Research from Stanford Medicine and Empatica, Inc: Early Detection of COVID-19 Using Empatica Smartwatch Data
Tejaswini Mishra, PhD, Michael Snyder, PhD, Erika Mahealani Hunting, Alessandra Celli, Arshdeep Chauhan, and Jessi Wanyi Li from the Stanford University School of Medicine’s Department of Genetics, and Empatica Inc. are the recipients of the second-annual FPF Award for Research Data Stewardship. The collaboration between the research team from Stanford Medicine and Empatica, a medical wearable and digital biomarker company, assessed whether wearable devices could be used to detect COVID-19 infections prior to the onset of symptoms, producing valuable insights that have the potential to change how we monitor and address the spread of infectious diseases.
Robust privacy protections built into the project – including setting clear limits on the sharing and use of data, a third-party ethics review, the use of specially-designed research devices, and a comprehensive assessment of privacy and security practices and risks – ensured that individuals’ health information remained private throughout the data sharing and research process.
“A large part of our job is to embed research and its results into products that will improve people’s lives.” Said Matteo Lai, CEO of Empatica, “Patients are always at the center of this endeavor, and so naturally are their needs: privacy, a great experience, a sense of safety, high quality are all part of our responsibility. We are honored that this approach and care is recognized as something to strive for.”
The Research Project
Wearable devices such as consumer smartwatches continuously measure biometric data, including heart rate and skin temperature, that can act as “digital vital signs” informing the wearer about their health status.The collaboration between the research team at Stanford University, led by Michael Snyder, professor and chair of genetics, and Empatica, Inc, explored whether data from wearable devices can be used to detect COVID-19 infections prior to the onset of symptoms. To study whether digital health data from the Empatica E4 Wristband could be used to identify the onset of COVID-19, researchers received skin temperature, electrodermal activity, heart rate, and accelerometer data collected by wristbands worn by 148 study participants for 30 consecutive days. Additionally, researchers received usage compliance metrics for each participant in order to ensure participant compliance with approved study protocol. The research project is ongoing.
Data Protection Procedures and Processes in the research by Stanford Medicine and Empatica Inc.
- Establish Limits on Sharing & Use of personal health information (PHI) Data. As part of its legally binding collaboration agreement, Stanford Medicine limited the Stanford PHI data shared with Empatica to COVID-19 test dates and results. Furthermore, Stanford arranged for COVID-19 lab test reporting to be delivered directly to the School of Medicine, without allowing PHI access to Empatica, even though the company paid for the COVID-19 tests.
- Ethics Review. During the launch process, the Stanford and Empatica teams developed a research ethics protocol for submission to the Stanford University Institutional Review Board (IRB). The ethics protocol was approved by the Stanford IRB.
- Assessment of Privacy & Security Practices. Stanford employed QR codes to link specific participants with specific wearable device serial numbers, such that participant identifiers including names and study record IDs, which are usually sequential, were not shared with Empatica.
- Privacy & Security Risk Assessment. Researchers at Stanford and Empatica assessed potential security risks that could arise through their collaboration by initiating a Data Risk Assessment (DRA) by the Stanford University Privacy office (SUPO) to examine the systems set up by Empatica for privacy and security. Empatica readily provided all of the required materials and SUPO certified the project as “low risk.”
- Privacy-Protective Research Tools. The project used “researcher version” Empatica devices for the study, which have privacy-enhanced functionality that prevents the Empatica mobile app from collecting geolocation data, IP address, or International Mobile Equipment Identifiers (IMEI). Additionally, Stanford employed QR codes to link specific participants with specific wearable device serial numbers to ensure that participant identifiers, including names and study record IDs, were not shared with Empatica.
Lessons for Future Data-Sharing Projects
The data-sharing collaboration between the research team at Stanford Medicine and Empatica highlights a number of valuable lessons that companies and academic institutions may apply to future data-sharing collaborations.
- Work the Process. Empatica and the research team at Stanford Medicine established a clear process to obtain necessary approvals and maintain privacy protections throughout the research collaboration, including a comprehensive Data Risk Assessment, Institutional Review Board (IRB) review, and legal review processes. The research team at Stanford Medicine worked diligently to ensure that they adhered to all plans, processes, and frameworks throughout the research collaboration.
- Use Technology to Enhance Privacy. The Stanford research team and Empatica took advantage of technology, where possible, to promote privacy throughout the project. Stanford employed QR codes to prevent the need to share participant identifiers, including names and study record IDs, with Empatica.
- Use Privacy-Protective Research Tools. The project used Empatica’s special “researcher version” wearable devices for the study, which include privacy-enhanced functionality to prevent the Empatica mobile app from collecting unnecessary data that could negatively impact study participants’ privacy. Furthermore, Empatica’s devices store and transmit data in an encrypted manner, ensuring that participants’ data could not be accessed by unintended users.
- Collaborate Constantly & Responsibly. Empatica and Stanford researchers maintained active communication throughout the study, including weekly meetings to assess the progression of their collaboration, as well as any issues or needs related to their research project. Empatica team members have proactively offered to leave meetings to avoid PHI being shared with them or discussed in their presence, even accidentally.
The Selection Process
Nominees for the Award for Research Data Stewardship were judged by an Award Committee comprised of representatives from FPF, leading foundations, academics, and industry leaders. The Award Committee evaluated projects based on several factors, including their adherence to privacy protection in the sharing process, the quality of the data handling process, and the company’s commitment to supporting the academic research.