Your company needs a software tool in the healthcare space. That is good news. The process of digitization is transforming the industry, reducing the cost and improving efficiency in many different areas. The benefits are real. The bad news, or difficult news if you prefer, is that if your application deals with any medical or personal information about patients you are required to make sure your software, data, and processes follow HIPAA requirements. This means extensive security measures. However with a proper understanding of what is required, a solid plan, and the right development partner, HIPAA compliance is not just manageable—when done right, by the right people, it can be a huge competitive advantage for your software.
HIPAA is the acronym for a federal law called the Health Insurance Portability and Accountability Act of 1996. The HITECH Act was added to the regulations in 2009 to encourage greater use of electronic healthcare records. Combined, these acts have four goals or intentions. The first three were to make private health insurance something workers could take from job to job, reduce fraud and abuse in healthcare, and establish standards for electronic billing along with other digital transactions. The fourth—and this is where compliance comes in—requires the protection and confidentiality of protected health information by healthcare organizations.
That last goal has major implications for anyone creating software applications in the healthcare space. Developers must understand what information is protected, how it should be protected, and make sure that their products and processes keep secure what should be confidential. To help you in your healthcare software development journey, this post will share what you need to know about the rules around HIPAA compliance and how to incorporate them into your product development process.
Six things software developers seeking HIPAA compliance should do
Knowing what HIPAA compliance means for software is more than half of the battle for maintaining that compliance. The following is a list of six things you should know if you are seeking or developing healthcare-related software.
Decode HIPAA rules and compliance
Start with the HIPAA rules themselves. The HIPAA Journal does an excellent job of summarizing the rules and staying current on HIPAA-related news. Just focus on that fourth goal of HIPAA, keeping protected information secure and confidential. Know that patient privacy rules apply to members of the healthcare industry that create, maintain, and transmit personal health information, referred to as covered entities. The rules also apply to business associates, a person or entity that provides a service to a covered entity only if providing the service gives them access to the personal health information maintained by a covered entity. The rules specify how anyone handling personal health information must keep that information private and secure. They also explain how covered entities and business associates must notify impacted parties when there is a breach.
Understand what is, and what is not, personal health information
When dealing with HIPAA compliance the term personal health information, or PHI, is used over and over again. PHI consists of sensitive identifying information about a patient, medical conditions as well as diagnostic information, and any health insurance claim data. This is the “what” of HIPAA compliance.
Bake technical, physical, and administrative safeguards into your software
The HIPAA regulations specify that covered entities, as well as business associates, must establish technical (software), physical (hardware), and administrative (process) safeguards over PHI. When developing software, technical safeguards are critical. However, you should also be aware of what physical and administrative safeguards are needed and your software should support or enable them.
Conceal personal identifying information
A large part of HIPAA compliance and any data security is making sure that the person that the PHI is linked to can be kept confidential. This includes de-identification of data, separating any personal identifying information from the medical information. Your application may do this so you can share the health data for business or research reasons. You must also make sure that only those with proper authorization can connect medical data to information that identifies a person.
Encrypt data about patients and healthcare customers
When data is being used, transmitted, or stored, HIPAA-compliant software applications should use encryption to make sure that if someone penetrates the physical safeguards protecting data the personal health information itself is encrypted.
Manage access to PHI
Users’ access to personal health information, abbreviated as PHI or e-PHI if it is electronically protected health information, is something that healthcare software must manage and monitor. Your applications must provide a mechanism for granting, monitoring, and revoking access to each individual’s personal health information. Roles-based access and two-factor authentication are great examples of this that you will need to consider. An important part of access control is also making sure that business associate agreements are in place before access is granted.
Track everything that happens to PHI
Because part of the HIPAA security rule is a requirement to report any type of security incident, including a data breach, your software should track who accesses PHI and what they do with that access. If a breach occurs, your application should be able to identify who accessed the data and if or how they changed it.
Making HIPAA compliance part of your software development process
Once you have an understanding of what HIPAA is all about, it is time to start creating requirements and writing software. Whether you are writing the software yourself or working with a partner, you need to make sure that compliance is part of both your culture and the culture of your software partner. When everyone is thinking about and aware of the security standards involved in handling and storing personal health information, they will naturally build them into the software.
When using an agile software development process for HIPAA-compliant software, the team should answer these questions:
- Will PHI be part of this requirement?
- Will any PHI data be secure at rest or in motion?
- What access controls are required?
- How will access be monitored?
The HIPAA rules also make auditing your software part of the compliance process. You will need to establish audit controls and document the results of your audits. Your audit must address HIPAA privacy, security, and breach notification rules. This type of risk assessment is not only required, but it will result in a better software solution.
A great place to start is to create a HIPAA compliance checklist. Your checklist should cover the technical, administrative, and physical safeguards required by the rules. It is a good idea to apply the checklist to your requirements and your software throughout its lifecycle.
When dealing with HIPAA, work with experienced software developers
The information shared above should help dispel any apprehension you have about creating HIPAA-compliant software. It should also make it clear that there is a lot to working with personal health information—much expertise and care are required. That is why finding a partner who has experience in this area is so essential.
If you are creating custom software in the healthcare space, you need a partner that already has HIPAA compliance in their culture. Just as Zibtek showed when we helped Fortify create an application to help people struggling with addiction.
Another excellent example of our ability to deliver fantastic custom software that is HIPAA compliant was the suite of online tools for clinic and healthcare service that we developed for Statix. These and other companies count on Zibtek for their custom software development in the healthcare space. Contact us to learn about our proven process, how we can help with HIPAA compliance, and why our whole custom software development process makes us a trusted partner to so many companies.