The Duke-Margolis Center is working to advance the development of new sources of data for the evaluation of medical products. The growth and sustainability of real-world evidence generation would be greatly enhanced by inclusion of data from apps and wearables, to complement existing data sources (registries, electronic health records, medical claims and other real-world data). The medical device field, in particular, would benefit from increased longitudinal information on safety and durability, as serious issues are often not immediately obvious.
Duke-Margolis has formed a working group tasked with creating an action plan on how to advance the use of data from mHealth apps and wearables for secondary research. In order to inform the working group’s action plan, Duke-Margolis is hosting a webinar to solicit feedback from interested stakeholders on the following topics:
- What are best practices to incentivize patients to regularly engage with mHealth apps and wearables to ensure their sustainability as partners in the evidence generation process—including people that do not consider themselves “patients”? How do these incentives have the potential to bias or confound the data?
- Can data from apps and wearables used for wellness or clinical practice be considered valid data for medical product evaluation? What characteristics define various fit-for-purpose?
- What are the priority outcomes measures that would be improved by more frequent or sustained collection in a real-world setting?
- What incentives exist to encourage mHealth developers to add this functionality to their products?
Duke-Margolis also welcomes public comments on this topic. Please send your thoughts to firstname.lastname@example.org by July 12, 2017.