29.C. Workshop: Assessment, regulation and use of apps for health management: where we are and where we are going?
Authors:   Organised by: EUPHA Health technology assessment section, EUPHA Digital health section,   Chair persons: Carlo Favaretti - EUPHA-HTA
Published: October 2020

Abstract
Maintaining and improving health is one of the fundamental human right that may be pursued through the assurance of an equal and affordable access to health services to everyone. In this light, the growing use of mobile communication technology in the health sector is helping people to use preventive, diagnostic and therapeutic services more easily. In fact, through mobile communications technologies, also known as mHealth, people can have access to different services, namely doctors' consultations, follow-up visits, and medication management. From the side of health professionals, mHealth could allow to streamline tracking patients' data and making a timely use of patients' health data. Eventually, mHealth could also affect citizens, patients and health service as a whole, improving monitoring, reducing hospital admissions and enhancing education. Available data on the use of mobile technology among population let mHealth, and in particular mobile health applications (health apps), be a cutting-edge tool for the management of population health. In witness of this, the NICE is developing a system for evaluating health apps following its experience in the healthcare technology assessment (HTA) program. Furthermore, new HTA-like framework, i.e. The Model for Assessment of Telemedicine Applications (MAST), and new guidance for health apps assessment have been proposed. In fact, health apps may be considered as a health technology and may be classified as medical device considering that the new regulation of the European parliament 2017/745 includes among medical devices software intended to be used, alone or in combination, for human beings for one or more specific medical purposes. Even though current statistics show that health apps are not among the top downloaded apps, it may be guessed that their use will increase in the next years because of observed general trend and health digitalization. In this light, where do we are in terms of regulation and assessment of health apps? From the regulatory viewpoint, Germany is playing a forerunner role as it is working in order to make health apps prescribed for patients. Anyway, this policy calls the attention on the value of using apps in the management of citizens' and patients' health. Considering the implications of the use of health apps not only in terms of effectiveness and safety, but also with respect to - among the others - privacy, usability and interoperability, a multidisciplinary approach is envisaged to assess their impact. HTA could therefore foster a comprehensive evaluation and enable the involvement of health apps users in the assessment process. This workshop will address these topics through a) a description of the current state of the art of health apps regulation; b) an overview of available HTA evaluation of health apps: c) a focus on the available evidence on the impact of health apps on clinical outcomes, with specific reference to the field of mental health.

Key messages
Health apps can improve population’s health management. International lessons on designing evaluation pathways to reimbursement can offer insights for the establishment of new systems. The evaluation of health apps deserves further development as only effectiveness and technical aspects are commonly evaluated.