Health Apps – Quality Criteria‚ Regulatory Mechanisms and Promotion


21st January 2020


5 min


Antonia Hayianni

In a market flooded with apps‚ how do consumers distinguish between a good health app and a not-so-good one? How can health firms win the trust of consumers and make them aware that their apps are the best?

The quality‚ content and function of these health apps varies considerably; not all of them are capable of rousing user interest or making full use of a mobile device’s capabilities. Good apps should be able to assist in the diagnosis‚ treatment and monitoring of diseases‚ capable of not only accumulating patient information but also informing‚ interpreting and analysing the accumulated data.

With the rapid progress in the app development market‚ it is imperative that mobile app developers take the users into confidence before launching their apps. Developers do not possess medical knowledge and hence it makes sense that they shake hands with healthcare providers‚ who can provide them with accurate knowledge to develop applications that can be accurate‚ trusted and user-friendly.

Secondly‚ it would be a good idea to test and validate apps with a group of ‘early adopters’‚ who would be willing to experiment with new ideas and technologies. The idea of involving end users during the app development phase would enable developers to obtain feedback from the initial stages. This engagement and involvement would give the developers necessary impetus to build in features required by the users‚ rather than going back to the drawing board or receding the app every time a new feature needs to be embedded in the core app.

With a plethora of healthcare apps being built‚ it is likely that some app stores would check them for compliance. However‚ it’s also important for healthcare providers to test the quality of the app in terms of clinical or health content. This blog aims to discuss a few strategies that healthcare providers can deploy for a scientific validation of the apps available in the market.

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Construction validity

Healthcare providers can undertake this test to determine whether the application succeeds to do what it is supposed to do. This basic but essential test will demonstrate if the particular application is able to deliver an appropriate response in real world situations.


Intra observer reliability

This quality test goes further‚ enabling healthcare providers to check highly reproducible outcomes when tested under constant conditions by the same observer.


Inter observer reliability

This test reflects the accuracy and precision of a particular application when used by multiple healthcare providers.


Content analysis

By testing the quality of an app in this way‚ the data accumulated is compared to a reliable source‚ equivalent to a gold standard textbook or an appropriate guideline‚ as issued by a respected medical council.

Medical and health applications can be deemed safe and fit for wider usage only after complete reviews from end users. However‚ health apps that are not deemed as such can still be registered on relevant app stores.


The regulatory environment impacting health apps

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There is huge potential for technology and innovation in the device sector; enterprises operating in the area of digital health have to be prepared to navigate a complex landscape of clinical trials and regulatory approvals. However‚ with the assistance of some spade work and background preparations‚ app development can be managed well and lead to a more successful outcome with increased visibility and maximum reach in the initial stages.

The regulatory medical software environment in the UK is primarily determined at the European level by the Medical Devices Directive (MDD)‚ which came into effect from the 21st March 2010. The MDD‚ however‚ does not specifically cover medical apps; the NHS and affiliated organisations are advised to seek professional advice before designing or venturing into hardware or software relating to diagnostic and therapeutic purposes.

Furthermore‚ in order to promote the growth of technology in the health sector‚ the current guidance permits NHS organisations to use beta versions‚ internally within organisations for research purposes. Healthcare enterprises and NHS organisations‚ however‚ are subjected to MDD regulations if they seek wider circulation or distribution of the apps‚ irrespective of whether it’s being made available free to the end user.

Regulatory hurdles are understandably high in the sector‚ meaning we’re still a long way off the vision for connected healthcare that we explored in our assistive healthcare research paper. But things are definitely changing and there’s real momentum in the sector now which your app could be able capitalise on.


Digital marketing and promotion of health apps

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At hedgehog lab‚ we understand the needs of our clients and develop apps that differ from those already available in the market. Our constant endeavour is to focus on creating apps that stand out in the marketplace and present a novel perspective to end users. Medical apps are niche products; hence‚ it’s imperative that we handhold our clients to target apps towards the medical community‚ rather than relying on saturated generic apps.

The genuine driver for the success of any app are need‚ usability‚ value solution and accessibility. An app’s success is also determined by its longevity; the true test of a health app would be its ability to sustain the interest of the community‚ especially clinicians‚ and its ability to offer a secure online environment where sensitive information of patients is protected.