In the last few years, there has been unprecedented growth in the number of mobile health applications (mHealth Apps) which are available in the market. In 2015, there were about 100,000 mobile applications under “Medical” and “Health and fitness” categories and by 2017 this number has increased, by more than three times, to 325,000. It’s not just number of mHealh Apps which is increasing their consumer is also increasing proportionately. In 2016, globally more than 500 million people used mHealth Apps which included consumers, patients, and healthcare professionals while by the end of 2017, an estimated 3.7bn mHealth Apps will have been downloaded. This global surge in the number of health applications (apps) has provided new opportunities to shape the way healthcare is managed and delivered. However, many of these apps make bold claims, although some are useful, others could possibly cause harm instead of doing any good. Hence, it is very important for individuals and their Health Care Providers to be able to identify “good” mHealth apps within the maze of mHealth Apps.
Unfortunately, clinicians and patients have been trying to safely navigate the mHealth Apps maze without any significant support from their respective regulatory bodies and health authorities. The lack of a standardized quality assessment framework makes selecting or recommending mHealth Apps an extremely challenging task for both the patients and Health Care Providers. Interestingly, it’s not just patients and health care providers, who face this challenge in the absence of a clear direction, mHealth Apps developers are also equally affected. Therefore, several questions arise: How should health authorities approach mHealth Apps evaluation and certification? How can this be accomplished without stifling innovation? Should efforts to determine risks, benefits, and appropriate use be held on a global, country, or regional level? How will policies and strategies be introduced to medical professionals and their practices? Which methods should be used to ensure that patients are properly informed on how to select and use mHealth Apps?
Today, there are many efforts underway to address these challenges. However, these are happening in silos and are often specific to a single country or medical system. Some regulatory bodies have released their recommendation or guidance, but they are ill-defined and restrictive. The Food and Drug Administration (FDA) was one of first regulatory body to release a guidance in 2013 but its guidance focusses primarily on a subset of mHealth Apps that transform the mobile platform into a regulated medical device (Mobile Medical Applications), and only about 100 apps fall in to this category. The remainder mHealth Apps are subjected to what the FDA calls “enforcement discretion”, that essentially means, no regulation. Other regulatory agencies such as the Medicines and Healthcare Products Regulatory Agency (MHRA) of UK and the Therapeutic Goods Administration (TGA) of Australia have offered limited guidance to health care providers by including mHealth Apps under their existing regulations for medical devices. However, these guidelines don’t provide a quality assessment framework for the mHealth Apps. Various organizations all over the world have developed some sort of guidance/recommendation to certify or register mHealth Apps and list of such organizations in different countries is mentioned below:
Before assessing mHealth Apps, it is imperative for healthcare professionals and consumers to understand the intended benefits, limitations, and risks associated with these apps to make an informed decision of choosing the most relevant and appropriate App. It is also important to understand and quantify the different kinds of risk posed by mHealth Apps. One of the proposed two-dimensional “App-space” for risk assessment of mHealth Apps is mentioned below.
Image Source: http://www.jmir.org/2014/9/e210/
Some of the key mHealth apps assessment tools/guidelines are as follows:
There are six main criteria with first four being the objective quality scales and the last two are based on the raters’ own impression of the mHealth Apps, including its usability and perceived effectiveness.
The mean score of each of the above criteria is calculated and is used to calculate the App quality mean score.
Subjective Quality and Perceived Impact are based on the raters’ own impression of the eTool, including its usability and perceived effectiveness.
MARS is one of the most comprehensive tool to assess the quality of mobile applications including mHealth Apps.
APA mHealth App Evaluation Model
These guidelines also recommend adapting the scope of assessment as per following risk-matrix table.
Green represents the lowest standard requirement, yellow being intermediate and red being the highest standard.
To summarize, mHealth Apps are a great tool which have contributed significantly by giving control of health in the hands of patients, thereby empowering them and making patients an active participant in the delivery of healthcare. Looking at the recent trends, the use and adoption of mHealth Apps is going to increase even further. As patients continue to use these apps regardless of clinical support or guidance, it is the responsibility of the health authorities and providers to adopt a multipronged, collaborative approach to create a simple, yet effective quality assessment tool for the mHealth apps, educating consumers and Health Care Professionals on how to navigate through the maze of mHealth Apps and a clear guidance for the App developers to help them developing mHealth Apps which will add maximum value to the consumers and healthcare system.
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