Elsevier

Health Policy and Technology

Volume 1, Issue 4, December 2012, Pages 199-206
Health Policy and Technology

A regulatory framework for pervasive e-health: A case study

https://doi.org/10.1016/j.hlpt.2012.10.008Get rights and content

Abstract

To facilitate superior healthcare delivery and address current challenges faced by healthcare today, a plethora of pervasive e-health solutions are emerging. However, existing regulatory regimes are ill-equipped for dealing with them. This not only causes frustration to various stakeholders including patients, providers, healthcare organizations and payers, not to mention vendors but also means that the most appropriate solution cannot be accessed and used. Hence this exploratory study serves to investigate institutional regulatory factors that can impact the adoption of such pervasive e-health solutions. These factors are important as they can shape both the nature of these solutions and their diffusion trajectory. We argue that co-regulation, a mixture of direct monitoring and intervention of regulators through legislation and complete industry self-regulation, can be an effective approach especially in view of the complex and dynamic nature of this industry, co-regulation can minimize monitoring costs and enhance compliance. We illustrate with a case vignette.

Highlights

► Existing regulatory regimes are ill-equipped for dealing with e-health solutions. ► We investigate the regulatory factors that impact the adoption these solutions. ► Co-regulation can minimize costs and enhance compliance of these solutions.

Introduction

Pervasive e-health constitutes the use of digitally enabled technologies to facilitate and enhance the exchange of clinical, administrative, informational, educational, and transactional data ubiquitously in healthcare settings [24], [52], [56]. Examples of pervasive e-health solutions include telemedicine and telecare services, virtual reality, computer-assisted surgery, mobile monitoring systems (e.g. for the electronic management of chronic diseases), electronic medical records management including digital imaging and archiving systems, and electronic prescribing [13]. Taken together, pervasive e-health solutions have the potential to generate enormous efficiencies and services quality and to reduce medical errors [2], [26].

Delivering pervasive e-health solutions requires the integration of diverse technological and organizational resources which typically cannot be found within individual organizations. The knowledge necessary for developing and deploying these solutions may involve several heterogeneous stakeholders that are often embedded in various technological, economic, and social settings [24]. In order to succeed, these stakeholders must interact with each other while complying with institutional requirements including legal and societal requirements that balance their diverging interests, motivations, and needs [8], [33], [54], [61]. These requirements constitute a regulatory regime which can operate at either industrial, national or international levels and can influence, direct, limit or prohibit any activity undertaken by stakeholders operating in the pervasive e-health solutions industry [24], [26], [47].

Given the nature of healthcare and the sensitivity of healthcare information, it is typically incumbent upon regulatory and legislative government authorities to set up regulatory regimes and mandate their use [27]. Generally, these regimes can facilitate the exchange of healthcare data and information amongst various healthcare stakeholders while also providing protection of patient rights including privacy [27]. Credible and transparent regulatory rules can boost much needed investments in the pervasive e-health solutions industry, promote public confidence and the development of innovative and affordable pervasive e-health solutions, and stimulate industry research and development efforts [33], [64]. However, regulation can also impact the industry in a negative way. Increasing the regulatory compliance burden for stakeholders can increase the overall cost of operation which can impede the development and deployment of pervasive e-health solutions by acting as a barrier and thus hampering pervasive e-health innovations [26], [47], [60].

It is not until particular pervasive e-health solutions have been commercialized that their originators realize the problems that they pose to patients in particular and more broadly to society [39]. Therefore, “one needs to be concerned with societal, legal, and general economic factors” (page 7 in [39]) when a service technology has reached a minimum standard of performance and reliability. This is a stage that is generally overlooked. That is, answers are needed for potential legal, societal, and general economic concerns that pervasive e-health solutions may introduce [17], [39], [48].

Even though regulation has been attracting the attention of policy makers as e-health matures, regulatory regimes around the globe are ill-equipped and moving slowly for dealing with these technologies [26], [47]. In fact, there are growing concerns in extant literature that regulatory agencies have failed to keep abreast with developments in the pervasive e-health realm [15], [23]. Yet, extant research also shows that regulatory issues including legal barriers have been identified as a major force in the development and deployment of pervasive e-health solutions [24], [42]. In fact, because extant policy frameworks that are inherited from specific national and international settings are “not well-placed to deal with contemporary communications technologies that blur the boundaries among these” (page 181 in [17]), pervasive e-health solutions may not always fit within traditional healthcare regulation models [47]. For example, while in some regulatory regimes there may be legal obstacles that influence the reimbursement structures and payments when treatments are carried out in the e-health realm (e.g. Internet), in others there are limitations that mandate physical face-to-face physician–patient consultation thereby restricting the use of corresponding emerging e-health opportunities [24]. These examples suggest that regulation can shape the form pervasive e-health solutions will (or will not) take [47], [48].

The following research in progress attempts to answer the key research question “why do current regulatory regimens fail to facilitate e-health solution adoption and what can/should be done to address such existing barriers?” To answer this question we first leverage extant literature by using the institution-based view as a tool to investigate how regulation can affect the adoption of pervasive e-health solutions. Then, we illustrate this with a case vignette and finally present an institutional regulatory framework that we contend is suitable to facilitate the adoption of the plethora of pervasive e-health solutions today.

Section snippets

Institution-based view

The institution-based view suggests that institutions interact with organizations or networks of organizations by indicating which choices can be acceptable and supportable, that is, institutions reflect “humanly devised constraints that structure human interaction” (page 3 in [46]). These constraints take the shape of regulative, normative, and cognitive structures and activities that provide stability and meaning to social behavior (page 33 in [55]). In providing constraints and establishing

Regulatory issues

This section serves to present prominent regulatory issues as they impact pervasive e-health solutions. Such issues include: privacy, quality of online health content, and access to development resources.

Diamond—case vignette

Chronic diseases are incurable diseases, said to be the greatest threat to the nation's health and to its health delivery system. There are five major chronic diseases: cardiovascular diseases (hypertension, heart disease, congestive heart disease), strokes, asthma, cancer, and diabetes (some add a sixth chronic disease, arthritis). These chronic diseases account for 83% of healthcare expenditures in the general population [1].

The focus of this case vignette is on the chronic disease of

Case study findings

Based on our exploratory case study research which subscribed to the recommendations of extant case study research [70], several key emergent themes have become apparent with regarding to the successful adoption of the DiaMonD solution in the Australian healthcare context.

First, given the complex nature and structure of the healthcare delivery system in Australia, at present there exists no clear method to identify how the adoption of a wireless device to assist with providing medical advice

An institutional framework for pervasive e-health

An institutional regulatory setting is generally implemented by organizations with legislative powers, such as regulatory bodies. These regulate the context in which pervasive e-health solutions are developed, deployed, and used. It is vital for such a framework to be well understood by all stakeholders that operate in a healthcare system. Compliance failure can have serious consequences that can range from fines to reputation damage or even operation license loss [14]. Therefore, the

Discussion and conclusion

This paper set out to answer the research question “why do current regulatory regimens fail to facilitate e-health solution adoption and what can/should be done to address such existing barriers?” In order to answer this question we first drew on existing literature. This served to not only provide the motivation and critical need but also assisted us in developing the appropriate themes for our exploratory case study research. In addition, we have presented our initial research findings from

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