By Matt Gross

Nobody knows better than the FDA that gathering real world evidence is challenging.  A new initiative called FDA MyStudies offloads the burden of technology infrastructure while making participant engagement as easy as checking an Instagram feed or ordering an Uber.

Last week at HealthTech Build in the Boston Seaport an interactive audience learned how this new open source software initiative is now freely available for implementation by any research team.

To understand FDA MyStudies, it’s perhaps easier to walk through a scenario.  Imagine a team of researchers who are investigating the association between levels of physical activity and prediabetes.  They want to study a population of 1000 people at risk and measure their activity over the course of several months.

Once their study plan is approved, the research team decides to send an invitation to a list of patients from their institution who have expressed interest in research.  These patients receive an invitation on their phone by text message containing an enrollment token and a link to download the app which has been branded with the institution’s colors and logo.  

The patient installs the app and sees a consent form.  This consent explains how their data will be used and with whom it will be shared.  The patient enters their enrollment token (which confirms that they are the same person who was invited) and signs the form electronically with their finger.  With that simple action, the patient becomes a study participant who has formally given informed consent to share data in the study as regulated by federal law.

The researcher may wish to gather qualitative data throughout the study by asking a few questions.  The researcher logs into the companion administrative website and creates a short survey and send it out to all participants.

The participants receiving alerts about the survey may be standing at a coffee shop line or sitting on a bus.  With a few clicks, they can answer the questions and receive immediate gratification by means of a visual dashboard of their progress including graphs of their activity levels over time.

During the study, the research team has access to a dashboard of data insights.  After the study concludes, they have access to a deep record of activity and survey responses which can be exported into data analysis software.

It’s important to note that the entire platform is designed with security and privacy in mind.  The data is stored securely in an isolated environment that’s set up as a HIPAA compliant hosting environment by the research team and is inaccessible to anyone else including any of the organizations involved in this open source software initiative.  The data cannot ethically or legally be shared beyond the permissions granted by the participant during the consent process.

The FDA MyStudies technology platform was built in a collaborative effort by three organizations.

A front-end mobile application framework allows researchers to create a branded custom mobile app with very little effort.  Researchers can integrate both iPhones and Google Android phones in the same research study and utilize the appropriate phone research framework (Apple Research Kit and/or Google ResearchStack).  This integration makes it easy for the researcher to pull health data that exists on the phone, with the user’s permission, such as activity data, heart rate data, audio, and data collected from bluetooth devices.  Researchers can easily customize the content, for example by embedding educational content like videos to explain concepts. They can also create their own custom code within the applications to enable new features.  The code for the iPhone and Android apps was built and made freely available in open source format by Boston Technology Corporation.  The company also offers commercial services for custom development.

A back-end data platform provides HIPAA compliant storage.  This component was built by LabKey and is available under an open source license.  The software can also licensed commercially for larger or more complex research efforts.

The overall platform development was led by the Harvard Pilgrim Health Care Institute, an independent research group and longstanding partner of the FDA including the Sentinel national electronic monitoring system which queries data sources of large amounts of electronic healthcare data, such as electronic health records (EHR), insurance claims data and registries, from a diverse group of data partners.

The FDA MyStudies initiative is only a few months old.  Future software releases are in the works to bring more robust research capabilities to the platform.  As more research teams utilize the platform, and more software developers get involved in the open source effort, the program has the potential to become stronger and expand to a greater array of needs such as clinical care scenarios, clinical trials, and patient registries.

Many thanks to our presenters for their contributions:

  • Chayim Herzig-Marx – Director, Center for Distributed Analytics and Informatics Systems at Harvard Pilgrim Health Care Institute
  • Zac Wyner – Senior Health Informatics Analyst at Harvard Pilgrim Health Care Institute
  • McKinley Hackett – VP of Business Development at the Boston Technology Corporation
  • Mary Beth Schoening – Digital Health Strategist and Co-founder, Behavioral Health Innovators