Keywords

1 Background

The 2015 Ageing Report [1] stated that one out of three Europeans would be over 65 years old, with a ratio of “working” to “inactive” population of 2 to 1 by 2060. For the European countries, the fact that their populations are ageing represents a great challenge for the sustainability, quality and demand coverage of their current health and social care systems. In this line, the European Commission has proposed the introduction of Information and Communication Technologies (ICT) for the management of eHealth and e-care services, prioritizing telemedicine and telehealth [2, 3]. However, the organizational challenges, legislation aspects, cost of technological infrastructures and technological updates, reimbursement policies and issues related with privacy, safety and security, constitute significant barriers for the development of ICT services at scale, where telemedicine and telehealth services play a substantial role. Health Technology Assessment (HTA) has been introduced to systematically evaluate properties, effects and impact of health technology from a multidisciplinary perspective. HTA has already become “an important part of evidence-based health decision-making in most EU countries” [4].

2 Introduction

The Institute of Electrical and Electronics Engineers (IEEE) recently produced an extensive report tapping on numerous research directions of IoT to provide a formal definition of IoT [5]. In general, IoT is often referred to as an idea, vision, infrastructure or paradigm that proposes, in a rather indistinct form, multiple future internet technologies where everyday objects exploit their inherent networking capabilities allowing them to communicate bi-directionally with other networked devices. Presently, various IoT solutions are being deployed in Europe for sensing, measuring and controlling indoor and outdoor smart connected objects to different emerging IoT platforms available in the market that have the aim to support the independent living idea of older users. IoT platforms are more numerous when compared to existing telemedicine platforms and therefore it is necessary an unequivocal interpretation that dictates what and how IoT telemedicine service solutions could be used for a specific purpose. Health technologies are essential for a modern health system, and among them emerging IoT medical equipment and devices have the potential to support the prevention, diagnosis, and treatment of disease, as well as patient rehabilitation. HTA is aimed at improving the uptake of cost-effective new technologies, by preventing or slowing the uptake technologies that seem promising but have persistent uncertainties or may cause an unjustified burden for the health system [6]. Available HTA models for the evaluation of IoT telehealth and telemedicine services need to be examined to ensure cover of IoT platforms, prior to their effective introduction to everyday provision of health and care services.

A few comprehensive HTA frameworks have been introduced for the evaluation of Telemedicine and Telehealth services [7, 8]. Among them the aim of the HTA Model for Assessment of Telemedicine (MAST) [7] is to provide a structure for assessment of effectiveness and contribution to quality of care of telemedicine applications which can be used as a basis for decision making. In other words, the aim is that clinical, administrative and political decision makers in hospitals, communities, regions, government department etc. will use the model as a structure for the description of the outcomes of telemedicine and as an important basis for decisions on whether to implement telemedicine services in the health care systems. Similarly, the producers of telemedicine, the biotech industry, can use MAST as a structure for description of the outcomes of their products for patients, hospitals etc. It is the overall aim that MAST will improve the possibilities for decision makers to choose the most appropriate technologies to be used in the most cost-effective way by providing a multidisciplinary assessment based on scientific methods and results. MAST was developed within a project that was funded by the EU under SMART 2008/0064 and was conducted as part of the MethoTelemed study.

3 Objective

This objective of this paper is to examine if the HTA framework MAST can be used to evaluate IoT based telemedicine services and identify any adaptation required for MAST to this direction. In addition an effort to identify potential synergies and complementary functions of MAST with existing HTA frameworks used for the evaluation of IoT supported telemedicine services, was made.

4 Methods

The definition of IoT telemedicine and telehealth solutions in accordance with the current literature [5,6,7,8,9,10] was identified together the characteristics that could interact with the domains of the MAST framework. Due to the vast heterogeneity of definitions of IoT in the literature, the definition [5] provided by the major technical professional organization for the advancement of technology, the Institute of Electrical and Electronics Engineers (IEEE) and the definition [9] from agency of the United Nations (UN) whose purpose is to coordinate telecommunication operations and services throughout the world, the International Telecommunication Union (ITU), were used. In addition, a respective survey on IoT definition highly cited in the literature was used [10].

MAST involves assessment of outcomes within seven domains as described in Fig. 1. When using the model, the assessment starts with several preceding considerations. The focus should be on the determination of the purpose of the telemedicine application, the relevant alternatives that should be compared in the assessment, the level in the health care system (local, regional, national) at which the assessment should be produced and whether the telemedicine application is a mature technology. Finally, MAST also includes assessment of the transferability of the results found in the multidisciplinary assessment, e.g., across borders or when going from a small-scale pilot to a large-scale implementation.

Fig. 1.
figure 1

The elements in MAST

Full size image

5 Results

Out of the seven domains of the MAST model and their subtopics (Table 1), the domains of Clinical effectiveness, Patient perspectives, Economic aspects and Organizational are based on methodologies and Key Performance Indicators that focus on the service provision rather than the technical platform itself. Therefore, we concluded that MAST framework can cover the HTA related to the specific domains for IoT telemedicine services.

Table 1. The domains and topics in MAST
Full size table

On the other hand, the following domains were identified as those that need careful consideration when applying MAST to evaluate IoT based telehealth and telemedicine solutions.

5.1 Description of the Application

The aim of MAST as a model for assessment of telemedicine is to provide a structure for the assessment of effectiveness and contribution to quality of care of telemedicine applications which can be used as a basis for decision making. In the MAST domain of description, the description of the health problem of the patients expected to use the telemedicine application and the description of the application being assessed. These two issues are included in one common domain because the description of the patients and the telemedicine application serve as an overall description of the background for the assessment. Even today, almost 20 years after the IoT term was coined, it remains a difficult exercise to formally define the broad vision of IoT.

IoT enables the development at a global scale of advanced services by interconnecting, both physical and virtual “things” based on interoperable information [9]. Atzori et al. [10] highlighted the pervasive nature of the technology to enable the interaction and cooperation of “things” to reach common goals. A more systematic definition of an IoT system is by validating a list of features that the things in an IoT system should exhibit, namely, the Interconnection of Things, Connection of Things to the Internet, Uniquely Identifiable Things, Ubiquity (“anywhere” and “anytime” referring to where and when it is needed), Sensing/Actuation capability, Embedded Intelligence, Interoperable Communication Capability, Self-Configurability, and Programmability [5]. Starting from things as low in complexity as an RFID-tagged “thing” and up to smart devices with embedded intelligence offering even advanced analytics on the edge, the IoT paradigm entails the necessary ingredients to drive another transformation of telemedicine. Therefore, a careful description of the content and aim of the IoT application becomes crucial, as does the description of the type of patients’ needs to be addressed, their health problem and the aim of using a specific IoT technology.

5.2 Safety

IoT telemedicine solutions include unprecedented capabilities and data from sensing, measuring, controlling smart connected objects and personal health systems. The remotely monitor of a patient’s health with the use of network of sensors, actuators and other mobile communication devices, is referred to as the Internet of Things for Medical Devices (IoT-MD) [11]. The IoT-MD provides a platform that allows patient’s vital parameters to get transmitted by medical devices via a gateway onto secure cloud based platforms where it is stored and analyzed. Thus, new challenges regarding patient’s safety for liability issues are expected for health professionals. The framework of definition and reporting of adverse events of IoT connected medical devices is regulated by the respective Medical Devices Directives in EU and different bodies in other countries (e.g., Food and Drug Administration in US). The IoT-MD capabilities could set additional safety challenges for service based on the connected medical devices and therefore in the respective MAST domain the assessment could focus on these challenges. This domain of MAST focuses on the legal obligations which must be met and will identify any specific legal barriers that may exist to the implementation of the application.

5.3 Ethics and Privacy

IoT telehealth services are characterized by pervasive computing aiming to make devices “smart,” thus creating a sensor network capable of collecting, processing and sending data, supporting a comprehensive platform to improve the human experience and quality of life. However, the data sharing capabilities of IoT platforms raise serious concerns regarding privacy of patients’ personal health data. In the EU, the Working Party on the Protection of Individuals about the processing of personal data, set up by Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995, has adopted the opinion 8/2014 on the Recent Developments on the Internet of Things [12].

In the respective domain, MAST considers the prevalent morals, values and behavioral models of society relevant for assessment of telemedicine applications in ethical analysis in this domain. These values, moral principles and social rules (norms) form the basis of social life as well as national laws and consequently it is important to understand them. These factors play a key role in shaping the context in which telemedicine applications are used. The moral rules of the society reflect the values of the society and the values may be weighted differently in various societies. Evident cultural (e.g. religious) and economic (e.g. gross national product) differences also have a major impact on the moral value of the consequences that the implementation of a telemedicine application can have.

The MAST domain on ethics and privacy could include the following subtopics to state the main principles arising from respective regulations for an IoT telemedicine service:

  • Informed consent: Informed consent is required for data collection, data storage, data processing and publication of raw or processed data. Before consent is sought, information must be given, specifying the alternatives, risks, and benefits for those involved, in a way users understand.

  • Voluntary participation: Participation must be on a voluntary basis.

  • Participation of disabled people: It is essential that every IoT telemedicine service provision, should deal with the challenges of ethical nature, such as personal autonomy and integrity regarding citizen rights and especially confidentiality aspects.

  • Minimal risk: Patients should not be exposed to more than minimal risk.

  • Anonymity: Patients have the right to remain anonymous. All data analyses must be performed on an anonymous basis.

  • Feedback: Participants shall be provided with the possibility to retrieve feedback on the results of research.

  • Privacy: Health professionals must ensure that the way outcomes of patients’ monitoring are reported does not contravene the right to privacy and data protection.

  • Confidentiality: Confidentiality is different from the patient’s right to privacy and it refers to how data will be stored.

  • Data control: The data subject has the right to access all data processed about him or her, and has the right to demand the rectification, deletion or blocking of data that is incomplete, inaccurate or is not being processed in compliance with the data protection rules.

  • Informed stakeholders: Informing stakeholders in detail on ethical aspects of research and evaluation/validation in reporting activities.

  • Incentives (financial inducements, etc.) for participation in a telemedicine service provision should be stated clearly, whenever they are allowed by the regulatory and legal framework.

6 Discussion

MAST has been used in several European telemedicine projects, including more than 25,000 patients [13]. Based on this, MAST can be considered the most widely used assessment framework in studies of telemedicine in Europe. The adaption of MAST framework for IoT services needs to be validated via quantitative and qualitative methods, as it was the case for a recent Delphi study for the validity of the standard version of MAST [13].

The emergence of remote IoT telemedicine services has motivated the need in measuring the impact and evidence of the benefits of these relatively modern practices in the health sector. Some of them are focused on specific application domains (e.g. telemedicine), others are related to specific aspects (e.g. technology user acceptance, socio-economic impact). Apart from MAST, other specific selected methodologies have been developed with relatively different focus (e.g. MAFEIP Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing services (EIPonAHA) [14], ASSIST Assessment and Evaluation Tools for Telemedicine [8]).

These methodologies have proved their reliability and scientific-based approach to help decision makers about future investments in the Smart Living and telemedicine domains, which have a strong parallelism with the IoT technologies for active and healthy ageing. For example, MAST has been already used in integrated care pilots with large number of users (BEYOND SILOS, SMARTCARE, MASTERMIND, RENEWING-HEALTH, etc.). MAST is very much focused in the assessment of the outcomes of telemedicine solutions, and may be more clinically oriented when compared to other contexts of IoT for ageing well.

The European Commission has recently decided to co-fund and launch the Horizon 2020 Large Scale IoT project ACTIVAGE (http://www.activageproject.eu/).

ACTIVAGE is in line with the strategic vision on evaluating and scaling up IoT-based solutions to support independent living and active and healthy ageing. It is a flagship H2020 project (25.000.000 Euros budget, 50 partners, pilots with 7,000 expected users). One of the most important objectives of ACTIVAGE is the implementation of a reference evaluation framework for Smart Living for aging well solutions. Attention has been dedicated to raise specific indicators related not only to QoL, Economic, Acceptability and Usability but also to deployment scale and service model achieved during the pilots. The evaluation framework reports together with the analysis of enabling factors and potential barriers, includes the ambition to shape the foundations for the mobilization of investment at public and private levels, not only in Europe but also worldwide, to start the way for massive adoption of IoT solutions in the European market.

ACTIVAGE has a pilot ecosystem, characterized by heterogeneous and complex scenarios, both at service and technological level. Some of the use cases will include telemedicine services.

The evaluation framework of the IoT services will be based on the ACTIVAGE “GLOCAL” evaluation framework based on element of frameworks, such as MAST. Α key aspect is the multilayer and multidimensional evaluation strategy, which can catch and integrate Global and Local specific features (GLOCAL approach). Each pilot site will measure not only global indicators related to domain standard reference parameters able to contribute to demonstrate effectiveness of the implemented solution (impact on citizens’ Quality of Life, sustainability, innovation), but also local socio-economic indicators that will attract the mobilization of investment by public and private entities in each site according to the actual socioeconomic context.

This framework will be applied to specific use-case implementation of the related stakeholders involved who will address the assessment of GLOCAL framework Key Performance Indicators (KPIs) in an aggregated reference evaluation integrated framework. Certain aspects of GLOCAL are similar to MAST framework and therefore the two HTA models are expected to be complementary for certain use cases. ACTIVAGE will not reinvent methods and approaches but will rather build on top of existing best practices and experiences, among which MAST is included.

The GLOCAL evaluation framework is based on three main evaluation categories referring to the main Triple Win indicators of the EIPonAHA: impact on QoL, Sustainability, Innovation and Growth [14]. Every category is composed of sub-criteria focused on specific aspects. Both global and local indicators will be detailed in terms of measurement tool, target and reference methodology. The skeleton of the GLOCAL approach is the following. ACTIVAGE demand side partners have initially listed specific KPIs, measurement tools and reference methodology of the GLOCAL evaluation framework.

Specific ACTIVAGE pilot targets will be described for each KPI at local level according to background and expected impact. Evaluation data concerning every GLOCAL KPI per sites will be collected in a global data-repository called “ACTIVAGE Evidence Open Data Base” that will be specifically implemented and exploited by the ACTIVAGE project.

ACTIVAGE Evidence Open Data Base will complement the role of the marketplace tailored to offer direct access to resources and applications. Specific goal of the project is to raise the “ACTIVAGE Evidence Open Data Base” as Reference Framework for evaluating IoT solutions in the AHA domain, acting as dashboard to collect evaluation data and as well as advisor tool for stakeholders and company that want to access ranking of IoT solutions in the AHA domain. ACTIVAGE exploitation plan will address a specific business model and will collaborate with the AHA key players to make ACTIVAGE Evidence Open Data Base a sustainable service. The ACTIVAGE Evidence Open Data Base aims to provide orientation and advisory services to a variety of users, including of course end-users of pilots, and motivate fieldwork players and manufacturing and product distributing companies to participate in enriching the collective knowledge which it represents. The outcome of such ACTIVAGE Public Evidence website is to be able to provide an evaluation data collection tool and at the same time to make available quantitative and qualitative KPI values reported by pilots and different initiatives.

7 Conclusion

Based on the characteristics of MAST as a comprehensive HTA model, it seems it can be used for the evaluation of IoT telemedicine services, by adaptation of those MAST domains referring to the detailed description of the IoT platform and the MAST domains related to ethics, safety and privacy aspects. Due to focus of MASTon telemedicine applications, it could be used for the evaluation of IoT telemedicine services, as long as a detailed description of the IoT platform will be provided, given their heterogeneity. The MAST domains related to ethics, safety and privacy issues require extra focus in order to address the related challenges posed by an IoT telemedicine service.