NARRATIVE/SYSTEMATIC REVIEWS/META-ANALYSIS

Ethics of Blockchain by Design: Guiding a Responsible Future for Healthcare Innovation

Muthu Ramachandran, PhD^1,2

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

Abstract

The rapid evolution of blockchain technology in healthcare presents unparalleled opportunities for advancements, including enhanced patient data security, decentralized systems for trustless operations, and transparent 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, transparency, 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 stakeholders 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 framework 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 stakeholder-driven research to validate and refine the framework, ensuring its applicability across diverse healthcare environments.

 

 

The Ethical Imperative in Blockchain Development

The applications of blockchain in healthcare, from immutable patient records to efficient clinical trial management, illustrate its transformative potential.^1,2 However, this potential raises significant ethical challenges, including 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 transparent governance structures. Shah and De Filippi⁴ argue that data permanence, a hallmark of blockchain’s immutability, creates ethical concerns surrounding patients’ right to amend or remove their data. Mechanisms that respect individual autonomy while maintaining system transparency and security are critical. Figure 1 illustrates key ethical dimensions such as privacy, security, governance, data sovereignty, and inclusivity, showing their interconnected nature within a healthcare blockchain system.

Fig. 1. Ethical dimensions of blockchain by design in healthcare.

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 ethical blockchain design.

Figure 1 illustrates the concept of an Ethical Blockchain in Healthcare, organized into a circular model emphasizing 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 identities for protection), Governance (smart contracts enabling stakeholder consensus), Inclusivity (ensuring multi-language 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 Compliance, 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 blockchain 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 governance 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 Werbach,⁷ decentralized systems often pose ethical questions regarding governance and accountability. Decentralized autonomous organizations (DAOs) can provide democratic governance models that emphasize fairness, accountability, and diverse stakeholder input. Incorporating explainability principles for blockchain-based systems, as explored in Ramachandran,^8,9 is essential to ensure decisions made by autonomous processes can be understood and evaluated by human stakeholders.

Alignment With International Regulations

Ensuring that blockchain systems align with international regulations is vital for their ethical and legal implementation 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 addressing 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 off-chain storage for sensitive data. In this model, only references or hashes of the data are stored on the blockchain, 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-compliant feature enabled by blockchain. Patients can grant or revoke access to their records through smart contracts, ensuring explicit, informed consent for every data transaction. 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 information (PHI) by mandating safeguards like encryption and role-based access controls.¹⁴ Blockchain systems inherently support encryption, ensuring that PHI is only accessible to authorized parties. Advanced techniques, such as homomorphic encryption, allow healthcare providers to perform computations on encrypted data without exposing sensitive information, maintaining compliance with HIPAA’s security standards.

Additionally, permissioned blockchain networks enable role-based access. Unlike public blockchains, permissioned systems ensure that only verified stakeholders, such as healthcare providers, patients, and insurers, can interact with the data. Smart contracts further enhance compliance by automating access permissions, 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 regulatory compliance in action.¹⁵ The country’s eHealth system 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 patient 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 applications. 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 benefits all populations and does not exacerbate existing healthcare disparities (e.g., frameworks such as the Quality Framework for Explainable Artificial Intelligence (AI))^17,18 offer tools to ensure accessibility and equitable engagement.

Accountability remains a critical challenge in decentralized systems, where responsibility for decisions is dispersed. Raval¹⁹ states that ethical-by-design frameworks must include clear accountability structures to ensure network participants adhere to established standards.

Best Practice Guidelines For Ethics of Blockchain By Design

To support ethical blockchain development in healthcare, Ramachandran^8,9,18 proposes the following best practices, 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 retain 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 Ethical frameworks should prioritize decentralized, inclusive governance models such as DAOs.

Interoperability and Sustainable Design

Systems must integrate seamlessly with existing healthcare infrastructure without compromising security or sustainability. Approaches like AI-blockchain integrated frameworks can enhance system interoperability while promoting secure data exchange.¹⁸ Figure 2 illustrates “Best Practice Guidelines for Blockchain Ethics” in healthcare, depicted as an interconnected framework highlighting key ethical dimensions and practices.

Fig. 2. Best practice guidelines for blockchain ethics illustrating the 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 upholding principles of data ownership, privacy, equitable access, transparent governance, and sustainable interoperability, 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 collaboration among healthcare stakeholders, technologists, and ethicists will be essential to further refine and operationalize 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 autonomy, foster trust, and maximize blockchain’s potential for social good.

Ethics are not a barrier to innovation but a catalyst 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 significant challenges. Future research should focus on several key areas.

Scaling Ethical Solutions Globally

Implementing blockchain across diverse healthcare systems requires accommodating varying levels of infrastructure, 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 deployment 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 models or privacy risks in IoT device data, must be addressed. Future studies should focus on designing governance frameworks 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 inequities 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 blockchain-based healthcare tools.

By addressing these areas, the healthcare community can advance blockchain’s potential while ensuring it serves as an equitable and ethical tool for global health innovation.

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.

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