The Football Players Health Study at Harvard:Informatics Platform

Chris Botka, Chief Technology Officer, HMSJoe Zurba, Information Security & IT Compliance Officer, HMSDoug MacFadden, Chief Informatics Officer, Harvard Catalyst

April 26, 2016

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GOALThe 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.

New Prevention Strategies,Diagnostics & Treatments

Researchers working on innovative and promising developments thathave the potential to impact the health of football players.

PILOT STUDIES

POPULATION STUDIESHealth Status & Quality of Life

Using questionnaires and testing to better understand player health and wellness.

PLAYERS & SCIENTISTSAdvice and Guidance

LAW & ETHICS

Understanding the legal and ethical issues that promote and impede player health and developing responsive recommendations

Promoting Player HealthThrough Structural Change

The Whole Player, The Whole Life

Timeline

2016Jan Apr Jul Oct 2015 Apr Jul Oct 2016 Apr Jul Oct

Contract signed with NFLPA2/2014

9/2014Pilot Questionnaire Launched

1/2015Full Questionnaire Launched

Largest study of living former players (2570 enrolled)10/2015

Pilot Listening Tour Launched11/2015 TeamStudy App launched

3/2016 Target for in-person assessments beginning9/2016

2014

Data

FINDINGS

Issues to AddressResults Hypotheses to

TestKnowledge

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, …)

Central Data Platform Logical ArchitectureResearch

Team Virtual

Desktop

Research Team Virtual

Desktop

Research Team Virtual

Desktops

Central Player Database

Q1 SurveyLaw and Ethics

Interviews

Sage Mobile App Imaging

Additional Research Protocols

Coded Data

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, …)

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

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.

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

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

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

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, …

TeamFPHS 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

Questions?