Considerations for Incorporating Digital Health Technologies into Federal Health Research Studies

Background

The All of Us Research Program is a historic effort to gather data from at least 1 million people in the US. Its goal is to accelerate research and medical breakthroughs and enable individualized prevention, treatment, and care—the program's core values, including diversity, transparency, and accessibility, guide All of Us. The program creates a national research resource to inform thousands of studies covering various health conditions.

Researchers use data from the program to learn more about how individual differences in lifestyle, environment, and biological makeup can influence health and disease. Over 820,000 adult participants have enrolled in All of Us since 2017, including over 560,000 who have authorized the sharing of EHR data. All of Us comprises a partner network of more than 100 organizations supporting community outreach and engagement, participant enrollment and retention, study operations, and longitudinal cohort management. Most program participants have enrolled with support from a network of HPO partners, including medical centers, Federally Qualified Health Centers, and US Department of Veterans Affairs medical centers.

The primary scientific objectives of the All of Us Research Program include understanding health and disease determinants, predicting disease, and developing precise treatment and prevention strategies. Currently, the program collects electronic health records, biospecimens, surveys, physical measurements, and digital health technologies (DHT). DHT like wearable fitness trackers are integral in collecting real-time health data outside clinical settings. DHT are not limited to wearable devices and may include computing platforms, software, and sensors for health care related use. To meet the program's goals, the data generated by these devices must be analytically and clinically valid. Analytic validity ensures the accuracy and reliability of data measurements, while clinical validity ensures the data's relevance to health outcomes.

The program distributes Fitbits devices to a subsample of participants and collects other digital health data from Apple Health for those participants willing to share it. As the program grows, a robust framework for evidence-based decision-making will ensure that program resources are utilized cost-effectively and scientifically grounded. 

Overall Project Objective and Mission

This project aims to inform All of Us about evaluating digital health technologies for analytic and clinical validity and examples of their application. The objective will be to produce a comprehensive white paper addressing relevant digital health technologies, a framework to evaluate these technologies, and the application of the framework to a few use cases.

Project Approach

We recommend that the project team consider the following four primary activities as follows:

1.    Catalog Development: Develop a catalog of future digital health technologies the program could use, aligned with the All of Us Scientific Priorities Roadmap. (See Appendix A). This activity might include market research and a literature review. In addition, a review of successful government or industry uses of digital health technologies for longitudinal research studies, particularly focusing on clinical translation of research results, may support the inclusion of technologies into the catalog.

2.    Evaluation framework: Develop an evaluation framework for All of Us to assess, prioritize, and select digital health technologies for analytic and clinical validity and the broader socio-technical issues identified for future data collection. This activity might include a literature review and synthesis. Considerations for the evaluation framework could include:
a.    Policy and regulatory considerations
b.    Device availability 
c.    Device accessibility and literacy
d.    Device performance compared to benchmark reference 
e.    Device data quality (e.g., validity and reliability)
f.    Cybersecurity considerations
g.    Connectivity (i.e., Bluetooth) and data transmission   
h.    Public health impact of disease

3.    Use Cases: Apply the evaluation framework to two or three of the digital health technologies described in the catalog, with a preferred focus on one for environmental data (e.g., home monitoring devices or wristbands) and another for continuous biometric monitoring. The technologies should be relevant for longitudinal research studies, public health, and clinical research/translation. The description of use should include the process for implementing the technology into the All of Us platforms for longitudinal data collection.

This review will also incorporate existing and suggested evaluation frameworks for device selection, providing a solid foundation for the proposed research. Specifically, the focus is on assessing the clinical validity of digital health technologies, including their performance and impact on clinical practice, by ensuring that a test is accurate, reliable, and clinically relevant.
We recommend applying the suggested framework to two to three case studies with digital health technologies described in the catalog. A preferred focus for the use case studies includes one for environmental data (e.g., home monitoring devices or wristbands) and another for continuous biometric monitoring.

Duration and Timeline 

The All of Us Research Program will meet with the ACT-IAC COI team every other week for four months to finalize the project plan and complete the agreed upon deliverables. Additional meetings will be held as needed by the COI with the All of Us Research Program to address important questions on the program. The project will commence as soon as the COI team has been finalized, in agreement with the All of Us Research Program.  It is anticipated that the project will take about six months to complete.

Outcomes

1.    White Paper: A white paper addressing the three items outlined in the overall project objective and mission section.  This will be disseminated to the public at the discretion of ACT-IAC and will be a product of ACT-IAC. This paper will be disseminated to All of Us Program for program use.
2.    Briefing: At the mid-way point of the project and at the conclusion, the ACT-IAC team will brief the All of Us Research Program on their project status and final findings.
3.    Slide Deck: A final slide deck will be produced, as used in the final project briefing, and delivered to the All of Us Research Program for program use. ACT-IAC will also make it available at their discretion.

Membership

We are seeking volunteers with:

• Digital Health Technology Expertise - deep domain expertise with environmental and biometric devices.  This includes device selection, quality assessments, SWOT analyses, testing, and implementation.  
• Policy / regulatory expertise

The deadline to sign up as a volunteer is August 26, 2024. 

For inquiries about participation in this project, please contact Reneta Din at [email protected]. 

Appendix A.