Mar 25, 2021 4 min read
The times when doctors and patients could meet only in person are gone. In our modern world, everything gets digital, and tele-health solutions became so common that we can find hundreds or even thousands of healthcare products online. Relying on Statista, it can be said that by 2021 the mobile and tele health domain will hit $100 billion.
Digital healthcare products should follow strict regulations or compliance. These regulations vary from country to country. For example, in the US it is HIPAA compliance, and in Europe, it is GDPR compliance. In this article, we will look at HIPAA compliance and things that the product owner and development team should keep in mind when building a healthcare app.
HIPAA is aimed at preventing PHI (protected health information) from unauthorized usage. This means that when electronic data is created, transmitted, received, or maintained it must be protected in a specific way.
Due to bureaucracy, developing healthcare products is not as easy as creating other applications. This is especially true for the market in the United States, where healthcare IT solutions are subject to HIPAA, the privacy of patients, and medical data security laws.
Federal penalties for non-compliance with HIPAA can start from $100 and go up to $50,000 per violation depending on its cause. For this reason, to prevent the product from fines and lawsuits, it is important to study the list by Compliancy Group. This way, you will be aware of things that must be implemented in your product.
In the picture below, two elements determine whether HIPAA will regulate the application.
In a nutshell, if a healthcare product does not involve interaction between doctor and patient or medical organization and other organizations, then it doesn't need to be HIPAA compliant. For example, if a user has an application that reminds them to take their pills, it is not a HIPAA compliant app. However, if a patient shares their personal health information with a doctor via the product, it must be compliant with HIPAA.
Data can be considered PHI if it can be associated with a specific person. For example, if a healthcare product has a user profile with data like first and last name, place of residence, and at the same time contains records about the health condition, medications, and so on, it is PHI. Such type of data is sensitive and must be securely protected. The same applies to the situations when a hospital or a doctor's practice keeps data or shares it with other entities like lawyer companies, cloud storage services, or billing organizations.
All organizations and business partners related to PHI must follow controls outlined in the HIPAA Security Rule.
In the United States, a nine-digit social security number is highly important because with the help of it is easy to get almost any personal information. It means that such threats as identity theft, money fraud, or debts may take place if any personal data leaks. Using a HIPAA compliant app will guarantee the user that their data is secured.
To be 100% sure that your future product follows all the regulations, find and hire a professional, whose specialty is auditing and consulting for healthcare online products. This person will help you identify risks and guide where specific things should be implemented.
Avoid requesting unnecessary information from a user. Then check if the data the user inputs in the product is PHI or not. In such a way you can minimize risks related to data leakage.
Instead of building all infrastructure by yourself, search for solutions that are already HIPAA regulated. The only thing you will need to do is to sign the agreement with this service provider. This strategy will be faster, cheaper, and more secure for your business.
Several levels of encryption are very important to verify that information is securely stored and transferred inside your app. Do not forget about keeping data secured on the physical device for example, impose login using TouchID, FaceID, or a pin code.
Quality assurance and quality control of the product should be one of the top priorities. Security testing should take place after major changes in the app, like dependencies update, library updates, and so on. Tests need to be both dynamic and static.
Before developing any healthcare product for the US market, make a brief analysis if it must be HIPAA compliant. If your research shows that it should, then do not waste time and hire a specialist. This person will prepare a detailed report of how the data should be managed. After that, build a strategy for product implementation. When the product is ready, make another HIPAA compliance testing by hiring a third-party company. Release your app only when you are sure that everything is perfect in terms of PHI storage and transfer.
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