Abstract
The United States (US) healthcare organizations are continuously struggling to cope-up with evolving regulatory requirements e.g. Health Information Technology for Economic and Clinical Health Act (HITECH) and International Organization for Standardization (ISO) 9001: 2015. These requirements are not only affecting the US healthcare industry but also other industries as well e.g. software industry that provides software products and services to healthcare organizations. It is vital for software companies to ensure and comply with applicable regulatory requirements. These evolving regulatory requirements may affect all phases of software development lifecycle including software architecture. It is difficult for Software architects to transform and trace regulatory requirements at software architecture level due to the absence of software design and architectural mechanisms. We have composed architectural mechanisms from given set of information security regulations i.e. Health Insurance Portability and Accountability Act (HIPAA) non-functional requirements, and these composed mechanisms were used to initiate initial architecture for the Electronic Health Record (EHR) and/or Health Level Seven (HL7). At next, style was selected for compliant and non-compliant software architecture. A layer of compliance was introduced in existing layered style that intends to help software companies to track compliance at software architecture level. Further, we have evaluated compliance-driven EHR architecture vs. non-compliant EHR architecture using a large healthcare billing and IT company with offices on three continents as a case study.
Highlights
It is vital for the United States (US) healthcare industry to ensure compliance with applicable standards and regulation e.g. Health Insurance Portability and Accountability Act (HIPAA) and Office of Inspector General (OIG) guideline, etc
Failing to accommodate regulatory requirements will result in a non-compliant aware architecture and it possibly results in to violation of regulation and penalty imposed by governing agencies
This paper proposes that Healthcare Billing Transcription Company (HTBIC) can integrate HIPAA requirements in its exiting International Organization for Standardization (ISO) 9001:2015 Quality Management System (QMS) to reduce HIPAA compliance implementation overhead
Summary
It is vital for the United States (US) healthcare industry to ensure compliance with applicable standards and regulation e.g. Health Insurance Portability and Accountability Act (HIPAA) and Office of Inspector General (OIG) guideline, etc. It is essential for software companies to ensure compliance with requirements while developing and providing software to the US healthcare industry. We have developed attributes for this purpose named Compliance Attributes (CA) that address the additional HIPAA requirements which are architectural and are derived from the federal regulations set forth in HIPAA [16]. Additional Compliance Attributes are introduced to address regulatory requirements which are architectural in nature. We will define compliance-driven architectural mechanisms [19] to achieve CA at software architecture level
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