Mobile healthcare app development poses a set of challenges very different from mainstream apps. Not only is security an area that requires a considerable attention, compliance with regulatory standards is also absolutely crucial. Here are things app developers should pay close attention to during the development process.

1. Focus

A successful mobile medical application should be able to demonstrate clinical benefits and offer real value to its users—whether they are patients, healthcare practitioners, or both. Using medical apps for routine self-monitoring and feedback is a cost-efficient strategy for self-management. The app should have only those functions and features relevant to its audience. Therefore, it is extremely important to understand and master the needs of all relevant stakeholders, aggregate real-time usage data, and use this information in development.

App developers must resist the temptation to throw in additional features that don't add much value or, in the worst case, confound or scare the users. The medical app should build on existing user behavior—if the app demands significant efforts or behavioral changes, it will probably not be successful. Innovations are born from great observations, so app developers should frequently engage with users and study their approaches to improve existing solutions, or design new ones. Furthermore, the app should deliver significant improvements across releases or versions.

According to Stacey Chang, Association Partner and Director of Health & Wellness at IDEO, in aan interview on iMedicalApps: “We get a lot of proposed solutions that make an incremental difference. It's not enough to solve the problem, because there are so many stakeholders, and people focus only on what they can effect, and it's a challenge for entrepreneurs.”

2. Understand the Healthcare System

Medical apps should align with the healthcare systems to not only be in compliance with the legal and regulatory systems in the local markets, but also to demonstrate value to other stakeholders, such as payers, providers, and employers. For example, a developing country may have fewer doctors-per-capita compared to a developed economy. The doctor to patient ratio is estimated to be 1:1,500 in India and 1:1,000 in China, while this ratio is 1:350 in the U.S. The smart phone might be the only conduit for care in rural areas of developing economies, building a strong case for telemedicine.

You can’t rely on end-users' technical expertise with things like data privacy and security

China has a less tortuous regulatory system and the Chinese government pays for the healthcare services. Although the Indian Government has implemented a variety of public healthcare systems and financing options to universalize healthcare services, out-of-pocket healthcare expenses continues to remain high. Understanding such demographic trends, patient psychology, local market conditions, and the healthcare systems is absolutely crucial in designing apps and mHealth services that resonate among the local populace.

3. Don't Rely on User Expertise

Not all users are alike and you can’t rely on end-users' technical expertise with things like data privacy and security. Over half of the patient population find passwords too cumbersome to remember, over 33% are not concerned with risks of data breaches, and over 55% of adults use the same password for nearly everything. Though pattern locks are less secure than pins—a five-digit pin has over 5 million combinations compared to only about 15,000 combinations with pattern combination—the latter is very popular among mobile users. In such cases, it's worthwhile to enforce stronger measures and eliminate options that could potentially compromise security. Complex functionalities should be abstracted from users wherever possible with proper validation checks to minimize data entry or usage errors.

4. On-Board Experts

When developing an app for a particular disease, it's mandatory that a medical expert with specialization in that disease be on-boarded and frequently consulted through the development cycle. Medical apps require deep and sometimes very specific medical knowledge that is beyond most developers. Field and beta testing using online, focus, or (ideally) patient groups is obligatory to ensure that the app has relevance with the target audience. A physician or specialist with a patient list populated by the target audience makes an invaluable ally. They can also direct field-testing as clinical trials and endorse the app to patients and colleagues.

5. Leverage Design Thinking Principles

According to Tim Brown of IDEO:

A lot of times we get a lot of proposed solutions that make an incremental difference. It's not enough to solve the problem, because there are so many stakeholders, and people focus only on what they can effect, and it's a challenge for entrepreneurs … Human-centered design thinking–especially when it includes research based on direct observation—will capture unexpected insights and produce innovation that more precisely effects what consumers want.

Medical apps should be powered by design thinking principles that revolve around a thorough understanding of customer needs gathered through direct observation—seeing what people want and need, how they use a particular product or service, and what they like or dislike about the way particular offerings are produced, packaged, delivered, and supported. Design thinking principles help overcome the “wicked problem,” which most medical app companies face. Wicked because the app company has too many options at its disposal and too many directions to explore—a situation that can potentially distract it from concentrating on the core activities that drive customer value. Design thinking offers a structured approach and a repeatable process framework that aims to discover and design feasible solutions that users appreciate. The focus on innovative product designs, humanizing technologies, and patient experiences is what propelled Apple into market leadership and what that GE Healthcare continuously pursues in areas that are intended to both improve care and make an emotional connection with patients.

6. Embed the App in Research

By its very nature, healthcare research is a long and convoluted process. The funding is front-loaded, but the impact can be assessed only after a substantial time lapse. An app development project embedded within a well-constructed and cost-accounted research project can build upon years of collective experience, development, and testing. A captive population of research participants and volunteers can accompany the development process as users, evangelists, advocates, testers, etc. From within the context and boundaries of an academic institution, the developer can forge industry partnerships, broker alliances, and scale the solution. Many medical apps were products of academic research and followed this strategy to success.

7. Get in the Trenches

To really understand stakeholder psychology, developers should entrench themselves in the worlds of both patients and physicians. The developer should understand and appreciate the utility of such knowledge. An app that accurately records real-time information from patients can be used by physicians to make crucial decisions and is far more useful and valuable than a tool gathering extraneous data. Moreover, patient-centric applications are systems built on partnerships among practitioners, patients, and other stakeholders, revolving around patients’ relationships, networks, needs, and preferences. Hence, app developers should solicit patients’ input to identify metrics that influence their decisions. Apps that bridge clinical and non-clinical sectors should include both individual- and population-oriented tools.

8. Test the Prototype

The medical app developer should take the time to thoroughly field-test the app before releasing it to the app marketplace. It's crucial to get the prototypes out among the target audience as early as possible. In other words, it's crucial to take the app for a spin in the real world. No matter how expensive this might seem, it is always better to budget some extra resources than compromise on app quality.

For example, mobile network availability is a factor that cannot be reliably predicted without rigorous field-testing. If the app requires constant online connectivity, but its users have only sporadic Internet connections, field-testing helps profile Internet availability to develop workarounds or alternatives. If the end-users experience difficulties using the prototype, the discovery can initiate the necessary changes and save considerable resources and frustration.

9. Data and Processes First; Then Logic

Traditionally, a lack of high quality data plagued the healthcare industry, leading to clinical trial delays and product failures. Today, however, high quality data is relatively inexpensive to acquire and use. Doctor's offices are also increasingly using electronic health records to closely monitor patients and deliver healthcare services. Most app developers, however, embrace approaches that involve logic- and rules-based clustering, expressing relationships between entities to articulate their app's value. Unless information about those entities is available, association maps, connections, and processes cannot be built. As more data becomes easily accessible for multi-application use, the key success strategy will be deploying these data assets with robust processes that create value. In other words, developers should cultivate process capabilities that demonstrate value and build competitive barriers.


Illustration of medical iconography courtest Shutterstock.

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Thank you that you raised the issue of the danger of this kind of application. I am afraid that many applications can be very dangerous. People will not go to a doctor And it will be dangerous for health . I found a company that is engaged in the development of such applications . and I have a question. Do you think that any company able to develop applications?

Interesting post. However, you have completely overlooked the single most important factor in UX design for medical products and services and that is the formal FDA guidelines and related requirements which have become increasingly critical to any company developing products in this space. There are numerous usability guidelines which now must be seriously considered and met in the design and usability testing of medical products including (FDA HE75) for example. The recent FDA guidence document "Design Considerations for Devices Intended for Home Use", requires rigurous human factors engineering be applied during the UX design process. Furthermore the FDA has recently signaled that it intends to classify Apps which gather and summarize phsiological data for the user as requiring serious usability performance testing and verification. This is going to impact every aspect of wearable technology and related Apps. Rather curious how you failed to mention these criitcal factors!


Charles L Mauro CHFP




The article is meant to serve as a starting point, rather than an exhaustive work on the regulations or standards that the App has to be in adherence with. In this regard, I'm completely in agreement with your views and a such a topic that covers compliance and validation strategy to ensure compliance warrants an exhaustive article in itself.