Promoting TEFCA with Blockchain Technology: A Decentralized Approach to Patient-centered Healthcare Data Management

Abstract

The Trusted Exchange Framework and Common Agreement (TEFCA) is a framework consisting of seven principles designed to create a secure and seamless health information exchange system across various healthcare settings. The ultimate goal of TEFCA is to facilitate public health surveillance, increase interoperability, promote data sharing, and ensure patient-centered healthcare data management. While the implementation of these principles is challenging, blockchain technology, with its unique features such as transparency, auditability, immutability, and anonymity, can provide a promising solution to the development of TEFCA. This article delves into the potential of blockchain technology to promote TEFCA design. By providing an immutable and transparent ledger, blockchain ensures data integrity, openness, and patient privacy. Overall, the use of blockchain technology can help address the challenges of implementing TEFCA principles and promote patient empowerment and control over their health data, improve data interoperability, and enhance healthcare quality.

Introduction

Trusted Exchange Framework and Common Agreement (TEFCA) is a nationwide initiative in the United States aimed at improving the exchange of health information between different healthcare providers, payers, and patients¹. The initiative is intended to create a standardized framework for secure and interoperable Health Information Exchange (HIE) across the country, leading to enhanced patient care and outcomes². The Office of the National Coordinator for Health Information Technology (ONC) established TEFCA in response to the growing need for a cohesive and coordinated approach to HIE³. Currently, there are many different Health Information Networks (HINs) in use across the country, each with its own set of rules and protocols, leading to fragmentation and challenges in sharing patient health data securely and effectively, ultimately impacting patient care⁴. To address these issues, TEFCA aims to establish a set of common principles and technical standards for HIE that can be adopted by all stakeholders, including guidelines for patient-centricity and rules for data sharing and access⁵. The ultimate goal is to create a trusted network of HIE that allows patients and providers to securely access and share medical records across the country, regardless of where they receive care⁶. The final version of TEFCA, published by the ONC in January 2022, comprises seven principles after multiple rounds of revisions and updates, highlighting its importance in enhancing HIE^1,7.

Although TEFCA represents a crucial step forward in improving HIE, there are still obstacles to overcome, such as placing patients at the center of HIE and ensuring the security and privacy of their data⁸. There is also a lack of standardization in the way health information is exchanged, making it difficult to integrate data from different sources⁹. Moreover, healthcare organizations lack trust in the HIE due to concerns about data security, privacy, and ownership¹⁰. To address these challenges, blockchain technology, a distributed ledger technology, can offer a potential solution by leveraging its decentralized and secure nature to create a trustworthy and transparent framework for HIE that aligns with the goals of TEFCA¹¹.

Blockchain technology was originally created for secure, anonymous, and transparent storage and management of financial transactions¹². However, due to its unique features, blockchain has been extensively evaluated for various sectors, including healthcare¹³, ¹⁴. Healthcare is a data-intensive industry where data privacy, security, and interoperability are major concerns. The decentralized nature of blockchain technology allows patient data to be stored and accessed securely across a network of different sources, eliminating the need for a central party to manage the data¹⁵. This capability enables the creation of a common decentralized platform, providing patients with greater control over their health data and enabling healthcare providers to access accurate and up-to-date patient information in real time¹⁶. It is noteworthy to mention that not all data needs to be stored on the blockchain. Instead, pointers or hashes of data are stored in the blockchain, with the actual data stored off-chain in traditional databases or systems. Moreover, the immutable, traceable, and transparent nature of blockchain ensures that patient data cannot be altered or tampered with, thereby reducing the risk of fraud or data breaches¹⁷. This quality has the potential to build trust among participants and provide public auditability¹⁸. Additionally, blockchain utilizes advanced cryptographic techniques to secure data, and with its anonymity feature, it can prevent the HIE process from unauthorized access and address a certain degree of the security and privacy concerns that have plagued the healthcare industry¹⁹. Finally, blockchain’s smart contract, which is a self-executing protocol programmed using Turing-complete languages²⁰, can embed TEFCA regulations and automatically enforce compliance across different networks and systems, promoting interoperability, regulatory compliance, efficiency, security, and trust in the seven principles of HIE design, as listed in Table 1. Compared to the existing approaches such as traditional centralized databases and federated data systems that are facing challenges such as central point failure, lack of transparency, and data ownership concerns, blockchain technology has the potential to achieve the goals of TEFCA, and its unique features to promote interoperability, efficiency, and security in the healthcare industry.

Table 1.

Seven principles of TEFCA and blockchain solutions

Principle	Definition	Blockchain potential approach
Principle 1: Standardization	A. Prioritize health information technology standards for interoperability. B. Allow authorized users to easily connect to data sources and leverage data to support person-centered care.	Establish a distributed standard infrastructure for exchanging health information by providing a common platform that connects disparate data sources for all participants to use.
Principle 2: Openness and Transparency	A. Ensure that agreements governing the HIE are easily accessible, publicly available, and clearly specify and obtain agreement from all participants regarding the disclosures of HIE. B. Establish and conduct dispute resolution processes in a fair and transparent manner.	Blockchain’s transparency, immutability, and auditability can help build trust among participants and ensure that data is being accessed and exchanged with authorization from appropriate individuals.
Principle 3: Cooperation and Non-Discrimination	Promote collaborations with stakeholders across the continuum of care through HIE even when a stakeholder may be a business competitor.	Enable secure and direct peer-to-peer transactions between stakeholders, reducing the need for intermediaries and promoting collaboration without discrimination.
Principle 4: Privacy, Security, and Safety	A. Ensure EHR is exchanged and used safely, including accurate patient matching and consistent data sharing. B. Enforce policies about consent to access, exchange, or data usage.	Cryptographic encryption and distributed ledger technology can ensure that data is secure and tamper-proof, protecting the privacy and security of health information.
Principle 5: Access	A. Allow individuals or their representatives to easily access and share their health information. B. Enable acknowledgment of how individuals’ information has been accessed or disclosed.	Enable patients to have full control over their health information by providing them with a secure and transparent platform to decide who, when, and what to share.
Principle 6: Equity	Prioritize health equity by designing policies and technology that consider the potential impacts on health equity from the outset.	Improve HIE to underserved populations regardless of the location or size to reduce disparities in healthcare.
Principle 7: Public Health	Enable use cases that advance the mission of public health authorities and advance the mission of public health authorities.	Enable intergradations of learning health systems through smart contracts and providing a secure and transparent platform for data analytics.

In this study, our primary focus is on how blockchain technology can promote TEFCA’s seven principles, and we propose feasible designs for some of these principles. Our main contribution is to assess the suitability of blockchain technology for the latest HIE guidelines in a timely fashion. The subsequent sections of this paper are structured as follows: the System design section elaborates on the rationale of using blockchain to satisfy each TEFCA principle; the System implementation section provides an in-depth description of the system’s setup, crucial implementation aspects, and a sample Graphical User Interface (GUI) of the proposed system; and finally, the Discussion and Conclusion section offers insights into our key contributions, limitations, and future research directions in extending the blockchain architecture for TEFCA.

Method

System design

Overall architecture design

The overall design depicted in Figure 1 comprises a master smart contract and multiple functional smart contracts connected to the master contract. In order for healthcare facilities, authorities, and HINs to join the system and integrate on-chain and off-chain activities through a Remote Procedure Call (RPC) server, a blockchain adapter that complies with local health IT regulations and is equipped with the blockchain system is required. It facilitates tool installation and leverages blockchain’s distinctive features such as immutability, traceability, and decentralization while integrating the InterPlanetary File System (IPFS) for efficient and scalable data storage²¹. IPFS is a peer-to-peer distributed file system that assigns a unique cryptographic hash for each stored file, ensuring indexing and consistency. It is a good pair to blockchain because it provides efficient and scalable data storage, while blockchain offers secure and decentralized data management²². Patients can install the blockchain app as a blockchain node on their mobile devices, and users must register and specify their roles in the blockchain to obtain a unique pair of public and private keys that represent their identity and obtain access to functional smart contracts. Healthcare facilities can install the blockchain system on any of their existing devices. The whole adapter conversion process will be automatically performed through an executable file. TEFCA’s primary aim is to minimize intermediaries in HIE, promoting direct data exchange between hospitals. However, during the transition phase to fully realize TEFCA’s vision, HINs might still possess data that needs to be shared with hospitals, hence the one-way exchange. As for smart contracts, they only record and validate all transactions. Once a transaction is verified and validated, the actual HIE is performed off-chain to ensure efficiency.

Figure 1.

The overall design of the master contract and functional contracts for TEFCA.

Principle 1: Standardization

The first principle of TEFCA refers to two key requirements: interoperability standardization and technology standardization. Interoperability standardization means that local healthcare facilities must adhere to the ONC Interoperability Standards Advisory (ISA) when implementing EHR systems, such as HL7 and FHIR. Technology standardization, on the other hand, pertains to the standardization of HIE platforms to enable authorized users to access health information seamlessly, without any hindrance caused by having to switch between different platforms. While Principle 5 will elaborate on how authorized users easily access appropriate data, this section will discuss the feasibility of integrating blockchain platforms with different healthcare systems to create a common platform for HIE.

When utilizing blockchain technology, a common protocol, as shown in the master smart contract in Figure 1, can be established for data sharing, storage, and access. There are existing notable blockchain works that encapsulate the common interoperability standard and enforce standardization during HIE23, ²⁴. Although blockchain cannot regulate the data standards from the data source, smart contracts can be utilized to standardize the HIE process, as shown in Figure 2 coded using Solidity, promoting standardization from the data source. Furthermore, blockchain as a distributed technology, eliminates the need for intermediaries, reducing the complexity, and accelerating the HIE process while ensuring the accuracy, completeness, and consistency of exchanged data. Healthcare facilities continue to use and maintain their original EHR systems, while only utilizing blockchain technology to receive and send HIE requests. The blockchain is used only for creating a common HIE platform for managing and regulating HIE transactions, enabling disparate healthcare systems to join this blockchain platform seamlessly.

Figure 2.

Smart contract for dispute cases interoperability standard matching and enforcement.

This smart contract can be used as part of a larger system to enforce interoperability standards in an HIE, ensuring that patient data is exchanged in a secure and standardized manner. In this contract, facilities can be added using the addFacility function, which takes the facility’s blockchain address and an array of interoperability standards that it supports as parameters. These standards could be represented using ISA standard nomenclatures. The getFacilityStandards function allows anyone to view the standards supported by a particular facility by passing in the facility’s blockchain address. If the facility is not found, the function will revert with an error message. The matchStandards function takes an array of standards that a patient’s data conforms to and a facility’s blockchain address as parameters. It first retrieves the standards supported by the facility using the getFacilityStandards function and then loops through each patient standard and facility standard to check if there is a match. If a match is found, the HIE will be automatically performed using the standard, otherwise, it will return a false notification.

In summary, in the realm of healthcare, interoperability is often categorized into semantic and functional interoperability. Semantic interoperability ensures that the data exchanged between systems maintains its meaning, which is where standards like HL7 and FHIR play a crucial role. Blockchain can support this by validating that data conforms to these standards before it’s added to the chain. On the other hand, functional interoperability pertains to the ability of systems to both send and receive data and use the received data. Blockchain’s decentralized nature inherently supports functional interoperability, as each participant in the network, regardless of their underlying system, can exchange information seamlessly as long as they adhere to the blockchain’s protocol. Blockchain is well-suited to fulfill principle 1 by using smart contracts to unify interoperability standards automatically, and by leveraging a decentralized, immutable, and peer-to-peer network to establish trust among all participants. This enables the creation of a common platform that links disparate data sources and facilitates HIE.

Principle 2: Openness and Transparency

Blockchain offers a transparent, immutable, and auditable system where all HIE requests and transactions can be permanently recorded. This technology provides a tamper-proof and decentralized ledger that authorized parties can access and audit at any time. Patients can see exactly what part of their health data has been accessed by whom and at what time, promoting transparency and trust. Furthermore, cryptographic identifications provide an extra layer of security to participants, without exposing their real identities.

Apart from the openness of public auditability, principle 2 of TEFCA involves two main components: agreement management and transparent dispute resolution processes. Our blockchain design includes a master smart contract that is used for clarifying agreements, and each user can sign the agreement using their private key. Blockchain technology ensures that the agreement is transparent and publicly auditable, with all modifications and different versions of agreements being recorded in the smart contract. Before signing the agreement, users’ signatures are validated through the blockchain, making the signing process public and auditable, thus reducing the risk of disputes. To prevent disputes from escalating into legal actions, it’s crucial to address misunderstandings and mistakes early on²⁵. Complaints should be promptly responded to and corrected before they turn into disputes. By taking proactive measures to address issues at an early stage, many disputes can be resolved before they become more serious problems. Blockchain provides peer-to-peer portals that improve communications between patients and healthcare providers. Any complications can be communicated through secure portals facilitated by blockchain. The auditability provided by blockchain enables all participants to monitor the accuracy of the HIE process, thereby reducing the occurrence of mistakes that may cause disputes. Furthermore, we have developed a dispute smart contract that is automatically generated for each disputed case, as shown in Figure 3. When a patient submits a dispute request, the relevant authorities and users involved in the case are notified and given access to the smart contract. The entire resolution process is recorded on the blockchain, ensuring fairness and transparency.

Figure 3.

Smart contract for dispute cases management.

The dispute smart contract can be deployed on a blockchain network to manage dispute cases in a transparent and decentralized manner. It defines a Case struct to hold information about a dispute case, including an ID, description, complainant, respondent, and status. It also defines an enum called Status to represent the current status of a case. The create case function allows a complainant to create a new case by providing a description of the dispute and the address of the respondent. The update status function allows the complainant or respondent to update the status of a case. The getCase function allows anyone to view the details of a case by providing the case ID. The function provides a transparent resolution process.

Blockchain’s transparency, immutability, and auditability make it an ideal solution to meet the needs of principle 2. Agreements can be publicly available on the blockchain and audited by the authority at any time. The secure peer-to-peer portal enables direct communication to resolve any misunderstandings and mistakes and blockchain makes the whole dispute resolution process clear, ensuring openness and transparency of HIE.

Principle 3: Cooperation and Non-Discrimination

Principle 3 of TEFCA aims to ensure fair access to healthcare information without discrimination against competitors. Blockchain technology can help promote this principle in two ways. Firstly, the transparency and decentralization nature of the blockchain system makes it difficult to limit access to health information, and any such attempts would be visible and auditable by all participants including authorities. Secondly, blockchain can ensure data reciprocity by enabling patient-centered HIE¹¹. This approach allows all participants to initiate the sharing of their health information, rather than solely relying on a network alliance to exchange data. With cryptography, parties can validate permission to access without revealing their identities reducing the potential for discrimination. Additionally, blockchain reduces interference with data sharing from intermediaries, while ensuring fees are transparently recorded and reasonable.

In summary, blockchain technology promotes cooperation and non-discrimination in TEFCA’s principle 3 by providing a transparent, secure, and decentralized system for patient-centered HIE, promoting data reciprocity, and preventing any attempts to limit access to data for competitive advantage or discrimination.

Principle 4: Privacy, Security, and Safety

Principle 4 indicates that HIE should respect and protect the privacy, security, and safety of exchanged data. This entails ensuring data consistency, and precise patient matching, as well as empowering patients to control their own health information. Blockchain technology can support this principle by offering a distributed ledger that is immutable, transparent, and verifiable. This can prevent unauthorized access, modification, or deletion of data by malicious actors or human errors. Blockchain can also safeguard the identity and confidentiality of medical data by using sophisticated encryption protocols that hide personal information from unauthorized parties. Moreover, blockchain can enable smart contracts that automate and enforce policies regarding individuals’ consent to share or use their digital health information with other entities. Several prominent studies have demonstrated the security advantages of blockchain over traditional systems, the feasibility of applying blockchain to enhance patients’ privacy rights, and innovative approaches for adding extra layers of security protocols on top of blockchain to protect sensitive medical data^26,27.

In summary, blockchain is a secure distributed system that employs advanced encryption and consensus mechanisms to ensure data integrity and provenance. Blockchain technology can facilitate data sharing and integration across diverse HINs, which can help establish a foundation for privacy, security, and safety in healthcare delivery and foster trust among stakeholders.

Principle 5: Access

Principle 5 of TEFCA emphasizes the importance of patient-centered HIE, which puts the patient in the center of HIE and has full control of their own health data access. Our recent work has evaluated the feasibility of using Blockchain technology to promote patient-centered HIE by creating a patient token with self-sovereign identity (SSI) mechanisms, as shown in Figure 4, to achieve this goal²⁸.

Figure 4.

Non-fungible patient token creation and linkage.

The first step in this architecture is the creation of non-fungible tokens (NFTs) from patients, which are then linked to the patients’ local accounts by healthcare facilities. Patients can then permit healthcare providers to access their tokens, and the legitimacy of the token is validated through SSI before data exchange. This patient token allows patients to link their local patient IDs from different healthcare facilities they have visited before and can be used to store medical data on their local devices or access their data from remote healthcare facilities with a simple click. Patients can use SSI to authenticate themselves through blockchain and control the permissions healthcare providers have to access their data. Furthermore, patients can always audit the records’ access history by tracking the blockchain history. By utilizing the features of blockchain, individuals are given full control over and consent to have their identities managed in a decentralized manner. This removes any obstacles and brings full control of personal data to the patient themselves. More details on encryption and setup can be found in our recently published work²⁸.

In summary, blockchain technology empowers patients to be more involved in their own care and ensures that health data is accessible to those who need it. By utilizing the unique features of blockchain, patients are given full control over their own data, ensuring that their health information is shared only with those they choose.

Principle 6: Equity

Principle 6 aims to promote health equity through HIE by taking the impacts on health equity from outsets into consideration. One of the key advantages of blockchain technology is its ability to provide a transparent environment which can be particularly useful in promoting health equity by ensuring that data is collected and shared in a way that is equitable and inclusive. For example, blockchain can be used to ensure that HIE has covered a wide range of sources, including those that may be traditionally underserved or marginalized²⁹. By promoting data collection and sharing in this way, blockchain can help to ensure that health information is more representative of the population as a whole, and can help to identify and address disparities in health outcomes. In addition, blockchain ensures that data is shared securely and privacy-preserving. This is particularly important in cases where patients may be hesitant to share their data due to privacy concerns. Blockchain may provide a secure and decentralized system that engages more patients. This can be particularly important in promoting health equity in communities that may be disproportionately affected by privacy concerns.

In summary, blockchain can promote equity by providing a transparent and secure system for HIE. By promoting equitable access to health information, blockchain can help to identify and address disparities in health outcomes and can help to promote better health for a broader population.

Principle 7: Public Health

Blockchain can promote Principle 7 by enabling secure and efficient sharing of population-level health data across public health authorities and healthcare providers. Blockchain’s decentralized architecture and cryptographic security can ensure that public health authorities have access to real-time data on disease outbreaks, adverse events, and other critical public health information. This can facilitate public health and post-marketing surveillance30, ³¹. In addition, blockchain can enable secure data sharing for population-level use cases such as quality improvement and biomedical research by creating a trusted, decentralized registry of patient data that can be accessed by qualified stakeholders³². This can improve data accuracy and completeness, facilitate quality measurement and improvement activities, and support biomedical research while ensuring compliance with applicable laws and ethical principles through the public audit³³. Furthermore, by promoting secure and transparent data exchange, blockchain can help advance the development of a learning health system that improves the health of the population and lowers the cost of care.

System Implementation

We have implemented the proposed blockchain architecture with smart contracts on the Quorum blockchain, a variant of Ethereum, with four blockchain nodes representing the hospital, healthcare facility, patient, and authority. Each node is connected to the blockchain network and serves as a blockchain adapter, implementing a remote procedure call server and an IPFS that link to each other. To test the functionalities involved in the HIE process, we created five blockchain accounts on the adapters for different staff members operating under the same facility, while the patient adapter only has one account. We synthesized medical records for patients and tested data requests, exchanges, and dispute case creation. The patient portal’s graphical user interface (GUI) is shown in Figure 5.

Figure 5.

Sample GUI for the patient portal of the proposed blockchain system.

The sample GUI presented above is designed for testing the proposed system’s functionalities, but it can be easily customized to meet the needs of consumers. For instance, GUIs for hospitals or HINs can indeed be developed based on specific requirements and user preferences. To access the portal, users need to log in to the local blockchain node using a username and password that links to their unique blockchain public and private key pair. Once logged in, users can view their transaction history, which is linked with the smart contract to retrieve the transaction information related to the specific user from the blockchain. Users can also grant providers permission to access their data by inputting the providers’ blockchain addresses. In addition, they can file dispute cases by providing the dispute transaction and reasons. Upon a simple click, the authority account and the user who initiated the disputed transaction will receive a notification on their GUIs. All transactions can be viewed in the blockchain, but only the users involved in these transactions can see the information inside the transaction. At the bottom of the page, a footer includes links to the user agreement and privacy policy stored in the master contract.

Discussions

We recognize the importance of situating our work within the broader landscape of blockchain research in healthcare. While our primary focus is on the application of blockchain for TEFCA, other works might concentrate on specific aspects like access management or data security. There are multiple limitations and challenges that need to have further investigation, such as scalability. Our recent work has tested the scalability of the single Quorum blockchain is near 500 transactions per second. Since this work mainly discusses the blockchain features and designs for TEFCA instead of the evaluation of the blockchain system, a more in-depth evaluation of the blockchain system is needed to assess its feasibility and performance. Another challenge is the cost of switching to a blockchain-based system for participants and HINs. Although the long-term benefits of blockchain may outweigh the initial costs, it is important to carefully evaluate the costs and benefits of the system before adoption. It is noteworthy to mention that, while blockchain can improve the transparency and patient-centeredness of HIE, it cannot replace the role of HINs. HINs are still essential for ensuring the quality and accuracy of health information, as well as facilitating communication between providers. Integration with a blockchain-based system for HINs can make the HIE process more transparent and patient-centered to align with the goal of TEFCA. The stringent regulations in healthcare can be navigated by developing blockchain systems that are compliant by design and incorporating regulatory requirements directly into the system’s architecture. To address concerns about patient privacy in a transparent system, advanced cryptographic techniques, such as zero-knowledge proofs, can be employed, ensuring data privacy without compromising the benefits of transparency. While the initial setup and integration costs can be substantial, the long-term benefits, including reduced fraud, efficient data exchange, and automated compliance checks, can provide significant cost savings over time. By actively addressing these challenges with innovative solutions, the adoption of blockchain in healthcare moves from being a conceptual idea to a feasible and transformative approach.

Despite these limitations, the potential benefits of blockchain in healthcare are significant. Blockchain can help to reduce inefficiencies in the current HIE system and enable new use cases, such as public health surveillance and automated interoperability standard conversion. In terms of future work, there are several areas for exploration. Firstly, blockchain integration with other emerging technologies, such as machine learning and artificial intelligence, creates a learning health system that can continuously improve the quality of care. Secondly, a blockchain-based automated interoperability standard conversion mechanism could be developed to further enhance the interoperability of HINs with different standards. Finally, collaboration with HINs to build blockchain-based HIE mechanisms could help to fully evaluate the feasibility and efficiency of using blockchain for HIE tasks. To promote the system, we plan to collaborate with healthcare institutions, conduct pilot tests, and gather feedback to refine the system^34,35. We also aim to engage with regulatory bodies and patient advocacy groups to highlight the benefits.

Conclusion

In this work, we have discussed the potential of blockchain to meet the needs of TEFCA and implemented the system to test the functionality through a sample GUI. However, there are still some limitations and challenges that need to be addressed. In our earlier research, we conducted extensive simulations on a blockchain-based system for HIE, and the results demonstrated the system’s stability, scalability, and efficiency. Through rigorous testing and analysis, we found that the blockchain architecture provides a secure and reliable foundation for healthcare data sharing, which is crucial for ensuring the confidentiality, integrity, and availability of patient information. In conclusion, blockchain technology is a promising solution for achieving the goals of TEFCA. The features of blockchain, such as its decentralized nature, immutability, and transparency, make it a good fit for facilitating secure transparent, and patient-centered HIE.