Prescription Digital Therapeutics

Uses

Benefits

Risks & contraindications

Comparisons

Highlighted claims

• Policy gaps in PDTx can delay market entry, complicate clinical use, and limit patient access to evidence-based digital therapies. — Developing a policy maturity model for prescription digital therapeutics based on expert consensus: protocol for an eDelphi study
• Current PDTx adoption is hindered by variation in regulatory classification, approval mechanisms for software as a medical device, reimbursement arrangements, healthcare infrastructure, interoperability, professional training, and patient access. — Developing a policy maturity model for prescription digital therapeutics based on expert consensus: protocol for an eDelphi study
• Prescription digital therapeutics are software-based healthcare interventions intended to prevent, manage, or treat specific diseases. — Developing a policy maturity model for prescription digital therapeutics based on expert consensus: protocol for an eDelphi study
• PDTx differ from general consumer health apps because they are expected to meet evidence-based standards comparable to medicines or medical devices, including clinical validation, regulatory oversight, and post-market surveillance. — Developing a policy maturity model for prescription digital therapeutics based on expert consensus: protocol for an eDelphi study
• The policy environment for PDTx remains fragmented, with countries differing in how they classify, authorise, reimburse, and integrate them into healthcare systems. — Developing a policy maturity model for prescription digital therapeutics based on expert consensus: protocol for an eDelphi study
• Digital health technologies including PDTx may help address unmet needs in chronic disease management, mental healthcare, and personalised medicine. — Developing a policy maturity model for prescription digital therapeutics based on expert consensus: protocol for an eDelphi study