Ensuring the integrity and confidentiality of protected health information (PHI) is of the utmost importance. This means implementing a comprehensive, risk-based security program tailored to the needs of the organization. You also need to make sure you have the ability to make your customers aware of your compliance efforts. Healthcare institutions such as hospitals and insurance companies mandate a base level of security features and conduct thorough security reviews before approving new projects.
Whether you’re working towards an FDA 510(k), trying to achieve a security certification such as HITRUST, NIST 800-53 or ISO 27001, or just want to ensure the security of PHI, you’ll need to consider the cost of compliance, the impact on your business, and the potential impact on your employees.
If your business is looking to outsource custom application development, security assessments or compliance, Saga can help. We're well versed in HIPAA/GDPR compliance requirements and have the know-how to implement the necessary components using established processes and quality management. We also have a roadmap for technical and policy documentation needed for FDA 510(k) or security certifications.
Saga has helped clients through a multitude of security audits conducted by hospitals and other organizations. Reach out to us to start a conversation, we're friendly and here to help.
Learn more about building HIPAA compliance medical software on our Tech Talk blog post.
As part of your HIPAA/GDPR compliance program, it’s vital to incorporate regular security assessments into your process. Conducting an initial cybersecurity vulnerability assessment may identify a number of security holes or bugs that will need to be remediated. Hospitals and other institutions mandate third-party vendors have at least yearly assessments conducted by an outside organization. It’s also recommended assessments be conducted internally on a quarterly basis.
Static code analysis is another tool that can help identify vulnerabilities and other issues. Incorporating static code analysis early in your release process can catch problems before improper code becomes a bug, ultimately saving time and money.
Not only does achieving a security certification tell your clients and business partners that you’re serious about security, it can help you sail through a security audit (such as those conducted by hospitals before approving a new medical device or other third-party vendor project).
Some of the popular security certifications in the healthcare industry include:
Our goal at Saga is always to build custom applications with the right security features from the ground up - not only to ensure our clients can meet the requirements of a security audit, but more importantly to ensure a data breach doesn’t occur. Many companies coming from the commercial sector simply aren’t aware of the requirements or how to implement them.
You’ll need to carefully consider the maturity of your security and HIPAA compliance program before deciding which certification to pursue, however it’s never a bad time to start! A security audit will help you identify gaps and how to fix them.
To learn more about security certifications, HIPAA/GDPR compliance or medical device software implementation, reach out to us and start a conversation today.