HIPAA-compliant cloud storage implements the guidelines of the U.S. Health Insurance Portability and Accountability Act (HIPAA). These guidelines ensure the protected health information (PHI) in a cloud is portable, available to healthcare practitioners, error-free, and has access control policies and standards in place.
Regulatory Environment Overview
Healthcare & Life sciences companies are quickly becoming confronted with Protected Health Information (PHI) covered by the Health Insurance Portability and Accountability Act (HIPAA). The HIPAA Security Rule establishes national standards to protect individuals’ electronic personal health information that is created, received, used, or maintained by a covered entity. The Security Rule requires appropriate administrative, physical and technical safeguards to ensure the confidentiality, integrity, and security of electronic protected health information.
Implications on IT
IT systems in healthcare & Life Sciences organizations are required to meet stringent compliance regulations as laid by GxP, CSV, CFR part 11, HIPAA etc. And since companies that can demonstrate better patient outcomes will hold a distinct competitive strength, they must know how to comply with the HIPAA / other rules or better yet, find a partner that can navigate and help them achieve this compliance. Healthcare CIO organizations have significant experience in delivering on premise compliant systems. However, developing and deploying compliant systems in the cloud is still a challenge. Healthcare organizations of all sizes can benefit from cloud services, but only if they lock down possible security leaks.
How can we help?
CloudMoyo’s Compliant Cloud Framework helps organizations build capabilities to host, develop, integrate and migrate to the cloud environment by building the right processes, tools and services, and controls. CloudMoyo can-
- Assess landscape & select the right cloud environment
- Choose from a set of available tools/capabilities to match their enterprise requirements, leveraging CloudMoyo’s reference architecture
- Build business-facing applications in the cloud environment by deploying processes, tools & services, and controls to meet the requirements of GxP, CSV, CFR part 11.
CloudMoyo solutions can help organizations meet their regulatory standards while benefiting from the use of cloud applications. CloudMoyo system validation for part 11 is a detailed process and is important for quality and safety, and record integrity. The approach to part 11 requirements such as Validation, Audit Trail, Legacy Systems, Copies of Records, Records Retention has been implemented with few of the top 5 Pharmaceuticals client.
Once a company is assured that data is protected and that data safeguards are compliant to regulations, it can look to broaden the cloud’s impact in three distinct areas such as clinical trials, R&D, Consumer Engagement. By working with a healthcare-dedicated cloud partner, healthcare organizations can glean real answers from this data, now strongly secured and compliant, to drive discovery and innovation.