TABLE 4.

Multi‐dimensional assessment framework of mobile medical apps (MMAs). The DECALOGUE

Domain	Recommendation
MMA development and update	Shared decision‐making approaches to the development of apps can enhance the replicability of apps and ultimately lead to improved outcomes
Classification and evidentiary requirements	An unambiguous classification of MMAs should be associated with corresponding evidence generation requirements and the possibility to flexibly review the associated level of risk of every single MMA
Performance and maintenance monitoring	MMA manufacturers must ensure that technical system implementation does not threaten the overall effectiveness. Analytical validity must be determined by the manufacturers and a core set of indicators should be developed that are coherent with the MMA classification
Usability testing	Usability should be continuously monitored, both in the development phase of the solution and after its implementation in the field
Additional outcome domains	Besides conventional outcomes similar to all healthcare technologies, patient empowerment associated with use and potential environmental impact are distinguishing outcome domains of MMAs that, where relevant, should be appropriately measured and valued
Clinical evidence requirements	Flexible study designs that account for the specific characteristics of MMAs and can generate fast and efficient results should be adopted and coupled with flexible policy arrangements, based on the level of risk and the position in the product lifecycle of the app
Safety and security	The assessment of the risks related to data privacy, cyber security and misinformation and their potential impact are emphasized issues for MMAs
Equity considerations	Given the context of escalating inequalities and persisting technological divide, it is paramount to evaluate the net effect brought by MMAs on equity
Organizational assessment	The assessment of direct and indirect implications of the adoption of MMAs on the organizational level should focus on process, people, structure, culture or management impacts
Cost and economic evaluation	The evaluation of cost and economic impacts of MMAs should require no innovative forms and methodologies (reporting should follow established guidelines for economic evaluations), but rather new metrics for outcomes and different structures for cost