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Project Overview

R11WG7 - CTA-2109, Evidence Based Performance Criteria for Digital Therapeutics

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Project Type:
American National Standard (ANSI)
Project Contact:
Emily Hoefer
Project State:
Voting
Updated:
2023-04-27

Start: 2021-10-04 Est. Complete: 2022-10-31

80% Complete
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Project Details

Project Description:

This standard will define what evidence-based criteria should be used to meet definition for DTx.

Designation of Proposed Standard:

CTA-2109

Title of Standard:

Evidence Based Performance Criteria for Digital Therapeutics

Project Need:

To define what evidence-based criteria should be used to meet definition for DTx.

Project Intent:

Create new ANS

Includes text from ISO or IEC standard?:

No

Scope Summary:

This standard will define what evidence-based criteria should be used to meet definition for DTx.

Keywords:

evidence based, digital theraputics, digital health

Consumer Product:

Yes

Identify Stakeholders:

consumers, manufacturers and retailers

Unit of Measure:

US

Public Review:

45

Order Paper Copy From:

standards@cta.tech

Send Comments To:

standards@cta.tech