Last Updated | September 30, 2021
With a large number of digital health apps being launched in the market, there’s a growing competition in the market. Today, companies are under increasing pressure to comply with the Health Insurance Portability and Accountability Act (HIPAA) for their healthcare mobile apps. The primary obligation for app development companies under HIPAA compliance is to secure the Protected Health Information (PHI). While on the surface it may sound easier, complying with HIPAA regulations is a daunting task for companies unfamiliar with the protection and privacy rules.
The ambiguous and outdated guidelines make it even harder for companies to have a clear vision for the development of healthcare apps. To add the woes for the healthcare app development companies, any non-compliance to the HIPAA regulations lead to hefty penalties and administrative restrictions.
So, if you are looking for a definitive checklist for developing HIPAA compliant apps, continue to read, as we decode the complete HIPAA compliance experience for you.
Why do you need to consider HIPAA Compliance?
The telehealth industry is just started to grow and it will continue to expand into the foreseeable future. Keeping in view the massive potential for healthcare apps, many companies have jumped into the market with their version of telehealth apps. However, unlike some of the other app markets, the healthcare industry is a highly regulated industry with strict privacy rules. Thereby, any development agency looking to launch a healthcare app needs to understand and comply with the various regulations that govern the market. Talking about the healthcare app market, HIPAA is certainly the most expansive and stringent regulations that are mandatory for all healthcare apps to comply with. Any app that deviates from HIPAA compliance may be liable to hefty administrative and financial penalties; often crippling for the businesses.
Out of the various regulations that make up HIPAA, the key is to ensure the privacy of Protected Health Information (PHI). PHI refers to the medical data transferred over the internet, which may contain personal, or medical records or financial information of patients. It is the responsibility of the app development agency to integrate stringent privacy and security features to ensure the privacy of all PHI records and avoid violation of the HIPAA regulations.
What do you need to know about HIPAA Compliance?
The HIPAA regulations may be broken down into two components; the privacy rules and the security rules.
As for the privacy rules, these details the definition of PHI, as well as, defines the entity responsible for the protection of the PHI. As mentioned above, PHI refers to any data transferred through any medium that may contain identifiable medical information. To make compliance even more difficult, the definition and responsibility of PHI protection don’t only include the stored or transmitted information by a healthcare entity. In fact, the definition is expansive and includes any entity that’s involved in storing or transmission of PHI.
HIPAA regulations defined two categories of firms subject to the compliance requirement.
Covered Entities
Covered entities include:
- Healthcare providers
- Health plans
- Healthcare clearinghouses
Any of the above-mentioned entity that’s involved in the electronic transmission of PHI against the transactions within the adopted standards of the Department of Health and Human Services (HHS) falls under the scope of covered entities.
Business Associate
A business associate includes all entities and individuals who collect, store, transmit, or maintain the PHI data on behalf of the covered entity.
A Definitive Checklist for Developing HIPAA Compliant Apps
Now that you know the basic regulations that makeup HIPPA, let’s see some important considerations for developers to comply with. This definitive checklist may make it easier for developers to understand the scope and requirements for HIPAA compliant healthcare app development. However, as mentioned earlier, HIPAA compliance may become tricky for developers or entities not familiar with the privacy rules, thereby, it is recommended to consult an expert.
Nonetheless, if you are able to follow and implement these best practices, you would be at least partially able to cover the due diligence required for healthcare app development. Just make sure you are able to conduct a circumspect and review of the development process to ensure compliance with the regulatory requirements.
Now, let’s start our definitive checklist for developing HIPAA compliant apps.
1) Understand your responsibility
- It’s important to have clearly defined security requirements for any healthcare app. The best practice in this regard is to get the security architecture of the app reviewed by a qualified security specialist.
- From the perspective of the product owner, it’s important to understand the use case for the app. Few points to ponder in this regard include; the type of information that will be maintained and handled by the app; especially when you are dealing with protected health information (PHI)
- Apart from HIPAA, also consider the other healthcare regulations like HITECH that may apply to your application
2) Minimize the risk and exposure
- While developing a healthcare app, make sure you don’t store or display any irrelevant data that’s not required. For instance, you may not need to store the full birthdate of the patient. Similarly, make sure all the information that is gathered by the app have a definite purpose
- Write a detailed and clear privacy policy. While maintaining a transparent and open privacy policy is a good practice for all mobile apps, it becomes a mandatory obligation for healthcare apps
- Not storing the data is a highly effective technique to minimize the chances of a data breach. In this regard, wherever possible avoid collecting and storing cache
- For apps that will use cloud storage for PHI data, it is mandatory to ensure that the data is transmitted and stored securely.
- Get into a business associate agreement (BAA) with any third-party entity that you may use for cloud storage
- Be very mindful of the geolocation data of patients, which may turn highly innocuous data into PHI
3) Secure storage and transmission of data
- Make sure to implement the security encryption, which means using HTTPS, instead of HTTP to connect with the backend servers
- By implementing the encryption, you may also ensure data verification, which is yet another important compliance requirement for HIPAA
- For local data encryption, make sure to use standard tested protocols instead of writing new encryption algorithms
4) Secure your app
- The app should include session timeout after inactivity and force user re-authentication. The period for the use-case may be considered as per the requirement
- PHI sent through push notification can be a serious violation as these can be seen by anyone. Thereby, make sure PHI couldn’t be sent through push notification
- Avoid PHI storage into log files or backups, which are loosely protected
When it comes down to optimizing the security of the healthcare apps, it’s essential to focus on the healthcare UX. That’s because loops in the UX design can lead to security compromises. So, make sure that UX is adequately secured.
5) Validate your security
- Make sure to perform dynamic and static application security testing, which is the most effective and surefire way to evaluate mobile app security features
- While the technology is available to test the app yourself, it is recommended to hire a security testing specialist to perform penetration testing of the app
- When the desired security level are met, make sure to label your app HIPAA Compliant
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