What Are 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 environments, such as clinics.
Further integration of DHT data into clinical research supports the 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 researchers, regulatory bodies, and health authorities alike.
The CDISC + DiMe Initiative
CDISC and the Digital Medicine Society (DiMe) have partnered to enhance the interoperability and comparability of data across different DHTs, and to 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 is focused in the following four areas:
- Key DHT Concepts — core concepts for applying DHTs in clinical research.
- Device Attributes — attributes that contextualize the data a device collects.
- Digital Endpoints — endpoints collected using digital health technologies.
- Best Practices — guidance for applying CDISC standards and DiMe resources to DHTs.
Participate
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 and/or 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 the 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.