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Connected Health is an emerging and rapidly developing field never before witnessed across the healthcare sector. It has the potential to transform healthcare service systems by increasing its safety, quality and overall efficiency. However, as healthcare technologies or medical devices continuously rely more on software development, one of the core challenges is examining how Connected Health is regulated – often impacting Connected Health innovation. The purpose of this paper is to present an understanding of how Connected Health is regulated. Many of these regulatory developments fall under “medical devices”, giving rise to Software-as-a-Medical Device (SaaMD).

Through an extensive literature review, this paper demystifies Connected Health regulation. It presents the outcome of expert discussions which explore the key regulatory developments in the context of Connected Health to provide a practical guide to understanding how regulation can potentially shape healthcare innovation.

Several key issues are identified, and the authors present a comprehensive overview of regulatory developments relating to Connected Health with a view to support the continued growth of IT-enabled healthcare service models. The authors also identify the key challenges in Connected Health and identify areas for future research.

A key outcome of this research is a clearer understanding of the opportunities and challenges that regulation and standards present to Connected Health. Furthermore, this research is of critical importance in a first attempt towards recognising the impact of regulation and standards compliance in Connected Health.

Gamification unlocks unprecedented opportunities in healthcare, wellness and lifestyle context. In this scenario, by leveraging on such an approach, information technologies now enabled gamification-based mobile applications primarily employed in health and wellness contexts, focusing on areas such as disease prevention, self-management, medication adherence and telehealth programs. The synergistic integration of gamification-based methodologies in conjunction with the utilization of digital tools, (e.g. as for Internet of Things, mobile applications) for the realm of digital therapeutics (DTx), thus unveiled powerful approaches and paradigms, yielding innovative applications that, through the harnessing of sensors and software-based systems, transform healthcare maintenance, wellness and lifestyle into an engaging pursuit, as a game. This paper explores the factors influencing individuals' intention to autonomously utilize mobile gamification-based apps for self-care and wellness maintenance.

Through explorative research designs an experiment has been conducted among a sample of 376 participants regarding the use of a fictitious gamification-based DTx solution, consisting in a mobile app namely “Health'n’Fit”.

Findings from an experiment conducted with a sample of 460 participants shed light on the possible antecedents and consequents of gamification. Results of the SEM model indicate that customization (CU), trust (TR), mobility (MO) and social value (SV) are the main determinants, although at a different extent of the playful experience; Moreover, gamification positively impacts attitudes and, in turn, perceived usefulness, intention to use and behavioral intentions.

This paper offers a dual-pronged approach that holds practical significance in the realm of healthcare innovation. First, the authors delve into the antecedents shaping individuals' intention to engage with gamification-based DTx, unraveling the factors that influence user adoption. Beyond this, the authors extend their focus to the realm of healthcare service design. By harnessing the potential of gamification and technology, the authors illuminate pathways to conceptualize and create novel healthcare services. This work not only identifies the building blocks of user engagement but also serves as a guide to innovatively craft healthcare solutions that leverage this amalgamation of technology and gamification, contributing to the evolution of modern healthcare paradigms.

In a social context, the paper introduces pioneering technological synergies that merge gamification and DTx to enhance individuals' health and wellness maintenance. By proposing innovative combinations, the authors present novel avenues for promoting healthier lifestyles and behavior change. This not only underscores the potential of technology to positively impact individuals but also highlights the significance of aligning technological advancements with societal well-being. As the research advocates for these innovative solutions, it reinforces the importance of collaborative technological and marketing endeavors, ultimately contributing to the betterment of society as a whole.

This is the first paper exploring the combined effect of gamification and DTx, by shedding light on the peculiarities of both the antecedents of individuals' intention to use such combined technologies.

The adoption of electronic health records (EHRs) and digitization of health data over the past decade is ushering in the next generation of digital health tools that leverage artificial intelligence (AI) to improve varied aspects of health system performance. The decade ahead is therefore shaping up to be one in which digital health becomes even more at the forefront of health care delivery – demanding the time, attention, and resources of health care leaders and frontline staff, and becoming inextricably linked with all dimensions of health care delivery. In this chapter, we look back and look ahead. There are substantive lessons learned from the first era of large-scale adoption of enterprise EHRs and ongoing challenges that organizations are wrestling with – particularly related to the tension between standardization and flexibility/customization of EHR systems and the processes they support. Managing this tension during efforts to implement and optimize enterprise systems is perhaps the core challenge of the past decade, and one that has impeded consistent realization of value from initial EHR investments. We describe these challenges, how they manifest, and organizational strategies to address them, with a specific focus on alignment with broader value-based care transformation. We then look ahead to the AI wave – the massive number of applications of AI to health care delivery, the expected benefits, the risks and challenges, and approaches that health systems can consider to realize the benefits while avoiding the risks.