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Blockchain: Information Tracking - Manion AFCEA/GMU C4i
- 1. Blockchain: Information Tracking AFCEA C4I,George Mason University – 22 May 2018 Sean T Manion PhD CEO, Science Distributed Vice President, American College of Military Public Health
- 2. My Background ▪ Academia(Neuroscience) ▪ 13 years ▪ Economics, Biochemistry (BS), Psychology, Psychiatry, Neuroscience (PhD) ▪ Temple University, Uniformed Services University of the Health Sciences, DoD, NIH ▪ Government Research Administration (Bureauscience) ▪ 8 years ▪ Deputy Chief of Staff, Research Activities Chief ▪ Defense & Veterans Brain Injury Center, w/ DoD, VA, ED, HHS (NIH, CDC, FDA) ▪ 17 sites, 60+ clinical studies, 100+ clinical researchers, 300+ publications ▪ American College of Military Public Health – Non-profit/Volunteer (Vice President) ▪ Startup – Science Distributed (Platform for Scientists, Blockchain for Trust) ▪ < 1 year (feels like a lot more)
- 3. What is aBlockchain? A Blockchain, a type of distributed ledger technology, is a system of distributed databases that enables the development of a permanent, tamper proof longitudinal record, irrefutable audit trail, more sophisticated data queries, and better data compiling from and data sharing among multiple parties. It is: Safe – Encryption plus public and private keys; distributed nature prevents corruption or physical disruption; no single point of failure Inexpensive – Distributed across existing system; automatic back-up; automatic data management via smart contracts; lower maintenance and 3rd party costs Efficient – Peer-to-peer data exchange; allows for sophisticated data queries; broader permissioned access to information 3
- 4. Blockchain is notbitcoin ▪ Blockchain is multi-purpose type of platform/system, like Windows OS or Mac OS ▪ Bitcoin is one application that can be run on that system ▪ There are an infinite number of different applications for blockchain beyond digital currency 4
- 5. Blockchain is nothot sauce ▪ “Blockchain isn’t hot sauce, you can’t just put that s*!t on everything” – Samson Williams ▪ Blockchain can be overkill in some applications, and may not be cost effective to implement. ▪ Blockchain won’t solve problems with humans (e.g. lack of data standardization).
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- 11. Advantages ▪ Distributive versioncontrol: data recorded on a blockchain ledger is extremely difficult to change or remove as doing so would require changing the record on many computers ▪ Trust – users establish their identities with one another in a secure, verified way ▪ Transparency ▪ Scaled information sharing ▪ Smart contract execution; data management ▪ Patient/end user will be in control of their data including health data via a data layer focused secure blockchain digital platform 11
- 12. Challenges ▪ Integrating blockchainwithin existing system ▪ Higher value by integrating end to end and avoiding blockchain silos ▪ Majority/monopoly risk: A majority (not 100%) of ‘nodes’ can confirm that a transaction is valid i.e. matches the blockchain history - the new transaction will be approved and added to the chain. ▪ Need to develop effective governance models among stakeholders ▪ Blockchain requires new rules of participation and operation, new procedures for decision making and new de- centralized governance framework ▪ Regulatory development and enforcement ▪ File size limitations, mitigating solutions available (e.g. side chains) ▪ Conflicting commercial interests need to balanced via technology transfer agreements ▪ Lack of maturity of blockchain technology ▪ While technology has constraints, adopting a specific approach helps to selectively implement ▪ Experimental and currently slow because of verifying contracts and cross--‐contract communication ▪ Nascent recognition as legal documentation ▪ Competing platforms 12
- 13. Science will beBlockchained by 2025 Sean Manion - Published on January 16, 2017 (LinkedIn Pulse) https://www.linkedin.com/pulse/science-blockchained-2025-sean-manion
- 14. Distributed Science ValueProposition ▪ Better Science (for Scientists) ▪ Problem: Reproducibility Issues ▪ Solution: Improved reproducibility through transparency and immutable audit trail for research data; better quality data from standardization; improved materials; increased meta-analysis capabilities ▪ Cheaper Research (for Funders) ▪ Problem: Expensive; decreasing ROI ▪ Solution: Increased return on investment for research dollars spent; reduced data management costs through blockchain/smart contracts, amplified with machine learning/AI ▪ Faster Miracles (for Everyone) ▪ Problem: 17 years from bench to bedside ▪ Solution: Moving more quickly from bench to bedside and improved outcomes with accelerated research and higher quality data; improved tracking of individual contribution will allow for expanded permissioned access of data to more brilliant minds for faster findings; assisting with administrative applications for blockchain (e.g. IRB file process)
- 15. U.S. Investments inMedical and Health Research and Development (2015) Breakdown by source: ▪ Industry invested more in R&D than any other sector, totaling $102.7 billion. ▪ Federal agencies invested a total of $35.9 billion, with the National Institutes of Health accounting for $29.6 billion. ▪ Research institutions, including universities and independent research institutes (IRIs), dedicated more than $12.5 billion to R&D. ▪ Foundations contributed $4.7 billion to U.S. medical and health R&D. ▪ Voluntary health associations, professional societies, and state and local governments invested nearly $3 billion in medical and health R&D.
- 16. U.S. Investments inMedical and Health Research and Development (2015) ▪ Worldwide $2.5 trillion annually on scientific R&D (data.oecd.org) ▪ Total U.S. medical and health R&D was $158.7 billion. “U.S. Investments in Medical and Health Research and Development, 2013 – 2015,” Research America! ▪ !!!!! U.S. biomedical research that can’t be replicated - $28 Billion per year !!!!!! “Economics of reproducibility in Preclinical Research” Freedman et al, PLoS 13(6) e1002165, 2015 ▪ What amount of clinical research can’t be replicated?
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- 18. Blockchain Ecosystem Blockchain by Industry($500K+ ICOs 2014 – Oct 2017; Energy Collective – 135 total): • Finance – 42% • Gaming – 13 • Infrastructure – 11 • Media – 9 • Other – 9 • Computer/Storage – 5 • Browser/Social – 4 • Identity/IoT – 3 • Energy – 2 • Healthcare - 2
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- 20. Blockchain Healthcare Ecosystem Key Areas: • Electronichealth record, patient-centric • Provider identity • Payments • Supply chain • Pharma, Devices • Clinical trials
- 21. Blockchain Health Science Research Ecosystem •Terraforming: Science Distributed • Legacy: Nature/Digital Science/Katalysis; Wolfram Alpha (Pluto); IEEE • Healthcare/Clin Research: Obesity PPM, Hashed Health, Genomics (Various), etc. • Other: Atana, Co-Lab, ScienceRoot, Frankl, Ovium, Peerwith, Scientist.com • Journal: Blockchain in Healthcare Today; IEEE; Ledger, Frontiers in Blockchain
- 22. Enhancing Federal Research:Traumatic Brain Injury & Blockchain Technology By Sean Manion - March 3, 2018 http://www.fedhealthit.com/2018/03/enhancing-federal-research-traumatic-brain-injury-blockchain-technology-part-1-introduction/
- 23. Blockchain: Distributed Science ValueProposition ▪ Better Science (for Scientists) ▪ Problem: Reproducibility Issues ▪ Solution: Improved reproducibility through transparency and immutable audit trail for research data; better quality data from standardization; improved materials; increased meta-analysis capabilities ▪ Cheaper Research (for Funders) ▪ Problem: Expensive; decreasing ROI ▪ Solution: Increased return on investment for research dollars spent; reduced data management costs through blockchain/smart contracts, amplified with machine learning/AI ▪ Faster Miracles (for Everyone) ▪ Problem: 17 years from bench to bedside ▪ Solution: Faster from bench to bedside: improved outcomes, accelerated research and higher quality data; improved tracking of individual researcher contribution will allow for expanded permissioned access of data; assisting with administrative applications for blockchain (e.g. IRB file process)
- 24. Traumatic Brain Injury(TBI): Problem Area • In 2013, about 2.8 million TBI-related emergency department (ED) visits, hospitalizations, and deaths occurred in the United States. • TBI contributed to the deaths of nearly 50,000 people. • TBI was a diagnosis in more than 282,000 hospitalizations and 2.5 million ED visits. These consisted of TBI alone or TBI in combination with other injuries. • In 2012, an estimated 329,290 children (age 19 or younger) were treated in U.S. EDs for sports and recreation-related injuries that included a diagnosis of concussion or TBI. • From 2001 to 2012, the rate of ED visits for sports and recreation-related injuries with a diagnosis of concussion or TBI, alone or in combination with other injuries, more than doubled among children (age 19 or younger). https://www.cdc.gov/traumaticbraininjury/get_the_facts.html
- 25. Federal Interagency TraumaticBrain Injury Research (FITBIR) Informatics System ▪ FITBIR was developed to share data across the entire TBI research field ▪ Created in Jan 2013 by NIH, DoD ▪ 25 federal agencies partnered: NIH, DoD, and VA; along with One Mind ▪ Hosted by NIH (fitbir.nih.gov) ▪ Central repository for data ▪ Encourages data sharing, cross- study comparison, and meta- analysis
- 26. TBI: Federal Research ▪NIH – 665 active studies; $307 Million (2018, NIH RePORTER) ▪ DoD - ~300 active studies (est.); ~$200 Million annually (est.*) * “Report to Congress: On Expenditures for Activities on Traumatic Brain Injury and Psychological Health, Including Posttraumatic Stress Disorder, for Calendar Year 2012” ▪ VA – 171 active studies (2018, NIH RePORTER) ▪ Fed TBI Research – 1,000+ studies; $500+ Million annually ▪ Studies in FITBIR (https://fitbir.nih.gov/content/submitted-data) ▪ 125 studies committed to contribute data ▪ 78 studies submitted some data ▪ 15 studies have made data available of more than 1000 federally funded TBI studies
- 27. FITBIR Challenges ▪ Researchersconcerned with sharing data; “being scooped” ▪ Limitations with tracking individual researcher contribution ▪ Costly for research groups to format data ▪ Limitations of centralized data quality control ▪ Centralized access to data slow ▪ Identity of requestors ▪ Regulatory approval ▪ Limited number of Common Data Elements (CDE) ▪ CDEs took 5+years to standardize by federal CDE working group ▪ Additional data elements challenging to add/standardize ▪ Limitations of centralized staff to approve new CDEs
- 28. How Blockchain CanHelp ▪ Expanded data contribution tracking for individual researchers ▪ Auditable record of use of data by other researchers ▪ Data formatting automated by smart contracts ▪ Identity of users verifiable; automated speeding access ▪ Confirmation of regulatory approvals automated ▪ Consensus for additional data elements to facilitate expanded data elements ▪ Consensus for new standards driven by protocol development with experts and facilitated by automation/smart contracts and assistance by AI analysis of available literature
- 29. General Challenges for Blockchainin Federal Research • Administrators are risk averse • Regulators are wary of the unknown • Acquisition standards matter • Researchers are complex • Science is a complex system • Layered incentives; $$ only one • Want input on protocols • Developers assume simple, clean data • Research data is messy, non-standardized • Research partially centralized/distributed • Central and single node intermediaries **Average federal scientist/ administrator perception on blockchain for research
- 30. Next Steps For Administrators: ▪Engage health regulators; sandbox approach successful in the UK ▪ Educate key stakeholders on the technology and processes For Researchers: ▪ Create networks of early adopters ▪ Convene standards committees in key health areas For Developers: ▪ Use UX design methodology to develop pilot governance protocol ▪ Understand complexities of health and research data
- 31. Levels of Evidencefor Clinical Practice
- 32. Questions – Comments– Future Follow Up Blockchain Healthcare Situation Report (BC/HC SITREP) ▪ Free weekly newsletter; curated news & events w/ commentary ▪ Email [email protected] w/ “BC/HC SITREP” in subject line Science Distributed Pilot Blockchain – in development ▪ Network, protocol, blockchain; in that order ▪ Email [email protected] w/ statement of interest