scholarly journals A Blockchain-Based Dynamic Consent Architecture to Support Clinical Genomic Data Sharing (ConsentChain): Proof-of-Concept Study

10.2196/27816 ◽  
2021 ◽  
Vol 9 (11) ◽  
pp. e27816
Author(s):  
Faisal Albalwy ◽  
Andrew Brass ◽  
Angela Davies
Keyword(s):  
Data Sharing ◽  
Genomic Data ◽  
Data Access ◽  
Patient Data ◽  
Smart Contracts ◽  
Proof Of Concept ◽  
Data Governance ◽  
Dynamic Consent ◽  
Patient Consent ◽  
Clinical Genomic

Background In clinical genomics, sharing of rare genetic disease information between genetic databases and laboratories is essential to determine the pathogenic significance of variants to enable the diagnosis of rare genetic diseases. Significant concerns regarding data governance and security have reduced this sharing in practice. Blockchain could provide a secure method for sharing genomic data between involved parties and thus help overcome some of these issues. Objective This study aims to contribute to the growing knowledge of the potential role of blockchain technology in supporting the sharing of clinical genomic data by describing blockchain-based dynamic consent architecture to support clinical genomic data sharing and provide a proof-of-concept implementation, called ConsentChain, for the architecture to explore its performance. Methods The ConsentChain requirements were captured from a patient forum to identify security and consent concerns. The ConsentChain was developed on the Ethereum platform, in which smart contracts were used to model the actions of patients, who may provide or withdraw consent to share their data; the data creator, who collects and stores patient data; and the data requester, who needs to query and access the patient data. A detailed analysis was undertaken of the ConsentChain performance as a function of the number of transactions processed by the system. Results We describe ConsentChain, a blockchain-based system that provides a web portal interface to support clinical genomic sharing. ConsentChain allows patients to grant or withdraw data requester access and allows data requesters to query and submit access to data stored in a secure off-chain database. We also developed an ontology model to represent patient consent elements into machine-readable codes to automate the consent and data access processes. Conclusions Blockchains and smart contracts can provide an efficient and scalable mechanism to support dynamic consent functionality and address some of the barriers that inhibit genomic data sharing. However, they are not a complete answer, and a number of issues still need to be addressed before such systems can be deployed in practice, particularly in relation to verifying user credentials.

scholarly journals A Blockchain-Based Dynamic Consent Architecture to Support Clinical Genomic Data Sharing (ConsentChain): Proof-of-Concept Study (Preprint)

2021 ◽  
Author(s):  
Faisal Albalwy ◽  
Andrew Brass ◽  
Angela Davies
Keyword(s):  
Data Sharing ◽  
Genomic Data ◽  
Data Access ◽  
Patient Data ◽  
Smart Contracts ◽  
Proof Of Concept ◽  
Data Governance ◽  
Dynamic Consent ◽  
Patient Consent ◽  
Clinical Genomic

BACKGROUND In clinical genomics, sharing of rare genetic disease information between genetic databases and laboratories is essential to determine the pathogenic significance of variants to enable the diagnosis of rare genetic diseases. Significant concerns regarding data governance and security have reduced this sharing in practice. Blockchain could provide a secure method for sharing genomic data between involved parties and thus help overcome some of these issues. OBJECTIVE This study aims to contribute to the growing knowledge of the potential role of blockchain technology in supporting the sharing of clinical genomic data by describing blockchain-based dynamic consent architecture to support clinical genomic data sharing and provide a proof-of-concept implementation, called ConsentChain, for the architecture to explore its performance. METHODS The ConsentChain requirements were captured from a patient forum to identify security and consent concerns. The ConsentChain was developed on the Ethereum platform, in which smart contracts were used to model the actions of patients, who may provide or withdraw consent to share their data; the data creator, who collects and stores patient data; and the data requester, who needs to query and access the patient data. A detailed analysis was undertaken of the ConsentChain performance as a function of the number of transactions processed by the system. RESULTS We describe ConsentChain, a blockchain-based system that provides a web portal interface to support clinical genomic sharing. ConsentChain allows patients to grant or withdraw data requester access and allows data requesters to query and submit access to data stored in a secure off-chain database. We also developed an ontology model to represent patient consent elements into machine-readable codes to automate the consent and data access processes. CONCLUSIONS Blockchains and smart contracts can provide an efficient and scalable mechanism to support dynamic consent functionality and address some of the barriers that inhibit genomic data sharing. However, they are not a complete answer, and a number of issues still need to be addressed before such systems can be deployed in practice, particularly in relation to verifying user credentials.

scholarly journals A Blockchain Framework for Patient-Centered Health Records and Exchange (HealthChain): Evaluation and Proof-of-Concept Study (Preprint)

2019 ◽  
Author(s):  
Ray Hales Hylock ◽  
Xiaoming Zeng
Keyword(s):  
Medical Records ◽  
Cumulative Record ◽  
Data Access ◽  
Patient Data ◽  
Mixed Block ◽  
Smart Contracts ◽  
Proof Of Concept ◽  
Patient Centered ◽  
Encrypted Data ◽  
Server Side

BACKGROUND Blockchain has the potential to disrupt the current modes of patient data access, accumulation, contribution, exchange, and control. Using interoperability standards, smart contracts, and cryptographic identities, patients can securely exchange data with providers and regulate access. The resulting comprehensive, longitudinal medical records can significantly improve the cost and quality of patient care for individuals and populations alike. OBJECTIVE This work presents HealthChain, a novel patient-centered blockchain framework. The intent is to bolster patient engagement, data curation, and regulated dissemination of accumulated information in a secure, interoperable environment. A mixed-block blockchain is proposed to support immutable logging and redactable patient blocks. Patient data are generated and exchanged through Health Level-7 Fast Healthcare Interoperability Resources, allowing seamless transfer with compliant systems. In addition, patients receive cryptographic identities in the form of public and private key pairs. Public keys are stored in the blockchain and are suitable for securing and verifying transactions. Furthermore, the envisaged system uses proxy re-encryption (PRE) to share information through revocable, smart contracts, ensuring the preservation of privacy and confidentiality. Finally, several PRE improvements are offered to enhance performance and security. METHODS The framework was formulated to address key barriers to blockchain adoption in health care, namely, information security, interoperability, data integrity, identity validation, and scalability. It supports 16 configurations through the manipulation of 4 modes. An open-source, proof-of-concept tool was developed to evaluate the performance of the novel patient block components and system configurations. To demonstrate the utility of the proposed framework and evaluate resource consumption, extensive testing was performed on each of the 16 configurations over a variety of scenarios involving a variable number of existing and imported records. RESULTS The results indicate several clear high-performing, low-bandwidth configurations, although they are not the strongest cryptographically. Of the strongest models, one’s anticipated cumulative record size is shown to influence the selection. Although the most efficient algorithm is ultimately user specific, Advanced Encryption Standard–encrypted data with static keys, incremental server storage, and no additional server-side encryption are the fastest and least bandwidth intensive, whereas proxy re-encrypted data with dynamic keys, incremental server storage, and additional server-side encryption are the best performing of the strongest configurations. CONCLUSIONS Blockchain is a potent and viable technology for patient-centered access to and exchange of health information. By integrating a structured, interoperable design with patient-accumulated and generated data shared through smart contracts into a universally accessible blockchain, HealthChain presents patients and providers with access to consistent and comprehensive medical records. Challenges addressed include data security, interoperability, block storage, and patient-administered data access, with several configurations emerging for further consideration regarding speed and security.

scholarly journals A Blockchain Framework for Patient-Centered Health Records and Exchange (HealthChain): Evaluation and Proof-of-Concept Study

10.2196/13592 ◽  
2019 ◽  
Vol 21 (8) ◽  
pp. e13592 ◽  
Author(s):  
Ray Hales Hylock ◽  
Xiaoming Zeng
Keyword(s):  
Medical Records ◽  
Cumulative Record ◽  
Data Access ◽  
Patient Data ◽  
Mixed Block ◽  
Smart Contracts ◽  
Proof Of Concept ◽  
Patient Centered ◽  
Encrypted Data ◽  
Server Side

Background Blockchain has the potential to disrupt the current modes of patient data access, accumulation, contribution, exchange, and control. Using interoperability standards, smart contracts, and cryptographic identities, patients can securely exchange data with providers and regulate access. The resulting comprehensive, longitudinal medical records can significantly improve the cost and quality of patient care for individuals and populations alike. Objective This work presents HealthChain, a novel patient-centered blockchain framework. The intent is to bolster patient engagement, data curation, and regulated dissemination of accumulated information in a secure, interoperable environment. A mixed-block blockchain is proposed to support immutable logging and redactable patient blocks. Patient data are generated and exchanged through Health Level-7 Fast Healthcare Interoperability Resources, allowing seamless transfer with compliant systems. In addition, patients receive cryptographic identities in the form of public and private key pairs. Public keys are stored in the blockchain and are suitable for securing and verifying transactions. Furthermore, the envisaged system uses proxy re-encryption (PRE) to share information through revocable, smart contracts, ensuring the preservation of privacy and confidentiality. Finally, several PRE improvements are offered to enhance performance and security. Methods The framework was formulated to address key barriers to blockchain adoption in health care, namely, information security, interoperability, data integrity, identity validation, and scalability. It supports 16 configurations through the manipulation of 4 modes. An open-source, proof-of-concept tool was developed to evaluate the performance of the novel patient block components and system configurations. To demonstrate the utility of the proposed framework and evaluate resource consumption, extensive testing was performed on each of the 16 configurations over a variety of scenarios involving a variable number of existing and imported records. Results The results indicate several clear high-performing, low-bandwidth configurations, although they are not the strongest cryptographically. Of the strongest models, one’s anticipated cumulative record size is shown to influence the selection. Although the most efficient algorithm is ultimately user specific, Advanced Encryption Standard–encrypted data with static keys, incremental server storage, and no additional server-side encryption are the fastest and least bandwidth intensive, whereas proxy re-encrypted data with dynamic keys, incremental server storage, and additional server-side encryption are the best performing of the strongest configurations. Conclusions Blockchain is a potent and viable technology for patient-centered access to and exchange of health information. By integrating a structured, interoperable design with patient-accumulated and generated data shared through smart contracts into a universally accessible blockchain, HealthChain presents patients and providers with access to consistent and comprehensive medical records. Challenges addressed include data security, interoperability, block storage, and patient-administered data access, with several configurations emerging for further consideration regarding speed and security.

scholarly journals Genomic Data-Sharing Practices

2019 ◽  
Vol 47 (1) ◽  
pp. 31-40 ◽  
Author(s):  
Angela G. Villanueva ◽  
Robert Cook-Deegan ◽  
Jill O. Robinson ◽  
Amy L. McGuire ◽  
Mary A. Majumder
Keyword(s):  
Data Sharing ◽  
Medical Information ◽  
Public Information ◽  
Genomic Data ◽  
Data Access ◽  
Privacy And Security ◽  
Participant Engagement ◽  
Information Commons ◽  
Derived Data

Making data broadly accessible is essential to creating a medical information commons (MIC). Transparency about data-sharing practices can cultivate trust among prospective and existing MIC participants. We present an analysis of 34 initiatives sharing DNA-derived data based on public information. We describe data-sharing practices captured, including practices related to consent, privacy and security, data access, oversight, and participant engagement. Our results reveal that data-sharing initiatives have some distance to go in achieving transparency.

scholarly journals Regulating Statistics in the Age of Data Abundance

2019 ◽  
Vol 4 (3) ◽  
Author(s):  
Catherine Bromley
Keyword(s):  
Data Sharing ◽  
Data Linkage ◽  
Resource Constraints ◽  
Data Access ◽  
Data Governance ◽  
Code Of Practice ◽  
Regulatory Guidance ◽  
Use Of Data ◽  
Regulatory Approach ◽  
Major Review

Background with rationaleThe Office for Statistics Regulation is the UK’s independent regulator of official statistics produced by public sector bodies. The Code of Practice for Statistics sets out our expectations for statistics to be produced in a trustworthy way, be of high quality, and to serve the public good by informing answers to society’s important questions. We now live in a world of increasingly abundant data. Statistics producers need to adapt to this environment, and so do we as regulators. ApproachThe Code of Practice was updated in 2018 with new provisions to maximise the potential use of data for both citizens and organisations, and to make data available for wider reuse with appropriate safeguards. We have supplemented our commitment to these provisions with a review of data sharing and linking in government, new regulatory guidance on data governance, an increased focus on data access challenges (particularly users of English health data), and by putting data at the heart of our regulatory vision (published in summer 2019). These steps build on our existing work around admin data quality. OverviewThe National Statistician’s response to our data sharing and linkage review included many welcome commitments and a major review of data linkage methodology is now underway. A data linkage community is developing across government. However, we have raised concerns about ongoing difficulties with admin data sharing between departments, resource constraints, and the limited extent of public engagement about data sharing and use. ConclusionsOur regulatory approach to data is evolving and we are building new relationships with organisations with an interest in data beyond the statistics world. Our work to support users to access admin data may yet require more direct interventions to bring about the outcomes we desire. We are keen to share our experiences with admin data users.

scholarly journals User-focused data sharing agreements: a foundation for the genomic future

JAMIA Open ◽  
2019 ◽  
Vol 2 (4) ◽  
pp. 402-406
Author(s):  
Carolyn Petersen
Keyword(s):  
Informed Consent ◽  
Cultural Differences ◽  
Data Sharing ◽  
Genomic Data ◽  
Barriers To Success ◽  
Potential Barriers ◽  
User Interests ◽  
Dynamic Consent ◽  
Environmental Considerations ◽  
Fundamental Values

Abstract Data sharing agreements that clearly describe what individuals are agreeing to and what responsibilities data stewards will undertake are crucial for the establishment, maintenance, and flourishing of genomic datasets. To optimize genomic data resources, researchers, care professionals, and informaticians must regard system design, user objectives, and environmental considerations through users’ eyes, identifying fundamental values on which to build and potential barriers to success that must be avoided. Design of agreements that promote desired data sharing and protect valuable data resources as necessary begins with a review of user interests and concerns. Nontraditional approaches for informed consent (eg, abbreviated informed consent, electronic informed consent, and dynamic consent) can facilitate achievement of data donors’ privacy-related goals while making data available to researchers. Transparency in individual-researcher interactions, recognition and accommodation of cultural differences, and identification of shared needs and goals create a foundation for data sharing agreements that work over short and long terms.

scholarly journals From the principles of genomic data sharing to the practices of data access committees

2015 ◽  
Vol 7 (5) ◽  
pp. 507-509 ◽  
Author(s):  
Mahsa Shabani ◽  
Bartha Maria Knoppers ◽  
Pascal Borry
Keyword(s):  
Data Sharing ◽  
Genomic Data ◽  
Data Access

Oversight of Genomic Data Sharing: What Roles for Ethics and Data Access Committees?

2017 ◽  
Vol 15 (5) ◽  
pp. 469-474 ◽  
Author(s):  
Mahsa Shabani ◽  
Edward S. Dove ◽  
Madeleine Murtagh ◽  
Bartha Maria Knoppers ◽  
Pascal Borry
Keyword(s):  
Data Sharing ◽  
Genomic Data ◽  
Data Access
Sign in / Sign up

Export Citation Format

Share Document