A Regulatory Readiness Assessment Framework for Blockchain Adoption in Healthcare
- Introduces the regulatory readiness framework research area, presenting a proper foundation, emphasizing definitions, and highlighting terminologies for both industry and academic affairs. We demonstrate the impact of data laws on blockchain and their enforcement.
- Propose a regulatory readiness assessment framework for blockchain; a framework defining the criteria to assess regulatory readiness and reduce regulatory burdens when adopting blockchain.
- The study is provided in a timely fashion and offers a guiding lamp to strengthen blockchain adoption.
- The proposed framework fills a considerable void in the literature, especially in healthcare, where there is still lack of trust among stakeholders.
- This paper addresses the lack of clarity in blockchain regulatory laws; these issues have become deterrents for stakeholders.
- The proposed framework is adaptable to several sectors and will be of value to policymakers as a tool for assessing readiness for blockchain adoption.
3. The Proposed Readiness Assessment Framework for Blockchain Regulation
3.1. Key Stakeholders
3.1.2. Business Entities
3.1.3. Solutions Providers
3.1.4. Blockchain End-Users
3.2. Relationship between Stakeholders to Develop a Regulatory Readiness Assessment Framework for Blockchain
3.2.1. Regulators and Business Entities
3.2.2. Regulators and Solutions Provider
3.2.3. Regulators and Blockchain End-User
3.2.4. Business Entities and Solutions Providers
3.2.5. Business Entities and End-Users
3.2.6. Solutions Providers and End-Users
3.3. Regulatory Design Framework Readiness
3.3.1. Motivational Readiness
3.3.2. Structural Readiness
3.3.3. Engagement Readiness
3.3.4. Technology Readiness
4. Application of Framework in Case Study
4.1. Regulatory/Government Readiness
4.2. Business Entity Readiness
4.3. Solutions Providers Readiness
4.4. End-User Readiness
4.5. Applying Key Regulatory Facilitating Conditions to Stakeholder Readiness
4.5.1. Regulatory Sandbox
4.5.3. Data Protection Laws
4.5.4. Multi-Disciplinary Research
5. Materials and Methods
- Gain more knowledge and understand the various applications of blockchain.
- Understand the implications of regulations and data laws on blockchain.
- Understand the roles of the key stakeholders associated with blockchain regulation in the healthcare sector.
- Understand their concerns regarding regulation, privacy, and security.
|Belchior et al. (2021) |
Summary: A framework for blockchain interoperability among blockchain entities.
Benefits: Reducing attacks through interoperability; improving data standards and privacy; insight into blockchain interoperability use-cases.
Challenges: Fast-paced development of blockchain, security, trust and privacy issues related to GDPR.
|Systematic Literature Review||Business Entities|
|Berdik et al. (2021) |
Summary: Reports on the issues and adoption of blockchain applications in information systems.
Benefits: Promotes blockchain adoption and interoperability among components; open source blockchain tools.
Challenges The layout and architecture of blockchain is crucial to its widespread adoption.
|Casino et al. (2019) |
Summary: The use of blockchain in supply chains, healthcare, IOT and data management.
Benefits: It contributes to the knowledge base and understanding of applying blockchains to real-world problems.
Challenges: Lack of review of current state-of-the-art devices due to limited information and research.
|Literature Review||Blockchain Researchers|
|Charles et al. (2019) |
Summary: Explores the use of blockchain-based application for clinical research, managing patient and laboratory data.
Benefits: Contributes to the knowledge and understanding of the regulatory constraints of adopting blockchain into the healthcare sector.
Challenges: Adhering to regulatory requirements, privacy regulations and guideline on how to achieve compliance when managing healthcare records.
|Dameri (2009) |
Summary: How to improve IT governance and compliance of digital applications. Compliance requirements when implementing IT governance into digital applications.
Benefits: Development of a compliance-automated system.
Challenges: Transparency, costs, data protection laws.
|Secondary Sources||Solutions Providers|
|Dorri et al. (2017) |
Summary: An investigation into the use of blockchain in a smart-home setting.
Benefits: Proposed a blockchain smart-home framework that is secure, and secure access control for IOT devices.
Challenges: Confidentiality, high costs and security issues.
|Ekblaw et al. (2016) |
Summary: Proposed the use of blockchain to manage medical records.
Benefits: The development of a working prototype to analyse the potential of blockchain in healthcare, improved interoperability of systems among healthcare providers and quality data for medical researchers.
Challenges: 51% attack on the private blockchain, high volume of medical data.
|Case Study |
Public Health Authorities.
|Esposito (2018) |
Summary: Proposed a blockchain solution to protect healthcare data hosted within the cloud.
Benefits: Recommends off-chain storage to combat GDPR “Right to be forgotten’ law.
Challenges: GDPR Laws, scalability, and storage of data.
|Filippi and Hassan (2016) |
Summary: An overview into the legal challenges of blockchain applications.
Benefits: Proposed automated legal governance using blockchain, improved transparency in carrying out regulatory obligations.
Challenges: Issues with GDPR’s right to be forgotten and immutability of blockchain transactions.
|Gozman et al. (2020)  |
Summary: Automating the process of regulatory reporting using blockchain technology.
Benefits: Reduce duplication, efficient regulatory reporting system, and creating a better understanding of blockchain for regulators by making them use the technology in regulatory reporting.
Challenges: Educating regulators and other stakeholders, confidentiality issues.
|Gupta and Sadoghi (2019) |
Summary: Proposed the use of blockchain in processing transactions.
Benefits: Improves trust and data integrity, tamper-proof solution, reduce fraud and accountability of data.
Challenges: High costs of maintenance and regulatory issues.
|Secondary Sources||Business Entities|
|Heston (2017) |
Summary: The application of blockchain in healthcare innovation using Estonia as a case study.
Benefits: Promotes better understanding of regulators, governments, and healthcare providers on the use of blockchain in the healthcare sector and how to leverage the opportunities provided by blockchain to improve healthcare data integrity. Puts the patient’s welfare at the forefront of innovation.
Challenges: 51% attack can occur; size of medical data can cause storage problems and end-user is responsible for data.
|Kwok and Koh (2018) |
Summary: Explores the use of blockchain to boost tourism among small economies.
Benefits: Increased commercial opportunities for small countries and improved stakeholder knowledge on blockchain.
Challenges: Educating stakeholders on blockchain and regulatory gaps.
|Lim et al. (2021) |
Summary: How blockchain technology can be used to improve supply chain activities.
Benefits: Improve stakeholder knowledge of using blockchain in supply chain tracking and management.
Challenges: Transparency, high costs and lack of expertise.
|Literature Review||Solutions Providers|
|Lin et al. (2017) |
Summary: The security issues and challenges of blockchain, and how these have shaped regulation laws and the adoption of blockchain as a solution.
Benefits: Easy access to data, integration of multiple tasks and less maintenance.
Challenges: Privacy issues.
|Kwok (2018) |
Summary: This research focused on the adoption of blockchain technology into
Tourism and the implications for tourism development in the Caribbean economy.
Benefits: Boosting of tourism revenue and the launching of the first digital legal tender in the Caribbean.
Challenges: Lack of IT infrastructure and government support for new technologies.
|Nguyen et al. (2021) |
Summary: An extensive survey into the application of blockchain and AI into combating the COVID-19 virus. An integration of blockchain and AI to revolutionize the healthcare sector.
Benefits: Early detection of outbreaks, ordering of medical data, support drug manufacturing and virus tracing.
Challenges: Lack of a regulatory framework for blockchain, data privacy concerns, implementation issues and interoperability of medical record systems.
|Prashanth (2018) |
Summary: A survey into the challenges and opportunities of using blockchain as a solution to privacy concerns.
Benefits: Improves trust in and credibility of data and has no third parties.
Challenges: Fear of strict regulations.
|Secondary Sources||Solutions Providers|
|Sarmah (2018)  |
Summary: A study into understanding the use of blockchain and how to it can be applied to several industries and sectors, as well as their challenges and advantages.
Benefits: Promotes a better understanding of how to leverage blockchain as a solution for organisations.
Challenges: A lack of regulatory framework is slowing down the pace of adoption and a lack of understanding of blockchain architecture by the key stakeholders.
|Secondary Sources||Solutions Providers|
|Siyal (2019) |
Summary: An overview into blockchain application in the healthcare sector, focusing on Electronic Health Records, clinical research, medical fraud detection, neuroscience, and biomedical research.
Benefits: New research opportunities for biomedical research.
Challenges: Storage and scalability, requires regulatory standards, social acceptance, and interoperability of healthcare systems.
|Secondary Sources||Healthcare providers|
|Yeoh (2017) |
Summary: This research examines the key regulatory challenges of blockchain adoption in the EU and US. It discusses the hands-off approach initiated by both countries, and how this has accelerated the growth of blockchain, in detail.
Benefits: Support for the right innovation for blockchain that will continue to add value to the technology and make it more accessible. It also promotes a better understanding between cryptocurrency and blockchain.
Challenges: Lack of adequate knowledge and blockchain expertise from regulators.
|Primary Sources |
|Kant (2021) |
Summary: Blockchain as a solution to organisations’ needs and a source of competitive advantage.
Benefits: Contributes to the body of knowledge of blockchain adoption.
Challenges: Social and legal issues.
|Secondary Sources||Blockchain Researchers|
|Pal (2021) |
Summary: Explores the possibility of applying blockchain to business management and business activities to create a safer transaction process.
Benefits: Safer business transactions, reduces error in transactions, helps prevent fraud.
Challenges: Regulatory and social challenges.
|Systematic Literature Review||Business Entities|
|Rajeb (2020) |
Summary: Explores the application of blockchain to food supply chains (FSC) to combat the issue of food traceability, improve health and safety standards of food, provide verifiable information on food nutrients.
Benefits: Improve supply chain transparency, effective traceability, automate data collection and minimize logistic errors.
Challenges: Limited scalability, technological immaturity, lack of industry standard, lack of a blockchain regulatory framework and privacy concerns.
|Systematic Literature Review|
|Sung (2021) |
Summary: This study focuses on the adoption of blockchain in an identity management system, with a focus on the Korean Government.
Benefits: Blockchain provides better control of data, integrity and data reliability and reduces the cost of delivery to public services. This system is a user-centric personal data management without a central authority. This will allow for quicker data access by leveraging the decentralized nature of blockchain.
Challenges: Educating public sector on blockchain, privacy concerns, regulatory concerns.
6. Impact of Regulatory Laws on Blockchain Adoption
6.1. Key Issues between Blockchain and Current Data Protection Laws
6.1.1. Recognizing Blockchain-Based Signatures
6.1.2. Location of Nodes
6.1.4. Liability Constraints
6.1.5. Data Protection Laws
- The identification of data controllers and processors is law under GDPR.
- Anonymity of personal data.
- The GDPR right to be forgotten.
6.2. Some Key Guidelines to Aid Regulators and Policy Makers on Their Journey to Regulate Blockchain Technology
- A simple dictionary of blockchain terminologies written by regulators, which defines blockchain EU Laws and data laws to ensure shared definitions among countries.
- Communication of these terminologies so that they reach a wider audience.
- Creation of a balance between blockchain terminologies and laws that will not deter innovation.
- A sandbox to improve understanding between regulators and the blockchain ecosystem.
- Use of case testing to obtain a clearer picture of the gap between blockchain and GDPR.
- Monitoring and reiteration in smaller use cases to test resistance to blockchain assets.
- A based regulatory tool is a good way of improving the understanding between regulators and blockchain. In their work Gozman and Aste  proposed a solution that involved the application of blockchain to regulatory reporting. This will help bridge the gap and harmonize the current situation between the data-protection regulators and blockchain solutions as they utilize this technology first-hand.
8. Conclusions and Future Work
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Appendix A. Case Study Brief
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|Citation Number||Authors Name||Year of Publish||Topic||Limitations|
|||Correia et al.||2021||Evolution of Blockchain Market||Lack of evidence-based studies of regulatory issues associated with blockchain.|
|||Ekblaw et al.||2016||A Case Study for Blockchain in Healthcare: “MedRec” prototype for electronic health records and medical research data MedRec: Using Blockchain for Medical Data Access and Permission Management.||Security and scalability of the solution are not discussed.|
|||Esposito et al.||2018||Blockchain: A Panacea for Healthcare Cloud-Based Data Security and Privacy?||The study did not address HIPAA and GDPR laws that guide the use of information technology in healthcare.|
|||Gozman and Aste||2020||A case study of using blockchain technology in regulatory technology.||The solution was not scaled to production to test its applicability.|
|||Guardtime||2016||Estonia e-health authority partners with Guardtime to accelerate transparency and auditability in healthcare.||The adaptability and scalability of the solution was not addressed.|
|||GSMA||2017||Blockchain for Development: Emerging opportunities for Mobile, Identity and Aid.||Regulatory drawbacks have not been considered in detail.|
|||Heston||2017||A case study in blockchain healthcare innovation.||Lack of applicability to other scenarios.|
|||Lapointe and Fishbane||2019||The Blockchain Ethical Design Framework. Innovations: Technology, Governance, Globalization.||The research did not go into detail to address the current data laws and how these govern the adoption of blockchain technology.|
|||Park and Park||2020||Regulation by selective enforcement.||Selective enforcement is difficult to apply in a broader context.|
|||Yeoh||2017||Regulatory issues in Blockchain Technology.||Their solution requires an approved regulatory framework and standard before implementation can be carried out.|
|Key Regulatory Facilitating Conditions||Regulators/Government||Business Entities||Solutions Providers||End Users|
There are plans to launch a Trade-Free Zone in Portugal, but there is no ongoing collaborative approach between regulators and blockchain providers.
There is a need for a regulatory sandbox to improve the understanding of regulators in Portugal that Bitcoin is not Blockchain.
There is little to no collaborative effort among business entities to improve blockchain adoption and minimize regulatory concerns.
There are collaborative research plans among the bigger technology companies to reduce regulation concerns by following regulatory practices when providing their blockchain solution.
High stakeholder motivation for blockchain adoption and innovation, especially due to Portugal’s tax-free law on cryptocurrency, but fear of harsh regulation causes concern.
Regulators and government understanding of blockchain anonymity is based on the darknet uses of Bitcoin. Regulators must have a technical understanding that blockchain anonymity is not a threat but an opportunity if leveraged correctly. There are always ways to reduce anonymity within a technology, but only through an understanding of its technology and terminology.
Business entities are individually taking advantage of blockchain in Portugal, especially cryptocurrency, which is the most popular use-case at present.
Solution providers such as Amazon and IBM are trying to figure out ways to blend anonymity when developing blockchain platforms with regulatory requirements.
There are concerns regarding how issues will be resolved and the high risk of losing their investments if everyone is anonymous.
The EU is considering blockchain regulation despite most laws still being at the planning phase.
Concerns relating to GDPR data laws and fines.
Concerns relating to GDPR laws, Portuguese data laws and anti-money-laundering laws.
Concerns relating to laws of the regulatory framework and how these will impact their data.
There is motivation for research on blockchain regulation to cut across all sectors, even though most research is still in the planning phase.
There is also a good IT infrastructure in Portugal.
There is no known multi-disciplinary research on blockchain regulation among business entities in Portugal.
There is limited multi-disciplinary research among small and large solution providers.
End-users show motivation to be part of multi-disciplinary research that forms a knowledge pool for the creation of a regulatory framework.
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Sanda, O.; Pavlidis, M.; Polatidis, N. A Regulatory Readiness Assessment Framework for Blockchain Adoption in Healthcare. Digital 2022, 2, 65-87. https://doi.org/10.3390/digital2010005
Sanda O, Pavlidis M, Polatidis N. A Regulatory Readiness Assessment Framework for Blockchain Adoption in Healthcare. Digital. 2022; 2(1):65-87. https://doi.org/10.3390/digital2010005Chicago/Turabian Style
Sanda, Olanrewaju, Michalis Pavlidis, and Nikolaos Polatidis. 2022. "A Regulatory Readiness Assessment Framework for Blockchain Adoption in Healthcare" Digital 2, no. 1: 65-87. https://doi.org/10.3390/digital2010005