handoffs of different team members before and after the implementation of the tool. RESULTS: Content overlap scores did not change post-implementation. The average number of discrepancies nearly doubled following the implementation (from 0.76 discrepancies per handoff group pre-implementation to 1.17 discrepancies per handoff group post-implementation); however, this change was not statistically significant (p=0.37). Discrepancies classified as related to dosage of treatment or procedure and to patients' symptoms increased in frequency post-implementation. DISCUSSION: The results suggest that the Handoff Tool did not have the desired positive impact on SMM within patient care teams. Future electronic tools for facilitating team handoff may need longer implementation times, complementary changes to handoff process and structure, and improved designs that integrate a common core of shared information with discipline-specific records. CONCLUSION: While electronic handoff tools provide great opportunities to improve communication and facilitate the formation of shared mental models within patient care teams, further work is necessary to realize their full potential.

Translation of Contextual Control Model to chronic disease management: A paradigm to guide design of cognitive support systems.

BACKGROUND: Electronic health records (EHRs) continue to be criticized for providing poor cognitive support. Defining cognitive support has lacked theoretical foundation. We developed a measurement model of cognitive support based on the Contextual Control Model (COCOM), which describes control characteristics of an "orderly" joint system and proposes 4 levels of control: scrambled, opportunistic, tactical, and strategic. METHODS: 35 clinicians (5 centers) were interviewed pre and post outpatient clinical visits and audiotaped during the visit. Behaviors pertaining to hypertension management were systematically mapped to the COCOM control characteristics of: (1) time horizon, (2) uncertainty assessment, (3) consideration of multiple goals, (4) causal model described, and (5) explicitness of plan. Each encounter was classified for overall mode of control. Visits with deviation versus no deviation from hypertension goals were compared. RESULTS: Reviewer agreement was high. Control characteristics differed significantly between deviation groups (Wilcox rank sum p<.01). K-means cluster analysis of control characteristics, stratified by deviation were distinct, with higher goal deviations associated with more control characteristics. CONCLUSION: The COCOM control characteristics appear to be areas of potential yield for improved user-experience design.

Operating lists are created by rational algorithms and use of power. What can a social scientific view offer surgeons?

PURPOSE: Algorithms for surgical operation planning are evidence-based. However, choices sometimes have to be made between medically equal solutions e.g. for staffing of sought-after operations. Such decisions are heavily influenced by micropolitics and power. The article examines the array of highly manipulated processes around operation theatre allocation of convenient time slots or staff, which play out in various ways in all of the world's main regional surgical cultures. METHOD: Essay supported by empiric data from an ethnographic power-analysis targeted to senior executive surgeons. Operations were categorized into "Interesting" (i.e. career-promoting) and "Uninteresting" (i.e. routine) operations. RESULTS: Fifty nine executives responded. Only one respondent contested the categorization of operations into Interesting and Uninteresting. The two categories were staffed according to significantly different criteria (p < 0.05). These were classified as Rational (e.g. "surgical expertise"), Social (e.g. "equity"), and Political (e.g. "status"). For Interesting operations, Rational criteria were deemed most relevant, while for the Uninteresting operations "equity" was ranked top. Moreover, we found significant differences between surgeons' and external observers' (experienced clerical and nursing staff) assessments of staffing decisions, the latter ranking Political motives higher. Decisions were almost exclusively negotiated among surgeons. 33% of respondents said they used subterfuges such as withholding information, incorrect duration-statements, and barter arrangements to defuse possible conflicts. CONCLUSIONS: Operating Lists are not merely the product of rational resource optimization. This article demonstrates the methodic feasibility of academic investigation into the typically tacit micro-political mechanisms in List-making. Developing such research further may potentially concern the practice and outcome of surgery.