Building a healthcare product might be an intimidating process. Healthcare is a complex industry as it involves complicated user types, workflows, and regulations. It’s definitely not the same to build a healthcare app as an app from another industry. So, what main pillars should you consider to have a smooth development process?
Understanding how to design a healthcare app and taking into consideration these pillars beforehand will guarantee a much more efficient and successful development process with your medical software developer.
1. Choosing a business model that adds value to healthcare
First of all, you must identify the real problem your healthcare product is solving. This means asking yourself in what way your product will improve the health industry and the users' lives. Hence, try defining your business model focusing specifically on the value you’re adding, and make sure your product's objective is oriented to one of the following key points:
- Leverage the life quality of patients by making treatments more efficient.
- Lower operational costs and other expenses.
- Save time and improve access to optimize processes.
- Leverage clinical experience to boost user satisfaction.
TIP: To ensure you are going in the right direction, you might want to conduct thorough market research where all users' needs, wants, characteristics, behaviors, and values are clearly understood. Consider that these users might be, for example, patients with serious medical conditions, physicians with a tight schedule, or hospitals with tons of data to process at once. Understanding their situation and pain points will give you insights on how to add real value to their lives with your healthcare app. You might have a great idea, but it won't thrive if you don't find the right way to deliver it to your target with an optimized user experience.
Developing any medical app will imply entering a whole complex health system. Thus, if your app needs to communicate with different actors in the health system, it's likely that you'd need to integrate it with other actors, such as EHRs, databases, medical devices, etc. Also, interoperability is a crucial factor to take into account in healthcare workflows, as it allows systems to exchange and use health information, optimizing and facilitating processes significantly. For example, suppose you want an integration with different devices to send them medical information or integrate with the patient's EHRs to upload all data in one place. In that case, you should know it beforehand as it would alter the app development process.
So, determining the possible integrations your product will have upfront is a good idea. Some questions you can ask yourself are: do I need an integration with an EHR/EMR? Which one? What about an internal hospital/clinic system or a physician's agenda? Etc.
This doesn't mean that you should have all the integrations ready from day one, but it will be helpful to have a clear roadmap regarding potential integrations to favor a smooth development process. Do your research and think of how you would like them to be addressed and clearly communicate them to your agency. These app features and app integrations will help you and your healthcare developer define the final platform's characteristics, translate them to requirements, and establish a specific workflow to create a product that will be the base from which you will escalate your idea.
Don’t be intimidated by software integrations, they are there to help. There are numerous options to communicate systems, such as using APIs. For example, if you want your user to receive an agenda confirmation message via SMS, you can use Twilio. Thank god there are APIs for everything! However, bear in mind that in the healthcare world, things might be more complex. When dealing with PHI, you want to ensure that information is not constantly circulating from one to another and in consequence, there are some standard protocols, such as HL7. For example, FHIR is an interoperability standard of HL7 intended to facilitate the exchange of healthcare information between healthcare providers, patients, caregivers, payers, researchers, and anyone else involved in the healthcare ecosystem. Still, some EHRs are less open which requires a vendor to create an agreement with an integrator so that you could get access through them. A clear example of this is using Redox Engine.
Therefore, if you are thinking of developing a medical app, I would highly recommend that you think beforehand about the workflow in terms of how your product will communicate with the health ecosystem. Think about protocols, standards, APIs, partners, vendors, interoperability, etc. How are you going to simplify the complex problem of integrating all parts?
Privacy and security are a must in all your app development processes. We all know that nowadays, data is the biggest asset of all, and in healthcare, we must be particularly careful protecting PHI. Remember that we’re dealing with sensitive and confidential information, and all measures must be taken to minimize risks while assuring top-notch quality.
Taking about HIPAA Compliance is relevant, but it is also simplifying a wider issue. There is much more to consider depending on the characteristics of the app you want to create. This doesn't mean that you should deep dive into every specification now, but it’s good to try to identify which regulations you must comply with based on your product specifics. From a macro perspective, some constraints are:
Does your app communicate with a medical device? This is an important point to consider because, if your app is involved in the delivery of a medical treatment, it must comply with specific ISO (International Organization for Standardization) standards that the FDA demands all medical devices in the US. These are risk management standards for medical devices. The FDA will carry out several clinical trials with different patients to evaluate if it causes a positive or negative effect on their health. Indeed, they demand 510 K for any medical device. For example, the TinnitusDoc App that our team at Light-it developed creates on the user's phone a therapeutic sound that patients with tinnitus must hear with any earphones before going to bed and it helps them cure their condition. Although this is an audio track created with a phone, it is considered a mobile medical device in the US and must comply with the FDA ISO13485. Thus, identifying what specific compliance your app will need to follow before starting the development will help you have a smooth process with your agency.
Likewise, the following question you must ask yourself before developing a medical software is if your product will manage PHI (Protected health information) or not. Here you can have two different scenarios. If you’re creating a wellness app, yoga app, meditation app, or similar products that don’t share PHI, you are on your lucky day… your app will not be as strictly regulated, and you can have a more effortless development process.
On the other hand, if the app you’re creating will deal with PHI, you must comply with numerous restrictions, considerations, standards, and more. Bear in mind that healthcare is one of the most regulated industries. So, if you manage with PHI, your app, you must consider numerous regulations with no margin of error. It’s super important to choose a development partner that you can trust with this. If you are seeking an experienced digital product agency, a good fit might be considering Light-it, as a partner. For software testing, you can consider an experienced company like Abstracta, who guarantees software quality without compromising the user's experience. They are a leading software testing company that ensures your healthcare systems keep patient data safe, are reliable, comply with regulations, and adhere to industry standards while reducing risk and costs.
Besides all these legal restrictions, others cannot be put aside when developing a healthcare app. For example, financial restrictions must be evaluated as straightforwardly as possible from the beginning of any project. Even personal restrictions or preferences must also be clearly communicated as they influence the following app development process.
HIPAA & PIPA
As we all know that in the US, if you collect, use or store PHI and transmit this to any covered entity, you must consider HIPAA compliance. Indeed, the four types of covered entities that must comply with HIPAA are health plans, health care clearinghouses, business associates, and healthcare providers. Nevertheless, there are some specific cases in which HIPAA isn't required. If your app exclusively uses PHI in the app, doesn’t involve an exchange of PHI with a covered entity, and doesn’t involve personally identifiable user information, it’s not subject to HIPAA compliance.
Still, for the interoperability apps in the US that exchange PHI from one EHR to another, it is not enough to just follow HIPAA compliance. There are many specific compliances to take into account. On top of that, many startups also need to be SOC2 compliant; if you are in Canada and have PHI, you must comply with PIPA, and so on and so forth. Thus, we can appreciate how there is a massive variety of compliance your medical app could have to follow. It all depends on the characteristics or type of product you want to develop.
App development process | Conclusion:
To sum up, we can point out that developing medical software isn’t the same as developing any other digital product, given some industry restrictions and specifics. In this article, we covered three distinctive pillars.
First, try to understand the problem you are solving from a healthcare point of view, then the workflow and how it integrates with the medical ecosystem, protocols, partners, standards, etc., and finally, understand the regulations your product must follow.
Having them thought through before starting building your sharp healthcare app will give you a real advantage in terms of efficiency and clarity, and it will help have a smooth process with your healthcare app developers. Nevertheless, remember that the digitization of healthcare is increasing, and updates, changes, and improvements are always part of the process in this competitive industry. Thus, don't worry if those three aspects change over time; keeping an open mind will help you constantly identify new opportunities to boost your app!