The document reports the activities of the Health Technology Assessment and the overall result of the standards and regulations specific to the field of Digital Health. This report has been organized into 2 parts that are summarized below. The first part provides a report on the health technology assessment, following a method proposed by the EU network of HTA (HTA CoreModel) and analyzing the proposed technology from different viewpoints that are: The current clinical context details the clinical problem and the current available solutions and approaches. Description and technical characteristics of the solution shortly present the CAPABLE solution. Safety aspects are described as incidental findings and risks associated with the use of CAPABLE. Clinical effectiveness of the solution, which briefly describes the main result of the clinical study. Cost and economics that depicts the overall costs for the deployment of the solution. Ethical analysis details the solutions that were adopted during the pilot studies to prevent or address any ethical issue. Organizational aspects section details the requirement at an organizational level to uptake the solution. Patients and social aspects section details the burden of patients and caregivers and how a system like CAPABLE is perceived. Legal aspects detail the legal frameworks to be followed in order to use the CAPABLE solution. The second part of the document focuses on the standardization practice considering two levels: Standardization of the information managed by the CAPABLE system. The required standardization following the Medical Device Regulation.

This deliverable is a part of a project receiving funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No. 875052