1 (page number not for citation purpose) Blockchain in Healthcare Today ISSN 2573-8240 NARRATIVE/SYSTEMATIC REVIEWS/META-ANALYSIS Ethics of Blockchain by Design: Guiding a Responsible Future for Healthcare Innovation Muthu Ramachandran, PhD1,2 1Forti5 Tech Ltd., London, England; 2Centre for Augmented Intelligence and Data Science (CAIDS), School of Computing, College of Science, Engineering and Technology, University of South Africa, Pretoria, South Africa Corresponding Author: Dr. Muthu Ramachandran, Email: muthuram@ieee.org DOI: https://doi.org/10.30953/bhty.v7.362 Abstract The rapid evolution of blockchain technology in healthcare presents unparalleled opportunities for advance- ments, including enhanced patient data security, decentralized systems for trustless operations, and transpar- ent supply chain management. However, as blockchain reshapes the healthcare landscape, it demands a robust ethical framework that guides its design and implementation. “Ethics of Blockchain by Design” emphasizes embedding ethical principles at the heart of blockchain innovation, fostering public trust, equity, and long- term societal benefits. In this article, the author proposes a set of best practices guidelines on the ethics of blockchain by design. Plain Language Summary This paper explores the ethical challenges and opportunities of using blockchain technology in healthcare, emphasizing the need for responsible design. Blockchain can not only improve data security, transpar- ency, and patient trust but also raises concerns about inequality, access, and unintended consequences. The author proposes an ethical framework to guide the development and use of blockchain in healthcare, ensuring it aligns with principles like fairness, inclusivity, and accountability. By involving diverse stake- holders and prioritizing human-centric design, this study aims to foster innovation that benefits while minimizing harm. The findings highlight the importance of considering equity and societal impact in healthcare technology. This study is conceptual and does not include empirical data or case-specific applications. The ethical frame- work proposed is based on a synthesis of existing literature and theoretical analysis, which may not capture the full diversity of perspectives or real-world complexities in implementing blockchain systems across varied healthcare contexts. Future work should consider field-specific studies, practical deployments, and stakehold- er-driven research to validate and refine the framework, ensuring its applicability across diverse healthcare environments. Received: November 12, 2024; Accepted: November 26, 2024; Published: December 16, 2024 The Ethical Imperative in Blockchain Development The applications of blockchain in healthcare, from im- mutable patient records to efficient clinical trial manage- ment, illustrate its transformative potential.1,2 However, this potential raises significant ethical challenges, in- cluding data privacy, patient autonomy, governance, and accessibility. As highlighted by Zwitter and Boisse- Despiaux,3 ethical frameworks are essential to ensure that emerging technologies do not inadvertently harm those they aim to serve. To develop ethically sound systems, blockchain must prioritize data protection, equitable access, and transpar- ent governance structures. Shah and De Filippi4 argue that data permanence, a hallmark of blockchain’s im- mutability, creates ethical concerns surrounding patients’ right to amend or remove their data. Mechanisms that respect individual autonomy while maintaining system https://orcid.org/0000-0002-5303-3100 mailto:muthuram@ieee.org https://doi.org/10.30953/bhty.v7.362 Citation: Blockchain in Healthcare Today 2024, 7: 362 - https://doi.org/10.30953/bhty.v7.3622 (page number not for citation purpose) Muthu Ramachandran transparency and security are critical. Figure 1 illustrates key ethical dimensions such as privacy, security, gover- nance, data sovereignty, and inclusivity, showing their interconnected nature within a healthcare blockchain system. The ethical dimensions of blockchain design—privacy, security, governance, data sovereignty, and inclusivity— are deeply interconnected. As illustrated in Figure 1, the effectiveness of ethical frameworks relies on addressing these dimensions holistically rather than in isolation. Each component influences and shapes the others, emphasizing the need for a comprehensive, integrated approach to eth- ical blockchain design. Figure 1 illustrates the concept of an Ethical Block- chain in Healthcare, organized into a circular model em- phasizing interconnected principles and outcomes. At its center is the main idea: leveraging blockchain technology to address ethical challenges in healthcare. Surrounding this core are the Core Ethical Dimensions that underpin its implementation, including (patient-controlled access to their data), Security (encryption and decentralized identi- ties for protection), Governance (smart contracts enabling stakeholder consensus), Inclusivity (ensuring multi-lan- guage accessibility), and Data Sovereignty (compliance with local jurisdiction laws for data storage). These ethical dimensions lead to tangible Outcomes, such as enhanced Patient Trust in the system, adherence to Regulatory Com- pliance, and greater Accessibility for users. This model provides a holistic framework for integrating blockchain into healthcare ethically and effectively. By embedding these values into the technological core, stakeholders can ensure that blockchain solutions in healthcare uphold transparency, fairness, and human rights, fostering public trust and enhancing patient outcomes. Privacy, Security, and Decentralization Privacy and security remain paramount in block- chain healthcare applications. Dagher et al.5 argue that protecting patient data from breaches and misuse requires robust cryptographic methods and decentralized access control mechanisms. However, decentralization presents challenges regarding shared responsibility and gover- nance among network participants. Kumar et al.6 propose that ethical frameworks must incorporate controls like encrypted keys, pseudonymization, and consent-based smart contracts. Decentralized architectures empower patients through transparency and data control. However, as noted by Wer- bach,7 decentralized systems often pose ethical questions regarding governance and accountability. Decentralized autonomous organizations (DAOs) can provide demo- cratic governance models that emphasize fairness, ac- countability, and diverse stakeholder input. Incorporating explainability principles for blockchain-based systems, as explored in Ramachandran,8,9 is essential to ensure deci- sions made by autonomous processes can be understood and evaluated by human stakeholders. Alignment With International Regulations Ensuring that blockchain systems align with interna- tional regulations is vital for their ethical and legal im- plementation in healthcare. Frameworks like the General Data Protection Regulation (GDPR) in Europe and the Health Insurance Portability and Accountability Act of 1996 (HIPAA)10 in the United States provide stringent guidelines for data protection and privacy. By address- ing these regulatory requirements, blockchain systems can uphold ethical principles while fostering trust among stakeholders. GDPR Compliance: Off-Chain Storage and Patient Consent The GDPR mandates that individuals have control over their personal data, including the “Right to be Forgotten,” which conflicts with blockchain’s immutable nature.11–13 To reconcile this, ethical blockchain frameworks can adopt Fig. 1. Ethical dimensions of blockchain by design in healthcare. https://doi.org/10.30953/bhty.v7.362 Citation: Blockchain in Healthcare Today 2024, 7: 362 - https://doi.org/10.30953/bhty.v7.362 3 (page number not for citation purpose) Blockchain: guiding the future for innovation off-chain storage for sensitive data. In this model, only references or hashes of the data are stored on the block- chain, while the actual data reside in secure, modifiable storage off-chain. If data must be updated or deleted, the hash becomes obsolete without altering the blockchain’s integrity. Patient consent mechanisms are another GDPR-com- pliant feature enabled by blockchain. Patients can grant or revoke access to their records through smart contracts, ensuring explicit, informed consent for every data trans- action. For example, a patient could permit access to their health data for a specific duration or purpose, aligning blockchain functionality with GDPR’s transparency and accountability principles. HIPAA Compliance: Encryption and Permissioned Access The HIPAA focuses on protecting protected health infor- mation (PHI) by mandating safeguards like encryption and role-based access controls.14 Blockchain systems in- herently support encryption, ensuring that PHI is only ac- cessible to authorized parties. Advanced techniques, such as homomorphic encryption, allow healthcare providers to perform computations on encrypted data without expos- ing sensitive information, maintaining compliance with HIPAA’s security standards. Additionally, permissioned blockchain networks en- able role-based access. Unlike public blockchains, permissioned systems ensure that only verified stake- holders, such as healthcare providers, patients, and insurers, can interact with the data. Smart contracts further enhance compliance by automating access per- missions, ensuring adherence to HIPAA’s minimum necessary standard. Case Study: Estonia’s National Blockchain System Estonia has become a global leader in blockchain-driven healthcare systems, providing a practical example of reg- ulatory compliance in action.15 The country’s eHealth sys- tem uses blockchain to secure over 95% of citizens’ health data. By integrating off-chain storage for sensitive data and blockchain-based logging for access transparency, Estonia aligns its system with GDPR while ensuring pa- tient trust. Citizens can track who accessed their data and for what purpose, exemplifying a human-centric approach to blockchain implementation. Data Sovereignty, Inclusivity, and Accountability Data sovereignty is critical for ethical blockchain ap- plications. Haque et al.16 and Lindman et al.17 state that patients should control their data and decide its usage, fostering trust and autonomy. Inclusivity should also be a guiding principle, ensuring blockchain bene- fits all populations and does not exacerbate existing healthcare disparities (e.g., frameworks such as the Quality Framework for Explainable Artificial Intelli- gence (AI))17,18 offer tools to ensure accessibility and equitable engagement. Accountability remains a critical challenge in decen- tralized systems, where responsibility for decisions is dis- persed. Raval19 states that ethical-by-design frameworks must include clear accountability structures to ensure net- work participants adhere to established standards. Best Practice Guidelines For Ethics of Blockchain By Design To support ethical blockchain development in healthcare, Ramachandran8,9,18 proposes the following best prac- tices, building on established research and frameworks such as the secure and sustainable software engineering framework for healthcare blockchain applications (S3EF- HBCA)5 and AI-blockchain frameworks,18 which include the following concepts. Principle of Data Ownership and Consent Patients should maintain ownership of their data and re- tain control over its use and sharing. Real-time consent management systems embedded within blockchain-based healthcare applications offer one way to ensure patient autonomy. Privacy-Preserving Mechanisms Incorporating privacy-preserving cryptographic protocols and security measures ensures that patient data remain confidential and secure.5 The S3EF-HBCA framework focuses on sustainable and secure healthcare blockchain systems.8 Equitable Access and Inclusivity Lindman et al.17 state that blockchain systems must be accessible to all populations, and mitigating healthcare disparities and ensuring inclusivity is a core value. This aligns with the ethical principles outlined in explainable AI frameworks to ensure interpretability and equitable decision-making.9 Transparent and Accountable Governance Governance mechanisms should be transparent, allowing for democratic participation from all stakeholders.3,7 Eth- ical frameworks should prioritize decentralized, inclusive governance models such as DAOs. Interoperability and Sustainable Design Systems must integrate seamlessly with existing health- care infrastructure without compromising security or sustainability. Approaches like AI-blockchain integrated frameworks can enhance system interoperability while pro- moting secure data exchange.18 Figure 2 illustrates “Best https://doi.org/10.30953/bhty.v7.362 Citation: Blockchain in Healthcare Today 2024, 7: 362 - https://doi.org/10.30953/bhty.v7.3624 (page number not for citation purpose) Muthu Ramachandran Practice Guidelines for Blockchain Ethics” in healthcare, depicted as an interconnected framework highlighting key ethical dimensions and practices. The proposed best practices for ethical blockchain development in healthcare provide a comprehensive framework to guide the design, implementation, and governance of blockchain-based systems. By uphold- ing principles of data ownership, privacy, equitable access, transparent governance, and sustainable in- teroperability, these guidelines ensure that blockchain technology is leveraged in a manner that empowers patients, protects sensitive information, and promotes inclusive and accountable healthcare services. As the adoption of blockchain in the medical sector continues to grow, adherence to these ethical considerations will be crucial in realizing the full transformative potential of this technology while safeguarding the rights and wellbeing of patients. Ongoing research and collabo- ration among healthcare stakeholders, technologists, and ethicists will be essential to further refine and op- erationalize these best practices, ultimately shaping the ethical development of blockchain in the healthcare domain. Conclusion: Moving Toward an Ethical Blockchain Future in Healthcare “Ethics of Blockchain By Design” calls on developers, healthcare professionals, policymakers, and stakeholders to collaborate on ethical innovation. Tsanidis20 proposes that by embedding ethics into every phase of blockchain system design and regulation, we can protect patient au- tonomy, foster trust, and maximize blockchain’s potential for social good. Ethics are not a barrier to innovation but a cata- lyst for responsible technology development. It ensures that blockchain systems align with human dignity, uphold the mission to “do no harm,” and enhance health outcomes globally. Through thoughtful design, ethical governance, and continuous evaluation, we can build blockchain solutions that truly serve patients’ needs. Future Research Directions While blockchain offers transformative potential for healthcare, scaling ethical solutions globally presents sig- nificant challenges. Future research should focus on sev- eral key areas. Fig. 2. Best practice guidelines for blockchain ethics illustrating the interconnected framework, highlighting key ethical dimen- sions and practices. https://doi.org/10.30953/bhty.v7.362 Citation: Blockchain in Healthcare Today 2024, 7: 362 - https://doi.org/10.30953/bhty.v7.362 5 (page number not for citation purpose) Blockchain: guiding the future for innovation Scaling Ethical Solutions Globally Implementing blockchain across diverse healthcare sys- tems requires accommodating varying levels of infrastruc- ture, technological maturity, and regulatory frameworks. Research should explore modular and adaptive blockchain frameworks that can be tailored to both high-resource and low-resource settings. This includes simplifying deploy- ment processes and reducing costs to ensure accessibility. Blockchain Integration With AI and the Internet of Things The integration of blockchain with emerging technologies like AI and the Internet of Things (IoT) promises enhanced interoperability and predictive analytics in healthcare. However, ethical considerations, such as bias in AI mod- els or privacy risks in IoT device data, must be addressed. Future studies should focus on designing governance frame- works that balance innovation with ethical safeguards. For example, AI-driven diagnostic tools can use blockchain for secure data sharing and model transparency.18 Addressing Equity and the Digital Divide Blockchain solutions risk exacerbating existing ineq- uities if underserved populations lack access to the necessary technology or infrastructure. Research must prioritize inclusive blockchain designs that address the digital divide by: 1. Supporting low-bandwidth networks. 2. Designing user-friendly interfaces for populations with limited digital literacy. 3. Partnering with governments and non-governmental organizations (NGOs) to subsidize access to block- chain-based healthcare tools. By addressing these areas, the healthcare commu- nity can advance blockchain’s potential while ensuring it serves as an equitable and ethical tool for global health innovation. Funding The author did not receive support from any organization for the submitted work. Financial and Non-Financial Relationship and Activities This article is an individual contribution of the author. There are no relevant relationships to report. Contributor The author is responsible for all aspects of the article. Application of AI-Generated Text or Related Technology ChatGPT4o was used to check for grammatical errors, rewrite, and proofread some sections in this article. Data Availability Statement (DAS), Data Sharing, Reproducibility, and Data Repositories The data that support the findings of this study are openly available in the published literature. References 1. Kuo T-T, Kim H-E, Ohno-Machado L. Blockchain distributed ledger technologies for biomedical and health care applica- tions. J Am Med Inform Assoc. 2017;24(6):1211–20. https://doi. org/10.1093/jamia/ocx068 2. Engelhardt MA. Hitching healthcare to the blockchain: the prom- ise and the challenges. Blockchain Healthc Today. 2017;1:1–10. 3. Zwitter A, Boisse-Despiaux M. Blockchain for humanitarian action and development aid. J Int Hum Assist. 2018;3(1):16. https://doi.org/10.1186/s41018-018-0044-5 4. Shah S, De Filippi P. Blockchain and data privacy: the role of trust and transparency in ethical data handling. J Inform Tech- nol Ethics. 2020;15(1):75–88. 5. Dagher GG, Mohler J, Milojkovic M, Marella PB. Ancile: pri- vacy-preserving framework for access control and interopera- bility of electronic health records using blockchain technology. Sustain Cities Soc. 2018;39:283–97. https://doi.org/10.1016/j. scs.2018.02.014 6. Kumar S, Smith R, Liao J. Privacy-preserving health informa- tion exchange with blockchain technology. Health Inform J. 2018;24(4):352–68. 7. Werbach K. The blockchain and the new architecture of trust. Cambridge, Massachusetts: MIT Press; 2018. 8. Ramachandran M. S3EF-HBCAs: secure and sustainable soft- ware engineering framework for healthcare blockchain applica- tions. Int J Blockchain Healthc Today. 2023;6:286. https://doi. org/10.30953/bhty.v6.286 9. FACTA UNIVERSITATIS. Series: Electronics and Energet- ics Vol. 37, No 1, March Wales: IET Press; 2024, pp. 169– 193. England,, and Scotland. Accessed November 10, 2024. https://doi.org/10.2298/FUEE2401169 10. Health Insurance Portability and Accountability Act of 1996. PUBLIC LAW 104-191, 104th Congress [Internet]. As- sistant Secretary for Planning and Evaluation; 1996 [cited 2024 Nov 29]. Available from: https://aspe.hhs.gov/reports/ health-insurance-portability-accountability-act-1996 11. Voigt P, Von dem Bussche A. The EU general data protec- tion regulation (GDPR): a practical guide. Cham: Springer Inter national Publishing; 2017. 12. Zyskind G, Nathan O, Pentland A. Decentralizing privacy: using blockchain to protect personal data. San Jose, CA: IEEE Security and Privacy Workshops; 2015, pp. 180–184. https://doi. org/10.1109/SPW.2015.27 13. Finck M. Blockchain and the general data protection regulation: can distributed ledgers be squared with Eu- ropean Data Protection Law? Eur Data Protect Law Rev. 2019;4(1):38–68. 14. McGhin T, Choo KKR, Liu CZ, He D. Blockchain in health- care applications: research challenges and opportunities. J Netw Comput Appl. 2019;135:62–75. https://doi.org/10.1016/j. jnca.2019.02.027 15. Anthes G. Estonia: a model for e-government. Commun ACM. 2015;58(6):18–20. https://doi.org/10.1145/2754951 16. Haque A, Milstein A, Fei-Fei L. Illuminating the dark spaces of healthcare with AI and blockchain: ethics and efficacy. J Health Ethics. 2021;17(2):45–61. https://doi.org/10.30953/bhty.v7.362 https://doi.org/10.1093/jamia/ocx068 https://doi.org/10.1093/jamia/ocx068 https://doi.org/10.1186/s41018-018-0044-5 https://doi.org/10.1016/j.scs.2018.02.014 https://doi.org/10.1016/j.scs.2018.02.014 https://doi.org/10.30953/bhty.v6.286 https://doi.org/10.30953/bhty.v6.286 https://doi.org/10.2298/FUEE2401169 https://aspe.hhs.gov/reports/health-insurance-portability-accountability-act-1996 https://aspe.hhs.gov/reports/health-insurance-portability-accountability-act-1996 https://doi.org/10.1109/SPW.2015.27 https://doi.org/10.1109/SPW.2015.27 https://doi.org/10.1016/j.jnca.2019.02.027 https://doi.org/10.1016/j.jnca.2019.02.027 https://doi.org/10.1145/2754951 Citation: Blockchain in Healthcare Today 2024, 7: 362 - https://doi.org/10.30953/bhty.v7.3626 (page number not for citation purpose) Muthu Ramachandran 17. Lindman J, Rossi M, Tuunainen VK. Opportunities and risks of blockchain technologies in healthcare: a systematic review. Telemat Inform. 2017;34(2):199–207. Boston, MA. https://doi.org/10.24251/ HICSS.2017.185 18. Ramachandran M. AI and blockchain framework for healthcare applications. Facta Univ Ser Electr Energ. 2024;37(1):169–93. https://doi.org/10.2298/FUEE240 1169R 19. Raval S. Decentralized applications: Harnessing Bitcoin’s block- chain technology. O’Reilly Media; 2016. 20. Tsanidis C. Ethical frameworks for blockchain governance. Technol Soc. 2019;21(3):49–63. Copyright Ownership: This is an open access article distributed in accor- dance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, adapt, enhance this work non-commercially, and license their derivative works on dif- ferent terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0. https://doi.org/10.30953/bhty.v7.362 https://doi.org/10.24251/HICSS.2017.185 https://doi.org/10.24251/HICSS.2017.185 https://doi.org/10.2298/FUEE240​1169R http://creativecommons.org/licenses/by-nc/4.0