Computational Medicine Legal Accelerator
Health data contains rich patterns and information that, if made available to machine learning researchers, could lead to breakthroughs in diagnosis and patient care. However, this data is siloed and fragmented within different medical and research institutions. Efforts that aggregate clinical data of patients across institutions are urgently needed. However, every time an institution gains access to patient data at another institution, there is a legal process that must take place, typically involving a data sharing agreement and / or Institutional Review Board approval. The COVID-19 crisis has made obvious what many researchers already knew: necessary and important legal agreements can slow their access to data significantly.
Our fundamental goal is to safely get more health data into the hands of machine learning researchers faster, while maintaining the critical legal review process involved in sharing health data between institutions.
The Toolkit
Based on our extensive user research, we designed a series of tools to expedite the review process involved with inter-institutional data sharing. By using our developed tools, institutions can expedite review processes that otherwise delay research on average by 6-12 months.These tools are customizable and designed to fit within the current knowledge sharing infrastructure of an institution while providing consistency from cross-institution collaboration.
- A legal white paper by Ropes and Gray detailing the current landscape of data sharing for computational medicine research.
- A guide for sharing health data including a fillable research cover sheet, an issues guide and a red flag checklist for researchers.
- Review process flow maps and templates showing the review process at example institutions and allows anyone at an institution to outline their own review process.
- An annotated template data use agreement (DUA) which significantly simplifies requirements compared with most data use agreements in use today while maintaining core structure and provisions.
- A downloadable clean DUA legal teams can use to streamline negotiations.
If these tools have helped you and your team--let us know at CMLA@chicagobooth.edu
The Coalition
To improve the current data-sharing process and advance science, we are building a coalition of individuals across institutions committed to a shared understanding of the issues and to making improvements in their communities of practice or home institutions. This group currently consists of 15 individuals across 11 institutions working to improve the process of data sharing for computational medicine research. If you are interested or involved in the data sharing process at your institution, we would love to hear from you!
Our Progress
At this stage, we are pleased to report we have completed the deliverables of this project in the form of the toolkit of resources you see linked above. In 2022, we will continue to work with our partners to build awareness and uptake of this toolkit in the hopes that research in the health sciences can benefit from a streamlined legal process for data use. We are grateful to our friends at Nightingale Open Science for assisting us in this followup phase of the project.
In the first six months we completed the first phase of our project, which was focused on user research. We interviewed 30+ people across 13 different institutions to better understand the current data sharing process within the university research ecosystem, and built a coalition of 15 advocates and advisors, diverse in title and institution, committed to helping us shape tools that address the legal process challenges we identified in our user research.
The output of this phase was to identify three core deliverables to be completed in the first half of 2021: a template DUA, a data sharing process flow chart template, and a guided set of worksheets for data sharing. These tools will help lawyers, principal investigators, researchers, reviewers, and other administrators at institutions address challenges we discovered across training, legal review, and process efficiency.
We are hopeful that these tools will help principal investigators, reviewers, and others at research institutions in addressing challenges we discovered pertaining to training, legal review, and process efficiency.
The Team
Amy Pitelka
Amy Pitelka is the chief legal officer of Nightingale Open Science, and the founder of Barker Pitelka PLLC, a legal and policy strategic advisory firm focused on technology startups and social good organizations. Prior to starting her own firm, Amy was the Acting Deputy Administrator and lead Counsel for the United States Digital Service at the White House, where she focused on identifying, combating, and removing key legal and policy hurdles to the USDS’s ongoing efforts to revolutionize the federal government’s use of technology in delivering services to the American people. In her time at the USDS, Amy led the legal effort to unlock key datasets used for health benefits administration to additional human services programs administered by states and counties across the country. Amy has also worked at Dropbox, Google, and Kirkland & Ellis International LLP. She graduated from Harvard Law School.
Amy Pitelka
Stephanie Nguyen
Stephanie is a principal designer and researcher focused on data privacy, product design and policy, exploring ways to measure and test privacy and security in consumer connected digital platforms and services. She is an appointed member with the IEEE Standards Association’s Global Advisory Council. Previously, she was a research scientist at MIT Media Lab focused on translating data privacy policy into design and development for data-collecting platforms. Stephanie has conducted global field research and usability testing for citizen- facing technology and services. She led user experience and privacy focused design for projects in healthcare with the National Institutes of Health’s All of Us project and Johns Hopkins’ Precision Medicine team. At U.S. Digital Service under the Obama Administration, she led design work at the Departments of Education, State and Health and Human Services on improving public interest technology. Stephanie received a Masters in Public Policy at Harvard Kennedy School and a Bachelor of Arts in Digital Media Theory and Design at the University of Virginia.
Stephanie Nguyen
Linda Pantale, '20
Linda Pantale has worked as a project manager and research assistant on several CAI initiatives, most recently the Economic Precision Epidemiology project and the Legal Accelerator. She has a background in higher education administration and strategy and recently finished her MBA at Chicago Booth, focusing on strategy, entrepreneurship, and behavioral science.
Linda Pantale, '20Join Our Mailing List
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