FDA Wants You – Wearable Data for Drug and Device Safety Surveillance

Health Consulting

Health tech disruptors creating in-home monitoring and wearable technologies that collect health data may be interested to know that the FDA is getting into the business of what they call “Real World Data (RWD).” RWD is data, often collected directly from the user or patient and provides information on  their health beyond a clinical encounter, like a visit to the doctor. This month the FDA awarded over $200 million to fund the next five years of their drug surveillance data program, The Sentinel Initiative.

The FDA’s vision, based on their Initiative, is to expand upon use of real-world data sources in order to enhance evaluation of medical product/drug performance. To achieve this aim, the new Sentinel award will include funds for an innovation center that focuses on developing and syncing with new technologies that funnel RWD to the FDA’s Sentinel Initiative.

The FDA is exploring new avenues of user-derived information beyond intended investments in accessing and use of EHR data. Currently, the agency has little to no access to data regarding the real-world experiences of patients that focus on their personal perspective, such as:

  • improvement or decline in ability to perform Activities of Daily Living (ADLs)

  • whether the medical device or drug helps or hinders

  • if a medication causes depression or boosts mental outlook

New projects must explore the effectiveness of information received from patient-derived data. That implies direct engagement with users inside and outside the scientific community. The FDA stated in its Sentinel Five Year Strategy, that wearables, mobile health technologies, and other wireless technologies will be data sources important to their surveillance efforts.

To keep up health technology activities at the Sentinel’s new Innovation Center, tune in here.

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