Regulatory Readiness

Cross-source consensus on Regulatory Readiness from 1 sources and 3 claims.

1 sources · 3 claims

How it works

Some health authorities have developed specialised approval pathways and reimbursement codes for PDTx, while others place them under broad mobile health categories. — Developing a policy maturity model for prescription digital therapeutics based on expert consensus: protocol for an eDelphi study
The regulatory readiness domain of the framework assesses whether the system has clear regulatory capacity for PDTx, including classification, oversight, and software as a medical device policy. — Developing a policy maturity model for prescription digital therapeutics based on expert consensus: protocol for an eDelphi study
Post-market oversight descriptors in the framework will assess real-world evidence expectations, safety monitoring, and feedback loops. — Developing a policy maturity model for prescription digital therapeutics based on expert consensus: protocol for an eDelphi study