Guide to HIPAA Compliance: Achieving & Maintaining Data Security

    Posted by Sierra Labs on Feb 9, 2022 6:59:21 PM

    Step by step guide for obtaining HIPAA Compliance for your Healthcare or Life Science organization.

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    For any healthcare organization, HIPAA compliance is a vital component to protecting important and sensitive health information whether stored electronically or on paper. Your organization's health information is specifically crucial for HIPAA because you are protecting patient privacy.

    This blog post will outline some steps to take to become HIPAA compliant in your organization. We'll discuss what you need to do if you're just starting out, what you should be doing while maintaining compliance, and how we can help.

    If you seek further guidance on developing a HIPAA compliance program, check out this thorough checklist!

    Becoming HIPAA Compliant

    The first step to becoming HIPAA compliant is understanding what the law entails. HIPAA is a complicated law with three parts:

    HIPAA Compliance Description
    Security Rule Protects electronic health information (ePHI) by establishing national standards for security of electronic protected health information.
    Privacy Rule Sets boundaries on how ePHI can be used and shared.
    Breach Notification Rule Requires organizations to notify individuals when there is a data breach of their ePHI.

    HIPAA covered entities are any healthcare provider, health plan, or clearinghouse that transmits electronic PHI. Business associates are entities that provide services to a HIPAA covered entity and have access to ePHI.

    Why is HIPAA Compliance Important

    Due to the high risk of data breaches, it is important for healthcare organizations to become HIPAA compliant. In the 2017 report by Ponemon Institute, the average cost of a data breach was $221 per record. This total cost is calculated by multiplying the number of records exposed by the average cost per record. Another discovery through this study was that healthcare organizations have the highest median number of breached records (over one million) and highest costs ($380 per record).

    Here are the main reasons why you should be HIPAA compliant:

    1. To protect patient data and PHI by following HIPAA guidelines.

    2. To prevent costly data breaches by creating infrastructure based on HIPAA rules.

    3. To demonstrate your organization's commitment to protecting patient privacy.

    Steps to HIPAA Compliance

    Becoming HIPAA compliant can be a time-consuming process, because of this, our compliance experts have created this quick guide highlighting the steps you need to know

    It is crucial to follow these steps to earn HIPAA compliance, but more notably to protect patient data and demonstrate your commitment to privacy. If you're just starting out on your HIPAA compliance journey, here's a checklist of what you need to do:

      Steps Action
    Educate your workforce about HIPAA. Make sure that everyone understands their role in protecting patient data, and how they can help prevent a data breach.
    Identify actions covered by the Security Rule and Privacy Rule. Create policies and procedures detailing how to comply with these two rules (and notify all affected individuals).
    Implement a secure electronic health information system. Implementation to meet the requirements of the Security Rule.
    Review your policies and procedures. Regularly update policies and procedures as needed.
    Conduct risk assessments. Identify potential security threats and vulnerabilities.
    Train employees. Your team must know how to respond to data breaches.

    If you're already compliant with HIPAA, it's important to continue taking steps to maintain compliance. This includes:

    • Monitoring and reviewing electronic health information systems for security threats and vulnerabilities.
    • Implementing new safeguards as needed in response to identified threats and vulnerabilities.
    • Conducting risk assessments every two years (or more often if necessary).
    • Continuously training employees on updated policies and procedures.

    HIPAA Made Simple with Sierra

    By now you understand the importance of HIPAA compliance and the protection of patient data for the Life Science and Healthcare industries. By following the steps outlined above, you will ensure that your organization is HIPAA compliant avoiding costly data breaches.

    All of the above steps are a starting point, but the world of HIPAA can get pretty overwhelming, nuanced, and hard to navigate. That's where we can help!

    Sierra Labs offers services to help you and your team achieve full HIPAA compliance within your desired goal time. We provide:

    • HIPAA Documentation: SOPs, Templates, Policies & Procedures
    • HIPAA Training for Your Internal Teams
    • HIPAA Assessments
    • Connection to 3rd Party HIPAA Auditors

    Don't let compliance overwhelm you or your team, we’re here to help you navigate regulatory frameworks like HIPAA compliance with you. Please feel free to reach out with any regulatory questions and we’d be happy to help.

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    Topics: SaMD, Data Security, Medical Device Company, Data Privacy, Data Requirements, SaMD Development, Software Requirement Specification, HIPAA, Personal Health Information, Health Data, HIPAA Compliance, HIPAA Checklist, Covered Entities, Business Associates, ePHI, PHI, eHealth, Health Applications

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