Standards Development

Scope

This PAS gives recommendations for performing clinical studies to generate clinical evidence in the pre-market phase and real-world data in the early implementation post-market phase involving digital mental health technologies (DMHTs) that qualify as software as a medical device (SaMD).

NOTE 1 This PAS might be useful for products that are not classed as medical devices in some jurisdictions, including AI.

This PAS covers the generation of clinical evidence during the pre-market phase and early implementation post-market phase in order to:

•           estimate and evaluate the associated benefits and risks during the pre-market period;

•           assess real-world performance of DMHTs in the early stages of implementation; and

•           monitor the effectiveness, safety and engagement of DMHTs.

This PAS is of use to those involved in the clinical study process (which demonstrates and monitors the benefits, risks and acceptability of the benefit/risk profile throughout the lifetime of a device,) and sponsors of DMHTs.

This PAS might be of use to:

•           other entities involved in the DMHT life cycle, including those conducting and assessing clinical evaluations of DMHTs; and

•           clinical studies conducted following commercial release of the SaMD.

This PAS does not cover early-stage feasibility studies or health economics.

NOTE 2 Early-stage feasibility studies are an important part of the overall package of evidence. See the 2021 IMDRF Post-Market Clinical Follow-Up Studies for further information[1]).

NOTE 3 While this PAS does not cover all post-market surveillance practices, it does apply to post-market follow up studies.