HIPAA Risk Assessments for Digital Health Developers

Blog / HIPAA Risk Assessments for Digital Health Developers

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    Leonardo Koshoni
    Leonardo KoshoniFebruary 27, 2022

    Head of Business Analysis

    Risk assessments are a common feature in the average daily working environment. Whether you have conducted one yourself, or your compliance department takes care of them, they are an important safety measure.

    HIPAA regulations require the security of protected health information (PHI). Typically, we think of healthcare providers and insurers as covered entities. However, the scope extends further than that. Anyone that handles PHI, or transfers this data, is bound by HIPAA regulations. 

    The covered entities outlined by HIPAA include 3rd parties that work on behalf of healthcare providers or insurers. Tech companies that work with or on behalf of a healthcare provider, or that handle PHI, are included in this bracket. 

    Therefore, it’s important that you take all necessary steps to be HIPAA compliant within your digital health developments. HIPAA risk assessments are a key step to securing personal patient data.

    HIPAA Risk Assessments

    Why Risk Assessments are Important

    Prevention is the best way to deal with potential HIPAA violations. It’s far better to be cautious, and plan ahead, than deal with a problem later. HIPAA requires risk assessments as part of its compliance regulations.

    Risk assessments are a key way to identify vulnerabilities within your development. They encourage in-depth analysis of your processes, the project and the development itself. 

    It’s important to take the time to conduct a risk assessment for each stage of your development. They take patience, but are worth the reward.

    Risk assessments also form the beginning of a compliance strategy. For each risk, security measures are assigned. Implement these steps into each component of your development. This allows you to build your solution with compliance in mind.

    Poor risk assessments, or lack of, results in poor or lack of HIPAA compliance. Incorrectly spotting mistakes can be detrimental to the security of your digital health solution. Ultimately, this could be critical for your organization. Violations result in fines, and loss of trust. 

    Utilize risk assessments as a protective measure for your organization. Stop potential security issues before they snowball into violations and breaches of data.

    How to Conduct a HIPAA Risk Assessment

    Your risk assessments need to be a thorough audit of your organization. You should include administrative, physical and technical elements of your business. HIPAA outlines safeguards for these three areas.

    • Administrative: This analysis should include your business processes. Identify what security procedures you have in place to protect PHI, and audit these. Employee HIPAA training might be included in this sector.

    • Physical: Assess your physical security measures. For example, consider who has access to databases, and how safely secure information is stored.

    • Technical: For digital health developments, this typically means encryption levels and technical protections against unauthorized access.

    You might want to conduct three individual risk assessments across the business, or conduct one for each team, depending on your architecture. However, generally your risk assessments should follow the following format:

    Step 1: Identify your PHI

    Begin by finding out what information your company has access to, or stores. Take a look at your databases, and learn where you keep protected information. If you’re unsure, speak to your teams. Create a detailed list outlining what information you have, and what needs to be protected under HIPAA. 

    Step 2: Your Current Security Measures

    Outline what security measures you’re currently using. Consider how well they’re working, and assess their success. Ensure that they’re configured to work according to HIPAA requirements.

    Step 3: Identify your Vulnerabilities

    During your security measure assessment, you will have likely identified areas to improve. Consider what your security measures aren’t achieving. It’s important to find your gaps, and take note of where there are potential threats to the privacy of PHI.

    Step 4: Risk Levels

    Create a risk scale. This should be based on ease of error, and the potential impact to victims, and your organization. Use this to assign levels of risk to each individual vulnerability that you outlined in the previous step. All risks should be a priority, but this helps you to understand the level of vulnerability of your data.

    Step 5: Mitigations and Fixes

    Create a list using your risk levels. The vulnerabilities with the highest risk should be at the top, down to the least risk. For each vulnerability, outline the steps you’re going to take to lessen or eliminate the risk. Consider how you can correct the problems. 

    Step 6: Complete your Documentation

    Your final document should outline what PHI you have access to, what risks there are, and how you’re going to deal with them. When finalizing this document, keep HIPAA in mind. Consider how each vulnerability aligns with HIPAA, and what the regulations’ expectations are. 

    Step 7: Start Again

    It’s critical that you conduct risk assessments regularly. Tech development is a constantly evolving and innovative process. Your organization needs to keep on top of compliance for each new project. Consider conducting them quarterly, and at the beginning of each new project. 

    HIPAA Risk Assessments

    Enforce your Mitigating Actions

    Risk assessments are a useful tool, but are fruitless if action is not taken. Your risk assessment has provided you with a list of fixes and corrections. The real final step is to ensure these are implemented. 

    Communicate your risk assessments with your development teams. You might even ask them to conduct their own risk assessments on their work. 

    Take the time to provide training on compliance regulations, like HIPAA. This will contextualize your risk assessments, and give them a wider understanding of their responsibilities to protect PHI.

    Teams that understand HIPAA are more likely to build compliant solutions. They can identify any potential violations or risks as they carry out their build. Your solutions should be built with compliance at the heart. 

    At Vertrical, our teams are experts in compliance. We have project managers, business analysts, compliance experts and developers available to staff your tech projects. Get in touch with us today to discuss your staffing requirements. Let us help to keep your project on time, on budget and HIPAA compliant. 



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