Digital Health Technology and Regulatory Overview
Digital Health Technology and Regulatory Overview
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This technology report provides an overview of the current landscape for digital health devices and software. This includes a summary of regulation and reimbursement policies and highlights of major product categories.
Author: Pharma Intelligence
Publisher: Meddevicetracker
- Description
- Contents
This report provides a technology and regulatory overview of the current landscape for digital health devices and software.
Topics covered
- the benefits of digital health technology
- an overview of major product categories and key products
- regulatory and reimbursement policies in the US, Europe, and Japan.
Contents
Digital Health Technology and Regulatory Overview …………………………………………………………………..1
1. Defining digital health ……………………………………………………………………………………………………1
2. Digital health benefits ……………………………………………………………………………………………………1
2.1 Digital therapeutics…………………………………………………………………………………….2
3. Regulation and reimbursement……………………………………………………………………………………….2
3.1 United States……………………………………………………………………………………………..3
3.2 Europe …………………………………………………………………………………………………….5
3.3 Japan …………………………………………………………………………………………………….7
3.4 Global …………………………………………………………………………………………………….8
4. Clinical trials …………………………………………………………………………………………………………………8
5. Products …………………………………………………………………………………………………………………8
5.1 Artificial intelligence/machine learning-enabled medical devices…………………….8
5.2 Cognitive assessment………………………………………………………………………………….9
5.3 Mobile applications…………………………………………………………………………………..10
5.4 Software-based devices…………………………………………………………………………….11
6. Bibliography ……………………………………………………………………………………………………………….12
Exhibit 1-1: Selected artificial intelligence/machine learning-enabled medical devices approved in the US……………………………………………………………………………………………….9
Exhibit 1-2: Selected cognitive assessment products………………………………………………………………….9
Exhibit 1-3: Selected cognitive assessment products in development…………………………………………10
Exhibit 1-4: Selected digital health mobile applications…………………………………………………………….10
Exhibit 1-5: Selected digital health software-based devices ………………………………………………………11
Exhibit 1-6: Selected digital health software-based devices in development……………………………….11
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