Unregulated M-health Threatens the Positive Influence On Healthcare

September 2, 2019

There are over 300 000 mobile health applications on the market. Is this enormous choice a chance or rather a challenge?

Recent studies indicated that there are more than 3 million healthcare and mobile health (m-Health) applications on the iOS and Android smartphone platforms, with an average of 200/day added [1]. This massive clutter of these apps in any imagined healthcare areas is perhaps reflected in the increasing level of investment levels in this sector that according to some financial forecasts was on the increase of $6B funding in 2017 from the $4.4B or similar funding levels in 2016 [2].

However, this massive increase of mobile health apps highlights the overwhelming crowded and unregulated landscape of the commercial facet of m-Health and its stake holders. This remains a challenge and in some aspects and a negative trend for mobile health. This market proliferation is mainly commercial and consumer driven and less based on large scale clinical evidence, validation and regulatory driven approach. This process led to the stigmatisation of mobile health (m-Health) since its first introduction and definition in 2003 [3].  The subsequent landscape that evolved especially after the dawn of the smart phone era in 2007 and the beginnings of the digital Apps global businesses and markets [3] had driven these products and services to the current fragmented path. These had mostly been less focused on the science of mobile health rather than “for-profit” drivers that lead to many questionable clinical evidence-based outcomes, validation risks and patient safety and privacy concern issues that tainted mobile health since its inception.

[1]  IQVIA, Institute of Human data science study: Impact of digital health grows as innovation, evidence and adoption of mobile health apps accelerate.

[2]  Rock Health, Year-end funding report 2017, The end of the beginning of digital health (2018).

[3]  Istepanian, R.S. H. and Woodard, B., ‘M-health Fundamentals and Applications’ John Wiley- IEEE Press, NJ, 2017.

Do we need regulatory policies for the evaluation of m-health app? Or should we instead leave it unregulated no to stop innovations?

The current clutter of mobile (digital) health apps definitely requires a transparent and robust regulatory mechanism on global scale. Currently these mechanisms are fragmented and to some extent unreliable where only a fraction of the mobile health apps market is subject to regulatory standards prior to market entry. These are mainly applied through the existing regulatory mechanisms in the USA (FDA), UK (NHS digital Apps library) and the EU (EUs medical devices regulation). Furthermore, there are more than ten certification bodies clustered across these areas such as (NHS digital, PCHA, Xcertia, Wellocracy and others). These aim to certify and accredit different mobile and digital health services and products. More recently, the World Health Organisation (WHO) is in the process of establishing a new digital health department and has recently published detailed guidelines for recommendations on digital interventions for health system strengthening [1].

[1] The World Health Organisation (WHO), WHO guideline: Recommendations on digital interventions for health system strengthening, WHO, Geneva, 1-150, 2019, (https://apps.who.int › iris).

Which kind of applications is the most promising? Could you please give some examples?

There are numerous mobile (digital) health applications that were listed as ‘successful’ on a global level. Most of these are clinically validated, and methodologically evaluated services and applications were classified and were the basis of the new WHO digital interventions guidelines [1].  These include areas of telemedical and teleconsultation (client-to-provider telemedicine and (provider-to-provider telemedicine), provision of educational and training content to health workers, (mobile learning/m-Learning), stock notification and commodity and others [1].

However, other mobile health applications and services that are available on the digital health market are mostly in health and wellness monitoring areas. These included wireless wearable devices, management of non-communicable and chronic disease, therapeutics, early detection of disease and others. However, there is still prevailing ambiguity on the validation approaches mostly in technical, clinical effectiveness, usability and cost of these applications. The lack of wide scale and global studies combined with rigorous and robust evidence can be best illustrated in the example of the digital diabetes area. In this area and whilst the recent estimates list the digital diabetes market to reach $12.03 billion by 2025 [2], yet some studies that evaluated 280 mobile diabetes applications found only five associated with clinically meaningful improvement and none were of high methodological quality [3]. This asymmetry between the market-driven thrust and the poor clinical validated evidence need major revision to understand this gap.  This can be done with more effective and systematic large scale validation paths and evolving approaches that effectively engage all the relevant digital health ecosystem and stakeholders on broader scale.

[1] The World Health Organisation (WHO), WHO guideline: Recommendations on digital interventions for health system strengthening, WHO, Geneva, 1-150, 2019, ( https://apps.who.int › iris).

[2] PRNewswire, Global $12.03 Billion of Digital Diabetes Market 2019-2025: Increase in Penetration of Smartphone & Advance Device-Agonistic Feature, 2019.

[3]  Veasie etal. Mobile applications for self-management of diabetes, Technical brief, No. 31, AHRQ publication no. 18-EHC010-EF, Agency for healthcare research and quality, MD, 2018.

Many users of m-health apps stop using them after a certain period or delete them. Where is the problem?

The challenge associated with long term app usage and adherence is termed as the “App stickiness factors”. These challenges are evident in many mobile health applications, for example the apps used for medication adherence or management of chronic disease and monitoring. There are few studies that address these challenges. Such studies involve complex app design and user interface factors including behavioural change, human interface and patient long term access and acceptability issues. Some examples of successful apps include these developed for cancer medication adherence, and long term disease management were recently reported.

A few years ago, there was a clear division between m-health and e-health. Now it seems like these two wordings are fusing. Why are you concerned about this?

There is wide misconception and misunderstanding of the differences between mobile health (m-Health) and e-health. More widely, the understanding and differentiation between the four key pillars or domains of ICT for healthcare are not uncommon. These pillars are in addition to the e-health and mobile include (m-Health) domains the earlier telemedicine and telehealth [1].

From the mobile health perspective, it is well known that the widely cited and accepted definition of mobile health is its first definition as “mobile computing, medical sensor and communications technologies for healthcare[2,3]. However, increasingly experts and non-experts alike are confused by the plethora of subsequent and alternative terms and abbreviations used to re-represent mobile health in one form or another, such as connected health, smart health, and even more recently digital health. From the e-health perspective it was defined by the World Health Organization (WHO) as “the cost-effective and secure use of ICT in support of health and health-related fields, including health-care services, health surveillance, health literature, and health education, knowledge and research[4]. It is to be noted that this was a pre-smartphone era definition and that e-health has been around since the early 1990s. This definition represented the key common grounds for e-health in the use technology, electronic processing and communication networks for different healthcare services.

The recent estimates list the digital diabetes market to reach $12.03 billion by 2025

In 2011 and nearly (8) years after the first introduction and citation of mobile health ( m-Health) in 2003, mobile health was defined by the WHO as “medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other wireless devices” [5]. This flawed but widely cited definition of mobile health and the subsequent classification and inclusion of m-health as part of e-health that not only did not match the WHO’s taxonomy the overall ICT for healthcare and the earlier definition of e-health [4,1]. These issues are perhaps a clear reflection of the fundamental misunderstanding and the lack of differentiation between the four ICT for healthcare pillar combined with a systematic process of replacement and arbitrary taxonomies and definitions of mobile health that are mostly either erroneous or incomplete that only reflects the smartphone-centric structure of mobile health. These facts on the beginnings of mobile health (m-Health) and the first and original definition have never been documented or widely published prima-facie until recently [1].

Furthermore, there is an ongoing and inordinate process of the metamorphoses of mobile health within digital health concept with unclear distinction and understanding of both.

This arbitrary trend will, unfortunately, continue unabashed, unless there are clear and scholarly discussions on these important issues to find a global and acceptable consensus and on the following questions:  What is digital health? What is its taxonomy and how it is defined and especially its rapprochement with mobile health (m-Health) and the other three key ICT for healthcare domains?

 [1] Istepanian, R.S. H. and Woodard, B., ‘M-health Fundamentals and Applications’, John Wiley- IEEE Press, NJ, 2017.

[2]  Istepanian, R S. H. And Lacal, J., ‘Emerging Mobile Communication Technologies for Health: Some Imperative notes on m-health’, Proceedings of the 25th.  Annual International Conference of the IEEE Engineering in Medicine and Biology,  EMBS, Cancun, Mexico, 17-21 September, (2003), 1414-1416.

[3] Istepanian, R.S.H., Jovanov, E. and Zhang, Y.T, ‘m-health: Beyond Seamless Mobility for Global Wireless Healthcare Connectivity-Editorial Paper’, IEEE Trans. Information Technology in Biomedicine, 8 (4) (2004) 405-412.

[4] World Health Organisation (WHO), WHO-Fifty eighth World Health Assembly. Agenda item 13.17. Geneva, World Health Organization, 2005. Here Available as a PDF.

[5] World Health Organisation (WHO), mHealth New horizons for health through mobile technologies, Global Observatory for eHealth series: 3: 5-6, WHO Library Cataloguing-in-Publication Data, ISBN 978 92 4 156425 0, 2011

How will m-health evolve in the future? Where is the most significant potential?

m-Health will develop massively in the next few years with more global impact systems and services. However, this process will mostly and likely to be cited under the mistaken terminology of digital health as described earlier. Most of the major global IT and telecom companies (Google, Apple, Amazon etc.) are already involved in this overhaul and in developing advanced mobile health systems and services that will embrace AI, Cloud, IoT, 5G and other technologies. These will aim to transform the existing healthcare services and current delivery mechanisms. However, there is less talk or more in-depth intellectual discussions on the “science of m-health” as opposed to this massive “market of m-health”.

Are there studies available that show the value of mobile health application in improving patients outcomes?

There are numerous and published studies on different mobile health applications that show clear improvement in patient outcomes. Some of these are cited in my book. These are mostly based on the “App or smartphone-based” model of mobile health and are on either small scale or pilot level studies. Few of the larger-scale studies are usually done by commercial and business entities.

These are not widely published or circulated due to either confidentiality or business constrains or might have unclear patient and cost outcomes. The path for mobile health validation is an evolving approach and is dependent on many factors. These include technical, clinical, patient or user usability and cost. There is an urgent need to conduct more extensive clinical studies on global scale. These are not necessarily market-driven but rather than on improving clinical outcomes and patient satisfaction and usability. This is a challenge as funding these large scale studies especially in Low- to Middle-Income countries (LMIC) can only be hosted and carried out by their governmental and healthcare organisation. Most of these countries although face major and ongoing healthcare challenges that are combined with population increase and disease prevalence, are unlikely or capable of achieving these goals and objectives and most does not even have a national mobile health programme. There is urgent need to consider these issues to make mobile health as globally impactful and effective and not only privilege to the few of the developed world.

What should developers mind when working on new mobile health apps? What should patients take into consideration when downloading and using them?

Several important factors need to be considered within this process. In the case of the most of the commercially successful wellness and fitness apps on the market, their developers consider issues such as interoperability with existing clinical management systems, API component considerations,  hardware and sensor interface and device compatibility with the smartphones, device and data security, the clinical validation and iterative testing of the minimal viable product ( MVP) of the app before the wider commercial release. Other factors were mentioned earlier such as “stickiness factor” and how the app usage for longer-term can be achieved effectively and based on ‘human- interface’ design factors. Also, the awareness of the concerns, regulatory control and certification are essential factors within this process.

Majority of the m-health app development and the industry is based on SMEs, where only few succeed in a very congested global business. Most of these failures are due to the lack of understanding of these basic but critical development elements.