Ethical issues in biomedical research using electronic health records: a systematic review

Piasecki, Jan; Walkiewicz-Żarek, Ewa; Figas-Skrzypulec, Justyna; Kordecka, Anna; Dranseika, Vilius

doi:10.1007/s11019-021-10031-6

Cited by 10 publications

(9 citation statements)

References 62 publications

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“…41,42 Such integration with artificial intelligence with natural language processing algorithms could somewhat alleviate the ongoing ethical dilemma in biomedical EHR-based research regarding the extraction of data from patients' medical records without informed consent. 43,44 In summary, we conclude that standardised psychometric assessments are essential for patients with FEP. Therefore, our proposal of a proxy instrument based on clinical records for the assessment of psychotic and affective symptoms offers a feasible, valid and reliable alternative to standard psychometric procedures in realworld practice settings.…”

Section: Clinical Implications and Future Directionsmentioning

confidence: 78%

Proxy measures for the assessment of psychotic and affective symptoms in studies using electronic health records

López-Díaz,

Palermo-Zeballos,

Gutierrez-Rojas

et al. 2024

BJPsych open

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Background There is a lack of standardised psychometric data in electronic health record (EHR)-based research. Proxy measures of symptom severity based on patients' clinical records may be useful surrogates in mental health EHR research. Aims This study aimed to validate proxy tools for the short versions of the Positive and Negative Syndrome Scale (PANSS-6), Young Mania Rating Scale (YMRS-6) and Montgomery–Åsberg Depression Rating Scale (MADRS-6). Method A cross-sectional, multicentre study was conducted in a sample of 116 patients with first-episode psychosis from 12 public hospitals in Spain. Concordance between PANSS-6, YMRS-6 and MADRS-6 scores and their respective proxies was evaluated based on information from EHR clinical notes, using a variety of statistical procedures, including multivariate tests to adjust for potential confounders. Bootstrapping techniques were used for internal validation, and an independent cohort from the Treatment and Early Intervention in Psychosis Program (TIPP-Lausanne, Switzerland) for external validation. Results The proxy versions correlated strongly with their respective standardised scales (partial correlations ranged from 0.75 to 0.84) and had good accuracy and discriminatory power in distinguishing between patients in and not in remission (percentage of patients correctly classified ranged from 83.9 to 91.4% and bootstrapped optimism-corrected area under the receiver operating characteristic curve ranged from 0.76 to 0.89), with high interrater reliability (intraclass correlation coefficient of 0.81). The findings remained robust in the external validation data-set. Conclusions The proxy instruments proposed for assessing psychotic and affective symptoms by reviewing EHR provide a feasible and reliable alternative to traditional structured psychometric procedures, and a promising methodology for real-world practice settings.

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Section: Clinical Implications and Future Directionsmentioning

confidence: 78%

Proxy measures for the assessment of psychotic and affective symptoms in studies using electronic health records

López-Díaz,

Palermo-Zeballos,

Gutierrez-Rojas

et al. 2024

BJPsych open

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“… 22 Concerns about the infrastructure set up to facilitate personalised medicine, potential use of genetic information for purposes other than research or treatment, concerns related to data security and the risk of privacy breaches, and not least tweets about design of a consent or opt-out, are also prevalent on Twitter. These are topics known to be discussed in relation to sharing of health data 5 , 52 , 65 and more specifically in relation to the implementation of personalised medicine. 23 Our study suggests that Twitter can be used as a platform for policymakers to gain insights into how these topics are perceived by people not directly affiliated with the implementation of personalised medicine.…”

Section: Discussionmentioning

confidence: 99%

“…However, the collection and reuse of health data for secondary purposes raise questions about data security, risk of misuse of health data by private companies or employers, as well as risk of violations of individuals’ autonomy if health data are used without their knowledge or for purposes they find inappropriate. 4 , 5 In recent years, there has also been an increased focus on how the collection of health data can have adverse effects through digital profiling 4 or by increasing inequality in healthcare. 6 , 7 In some cases, publics, consisting of the people the data concern, ‘bite back’ if data are used in ways they find inappropriate.…”

Section: Introductionmentioning

confidence: 99%

Who tweets what about personalised medicine? Promises and concerns from Twitter discussions in Denmark

Skovgaard

Grundtvig

2023

DIGITAL HEALTH

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Digital health data are seen as valuable resources for the development of better and more efficient treatments, for instance through personalised medicine. However, health data are information about individuals who hold opinions and can challenge how data about them are used. Therefore it is important to understand public discussions around reuse of digital health data. Social media have been heralded as enabling new forms of public engagement and as a place to study social issues. In this paper, we study a public debate on Twitter about personalised medicine. We explore who participates in discussions about personalised medicine on Twitter and what they tweet about. Based on user-generated biographies we categorise users as having a ‘Professional interest in personalised medicine’ or as ‘Private’ users. We describe how users within the field tweet about the promises of personalised medicine, while users unaffiliated with the field tweet about the concrete realisation of these ambitions in the form of a new infrastructure and express concerns about the conditions for the implementation. Our study serves to remind people interested in public opinion that Twitter is a platform used for multiple purposes by different actors and not simply a bottom-up democratic forum. This study contributes with insights relevant to policymakers wishing to expand infrastructures for reuse of health data. First, by providing insights into what is discussed about health data reuse. Second, by exploring how Twitter can be used as a platform to study public discussions about reuse of health data.

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“…There are also group- risks that affect not only individuals, but also stigmatized and discriminated groups. Moreover, health data can have different levels of sensitivity [ 27 ]. Sensitive health data can contain information about mental disorders, sexually transmitted diseases, fertility problems, facial and body images, and genes.…”

Section: The Communization Postulate (Cp) and Its Problemsmentioning

confidence: 99%

Ownership of individual-level health data, data sharing, and data governance

Piasecki

Cheah

2022

BMC Med Ethics

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Background The ownership status of individual-level health data affects the manner in which it is used. In this paper we analyze two competing models of the ownership status of the data discussed in the literature recently: private ownership and public ownership. Main body In this paper we describe the limitations of these two models of data ownership with respect to individual-level health data, in particular in terms of ethical principles of justice and autonomy, risk mitigation, as well as technological, economic, and conceptual issues. We argue that undifferentiated application of neither private ownership nor public ownership will allow us to resolve all the problems associated with effective, equitable, and ethical use of data. We suggest that, instead of focusing on data ownership, we should focus on the institutional and procedural aspects of data governance, such as using Data Access Committees (DACs) or equivalent managed access processes, which can balance the elements of these two ownership frameworks. Conclusion Undifferentiated application of the ownership concept (private or public) is not helpful in resolving problems associated with sharing individual-level health data. DACs or equivalent managed access processes should be an integral part of data governance. They can approve or disapprove data access requests after considering the potential benefits and harms to data subjects, their communities, primary researchers, and the wider society.

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Ethical issues in biomedical research using electronic health records: a systematic review

Cited by 10 publications

References 62 publications

Proxy measures for the assessment of psychotic and affective symptoms in studies using electronic health records

Proxy measures for the assessment of psychotic and affective symptoms in studies using electronic health records

Who tweets what about personalised medicine? Promises and concerns from Twitter discussions in Denmark

Ownership of individual-level health data, data sharing, and data governance

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