Working Group Recommends steps for using data from mobile health apps and wearables in research

The Robert J. Margolis, MD, Center for Health Policy at Duke University presented a set of recommendations aimed at advancing the use of data from mHealth apps and wearables for real-world evidence generation at a meeting in Washingtion, DC on Friday, September 15, 2017 from 2:00-4:00 pm.

The workshop, supported by a cooperative agreement with the U.S. Food and Drug Administration, presents a set of broad recommendations and next steps formulated by an expert working group and informed by a public webinar and stakeholder comments.

Mobile health (mHealth), particularly “patient/consumer-facing” apps and wearables that collect patient-generated health data, can fill key data gaps by providing real-time, high frequency, and/or longitudinal data on measurable outcomes that people care about. As these types of mHealth technologies are increasingly adopted for clinical use and in the consumer space, the data may be highly useful for more meaningful and relevant real-world evidence generation.

The recommendations of the multi-stakeholder working group throughout the healthcare and mHealth ecosystem cover a broad array of action steps aimed at designing mHealth technologies to provide long-term value to the patient/consumer as well as improving the collection and use of data for high-priority research and public health activities. The steps will help mHealth developers and companies with improving standardization, creating collaborations among the patient, clinical, and research communities and mHealth companies to advance the science on collecting and using mHealth data for evidence generation and ensuring that patients understand and can more efficiently consent to how their data may be used, and are kept informed of research developments resulting from their data contributions.

These include:

Establish a Learning mHealth Research Community to advance the development and use of person-facing mHealth technologies in evidence generation;
Help mHealth companies save development time and increase marketability with a research-capable design that returns actionable insights to patients and/or consumers to encourage long-term use;
Ensure efficient access to well-characterized, standardized, and robust patient/consumer-generated health data;
Use mHealth technologies to communicate with study participants to provide meaningful and understandable feedback of study progress and research results; and
Use mHealth to promote easier participation in research through the awareness and adoption of standardized approaches for informed consent and patient privacy starting by the adoption of reusable mobile-ready frameworks, incorporating clear guidelines, and providing a clear explanation on what information from users is collected and shared with external parties

Each recommendation is followed by specific action steps that can be taken immediately. Some of these steps require collaboration, but others can be undertaken by individual stakeholders.

Read the full report and watch the video

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