Blockchain for Health Research presentation by Sean Manion on 16 Dec 2019 for the U.S. Dept of Health and Human Services Asst Secretary for Programs & Evaluation, Patient Centered Outcomes Research Trust Fund Webinar

1. Blockchain for Health Research
Sean T Manion, PhD
Science Distributed // Blockchain in Healthcare Global (IEEE International Standards & Trade Organization)
HHS ASPE Patient Centered Outcomes Research –Trust Fund Webinar
16 December 2019
Sean T Manion, PhD - Science Distributed
seanmanion@sciencedistributed.com - Dec 2019
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2. Blockchain/Distributed Ledger Technology(DLT)
• Blockchain is a distributed
ledger of data transactions,
exchanges, or events.
• Allows a distributed network
to automatically maintain a
single, virtually immutable
record based on an agreed
upon governance protocol
for consensus.
• Can be public, permissioned,
or private. Consensus
mechanisms will vary.
• Tokenization of activity
allows for incentivization
• Blockchain is not Bitcoin!
Sean T Manion, PhD - Science Distributed
seanmanion@sciencedistributed.com - Dec 2019
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Example of a financial application of blockchain (By B140970324- Wikimedia Commons)
More info: hyperledger.org/ (Hyperledgeris the blockchain arm of the Linux foundation)

3. Blockchain Value Proposition in Research
• Blockchain can be overkill and won’t solve human problems.
• OTOH: If we can do it with existing technology, why aren’t we?
• Blockchain changes the value proposition for tech in research:
• BetterScience(for Scientists)
• Problem: Reproducibility Issues;20% of U.S. health science research can’t be replicated/reproduced*
• 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;$30 billion in U.S. health science on non-replicable research*
• Solution: Increased return on investment for research dollars spent; reduced data management costs through
blockchain/smart contracts, amplified with machine learning/AI; cheaper administration
• Faster Miracles (for Everyone)
• Problem: 17 years from bench to bedside; 2-5 years on administrative processes (my estimate)**
• Solution: Faster time from idea to treatment; improved outcomes with accelerated research and higher quality
data; improved tracking of individual contribution allowing for expanded permissioned access of data to more
researchers; faster administrative processes (e.g. IRB, grant review)
* “Economics of reproducibility in Preclinical Research” Freedman et al, PLoS 13(6) e1002165, 2015
** “Enhancing Federal Research: Traumatic Brain Injury & Blockchain Technology - Part 1.5, The Why.” Manion, Feb 2018 https://www.linkedin.com/pulse/enhancing-federal-research-traumatic-brain-
injury-part-sean-manion-1/
Sean T Manion, PhD - Science Distributed
seanmanion@sciencedistributed.com - Dec 2019
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“Blockchain isn’t hot sauce,
you can’t just put that [stuff]
on everything” – Samson
Williams

4. Blockchain Healthcare Ecosystem
KeyUse Cases Areas (Examples):
• Admin, financial (GSA,Health & Human Services)
• Provider identity/credentialing(Professional
Credential Exchange; Synaptic Health Alliance)
• Medicaldevice tracking(Spiritus Partners,Edinburgh
Napier University, Scotland NHS)
• Pharma supply chain (FDA: Good Shepherd
Pharmacy/Remedichain+; MediLedger/Walmart)
• Clinicaltrials (Boehringer Ingelheim, IBM;UCSF*)
• *Prototypeof running clinical trials in an untrustworthy
environmentusing blockchain. Wong et al. Nature
Communications volume10, Article: 917 (2019)
• Publishing (Ledger,Blockchainin HealthcareToday,
Springer Nature)
• ClinicalSupport Tools (Elsevier)
• Electronichealth record(Amsys; Rymedi)
Sean T Manion, PhD - Science Distributed
seanmanion@sciencedistributed.com - Dec 2019
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5. FarmtoTable,BenchtoBedside: HealthResearchas DataSupply Chain
from “Advancing HealthResearchwithBlockchain” (Manion) in HIMSS textbook
Blockchain inHealthcare: Innovations thatEmpower Patients, ConnectProfessionals and ImproveCare
Sean T Manion, PhD - Science Distributed seanmanion@sciencedistributed.com - Dec 2019
Seed
•Crop
•Strain
•Soil
Farm
•Plant
•Grow
•Harvest
Processing
•Cleaning
•Preparation
•Packaging
Distribution
•To consumeror
retail
•Nextstage
processing
Table
•Restaurant
•Retail/Home
cooking
Idea
•Hypothesis
•Design
•Funding
Bench
•Research
execution
•Data Collection
•Basic to Clinical
Analysis
•Hypothesis
testing
•Statistics
•Interpretation
Dissemination
•Conference
presentation
•Peer-review
publication
Bedside
•Knowledge
translation
•Clinical practice
guidelines
Repeats several times
Food Supply Chain
• Linear progression
• Timeline:< 30 days*
• Key variables:type,
quantity,quality,
variables(e.g. temp)
Health ResearchData
Supply Chain
• Parallel progression
• Timeline:2-5yrs (x
multiplerepeats)
• Key Variables:design,
methodology, patient
demographics research
contribution,statistical
approach,outcomes
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6. What are the
pre-publication
presentations?
What is the
quality or
confidence level?
How is feedback
captured?
Gray lit?
What are the
comments?
Are there
objective
criteria?
Crowd-sourced
peer review?
7. Publish &
Present
Are analyses tied
to original
hypotheses?
Are analyses
outlined in
protocol?
Justification of
new analyses?
Record of
attempted
analyses?
Statistical power?
Lit basis of
interpretation?
Quality of refs?
Replicable?
Retractions?
6. Analyze &
Interpret
What are the
data standards?
Will it be
mergeable with
other studies?
What are the
quality assurance
steps?
Is PHI secure?
Is there existing
data that can be
used?
How accessible is
the data?
What is the ROI
for the data?
5. Collect Data
Can parts of this
process be
automated?
Will that be
faster and more
reliable for
researchers and
regulator?
Can multiple IRBs
be aligned?
Can parts of IRB
review be
crowdsourced?
Can audits be
easier?
4. Regulatory
Approval
Where are
funds?
Does my plan
match
programmatic
need?
Have I applied
here before?
Why am I filling
in all this
information
again?
How is the
money being
tracked?
3. Get Funding
What methods
are available?
What variations
have been
developed?
Are skilled
collaborators
available?
Where?
Are other
resources (i.e.
space,
equipment)
available?
2. Plan research
What hypotheses
have already
been tested?
By whom?
When?
What happened?
What was the
approach?
What was the
result?
Current status?
1. Form Hypotheses
Blockchain Questions in Research
• Where canthings be improvedineacharea?
• Can blockchain/DLTfacilitateand/or incentivize?
• What is the cost/benefitof implementation?
• If it can be achievedw/oblockchain/DLT, why isn’t it?
Questions to consider acrossthe steps in research:
Sean T Manion, PhD - Science Distributed
seanmanion@sciencedistributed.com - Dec 2019
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7. Blockchain, Cloud, & AI/ML
Sean T Manion, PhD - Science Distributed
seanmanion@sciencedistributed.com - Dec 2019
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Photographyby Lucy Hewett
AI/ML
Blockchain
Cloud

8. Blockchain for Research Administration
SeanT Manion, PhD - Science Distributedseanmanion@sciencedistributed.com - Dec 2019 8

9. Blockchain for Data Management
Sean T Manion, PhD - Science Distributed
seanmanion@sciencedistributed.com - Dec 2019
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10. The Way Forward
from Blockchain for Medical Research: Accelerating Trust in Healthcare Manion & Bizouati-Kennedy (April 2020, CRC Press)
Sean T Manion, PhD - Science Distributed
seanmanion@sciencedistributed.com - Jan 2019
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Key Areas of Impact Recommendations
Sharing ideas/hypotheses Cross-agency,public-private, subject matter
working groups
Accelerated proposal review University and researchgroup engagement
Funding innovations IEEE/NIST standards
Protocol development Strategic Planning
Enhanced data sharing Administrative pilots
Methods and analyses tracking Regulatory engagement
Pre-review of interpretations Network research pilots
Crowdsourced peer-review Enterprise deployment
Fractionalized publishing Distributed Autonomous Organization

11. More information
• IEEE Standards Association – Standards for Blockchainin Health and Life
Sciencesw Research Subgroup: https://standards.ieee.org/project/2418_6.html
• Frontiers’Blockchainfor Science – Peer-reviewedscientific journal:
https://www.frontiersin.org/journals/blockchain/sections/blockchain-for-science#
• HIMSS BlockchainTask Force Library: https://www.himss.org/blockchain-healthcare
• HIMSS Textbook – Blockchainin Healthcare: Empower Patients and
Improve Care (2019,CRC Press): https://www.crcpress.com/Blockchain-in-Healthcare-
Innovations-that-Empower-Patients-Connect-Professionals/Dhillon-Bass-Hooper-Metcalf-
Cahana/p/book/9780367031084
• New Book – Blockchainfor Medical Research: Accelerating Trust in
Healthcare Manion & Bizouati-Kennedy(April 2020,CRC Press):
https://www.crcpress.com/Blockchain-for-Medical-Research-Accelerating-Trust-in-Healthcare/Manion-
Bizouati-Kennedy/p/book/9780367347468
Sean T Manion, PhD - Science Distributed
seanmanion@sciencedistributed.com - Dec 2019