The mobile health market looks set to grow substantially over the next few years. After a welcome boost during the global COVID-19 pandemic, there’s demand for novel and innovative healthcare apps. Because most mobile health solutions handle sensitive patient data, they must comply with the relevant data protection legislation, including the Health Insurance Portability and Accountability Act (HIPAA).
What is HIPAA?
HIPAA, which became law in 1996, regulates the use and disclosure of sensitive patient information to protect its integrity and security. When developing a healthcare app that will handle protected health information (PHI), developers must carefully follow HIPAA guidelines to ensure full compliance. HIPAA breaches can lead to costly penalties — both financially and professionally — so app developers must minimize the risk of noncompliance.
This post will summarize the key rules that must be followed when developing a healthcare app.
Who needs to be HIPAA compliant?
Understanding complex HIPAA regulations is challenging, particularly if you’re unfamiliar with them, so where exactly do you start? Before developing your healthcare app, it’s crucial to determine whether you need to comply with HIPAA rules.
Put simply, if your healthcare app collects, stores, manages, or distributes PHI, then it must comply with HIPAA regulations. PHI, or personally identifiable information, includes things such as demographic data, medical history, and clinical results.
HIPAA rules may not apply to apps where the user inputs their own, non-PHI data, and the data isn’t accessed by the app maker or its business associates. An example of this is a fitness tracker that monitors activity, body weight, and heart rate.
What rules apply when developing a HIPAA-compliant app?
App developers must follow four distinct rules to make their app compliant:
- The Privacy Rule
- The Security Rule
- The Enforcement Rule
- The Breach Notification Rule
While all of these rules are important, the primary focus during the development of a healthcare app should be on the HIPAA Privacy and Security Rules. To comply with these rules, app developers need to implement the required technical, physical, and administrative safeguards to assure the safety and security of PHI.
App developers will also need to make sure a Business Associate Agreement (BAA) is in place with any third-party service providers that will be accessing PHI to ensure their compliance with HIPAA.
How can you ensure HIPAA compliance?
You’re probably wondering what you need to consider on your path to HIPAA compliance. Here, we summarize the steps you should take as you develop your healthcare app:
Ensure you understand HIPAA compliance
Make sure you understand your roles and responsibilities in adhering to HIPAA regulations. As an app developer, you may not have any experience with HIPAA, so consider consulting a compliance expert.
Implement adequate security features
Technical safeguards must be implemented to protect data. While HIPAA regulations don’t specify the security features to include, following industry best practices will set you on the right track.
Strict access control, such as unique user authentication, needs to be built into the app to ensure that only authorized users can access it. Biometric authentication using fingerprint or facial ID can make an app user-friendly while protecting data integrity.
If public access is available, controls need to be in place to make sure only relevant data is displayed to the patient and that PHI cannot be altered or accessed in any other way; this includes system admins.
All PHI should be fully encrypted both in transit and at rest. Incorporate an automatic logoff feature in your app to eliminate the risks associated with users forgetting to sign out, an all too regular occurrence. Only necessary PHI should be stored and disclosed, and it should be appropriately disposed of when no longer needed.
Physical safeguards protect the integrity of the backend infrastructure and mobile devices used to access the app. These safeguards may include data center access controls, 24-7 security, locked server racks, CCTV, and environmental protections such as redundant power and cooling.
HIPAA requires that PHI be available at all times, and the easiest way to achieve this is with 100 percent uptime guarantees.
Administrative safeguards refer to internal policies and procedures that are put into place to maintain data integrity. Policies and procedures should highlight how PHI can be stored, accessed, and disclosed. The development team (or anyone responsible for updating the app) should be appropriately trained in the correct handling of PHI.
Regularly test and maintain the security of your app
Regular testing should be performed to highlight any vulnerabilities in the security of your app. By routinely updating your app, you’ll be able to deal with any security issues that arise. Public-facing apps need to be impenetrable; perform external vulnerability testing to ensure the app can’t be exploited.
Monitor user activity through audit logging
Effective audit logging will enable the intelligent monitoring of user activity and provide near real-time reporting of suspicious events. IPS platforms and SIEM products can intelligently alert you of any deviations from the norm, which could be caused by malicious activity.
Deploy HIPAA-compliant third-party hosting solutions
By using a HIPAA-compliant hosting provider, you can save time and money associated with building the necessary infrastructure, taking the stress out of compliance. HIPAA-compliant infrastructure-as-a-Service (IaaS) solutions will adhere to all of the necessary HIPAA requirements, providing you with a ready platform on which to build your healthcare app. Remember that any third-party service provider must sign a BAA.
Developing a HIPAA-compliant healthcare app is a complicated process, and it can take time to get your head around the intricacies of HIPAA compliance. By carefully researching the legalities involved before starting development, you’ll save yourself a lot of money and headaches down the line.