FHIRChain: Applying Blockchain to Securely and Scalably Share Clinical Data

Secure and scalable data sharing is essential for collaborative clinical decision making. Conventional clinical data efforts are often siloed, however, which creates barriers to efficient information exchange and impedes effective treatment decision made for patients. This paper provides four contributions to the study of applying blockchain technology to clinical data sharing in the context of technical requirements defined in the “Shared Nationwide Interoperability Roadmap” from the Office of the National Coordinator for Health Information Technology (ONC). First, we analyze the ONC requirements and their implications for blockchain-based systems. Second, we present FHIRChain, which is a blockchain-based architecture designed to meet ONC requirements by encapsulating the HL7 Fast Healthcare Interoperability Resources (FHIR) standard for shared clinical data. Third, we demonstrate a FHIRChain-based decentralized app using digital health identities to authenticate participants in a case study of collaborative decision making for remote cancer care. Fourth, we highlight key lessons learned from our case study.

[1]  M Terry,et al.  Medical identity theft and telemedicine security. , 2009, Telemedicine journal and e-health : the official journal of the American Telemedicine Association.

[2]  Tatu Ylönen,et al.  The Secure Shell (SSH) Protocol Architecture , 2006, RFC.

[3]  Adrian Gropper,et al.  Powering the Physician-Patient Relationship with HIE of One Blockchain Health IT , 2016 .

[4]  Oded Goldreich,et al.  Electronic Wallet , 1983, CRYPTO.

[5]  G E Gross,et al.  The role of the tumor board in a community hospital , 1987, CA: a cancer journal for clinicians.

[6]  Hyeon-Eui Kim,et al.  Blockchain distributed ledger technologies for biomedical and health care applications , 2017, J. Am. Medical Informatics Assoc..

[7]  Stephan Brandauer.  Structured Data , 2018 .

[8]  Wei Jiang,et al.  Healthcare Data Gateways: Found Healthcare Intelligence on Blockchain with Novel Privacy Risk Control , 2016, Journal of Medical Systems.

[9]  Patrick Blake,et al.  Clinical decision support systems for improving diagnostic accuracy and achieving precision medicine , 2015, Journal of Clinical Bioinformatics.

[10]  Monika Alise Johansen,et al.  Challenges in Telemedicine and eHealth: Lessons Learned from 20 Years with Telemedicine in Tromsø , 2007, MedInfo.

[11]  P. Whitten,et al.  E-Health, telehealth, and telemedicine : a guide to start-up and success , 2001 .

[12]  D. Bates,et al.  Effects of computerized physician order entry and clinical decision support systems on medication safety: a systematic review. , 2003, Archives of internal medicine.

[13]  Andrew Lippman,et al.  A Case Study for Blockchain in Healthcare : “ MedRec ” prototype for electronic health records and medical research data , 2016 .

[14]  Andre B. Bondi,et al.  Characteristics of scalability and their impact on performance , 2000, WOSP '00.

[16]  Elizabeth Warren.  Strengthening Research through Data Sharing. , 2016, The New England journal of medicine.

[17]  N. Petersen,et al.  Implementation of a regional virtual tumor board: a prospective study evaluating feasibility and provider acceptance. , 2014, Telemedicine journal and e-health : the official journal of the American Telemedicine Association.

[18]  Avraham Leff,et al.  Web-application development using the Model/View/Controller design pattern , 2001, Proceedings Fifth IEEE International Enterprise Distributed Object Computing Conference.

[19]  Daniel R. Simon,et al.  Non-Interactive Zero-Knowledge Proof of Knowledge and Chosen Ciphertext Attack , 1991, CRYPTO.

[20]  Douglas Crockford,et al.  The application/json Media Type for JavaScript Object Notation (JSON) , 2006, RFC.

[21]  G Eysenbach,et al.  What is e-health? , 2001, Encyclopedia of Social Network Analysis and Mining. 2nd Ed..

[22]  Mary F. Wisniewski,et al.  Diagnostic error in medicine: analysis of 583 physician-reported errors. , 2009, Archives of internal medicine.

[23]  Dick Hardt,et al.  The OAuth 2.0 Authorization Framework , 2012, RFC.

[24]  S. Thacker.  HIPAA Privacy Rule and Public Health , 2003 .

[25]  Atul J. Butte,et al.  Opening clinical trial data: are the voluntary data-sharing portals enough? , 2015, BMC Medicine.

[26]  MultiChain Private Blockchain — White Paper , 2022 .

[27]  Michael D. Reis,et al.  Types and origins of diagnostic errors in primary care settings. , 2013, JAMA internal medicine.

[28]  Robert LaRose,et al.  The impact of rural broadband development: Lessons from a natural field experiment , 2010, Gov. Inf. Q..

[29]  Variable Stars in the Local Group ASP Conference Series, Vol. 2nn, 2004 , 2003 .

[30]  Douglas C. Schmidt,et al.  Applying Software Patterns to Address Interoperability in Blockchain-based Healthcare Apps , 2017, ArXiv.

[31]  George Hripcsak,et al.  Health data use, stewardship, and governance: ongoing gaps and challenges: a report from AMIA's 2012 Health Policy Meeting , 2014, J. Am. Medical Informatics Assoc..

[32]  Matthias Mettler,et al.  Blockchain technology in healthcare: The revolution starts here , 2016, 2016 IEEE 18th International Conference on e-Health Networking, Applications and Services (Healthcom).

[33]  Kamran Sartipi,et al.  HL7 FHIR: An Agile and RESTful approach to healthcare information exchange , 2013, Proceedings of the 26th IEEE International Symposium on Computer-Based Medical Systems.

[34]  Harold Ossher,et al.  Using multidimensional separation of concerns to (re)shape evolving software , 2001, CACM.

[35]  Amnon Shabo,et al.  Model Formulation: HL7 Clinical Document Architecture, Release 2 , 2006, J. Am. Medical Informatics Assoc..

[36]  Alfred Menezes,et al.  Handbook of Applied Cryptography , 2018 .

[37]  D. Koo,et al.  HIPAA privacy rule and public health; guidance from CDC and the U.S. Department of Health and Human Services , 2003 .

[38]  Laura A. Levit,et al.  Ensuring quality cancer care through the oncology workforce. , 2010, Journal of oncology practice.

[39]  Hugo Krawczyk,et al.  The Order of Encryption and Authentication for Protecting Communications (or: How Secure Is SSL?) , 2001, CRYPTO.

[40]  Douglas C. Schmidt,et al.  Metrics for assessing blockchain-based healthcare decentralized apps , 2017, 2017 IEEE 19th International Conference on e-Health Networking, Applications and Services (Healthcom).

[41]  J Ricke,et al.  Telemedicine and its impact on cancer management. , 2000, European journal of cancer.

[42]  Kensaku Kawamoto,et al.  Key principles for a national clinical decision support knowledge sharing framework: synthesis of insights from leading subject matter experts , 2013, J. Am. Medical Informatics Assoc..

[43]  Kevin J. Peterson,et al.  A Blockchain-Based Approach to Health Information Exchange Networks , 2016 .

[44]  Andrew Lippman,et al.  MedRec: Using Blockchain for Medical Data Access and Permission Management , 2016, 2016 2nd International Conference on Open and Big Data (OBD).

[45]  Satoshi Nakamoto.  Bitcoin : A Peer-to-Peer Electronic Cash System , 2009 .

[46]  S. Thacker,et al.  HIPAA privacy rule and public health. Guidance from CDC and the U.S. Department of Health and Human Services. , 2003, MMWR supplements.

[47]  M. Berman,et al.  Technology and managed care: patient benefits of telemedicine in a rural health care network. , 2005, Health economics.

[48]  Fusheng Wang,et al.  Secure and Trustable Electronic Medical Records Sharing using Blockchain , 2017, AMIA.

[49]  Anirban Basu,et al.  MediBchain: A Blockchain Based Privacy Preserving Platform for Healthcare Data , 2017, SpaCCS Workshops.

[50]  John Fletcher,et al.  Sharing clinical trial data: a proposal from the International Committee of Medical Journal Editors. , 2016, Danish medical journal.

[51]  Thad E. Hall,et al.  Internet Voting in Comparative Perspective: The Case of Estonia , 2009, PS: Political Science & Politics.

[52]  P. V. Biron,et al.  The HL7 Clinical Document Architecture. , 2001, Journal of the American Medical Informatics Association : JAMIA.