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Covered Entities (including health providers, health plans) and Business Associates (including healthcare vendors and digital health companies) are responsible for following complying with HIPAA and The Privacy Rule.
Both Covered Entities and Business Associates are responsible for implementing all required HIPAA safeguards when interacting with protected health information (PHI).
Violations can result in fines as well as jail time and criminal penalties in certain circumstances. Fines or civil money penalties (CMPs) for HIPAA violations are based on a tiered structure, and increase based on the number of effected patients and amount of neglect. The amount of the penalty is at the discretion of HHS OCR.
The penalty guidelines are outlined as followed:
Violation | Amount per violation | Maximum annual penalty |
---|---|---|
Did Not Know | $100 – $50,000 | $1,500,000 |
Reasonable Cause | $1,000 – $50,000 | $1,500,000 |
Willful Neglect — Corrected | $10,000 – $50,000 | $1,500,000 |
Willful Neglect — Not Corrected | $50,000 | $1,500,000 |
Source: HHS, Federal Register.gov
A Business Associates Agreement (BAA) dictates how a business associate (BA) operates and deals with protected health information (PHI). These agreements typically state how the business associate will maintain compliance and lays out responsibilities for both sides. Most cloud platforms, including Amazon Web Services (AWS) and Google Cloud Platform (GCP) operate on a “Shared Responsibility” model, where the cloud provider, as well as your organization are responsible for specific safeguards.
Although it is recommended you sign a BAA with service partners who will be storing PHI, BAAs do not automatically make your organization compliant. Your organization’s internal policies, procedures, and review of administrative, physical, and technical safeguards is an important responsibility that ultimately helps dictate if your organization is in compliance.
SOC 2 compliance is a critical benchmark for organizations that handle sensitive customer data. Achieving compliance demonstrates that your company meets the highest standards for Trust Service Criteria (TSC) including security, availability, processing integrity, confidentiality, and privacy.
Despite its importance, many organizations struggle with SOC 2 due to the extensive documentation, complex controls, and ongoing monitoring required. Fortunately, there are practical paths to compliance depending on your organization’s resources, expertise, and appetite for automation.
Here are three pathways to consider for building and managing your SOC 2 compliance program.
The manual approach to SOC 2 compliance involves creating, maintaining, and tracking all policies, controls, and evidence manually. Teams typically rely on spreadsheets, shared documents, and internal processes to document compliance requirements. While this may seem like the easiest option to get started with, remember that your team will have to continue to perform these manual functions annually to keep these reports up-to-date. Also note that for a SOC 2 Type II report, your team is assessed over a period of time, and will have to continue to produce documentation for a longer timeframe.
Manual compliance can be a good starting point for very small companies or startups. However, the process quickly becomes cumbersome as the number of controls increases and audits become more frequent.
Many organizations opt to hire SOC 2 consultants or cybersecurity consultants who provide guidance on compliance frameworks, internal controls, and audit preparation. Consultants can help identify gaps, craft policies, and ensure your organization meets all trust service criteria. This can be a great option for organizations with limited staff, but may make your team dependent on third party staff to meet requirements and perform certain operations.
Consultant-led compliance is ideal for organizations that need expert guidance but may not have internal compliance teams. However, without proper tools, teams can still spend weeks compiling evidence and managing policies. Dash ComplyOps provides customized security onboarding, SOC 2 consultation, and white glove support alongside it’s software platform to ensure your team is well equipped to achieve and maintain SOC 2.
Automated SOC 2 compliance platforms integrate directly with your administrative policies, cloud service providers, and software tools, to continuously monitor controls and collect evidence in real-time, and prepare for SOC 2 audits. Additionally, some of these platforms provide support for performing SOC 2 required security processes such as policy creation, security gap assessment, risk assessment, and penetration testing.
Automated SOC 2 compliance is ideal for organizations seeking efficiency, scalability, and minimal manual overhead. By automating routine tasks, companies can focus on strategic security initiatives rather than administrative burden.
Dash ComplyOps provides a fully automated SOC 2 compliance software platform. Unlike other platforms that only provide basic evidence collection, Dash provides one central platform for managing security operations, preparing for audits and completing your SOC 2 report:
With Dash ComplyOps, audit preparation becomes faster, simpler, and more reliable. Whether you’re a small startup or a large enterprise, Dash ComplyOps ensures your organization maintains continuous compliance with minimal effort.
Dash ComplyOps has established itself as the modern solution for SOC 2 compliance. Whether you’re navigating the manual path, leveraging consultant expertise, or fully automating your compliance program, Dash ComplyOps provides:
Take the first step toward SOC 2 compliance and explore Dash ComplyOps today.
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