Εφαρμογές υγείας και φορετές συσκευές στην έξυπνη υγεία. Προκλήσεις και προοπτικές για τα δεδομένα υγείας
Health apps and wearable devices in smart health. Challenges and perspectives for health data
KeywordsDigital health ; Smart health ; Smart hospitals ; Wearables ; Health apps ; Internet of Things ; Sensors ; Medical devices ; Privacy ; Data protection ; Regulatory compliance ; Έξυπνη υγεία ; Τομέας υγείας ; Ιδιωτικότητα ; Προστασία προσωπικών δεδομένων ; Ασφάλεια ; Τεχνητή νοημοσύνη ; Έξυπνες πόλεις ; Δεδομένα υγείας ; Health data ; Data concerning health ; Αισθητήρες ; Διαδίκτυο των Πραγμάτων
The footprint of our era, the Information Age, in the modern globalised market is determined by the value of information, which has been elevated to a maximum degree. However, data flows are gradually elevating "things", marking the transition from the analogue to the digital world, blurring their boundaries. In the new digital world, 'things', by gaining a degree of autonomy, perceive the physical environment, and respond automatically to its changes thanks to sensors and actuators, and, thanks to predictive data analysis, participate in decision-making. The collection, analysis, sharing and preservation of data by service providers, things and machines is pervasive and ubiquitous in the new ecosystem vision of the disruptive and innovative Internet of Things. The Internet of Things is included in the EU's strategy for technological dominance and the development of vertical sectors such as health. In the Internet of Things, in the form of everyday objects such as a phone, a watch, a pair of glasses, with almost zero human intervention, 'things' communicate with each other because they are connected both to the Internet and to each other, to powerful new technologies and become extensions of the human body, invading everyday life, health, work, augmented reality, creating new identities. Goods, people and services radiate valuable data, "at the same time as the habitats inside and outside the human body are full of data and emerge as opportunities for observation, analysis, interpretation, prediction to achieve behaviour modification and profit." Interconnected software programs in the form of applications make the devices fully functional, allowing for the creation, dissemination and sharing of information. Through these everyday objects and apps the healthcare industry, spurred on by the Covid -19 pandemic, is undergoing fundamental changes in the era when "Never before have we had the ability to collect so much data about a health incident." The emerging and existing technological paradigms of the Internet of Things are expected to have a huge and multi-level benefit in facilitating access to care, delivering care more accurately, collecting evidence in real time, making optimal use of resources in terms of greater savings of time, energy and money, contributing in multiple ways to the sustainability and efficiency of health systems, as well as activating and empowering citizens, for the health and well-being The European Commission has developed large-scale innovation pilot projects leading to effective technological solutions with real-life application in smart cities to help promote the Internet of Things in healthcare. However, the explosive pace of development of these new devices and applications with undeniable invasion of everyday life and intended institutional-level application in the healthcare sector as a means of harnessing real-world data, implies a 'data storm' and the collection of personal data from the most sensitive aspect of our lives to unexpected proportions. The business interest of the technology giants in gaining access to the healthcare industry and citizens' health data is evidenced by the acquisition of a digital health services company in the US for a price of USD 4 billion. Under the pressing circumstances of the Covid-19 pandemic and the imposed restrictions on human rights to prevent the spread of the virus and protect human health and life, and the UK's plan to 'scan' all connected devices in the UK in order to diagnose their vulnerability, the protection of personal data and the right to privacy when using the technological solutions of the Internet of Companies, but also public bodies, are called upon to find the best solution and methods to obtain the maximum value from data within the framework of the protection of these two rights. In this paper, we examine the current regulatory protection framework and its adequacy to ensure European citizens control over their health data in the gradually coming transformation of the health ecosystem and the development of smart cities. Do ubiquitous sensors raise concerns among citizens about the security and sensitivity of their health data and ultimately their privacy? What are the tools, key principles and safeguards that the European legislator has intended to include in the protection framework introduced by the GDPR in addressing the implications and challenges posed by the Internet of Things and its synergies with health applications, AI, Big Data and Robotics in the area of data protection? Do vulnerable subjects when using new technologies have tools to ensure the protection of their health data? We attempt to answer the above questions with this study, which through an overview of the regulatory framework, be it shaped by the legislator's choices or by soft law makers, aspires to document developments in order to feed the debate of law practitioners and to guide innovators in smart health. The first part explains the trends in the digital transformation of healthcare in general. The second part then develops the individual technological characteristics of wearable technology and health applications. This is followed in the third part by an explanation of the terms related to smart health. The following parts are devoted to an overview, in order, of the regulatory framework for data protection, the two-way relationship between the transformation of health into smart health and its impact on health data, and the regulatory framework for the processing of health data in general under the GDPR, with reference to the health data protection regime in the US. Parts eight and nine respectively analyse the impact on data subjects due to the processing of their health data when using wearable technology and health apps with a corresponding overview of the regulatory and statutory framework. In Part I it was deemed necessary to mention the position of vulnerable subjects in smart health. A brief reference to the implementation of Directive 2002/58 and the expected Regulation follows. Our analysis then moves from the microcosm of data subjects and smart hospitals to the public sphere and smart health infrastructure, to the smart cities of the future. It was only inevitable to refer to the Data Governace Act and Data Act, which are in the process of being fully adopted, and to the European Health Data Space. Eventually, in the parts preceding the conclusions, an attempt is made to approach the issues that arise for the processing of health data when wearable technology and health applications team up with robotics and artificial intelligence.