Subscribe to RSS
DOI: 10.1055/a-2291-1482
Pediatric Consent on FHIR
Funding This research was funded by the National Institute on Drug Abuse, through the Substance Use HeAlth REcords Sharing (SHARES) grant (9R01DA056984-06A1).
Abstract
Background Standardizing and formalizing consent processes and forms can prevent ambiguities, convey a more precise meaning, and support machine interpretation of consent terms.
Objectives Our goal was to introduce a systematic approach to standardizing and digitizing pediatric consent forms, which are complex due to legal requirements for child and legal guardian involvement.
Methods First, we reviewed the consent requirements from the Arizona regulation, and we used 21 pediatric treatment consents from five Arizona health care organizations to propose and evaluate an implementation-agnostic Consent for Treatment Framework. Second, we assessed the adequacy of the Fast Healthcare Interoperability Resources (FHIR) to support the proposed framework.
Results The resulting Consent for Treatment Framework supports compliance with the state consent requirements and has been validated with pediatric consent forms. We also demonstrated that the FHIR standard has the required expressiveness to compute the framework's specifications and express the 21 consent forms.
Conclusion Health care organizations can apply the shared open-source code and FHIR implementation guidelines to standardize the design of machine-interpretable pediatric treatment consent forms. The resulting FHIR-based executable models may support compliance with the law and support interoperability and data sharing.
Note
This study does not engage human subjects. The Arizona State University Institutional Review Board deemed the research exempted.
Publication History
Received: 07 January 2024
Accepted: 18 March 2024
Accepted Manuscript online:
20 March 2024
Article published online:
08 May 2024
© 2024. Thieme. All rights reserved.
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
-
References
- 1 Murray B. Informed consent: what must a physician disclose to a patient?. Virtual Mentor 2012; 14 (07) 563-566
- 2 Shah P, Thornton I, Turrin D, Hipskind JE. Informed Consent. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023
- 3 Curcin V, Miles S, Danger R, Chen Y, Bache R, Taweel A. Implementing interoperable provenance in biomedical research. Future Gener Comput Syst 2014; 34: 1-16
- 4 Sisk BA, DuBois J, Kodish E, Wolfe J, Feudtner C. Navigating decisional discord: the pediatrician's role when child and parents disagree. Pediatrics 2017; 139 (06) e20170234
- 5 Zutlevics TL, Henning PH. Obligation of clinicians to treat unwilling children and young people: an ethical discussion. J Paediatr Child Health 2005; 41 (12) 677-681
- 6 Sarabu C, Sharko M, Petersen C, Galvin H. Shifting into action: from data segmentation to equitable interoperability for adolescents (and everyone else). Appl Clin Inform 2023; 14 (03) 544-554
- 7 You JGT, Potter JE, Mishuris RG. Adolescent privacy and the electronic health record- electronic health record adolescent confidentiality in a safety net setting. Appl Clin Inform 2023; 14 (03) 544-554
- 8 Xie J, Hogan A, McPherson T, Pageler N, Lee T, Carlson J. Creating a guardrail system to ensure appropriate activation of adolescent portal accounts. Appl Clin Inform 2023; 14 (02) 258-262
- 9 Lehmann CU, Petersen C, Bhatia H, Berner ES, Goodman KW. Advance directives and code status information exchange: a consensus proposal for a minimum set of attributes. Camb Q Healthc Ethics 2019; 28 (01) 178-185
- 10 Grando MA, Boxwala A, Schwab R, Alipanah N. Ontological approach for the management of informed consent permissions. In: 2012 IEEE Second International Conference on Healthcare Informatics, Imaging and Systems Biology. 2012: 51-60
- 11 Obeid JS, Gerken K, Madathil KC. et al. Development of an electronic research permissions management system to enhance informed consents and capture research authorizations data. AMIA Jt Summits Transl Sci Proc 2013; 2013: 189-193
- 12 Grando A, Schwab R. Building and evaluating an ontology-based tool for reasoning about consent permission. AMIA Annu Symp Proc 2013; 2013: 514-523
- 13 Index—v5.0.0 [Internet]. Accessed October 28, 2023 at: https://hl7.org/fhir/
- 14 Lin AM, Lin AC, Krauss O, Hearn J, Helm E. A model for implementing an interoperable electronic consent form for medical treatment using HL7 FHIR. Eur J Biomed Inform (Praha) 2018; 14 (03) 37-47
- 15 Bialke M, Geidel L, Hampf C. et al. A FHIR has been lit on gICS: facilitating the standardised exchange of informed consent in a large network of university medicine. BMC Med Inform Decis Mak 2022; 22 (01) 335
- 16 Arizona Administrative Code [Internet]. Office of the Secretary of State, Administrative Rules Division. Accessed March 14, 2024 at: https://apps.azsos.gov/public_services/Title_09/9-10.pdf
- 17 Umberfield EE, Jiang Y, Fenton SH. et al. Lessons learned for identifying and annotating permissions in clinical consent forms. Appl Clin Inform 2021; 12 (03) 429-435
- 18 PubMed. Accessed February 27, 2024 at: https://pubmed.ncbi.nlm.nih.gov/?term=%28%22FHIR%22%5BTitle%2FAbstract%5D+OR+%22HL7%22%5BTitle%2FAbstract%5D+OR+%22ontology%22%5BTitle%2FAbstract%5D+OR+%22ontological%22%5BTitle%2FAbstract%5D%29+AND+%28%22permissions%22%5BTitle%2FAbstract%5D+OR+%22consent%22%5BTitle%2FAbstract%5D+%29+AND+%282012%3A2023%5BDP%5D%29
- 19 Form Data Extraction—Structured Data Capture v3.0.0 [Internet]. Accessed October 28, 2023 at: https://build.fhir.org/ig/HL7/sdc/extraction.html
- 20 Questionnaire—FHIR v6.0.0-cibuild [Internet]. Accessed October 28, 2023 at: https://build.fhir.org/questionnaire.html
- 21 QuestionnaireResponse—FHIR v6.0.0-cibuild [Internet]. Accessed October 28, 2023 at: https://build.fhir.org/questionnaireresponse.html
- 22 Lackerbauer AM, Krauss O, Helm E. Automated verification of structured questionnaires using HL7. Stud Health Technol Inform 2019; 258: 11-15
- 23 Bild R, Bialke M, Buckow K. et al. Towards a comprehensive and interoperable representation of consent-based data usage permissions in the German medical informatics initiative. BMC Med Inform Decis Mak 2020; 20 (01) 103
- 24 Lin Y, Zheng J, He Y. VICO: ontology-based representation and integrative analysis of Vaccination Informed Consent forms. J Biomed Semantics 2016; 7: 20
- 25 Bialke M, Bahls T, Geidel L. et al. MAGIC: once upon a time in consent management-a FHIR® tale. J Transl Med 2018; 16 (01) 256
- 26 Debruyne C, Pandit HJ, Lewis D, O'Sullivan D. “Just-in-time” generation of datasets by considering structured representations of given consent for GDPR compliance. Knowl Inf Syst 2020; 62 (09) 3615-3640
- 27 Milosevic Z. On computable expressions of policies for digital health: use for privacy consent. In: Merolli M, Bain C, Schaper LK. eds. Studies in Health Technology and Informatics [Internet]. IOS Press; 2021. . Accessed June 3, 2023 at: https://ebooks.iospress.nl/doi/10.3233/SHTI210011
- 28 Hong F. Notes [Internet]. 2023 . Accessed 22, 2024 at: April https://github.com/swantrace/asu-fhir-consent-management
- 29 LHC-Forms. A Form-Rendering Widget [Internet]. Accessed October 28, 2023 at: http://lhncbc.github.io/lforms/
- 30 Questionnaire response extract to resource(s)—Structured Data Capture v3.0.0 [Internet]. Accessed October 28, 2023 at: https://build.fhir.org/ig/HL7/sdc/OperationDefinition-QuestionnaireResponse-extract.html
- 31 Arizona State Legislature. ARS 36-2271 [Internet]. Arizona State Legislature; . Accessed March 14, 2024 at: https://www.azleg.gov/viewDocument/?docName=http://www.azleg.gov/ars/36/02271.htm
- 32 Arizona State Legislature. ARS 36-3602 [Internet]. Arizona State Legislature; . Accessed March 14, 2024 at: https://www.azleg.gov/viewDocument/?docName=http://www.azleg.gov/ars/36/03602.htm
- 33 Fenton SH, Manion F, Hsieh K, Harris M. Informed consent: does anyone really understand what is contained in the medical record?. Appl Clin Inform 2015; 6 (03) 466-477
- 34 CDS Hooks [Internet]. Accessed October 28, 2023 at: https://cds-hooks.hl7.org/
- 35 Abujarad F, Alfano S, Bright TJ. et al. Building an informed consent tool starting with the patient: the patient-centered virtual multimedia interactive informed consent (VIC). AMIA Annu Symp Proc 2018; 2017: 374-383
- 36 Sharko M, Jameson R, Ancker JS, Krams L, Webber EC, Rosenbloom ST. State-by-state variability in adolescent privacy laws. Pediatrics 2022; 149 (06) e2021053458
- 37 Home | ClinicalTrials.gov [Internet]. Accessed October 28, 2023 at: https://clinicaltrials.gov/
- 38 Jafari M. ASU FHIR consent validation [Internet]. 2023 . Accessed at: https://github.com/mojitoj/ASU-FHIR-consent-validation