The use of health apps is rapidly increasing. They intend to promote health or to treat diseases; in some cases, substituting medical duties. No specific frameworks to assess mHealth solutions in a broad scope and in a comprehensive way have been identified. We aim to propose a framework for mHealth assessment.

The framework development was based on:

• • Literature review to identify existing assessment models including the evaluation of health effects

• • Exploratory analysis with experts and user group discussions

• • Definition of the assessment model, following the domains of health technology assessment.

Existing frameworks are mainly focused on certification criteria. Professionals and users agreed on the need to undertake mHealth assessments as to better inform user decisions. Assessments should be sensible to continuous changes of these technologies and be undertaken by independent organizations.

The proposed framework offers a step-by-step process by which any mHealth solution can be categorized and analyzed, according to: (i) Risk classification matrix: combining intervention type and patient type, (ii) Users: patients, professionals, informal caregivers individually or all of these together and (iii) Integration: stand-alone, fully integrated.

The model has four evaluation domains: technical maturity, risks, benefits and resources needed, including the commonly accepted evaluation perspectives: technical, contents, clinical/health, user perspective, organizational and socio-economic. Sub-domains are defined as: end-user, organization, healthcare system and community (society as a whole). Aspects to be assessed are selected according to the purpose of the evaluation (intended use / intended impact) and vary depending on the type of the mHealth solution: product or service.

The mHealth assessment process is needed and should be: (i) continuous/iterative, providing timely conclusions and recommendations for improvement, (ii) inclusive/collaborative, involving all stakeholders,and (iii) constantly adapting to standards. The proposed framework is intended to support informed decisions when developing, integrating, selecting, recommending, or adopting mHealth solutions.