Digital Health Technologies

Digital Health Technologies 

Digital Health Technologies (DHTs) can be defined as an electronic method, system, product, or process that generates, stores, displays, processes and/or uses data within a clinical research or healthcare setting. The advantages of DHTs include the ability to collect rich high-resolution data in real-world settings outside of traditional research settings, such as clinics. Further integration of data from DHTs into clinical research supports development of preventive approaches, harm reduction strategies, and quality therapies to improve health outcomes. The potential for DHTs to elevate clinical research makes data from these technologies of interest to both researchers, and regulatory and health authorities. 

CDISC and the Digital Medicine Society (DiMe) have partnered to enhance interoperability and comparability of data across different DHTs and accelerate innovation in digital health through shared standards and common semantics. To this end, a volunteer team of diverse stakeholders is working to address opportunities for data standardization. 

Standards Development 

Standards development in 2024 is focused in the following areas: 

  • Key DHT Concepts in clinical research
  • Device Attributes that contextualize collected data 
  • Digital Endpoints collected using DHTs
  • Best Practices for using CDISC standards and DiMe resources with DHTs in clinical research. 
How to Participate 

We invite your organization to participate in this innovative initiative. Please visit the Participate tab to learn more. 


We are looking for volunteers with expertise and skills in the following areas to support standards development. 

Essential Skills 
  • Strong experience developing and/or using digital health technologies (DHTs) for data collection in clinical research. 
  • CDISC standards practitioners should have solid implementation experience with CDASH and/or SDTM , including SDTM standards for Medical Devices.
“Plus” Skills 
  • CDISC standards practitioners with experience implementing: 
    • SDTM QRS domain standards
    • ADaM standards
  • Some familiarity with FHIR/HL7 and/or other raw data standards and formats. 

The expected time engagement is a six-month commitment, or longer if able with ability to attend a one-hour weekly meeting. One to two additional hours may be requested per week for preparation, specialized workstream, and/or general standards development work, as needed. Weekly meetings and workshops are recorded and available for review. 

Please Join Us! 

To participate, please complete our Volunteer Form and indicate Digital Health Technologies on the form as the Standards Development team. 

Please contact us using the form below with questions and/or feedback regarding this initiative. If you are interested in volunteering, please navigate to the Participate tab.

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