Understand HIPAA Compliance for your Digital Health Software Development

Blog / Understand HIPAA Compliance for your Digital Health Software Development

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    Leonardo Koshoni
    Leonardo KoshoniJanuary 28, 2022

    Head of Business Analysis

    In 1996, the HIPAA regulatory standards came into effect. It was formulated to protect individual health information during data transfers. Specifically, it was intended to protect patients when changing insurance providers. 

    HIPAA stands for the Health Insurance Portability and Accountability Act. However, its reach has extended beyond insurance providers. Today, HIPAA covers health plans, healthcare clearinghouses, and health care providers.

    Since 1996, the world has moved into a digital age. The storing and transferring of protected health information (PHI) is very different than it used to be. Today, we have large digital databases full of PHI, and information can be transferred in a matter of seconds.

    HIPAA compliance is more important today than ever. As we continue to improve healthcare with digital technologies, it’s key that compliance takes the forefront in digital health development.

    HIPAA compliance

    The Privacy Rule

    HIPAA’s Privacy Rule is the main component of the HIPAA regulations. It dictates who must follow HIPAA, what data is covered, and how that data can be used.

    The Privacy Rule strikes a fine balance between the protection of data, while maintaining high-quality healthcare. As a result, the legislation needs to be flexible to suit individual scenarios. This is especially true in the varied industry of digital health development. 

    The rule requires covered entities to guarantee the security and confidentiality of PHI. You must assess and prevent any threats to the security of PHI. It’s important to protect against any potential unauthorized access or transfer. It also sets standards for permissible use of PHI. 

    All HIPAA laws are enforced by the Office for Civil Rights (OCR). Any breaches or violations must be reported to the OCR. They also monitor audits for covered entities. This is where patient complaints can be made, and breach notifications should be received by OCR.  

    In development, it’s also important to understand the Security Rule subset to the Privacy Rule. While the Privacy Rule dictates the overarching use of protected health information, the Security Rule applies specifically to electronic information. 

    Again, the Security Rule dictates how ePHI may be disclosed, and the regulatory obligations when using or transferring ePHI. It’s important that all digital health development projects take note of the Security Rule to be HIPAA compliant.

    What is Protected by HIPAA?

    Both the Privacy and Security Rule are applicable to the same information, provided by the HIPAA laws. For wider context, HIPAA protects all individually identifiable health information. This leaves a large scope for potential compliance issues. 

    Here are just a few categories of information that might be covered by HIPAA:

    • Names

    • Location Identifiers

    • Telephone Numbers

    • Email Addresses

    • Treatment or Diagnosis Information

    • Photographs

    • Dates

    • Health Insurance or Social Security Numbers

    • Ethnicity

    • Biometric Identifiers

    • Test Results

    • Prescription Information 

    • And More

    Digital healthcare software development might mean you need to handle a variety of information, depending on the project goals. Assess what information is stored and handled by your health technology solution. It’s critical to understand what the regulations are for that information, and what safeguards you need to put in place. 

    Why we Need HIPAA

    HIPAA was initially created in 1996. Prior to that, there was no privacy law for health information. Therefore, there were no protections for private information nationally. 

    The information was stored and disclosed as health insurers and providers saw fit. There was also no federal law dictating people’s right to their health information.

    Health information was largely stored on paper records at the time. Typically, these records were stored in large rooms full of filing cabinets, with no secure access protocols. 

    Lack of security left private information accessible to almost anyone in a facility or insurance organization. It also meant that transferring important information was challenging, affecting the quality of care. Healthcare organizations attempted to act as reasonably as possible, but there were no guarantees. 

    It was also common that employers received regular health updates from their employee’s insurance companies. However, the patients themselves had limited access.

    HIPAA helps healthcare organizations to understand the correct way to handle patient data. It also ensures that important information pertaining to the care of an individual can be transferred with ease. They are able to provide better patient care as a result.

    For the individual, HIPAA guarantees that their PHI is only accessible to relevant parties. They are reassured that their information is stored and transferred securely. The patient can also have reasonable access to their own information, when needed.

    HIPAA compliance

    Consequences of Non-Compliance

    Non-compliance with HIPAA, or HIPAA violations, can be a costly mistake. Depending on the severity of the violation, there could be both a civil and criminal case.

    HIPAA violations can occur as a result of human error, poor security measures, loss of devices containing PHI and more. However, as a HIPAA compliant organization, it’s your responsibility to prevent these risks. 

    Should a breach or violation take place, you are required to notify the victims, and the OCR. The penalty or fine amount for non-compliance will be calculated based on a few factors:

    • Degree of Negligence

    • Malicious Intent

    • Future Risk

    • Quantity of Exposure

    • Breach or No Breach

    Fines can be up to $50,000 for each breach, in a civil case. However, depending on the extent of the breach, victims can carry out criminal cases. Unfortunately, there is no specified limit for criminal case fines. This will be calculated on the extent of the damages to the victim. 

    Protect your digital health development by learning about HIPAA and its requirements. Ensure that your development is HIPAA compliant every step of the way. This includes those in project management to the individual engineers. It’s better to build with HIPAA compliance, than risk a potential violation.

    At Vertrical, we build with compliance in mind, throughout our projects. We have compliance experts in-house, and teams of experienced engineers. Get in touch today to discuss the compliance requirements for your projects.



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