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June 14, 2024   
Health Law Weekly

NIH Develops Key Considerations and Sample Language for Informed Consent for Research Using Digital Health Technologies

  • June 14, 2024
  • David Peloquin , Ropes & Gray LLP
  • Leslie Thornton , Ropes & Gray LLP
  • Carolyn Lye , Ropes & Gray LLP
Digital Health

On May 20, 2024, the National Institutes of Health Office of Science Policy (NIH OSP) released a resource document entitled “Informed Consent for Research Using Digital Health Technologies: Points to Consider & Sample Language” (Resource), which provides key considerations and sample language for research teams and Institutional Review Boards (IRBs) to use when developing and conducting studies that utilize digital health technologies, such as wearable devices, sensor technologies and mobile software applications. The Resource aims to assist researchers in developing materials that promote potential study participants’ understanding of the unique data privacy and security risks created by digital health technologies. NIH OSP finalized the Resource after considering comments received in response to a Request for Information issued on October 11, 2023.


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