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Secure Data Sharing and Related
Matters – An NIH View
Philip E. Bourne, PhD, FACMI
Associate Director for Data Science
Nat...
Disclaimer…
I am not a cybersecurity expert, and
as an informatician previously
working primarily in the pre-clinical
spac...
Conversation Cards
 What is happening that makes a
discussion of security important
 What is secure anyway?
 How is the...
Conversation Cards
 What is happening that makes a
discussion of security important
 What is secure anyway?
 How is the...
Big Data in the Life Sciences …
This speaks to something more
fundamental that more data …
It speaks to new methodologies,...
Consider this change from my own
career experience ….
The History of Computational
Biomedicine According to Bourne
1980s 1990s 2000s 2010s 2020
Discipline:
Unknown Expt. Driven...
Consider what the expert
prophets are saying …
We are at a Point of Deception …
 Evidence:
– Google car
– 3D printers
– Waze
– Robotics
– Sensors
From: The Second Machi...
Example - Photography
Digitization
Deception
Disruption
Demonetization
Dematerialization
Democratization
Time
Volume,Veloc...
We Are At a Point of Deception
The 6D Exponential Framework
Digitization of Basic &
Clinical Research & EHR’s
Deception
We...
What Are Some General Implications
of Such a Future?
 Open collaborative science becomes of increasing
importance
 The v...
An Example of That Promise:
Comorbidity Network for 6.2M Danes
Over 14.9 Years
Jensen et al 2014 Nat Comm 5:4022
“And that’s why we’re here today. Because something
called precision medicine … gives us one of the greatest
opportunities...
Precision Medicine Initiative
 National Research Cohort
– >1 million U.S. volunteers
– Numerous existing cohorts (many fu...
Conversation Cards
 What is happening that makes a
discussion of security important
 What is secure anyway?
 How is the...
For the Purposes of this NIH Centric
Digital Discussion:
What is Secure Anyway?
Access to digital research objects
when, h...
Some of the Complexities
 Research objects
– Narrative
– Data – preclinical and
clinical
– Software
– Publications
 Owne...
Conversation Cards
 What is happening that makes a
discussion of security important
 What is secure anyway?
 How is the...
Consider This Response from 3
Intersecting Perspectives
Community
Policy
Infrastructure
Consider This Response from 3
Intersecting Perspectives
Community
Policy
Infrastructure
Laying the Foundation for Open
Access:
HGP, Bermuda, 1996
“The HGP changed the norms around data sharing
in biomedical research.”
“The HGP changed the norms around data sharing
in ...
Data Sharing Goes Global: GA4GH
Global Alliance for Genomics and
Health
 Accelerating the potential of genomic medicine t...
Consider This Response from 3
Intersecting Perspectives
Community
Policy
Infrastructure
A Culture of Sharing
1999 20042003 2007 20142008
Research
Tools
Policy
NIH Data
Sharing Policy
Model
Organism
Policy
Genom...
Guiding Principle of NIH GWAS Policy
The greatest public benefit will be
realized if data from GWAS are made
available, un...
Data Access Requests Per Year
2007–September 2015
A Culture of Sharing
1999 20042003 2007 20142008
Research
Tools
Policy
NIH Data
Sharing Policy
Model
Organism
Policy
Genom...
NIH Public Access Policy for Publications
 Ensures public access to published results of all
research funded by NIH since...
A Culture of Sharing
1999 20042003 2007 20142008
Research
Tools
Policy
NIH Data
Sharing Policy
Model
Organism
Policy
Genom...
Harnessing Data to Improve Health:
BD2K (Big Data to Knowledge)
NIH’s 6-year initiative to use data science to foster an
o...
A Culture of Sharing
1999 20042003 2007 20142008
Research
Tools
Policy
NIH Data
Sharing Policy
Model
Organism
Policy
Genom...
NIH Genomic Data Sharing (GDS)
Policy
 Purpose
– Sets forth expectations, responsibilities that ensure broad,
responsible...
A Culture of Sharing
1999 20042003 2007 20142008
Research
Tools
Policy
NIH Data
Sharing Policy
Model
Organism
Policy
Genom...
Modernizing NIH Clinical Trials
Activities:
The Need
 NIH-Funded trials published within 100 months of
completion
Less th...
Modernizing NIH Clinical Trials
Activities:
Call to Action
Increasing Clinical Trial Transparency
Proposed November 2014; Final Spring 2016 (est.)
 Notice of Proposed Rulemaking: C...
Consider This Response from 3
Intersecting Perspectives
Community
Policy
Infrastructure
BD2K
Center
BD2K
Center
BD2K
Center
BD2K
Center
BD2K
Center
BD2K
Center
DDICC
Software
Standard
s
Infrastructure - The
Com...
The Commons: Components
The Commons
Digital Object Compliance: FAIR
 Attributes of digital objects in the Commons
 Initial Phase
• Unique digita...
BD2K Targeted Software Topics
Supports innovative analytical methods and software tools
that address critical current and ...
I not only use all the brains
I have, but all I can borrow.
– Woodrow Wilson
The Team
45
NIHNIH……
Turning Discovery Into HealthTurning Discovery Into Health
philip.bourne@nih.gov
https://datascience.nih.gov/
htt...
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Secure Data Sharing and Related Matters – An NIH View

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http://projects.iq.harvard.edu/researchdataaccessandinnovationsymposium/event/harvard-research-data-access-innovation-symposium

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Secure Data Sharing and Related Matters – An NIH View

  1. 1. Secure Data Sharing and Related Matters – An NIH View Philip E. Bourne, PhD, FACMI Associate Director for Data Science National Institutes of Health October 26, 2015
  2. 2. Disclaimer… I am not a cybersecurity expert, and as an informatician previously working primarily in the pre-clinical space not an expert in security associated with human subjects
  3. 3. Conversation Cards  What is happening that makes a discussion of security important  What is secure anyway?  How is the NIH responding in this changing landscape
  4. 4. Conversation Cards  What is happening that makes a discussion of security important  What is secure anyway?  How is the NIH responding in this changing landscape
  5. 5. Big Data in the Life Sciences … This speaks to something more fundamental that more data … It speaks to new methodologies, new skills, new emphasis, new cultures, new modes of discovery …
  6. 6. Consider this change from my own career experience ….
  7. 7. The History of Computational Biomedicine According to Bourne 1980s 1990s 2000s 2010s 2020 Discipline: Unknown Expt. Driven Emergent Over-sold A Service A Partner A Driver The Raw Material: Non-existent Limited /Poor More/Ontologies Big Data/Siloed Open/Integrated The People: No name Technicians Industry recognition data scientists Academics Searls (ed) The Roots in Bioinformatics Series PLOS Comp Biol
  8. 8. Consider what the expert prophets are saying …
  9. 9. We are at a Point of Deception …  Evidence: – Google car – 3D printers – Waze – Robotics – Sensors From: The Second Machine Age: Work, Progress, and Prosperity in a Time of Brilliant Technologies by Erik Brynjolfsson & Andrew McAfee
  10. 10. Example - Photography Digitization Deception Disruption Demonetization Dematerialization Democratization Time Volume,Velocity,Variety Digital camera invented by Kodak but shelved Megapixels & quality improve slowly; Kodak slow to react Film market collapses; Kodak goes bankrupt Phones replace cameras Instagram, Flickr become the value proposition Digital media becomes bona fide form of communication
  11. 11. We Are At a Point of Deception The 6D Exponential Framework Digitization of Basic & Clinical Research & EHR’s Deception We Are Here Disruption Demonetization Dematerialization Democratization Open science Patient centered health care
  12. 12. What Are Some General Implications of Such a Future?  Open collaborative science becomes of increasing importance  The value of data and associated analytics becomes of increasing value to scholarship  Opportunities exist to improve the efficiency of the research enterprise and hence fund more research  Cooperation between funders will be needed to sustain the emergent digital enterprise  Current training content and modalities will not match supply to demand  Balancing accessibility vs security becomes more important yet more complex
  13. 13. An Example of That Promise: Comorbidity Network for 6.2M Danes Over 14.9 Years Jensen et al 2014 Nat Comm 5:4022
  14. 14. “And that’s why we’re here today. Because something called precision medicine … gives us one of the greatest opportunities for new medical breakthroughs that we have ever seen.” President Barack Obama January 30, 2015
  15. 15. Precision Medicine Initiative  National Research Cohort – >1 million U.S. volunteers – Numerous existing cohorts (many funded by NIH) – New volunteers  Participants will be centrally involved in design and implementation of the cohort  They will be able to share genomic data, lifestyle information, biological samples – all linked to their electronic health records
  16. 16. Conversation Cards  What is happening that makes a discussion of security important  What is secure anyway?  How is the NIH responding in this changing landscape
  17. 17. For the Purposes of this NIH Centric Digital Discussion: What is Secure Anyway? Access to digital research objects when, how, and by whom are authorized to access them in accordance of the wishes of the owner and/or laws and policies which define accessibility
  18. 18. Some of the Complexities  Research objects – Narrative – Data – preclinical and clinical – Software – Publications  Owner – Individual – Institution – Funding agency – Third party  Governance – Federal – Funding agency – Institutional – Third party
  19. 19. Conversation Cards  What is happening that makes a discussion of security important  What is secure anyway?  How is the NIH responding in this changing landscape
  20. 20. Consider This Response from 3 Intersecting Perspectives Community Policy Infrastructure
  21. 21. Consider This Response from 3 Intersecting Perspectives Community Policy Infrastructure
  22. 22. Laying the Foundation for Open Access: HGP, Bermuda, 1996
  23. 23. “The HGP changed the norms around data sharing in biomedical research.” “The HGP changed the norms around data sharing in biomedical research.”
  24. 24. Data Sharing Goes Global: GA4GH Global Alliance for Genomics and Health  Accelerating the potential of genomic medicine to advance human health, by: – Establishing common framework of approaches to enable effective, responsible sharing of genomic and clinical data – Catalyzing data sharing projects that drive and demonstrate value of data sharing  Alliance*: >350 leading institutions (healthcare, research, advocacy, life science, IT) representing 35 countries  Working groups (Clinical, Data, Security, Regulatory & Ethics) assess, prioritize needs – Form task teams to produce tools, solutions, demonstration projects *Statistics as of October 5, 2015
  25. 25. Consider This Response from 3 Intersecting Perspectives Community Policy Infrastructure
  26. 26. A Culture of Sharing 1999 20042003 2007 20142008 Research Tools Policy NIH Data Sharing Policy Model Organism Policy Genome-wide Association (GWAS) Policy 2012 NIH Public Access Policy (Publications) Big Data to Knowledge (BD2K) Initiative Genomic Data Sharing (GDS) Policy Modernization of NIH Clinical Trials White House Initiative (2013 “Holdren Memo”)
  27. 27. Guiding Principle of NIH GWAS Policy The greatest public benefit will be realized if data from GWAS are made available, under terms and conditions consistent with the informed consent provided by individual participants, in a timely manner to the largest possible number of investigators. NIH expectation that data would be shared in the NIH database of Genotype and Phenotype (dbGaP)
  28. 28. Data Access Requests Per Year 2007–September 2015
  29. 29. A Culture of Sharing 1999 20042003 2007 20142008 Research Tools Policy NIH Data Sharing Policy Model Organism Policy Genome-wide Association (GWAS) Policy 2012 NIH Public Access Policy (Publications) Big Data to Knowledge (BD2K) Initiative Genomic Data Sharing (GDS) Policy Modernization of NIH Clinical Trials White House Initiative (2013 “Holdren Memo”)
  30. 30. NIH Public Access Policy for Publications  Ensures public access to published results of all research funded by NIH since 2008 – Recipients of NIH funds required to submit final peer- reviewed journal manuscripts to PubMed Central (PMC) upon acceptance for publication – Papers must be accessible to the public on PMC no later than 12 months after publication
  31. 31. A Culture of Sharing 1999 20042003 2007 20142008 Research Tools Policy NIH Data Sharing Policy Model Organism Policy Genome-wide Association (GWAS) Policy 2012 NIH Public Access Policy (Publications) Big Data to Knowledge (BD2K) Initiative Genomic Data Sharing (GDS) Policy Modernization of NIH Clinical Trials White House Initiative (2013 “Holdren Memo”)
  32. 32. Harnessing Data to Improve Health: BD2K (Big Data to Knowledge) NIH’s 6-year initiative to use data science to foster an open digital ecosystem that will accelerate efficient, cost-effective biomedical research to enhance health, lengthen life, and reduce illness and disability Programs and activities: Advance discovery for biomedical research Facilitate use and re-use of biomedical data Develop analytical methods and software Enhance biomedical data science training
  33. 33. A Culture of Sharing 1999 20042003 2007 20142008 Research Tools Policy NIH Data Sharing Policy Model Organism Policy Genome-wide Association (GWAS) Policy 2012 NIH Public Access Policy (Publications) Big Data to Knowledge (BD2K) Initiative Genomic Data Sharing (GDS) Policy Modernization of NIH Clinical Trials White House Initiative (2013 “Holdren Memo”)
  34. 34. NIH Genomic Data Sharing (GDS) Policy  Purpose – Sets forth expectations, responsibilities that ensure broad, responsible sharing of genomic research data in a timely manner  Scope – All NIH-funded research generating large-scale human or non-human genomic data – and their use for subsequent research • Data to be submitted to NIH-designated data repositories (e.g., dbGaP, GEO, GenBank, WormBase, FlyBase, Rat Genome Database) – Applies to all funding mechanisms (grants, contracts, intramural support) with no minimum threshold for cost  Released August 2014; effective January 25, 2015 gds.nih.gov
  35. 35. A Culture of Sharing 1999 20042003 2007 20142008 Research Tools Policy NIH Data Sharing Policy Model Organism Policy Genome-wide Association (GWAS) Policy 2012 NIH Public Access Policy (Publications) Big Data to Knowledge (BD2K) Initiative Genomic Data Sharing (GDS) Policy Modernization of NIH Clinical Trials White House Initiative (2013 “Holdren Memo”)
  36. 36. Modernizing NIH Clinical Trials Activities: The Need  NIH-Funded trials published within 100 months of completion Less than 50% published within 30 months of completion BMJ 2012;344:d7292
  37. 37. Modernizing NIH Clinical Trials Activities: Call to Action
  38. 38. Increasing Clinical Trial Transparency Proposed November 2014; Final Spring 2016 (est.)  Notice of Proposed Rulemaking: Clinical Trials Registration and Results Submission (FDAAA, Section 801) – Further implements statutory requirements on private and public sponsors to register; report results on phase 2, 3, and 4 trials – Includes drugs, biologics, and devices (except small feasibility)  Draft NIH Policy on Clinical Trial Information Dissemination – Extends Section 801 requirements to all NIH-funded clinical trials – Includes phase 1 trials and trials of non-FDA regulated interventions such as behavioral trials
  39. 39. Consider This Response from 3 Intersecting Perspectives Community Policy Infrastructure
  40. 40. BD2K Center BD2K Center BD2K Center BD2K Center BD2K Center BD2K Center DDICC Software Standard s Infrastructure - The Commons Labs Labs Labs Labs
  41. 41. The Commons: Components
  42. 42. The Commons Digital Object Compliance: FAIR  Attributes of digital objects in the Commons  Initial Phase • Unique digital object identifiers of some type • A minimal set of searchable metadata • Physically available in a cloud based Commons provider • Clear access rules (especially important for human subjects data) • An entry (with metadata) in one or more indices – Future Phases • Standard, community based unique digital object identifiers • Conform to community approved standard metadata for enhanced searching • Digital objects accessible via open standard APIs • Are physically and logical available to the commons
  43. 43. BD2K Targeted Software Topics Supports innovative analytical methods and software tools that address critical current and emerging needs of the biomedical research 2015 Topics (18 awards, U01s) – Data Compression – Data Provenance – Data Visualization – Data Wrangling 2016 Topics (U01s, under review) – Data Privacy – Data Repurposing – Applying Metadata – 2016: Crowdsourcing and interactive Digital Media (UH2)
  44. 44. I not only use all the brains I have, but all I can borrow. – Woodrow Wilson
  45. 45. The Team 45
  46. 46. NIHNIH…… Turning Discovery Into HealthTurning Discovery Into Health philip.bourne@nih.gov https://datascience.nih.gov/ http://www.ncbi.nlm.nih.gov/research/staff/bourne/

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