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• Are there any ethical or legal obligations for HealthySensors aside from those that apply to third party vendors collecting user data?
• Is “bundled consent” for the Piggyback study ethical, given the incentives for participation in the wellness program?
• What are consent best practices?
  • Should the company broker consent? What if the company’s consent or privacy policies change during the course of the researcher’s study?
  • Should the researcher obtain consent at the beginning of the study, independent of the company?
  • The standards for PGHD-based consent are changing more quickly than research protocols. Are there any concerns for longitudinal studies that have not budgeted for changes in participant expectations for privacy, consent, and security?
  • What other concerns should be raised about use of PGHD in research?
  • Different private organizations have different mechanisms related to terms of use and how personal data will be governed (e.g. Withings and Sage have different policies). Would different standards for these agreements clarify restrictions for both users and researchers (e.g. the way that different open-source software license standards have different, but known and well understood, terms)?
  • If participants submit additional data as part of their activity tracking (e.g., weight, exercise and meal regime, sleep patterns, mood), do concerns arise over the sensitivity or identifiability of this data? Should another consent be completed to cover the additional data collected from the individual?
    • Is additional consent required for the study of this data vs. the data automatically recorded by the sensor?
    • Are there any employer obligations for data collected under the wellness program under GINA or ADA?
    • What privacy and consent consideration arise if the device platform includes functionalities such as voice recordings (e.g., goals, mood, responses to optional surveys)?

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