Fphs informatics for 2016 it summit 160531

1. The Football Players Health Study at Harvard:
Informatics Platform
Chris Botka, Chief Technology Officer, HMS
Joe Zurba, Information Security & IT Compliance Officer, HMS
Doug MacFadden, Chief Informatics Officer, Harvard Catalyst
April 26, 2016

2. GOAL
The goal of the Football Players Health Study (FPHS) at
Harvard University is to improve the health and wellbeing of
former NFL players, while furthering our understanding of the
benefits and risks of participation in American football.
2

3. New Prevention Strategies,
Diagnostics & Treatments
Researchers working on innovative and
promising developments that
have the potential to impact the health of
football players.
PILOT
STUDIES
POPULATION
STUDIES
Health Status & Quality of Life
Using questionnaires and testing to better
understand player health and wellness.
PLAYERS &
SCIENTISTS
Advice and Guidance
LAW &
ETHICS
Understanding the legal and ethical
issues that promote and impede player
health and developing responsive
recommendations
Promoting Player Health
Through Structural Change
The Whole Player, The Whole Life

4. Timeline
2016Jan Apr Jul Oct 2015 Apr Jul Oct 2016 Apr Jul Oct
Contract signed with NFLPA
2/2014
9/2014
Pilot Questionnaire Launched
1/2015
Full Questionnaire Launched
Largest study of living former players
(2570 enrolled)
10/2015
Pilot Listening Tour Launched
11/2015
TeamStudy App launched
3/2016 Target for in-person
assessments beginning
9/2016
2014

5. Data
FINDINGS
Issues to
Address
Results
Hypotheses to
Test
Knowledge
Deficits
• Population
characterization
• Prevalence
• Open RFAs
• Ideation
challenges
• Knowledge
accelerators
• Targeted
experiments
• Case-control
studies
• Detailed sub-
analyses
PLAYERS Literature
Characterization of the
Health and Wellness of
Former Players
First
questionnaire
TeamStudy App
Clinical
Assessments
Biosamples
Follow up
questionnaires
Onsite Visit
(imaging, …)

6. Central Data Platform Logical Architecture
Research
Team
Virtual
Desktop
Research
Team
Virtual
Desktop
Research
Team
Virtual
Desktops
Central Player
Database
Q1 Survey
Law and
Ethics
Interviews
Sage
Mobile App
Imaging
Additional
Research
Protocols
Coded Data

7. Implementation Plans for Central Data
Platform
• 2014 - Original implementation at Beth Israel
• 2015 - Move and Implementations at Partners ERIS
• 2016 - Move to HMS IT
– Initial go live implementation March 2016 (Sage App)
• 2016 - Reuse of HMS infrastructure for new separate
project (Department of Public Health, Prevention
Wellness Trust Fund)
• 2016++ – On-site visit protocol (imaging, …)

8. Informatics Challenges
• Secure central data repository to support
recruitment and research protocol data
• Compliant with Harvard level 4 and with the HIPAA
Security Rule
• Support comprehensive analysis of all data by
internal researchers and limited controlled access
by external researchers

9. Data Security
• Due to the high profile nature of the subjects and
the breadth of information being collected, a
comprehensive data security architecture is
required.

10. Harvard Data Classification
Level 5 – Extremely Sensitive
Level 4 – High-Risk Confidential Information
Level 3 – Confidential Information
Level 2 – Private/Institutional Information
Level 1 – Public Information

11. HIPAA
• Health Insurance Portability and Accountability Act of 1996
• Defines PHI
• Sets requirements under the Security Rule and Privacy Rule
• Defines covered-entities as:
– Health Care Providers
– Health Plans
– Clearing Houses (Billing Services, repricing companies, etc.)
• Defines requirements for Business Associate Agreements
(BAAs)
• Exemptions for research

12. Data Security Strategy
• The data security program includes:
– Leverage HMS and HUIT IT Security
– Improvements to PHC Operations
– System Isolation
– 2-step verification
– Implementation of a data segregation strategy to isolate HRCI
and protect against unauthorized identification of subjects (Key)
– HIPAA Security Rule Compliance:
• Risk Assessment
• Policies and procedures
• Training
• Penetration Test
– The Story of Sage BioNetworks

13. Harvard Medical School
FPHS (Logical)
Create Date: 5/12/15
Created By: David Bloom
Version: 2.0
Date: 04/20/16
Page 1 of 1
FPHS-ADMIN
FPHS-DATABASE
REDCAP-ADMIN
FPHS-RESEARCHER
External
USER / ROLE LEGEND
FPHS-RESEARCHER
Internal
INTERNET
EXTERNAL FIREWALL
DMZ
LOAD BALANCER
INTERNAL FIREWALL INTERNAL FIREWALL INTERNAL FIREWALL INTERNAL FIREWALL
LEVEL 4 WEB LEVEL 4 DATABASE FPHS-LEVEL4 FPHS-ANALYSIS
REDCAP
Apache
PHP
REDCAP DB
MySQL
REDCAP
Apache
PHP
INTERNAL
ANALYSIS
Software / Flat Files
Data Mart / SAS
EXTERNAL
ANALYSIS
Software / Flat Files
Data Mart / SAS
REDCAP
MySQL
Apache
PHP
ETL
(Landing Zone)
Postgres
MASTER
PLAYER LIST
TCP 80/443
Inbound
NFS NAS
Storage
APPLICATION
CRM
SAGE
DMZ: VLAN 150: 134.174.150.0/24
LEVEL 4 WEB: VLAN 1046: 10.120.21.0/24
LEVEL 4 DATABASE: VLAN 1047: 10.120.22.0/24
FPHS-LEVEL4: VLAN 1025: 10.120.2.64/26
FPHS-ANALYSIS: VLAN 1026: 10.120.2.128/26
NETWORK LAN SEGMENTS

14. Next Steps
• Expand Research: Onsite Visit (e.g. imaging)
Protocol
• Reuse: Department of Public Health, Prevention
and Wellness Trust Fund
• Leverage other Platforms: PCORI/PMSDN, UDN,
DBMI, AWS, …

15. Team
FPHS Core Team
• Leadership – Douglas MacFadden
• Technical Lead – James Drummey
• Project Management – Jillian Dudek
• Application Development – Phil Ayres (former)
• Data Manager – Zubair Butt
• DevOps Team - David Hummel
• FPHS Research Support Team – Lydia Bergen, …
Beth Israel
• Informatics Lead - Steve Berry
HU
• CISO – Christian Hamer
• Information Security Specialist - Miguel Sanchez
• Senior Database Administrator - Joel Fanton
• Manager, Database Administration - Sunil Saxena
Partners (ERIS)
• Lead Systems Analyst - Allan Harris
• Account Project Manager - Doug Shore
• Account Systems Support - Trevor Williams
• Account Systems Support – Fabio Martins (former)
• REDCap Systems Administrator – Lynn Simpson
• REDCap Systems Analyst - Dimitar Dimitrov
• Database Administrator - Eric Dyer
HMS
• CTO – Chris Botka
• CISO – Joe Zurba
• Information Security Engineer - Elmir Skaljic
• Director of IT Infrastructure - Paul Williams
• DevOps Team - Tim Hartman
• DevOps Team - Matt Nicholson

16. Questions?