Digital health technologies for remote data acquisition in clinical investigations: guidance for industry, investigators, and other stakeholders
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Devices and Radiological Health (U.S.), issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Oncology Center of Excellence (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, December 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Data Collection Digital Health Equipment Design Equipment Safety Government Regulation Medical Device Legislation Remote Sensing Technology -- standards United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- A digital health technology (DHT) is a system that uses computing platforms, connectivity, software, and/or sensors, for health care and related uses. This guidance provides recommendations for sponsors, investigators, and other stakeholders on the use of DHTs for remote data acquisition from participants in clinical investigations that evaluate medical products. There is a large spectrum of DHTs available for potential use in a clinical investigation. DHTs for remote data acquisition in clinical investigations can include hardware and/or software to perform one or more functions. Appendix A includes examples of DHTs that can be used for remote data acquisition in clinical investigations, such as wearables and software applications (including mobile apps). Depending on the intended use of a DHT, the DHT may meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance provides recommendations for ensuring that a DHT is fit-for-purpose (i.e., that the level of validation associated with the DHT is sufficient to support the use, including the interpretability of its data in the clinical investigation), which involves considerations of both the DHT’s form (i.e., design) and function(s) (i.e., distinct purpose(s) within an investigation). DHTs may rely on or work with other technologies that support their operation, such as general-purpose computing platforms (e.g., smartphones) and communication networks. Therefore, when implementing the recommendations in this guidance related to DHTs, sponsors should ensure that these other technologies are adequate to support the function(s) of the DHT. The recommendations in this guidance may be relevant to the other technologies used to support remote data acquisition in a clinical investigation.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (32 pages))
- NLM Unique ID:
- 9918751183606676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918751183606676