FEBRUARY 2019 – Innovation at the FDA: Introduction to MyStudies, An Open Source App and Platform for Patient Research

Join us for our kickoff event for 2019!

When: February 5th, 5:30 – 7:30PM
Where: WPI Seaport, 303 Congress Street, Boston
Space is limited and pre-registration is required – Register Now

Join us for networking and a cutting-edge discussion of the FDA’s new open source research app platform called MyStudies. This new digital platform, announced in November 2018, enables researchers and developers to adapt MyStudies technology to advance new ways to access and use data collected directly from patients—with the necessary controls in place to ensure patient privacy, compliance with regulations and assist with safety monitoring. Data can be collected from a variety of sources, such as patient-generated and provided data including in home-use settings, or from data gathered from other sources, such as mobile device and external sensors.

Hear from Harvard Pilgrim Health Care and Boston Technology Corporation, two of the companies contracted by the FDA to create the open-source HIPAA and FISMA compliant platform that will encourage the development and use of mobile health technology for real world evidence collection and patient engagement. The open source code that serves as the foundation of the MyStudies platform, as well as specifications for a secure patient data storage environment, were developed through a collaboration with Harvard Pilgrim Health Care Institute, LabKey and Boston Technology Corporation.

This event is intended to convene diverse groups interested in advancing research using these and other tools. We expect a mix of attendees including medical researchers, clinicians, academia/students, data scientists, public health specialists, app developers, UX designers, big data analysts, entrepreneurs, HIT, VCs and more.

Speakers include:

Chayim Herzig-Marx is the Director of the Center for Distributed Analytics and Informatics Systems within the Harvard Pilgrim Health Care Institute. He is responsible for a portfolio of informatics systems and applications, primary of which is the PopMedNet™ system that provides a secure infrastructure for several distributed research networks, including the FDA’s Sentinel System, the Patient-Centered Outcomes Research Institute’s PCORnet, and the National Institute of Health’s Healthcare Systems Research Collaboratory.

Zachary Wyner, MPH, is a Senior Health Informatics Analyst in the Department of Population Medicine at the Harvard Pilgrim Healthcare Institute. He oversees development of the PopMedNet Sentinel Query Tool and serves as the technical lead on behalf of FDA for projects that utilize the FDA My Studies system.

McKinley Hackett is the VP of Business Development for Boston Technology Corporation, an award-winning software development company, specializing in web and mobile applications for the healthcare industry.

Mary Beth Schoening is a Digital Health Strategist and Co-founder of Behavioral Health Innovators. She is focused on identifying best practices and gaps in screening, early intervention and treatment of behavioral health conditions, conducting journey mapping research, and developing innovative, technology-enabled digital health models to fill the gaps.

Doors open at 5:30PM and the discussion and Q&A will run from 6:00-7:30PM. Light refreshments will be provided. Space is limited so please register early to secure your spot.

Join us for our first event of 2019: a partnership between HealthTech BuildApple ResearchKit Meetup Group, and Behavioral Health Innovators.

Thank you to Boston Technology Corporation for sponsoring this event and to WPI for hosting this event.