Clinical, Organizational and Regulatory, and Ethical and Social (CORES) Issues and Recommendations on Blockchain Deployment for Healthcare: Evidence From Experts
DOI:
https://doi.org/10.30953/bhty.v5.199Keywords:
blockchain, focus group, health, MediLinker, socio-technicalAbstract
Objective: While existing research by our team has demonstrated the feasibility of building a decentralized identity management application (‘MediLinker’) for health information, there are implementation issues related to testing such blockchain-based health applications in real-world clinical settings. In this study, we identified clinical, organizational and regulatory, and ethical and social (CORES) issues, including recommendations, associated with deploying MediLinker, and blockchain in general, for clinical testing.
Method: CORES issues and recommendations were identified through a focus group with 11 academic, industry, and government experts on March 26, 2021. They were grouped according to their expertise: clinical care (n = 4), organizational and regulatory concerns (n = 4), and ethical and social issues (n = 3). The focus group was conducted via Zoom in which experts were briefed about the study aims, formed into breakout groups to identify key issues based on their group’s expertise, and reconvened to share identified issues with other groups and to discuss potential recommendations to address such issues. The focus group was video recorded and transcribed. The resulting transcriptions and meeting notes were imported to MAXQDA 2018 for thematic analysis.
Results: Clinical experts identified issues that concern the clinical system, clinical administrators, clinicians, and patients. Organizational and regulatory experts emphasized issues on accountability, compliance, and legal safeguards. Ethics and social-context experts raised issues on trust, transparency, digital divide, and health-related digital autonomy. Accordingly, experts proposed six recommendations that could address most of the identified issues: (1) Design interfaces based on patient preferences; (2) ensure testing with diverse populations; (3) ensure compliance with existing policies; (4) present potential positive outcomes to top management; (5) maintain clinical workflow; and (6) increase the public’s awareness of blockchain.
Conclusion: This study identified a myriad of CORES issues associated with deploying MediLinker in clinical settings. Moreover, the study also uncovered several recommendations that could address such issues. The findings raise awareness on CORES issues that should be considered when designing, developing, and deploying blockchain for healthcare. Further, the findings provide additional insights into the development of MediLinker from a prototype to a minimum viable product for clinical testing. Future studies can use CORES as a socio-technical model to identify issues and recommendations associated with deploying health information technologies in clinical settings.
Downloads
References
Harrell DT, Muhammad U, Hanson L, Abdul-Moheeth M, Desai I, Shriram J, et al. Technical design and development of a self-sovereign identity management platform for patient-centric healthcare using blockchain technology. BHTY. 2022;7(1) in press.
Khurshid A, Holan C, Cowley C, Alexander J, Harrell DT, Usman M, et al. Designing and testing a blockchain application for patient identity management in healthcare. JAMIA Open. 2021;4(3):ooaa073. https://doi.org/10.1093/jamiaopen/ooaa073
Bautista JR, Muhammad U, Harrell DT, Desai I, Holan C, Cowley C, et al. Qualitative study of participant impressions as simulated patients of Medilinker—A blockchain-based identity verification application. ACI-Open.
Abdul-Moheeth M, Muhammad U, Harrell DT, Khurshid A. Improving transitions of care: Designing a blockchain application for patient identity management. BHTY. 2022;7(1) in press.
Tzinis I. Technology readiness level [Internet]. NASA. 2015 [cited 2021 Nov 29]. Available from: http://www.nasa.gov/directorates/heo/scan/engineering/technology/technology_readiness_level
Straub J. In search of technology readiness level (TRL) 10. Aerosp Sci Technol. 2015;46:312–20. https://doi.org/10.1016/j.ast.2015.07.007
Dubovitskaya A, Novotny P, Xu Z, Wang F. Applications of blockchain technology for data-sharing in oncology: Results from a systematic literature review. Oncology. 2020;98(6): 403–11. https://doi.org/10.1159/000504325
Holm K, Goduscheit RC. Assessing the technology readiness level of current blockchain use cases. In: 2020 IEEE Technology Engineering Management Conference (TEMSCON). 2020. pp. 1–6.
Rahmadika S, Rhee K-H. Blockchain technology for providing an architecture model of decentralized personal health information. Int J Eng Bus Manag. 2018;10:1847979018790589. https://doi.org/10.1177/1847979018790589
Bostrom RP, Heinen JS. MIS problems and failures: A socio-technical perspective, part II: The application of socio-technical theory. MIS Q. 1977;1(4):11–28. https://doi.org/10.2307/249019
Shin D, Ibahrine M. The socio-technical assemblages of blockchain system: How blockchains are framed and how the framing reflects societal contexts. Digit Policy Regul Gov. 2020;22(3):245–63. https://doi.org/10.1108/DPRG-11-2019-0095
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(2):104–12. https://doi.org/10.1197/jamia.M1471
Harrison MI, Koppel R, Bar-Lev S. Unintended consequences of information technologies in health care—An interactive sociotechnical analysis. J Am Med Inform Assoc. 2007;14(5):542–9. https://doi.org/10.1197/jamia.M2384
Charles W, Marler N, Long L, Manion S. Blockchain compliance by design: Regulatory considerations for blockchain in clinical research. Front Blockchain. 2019;2:18. https://doi.org/10.3389/fbloc.2019.00018
Durneva P, Cousins K, Chen M. The current state of research, challenges, and future research directions of blockchain technology in patient care: Systematic review. J Med Internet Res. 2020;22(7):e18619. https://doi.org/10.2196/18619
Lapointe C, Fishbane L. The blockchain ethical design framework. Innov Technol Gov Glob. 2019;12(3–4):50–71. https://doi.org/10.1162/inov_a_00275
Mackey TK, Kuo T-T, Gummadi B, Clauson KA, Church G, Grishin D, et al. ‘Fit-for-purpose?’—Challenges and opportunities for applications of blockchain technology in the future of healthcare. BMC Med. 2019;17(1):68. https://doi.org/10.1186/s12916-019-1296-7
Balasubramanian S, Shukla V, Sethi JS, Islam N, Saloum R. A readiness assessment framework for blockchain adoption: A healthcare case study. Technol Forecast Soc Change. 2021;165:120536. https://doi.org/10.1016/j.techfore.2020.120536
Srivastava V, Mahara T, Yadav P. An analysis of the ethical challenges of blockchain-enabled E-healthcare applications in 6G networks. Int J Cogn Comput Eng. 2021;2:171–9. https://doi.org/10.1016/j.ijcce.2021.10.002
de Korte EM, Wiezer N, Janssen JH, Vink P, Kraaij W. Evaluating an mHealth app for health and well-being at work: Mixed-method qualitative study. JMIR MHealth UHealth. 2018;6(3):e72. https://doi.org/10.2196/mhealth.6335
Vosbergen S, Mahieu GR, Laan EK, Kraaijenhagen RA, Jaspers MW, Peek N. Evaluating a web-based health risk assessment with tailored feedback: What does an expert focus group yield compared to a web-based end-user survey? J Med Internet Res. 2014;16(1):e1. https://doi.org/10.2196/jmir.2517
Tracy SJ. Qualitative research methods: Collecting evidence, crafting analysis, communicating impact. 2nd ed. Hoboken, NJ: Wiley.
Shenton AK. Strategies for ensuring trustworthiness in qualitative research projects. Educ Inf. 2004;22(2):63–75. https://doi.org/10.3233/EFI-2004-22201
Evans M. Hospitals give tech giants access to detailed medical records. Wall Street Journal [Internet]. 2020 Jan 20 [cited 2021 Nov 30]. Available from: https://www.wsj.com/articles/hospitals-give-tech-giants-access-to-detailed-medical-records-11579516200
Wetsman N. Hospitals are selling treasure troves of medical data—what could go wrong?—The Verge [Internet]. 2021 [cited 2021 Nov 2]. Available from: https://www.theverge.com/2021/6/23/22547397/medical-records-health-data-hospitals-research
Tinianow A. Blockchain technology is already improving lives at 22 hospitals [Internet]. 2019 [cited 2021 Nov 2]. Available from: https://www.forbes.com/sites/andreatinianow/2019/09/23/blockchain-technology-is-already-improving-lives-at-22-hospitals/?sh=2e27129a6c7d
IBM Corporation. Healthcare rallies for blockchains: Keeping patients at the center [Internet]. 2016 [cited 2021 Nov 2]. Available from: https://www.ibm.com/downloads/cas/BBRQK3WY
Assistant Secretary for Planning and Evaluation. Health Insurance Portability and Accountability Act of 1996 [Internet]. ASPE. 1996 [cited 2021 Nov 30]. Available from: https://aspe.hhs.gov/reports/health-insurance-portability-accountability-act-1996
Harris DA, Haskell J, Cooper E, Crouse N, Gardner R. Estimating the association between burnout and electronic health record-related stress among advanced practice registered nurses. Appl Nurs Res. 2018;43:36–41. https://doi.org/10.1016/j.apnr.2018.06.014
Kroth PJ, Morioka-Douglas N, Veres S, Babbott S, Poplau S, Qeadan F, et al. Association of electronic health record design and use factors with clinician stress and burnout. JAMA Netw Open. 2019;2(8):e199609. https://doi.org/10.1001/jamanetworkopen.2019.9609
Sanders C, Burnett K, Lam S, Hassan M, Skinner K. “You need ID to get ID”: A scoping review of personal identification as a barrier to and facilitator of the social determinants of health in North America. Int J Environ Res Public Health. 2020;17(12):4227. https://doi.org/10.3390/ijerph17124227
Kaplan B. How should health data be used?: Privacy, secondary use, and big data sales. Camb Q Healthc Ethics. 2016;25(2):312–29. https://doi.org/10.1017/S0963180115000614
Xie H, Prybutok G, Peng X, Prybutok V. Determinants of trust in health information technology: An empirical investigation in the context of an online clinic appointment system. Int J Human–Computer Interact. 2020;36(12):1095–109. https://doi.org/10.1080/10447318.2020.1712061
Or CKL, Karsh B-T. A systematic review of patient acceptance of consumer health information technology. J Am Med Inform Assoc. 2009;16(4):550–60. https://doi.org/10.1197/jamia.M2888
Wolff JL, Darer JD, Larsen KL. Family caregivers and consumer health information technology. J Gen Intern Med. 2016;31(1):117–21. https://doi.org/10.1007/s11606-015-3494-0
Lee K, Lim K, Jung SY, Ji H, Hong K, Hwang H, et al. Perspectives of patients, health care professionals, and developers toward blockchain-based health information exchange: Qualitative study. J Med Internet Res. 2020;22(11):e18582. https://doi.org/10.2196/18582
Campbell BR, Ingersoll KS, Flickinger TE, Dillingham R. Bridging the digital health divide: Toward equitable global access to mobile health interventions for people living with HIV. Expert Rev Anti Infect Ther. 2019;17(3):141–4. https://doi.org/10.1080/14787210.2019.1578649
Sieck CJ, Sheon A, Ancker JS, Castek J, Callahan B, Siefer A. Digital inclusion as a social determinant of health. Npj Digit Med. 2021;4(1):52. https://doi.org/10.1038/s41746-021-00413-8
Laacke S, Mueller R, Schomerus G, Salloch S. Artificial intelligence, social media and depression. A new concept of health-related digital autonomy. Am J Bioeth. 2021;21(7):4–20. https://doi.org/10.1080/15265161.2020.1863515
Texas Health and Safety Code Chapter 166—Advance Directives (2019) [Internet]. [cited 2021 Nov 12]. Available from: https://statutes.capitol.texas.gov/Docs/HS/htm/HS.166.htm
General Services Administration. Section508.gov [Internet]. 2017 [cited 2021 Nov 23]. Available from: https://www.section508.gov/blog/do-section-508-accessibility-standards-apply-to-mywebsite/
Ehrenberg AJ, King JL. Blockchain in context. Inf Syst Front. 2020;22(1):29–35. https://doi.org/10.1007/s10796-019-09946-6
Published
How to Cite
Issue
Section
License
Copyright (c) 2022 John Robert Bautista, Muhammad Usman, Daniel Toshio Harrell, Eric Meyer, Anjum Khurshid
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors retain copyright of their work, with first publication rights granted to Blockchain in Healthcare Today (BHTY). Read the full Copyright Statement.
