Ethics of digital therapeutics (DTx)

Area of Science:

• Digital Health
• Artificial Intelligence (A.I.)
• Medical Technology

Background:

• Digital therapeutics (DTx) represent a growing segment of digital health, integrating A.I. and machine learning.
• Unlike wellness apps, DTx require rigorous clinical evidence and are emerging as novel treatment options.
• DTx applications span numerous conditions including diabetes, hypertension, mental health disorders, and neurological diseases.

Purpose of the Study:

• To provide an overview of the primary ethical concerns associated with digital therapeutics.
• To examine ethical issues related to the assessment, implementation, and utilization of DTx.
• To foster open and transparent deliberation regarding DTx in healthcare.

Main Methods:

• Literature review of current digital therapeutics.
• Analysis of regulatory approvals and market trends.
• Identification and discussion of key ethical challenges.

Main Results:

• Approximately 35-40 DTx products are available, with 8 regulatory approvals.
• The global DTx market was valued at USD 1.8 billion in 2018, projected to reach USD 8.9 billion by 2027.
• Ethical concerns arise in the assessment, implementation, and use of DTx within healthcare systems.

Conclusions:

• Digital therapeutics offer significant potential as new treatment modalities.
• Addressing ethical considerations is crucial for the responsible integration of DTx.
• Facilitating transparent dialogue is essential for the advancement of DTx in healthcare.