Table 1.

Classification of digital therapeutics by purposes

Classification	Disease prevention and health function improvement	Disease management	Disease treatment
Regulatory oversight	The extent of regulation depends on local regulatory systems	Validation of efficacy and safety claims is conducted by a national regulatory organization or its equivalent	Validation of efficacy and safety claims is conducted by a national regulatory organization or its equivalent
Level of medical claims	Low to medium-risk claims	Medium to high-risk claims	Medium to high-risk claims
Clinical evidence	Clinical trials and ongoing evidence generation are required	Clinical trials and ongoing evidence generation are required	Clinical trials and ongoing evidence generation are required
Patient access	Nonprescription or Prescription	Nonprescription or Prescription	Prescription
Clinical endpoints	Delivering a therapeutic intervention while supporting product claims with clinical endpoints	Delivering a therapeutic intervention while supporting product claims with clinical endpoints	Delivering a therapeutic intervention while supporting product claims with clinical endpoints

Adapted from Digital Therapeutics Alliance [18], under the permission of Digital Therapeutics Alliance