The Challenges of Cloud Compliance in a Regulated Environment


2020-bl-arbour-day-group_mainEffective cloud compliance in a regulated environment demonstrates that your organization has met the appropriate industry regulatory requirements to protect data integrity and privacy. As more organizations transition to the cloud, so does the influx of sensitive data. Rigorously regulated industries like the life sciences and healthcare must not only understand the depth of requirements regarding regulatory compliance in the cloud but the challenges that also come with maintaining compliance. Here are key challenges to keep in mind when addressing cloud compliance in a regulated environment.  

The Responsibility of Cloud Compliance

Cloud service providers offer supplemental compliance and security features to assist in the security of your regulated data. However, from the perspective of regulatory agencies, the protection of your data is foremost the responsibility of the organization using a cloud platform as a service. It is essential to understand the data protection and compliance is always the responsibility of the user.

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Whether you are a healthcare business abiding by the Health Insurance Portability and Accountability Act (HIPAA), a retail company following the Sarbanes-Oxley Act (SOX) or a life science company addressing 21 CFR Part 11, the obligation — and liability — to maintain compliance remains with the organization.

If using a third-party vendor to assist in running your cloud, it is crucial to ensure they are running a compliant environment to meet your industry regulatory requirements.  As cloud providers work diligently to ensure their platforms are compliant from their end, organizations have the responsibility to confirm the infrastructure, applications and services from third parties are certified compliant.

Cloud Migration Considerations

Organizations may migrate to the cloud for the benefits of increased scalability, lowered IT infrastructure costs, and increased interoperability of data that is readily available and reliable — moving to the cloud benefits the consumer and the organization. The increased demand in cloud technology for regulated industries means needing strengthened solutions to meet security and compliance requirements. Cloud providers offer encryption, secure authentication, production audit logs, and tokenization to meet cloud security needs. Cloud providers even work with heavily regulated organizations to assist in compliance programs and security protocols.

However, security is still a massive challenge when migrating to the cloud. No cloud provider can guarantee their product is impenetrable. Authentication violations, hacks, data breaches, and account takeovers are still risks and challenges that affect organizations implementing the cloud. It is helpful to hold a cloud provider transparent by conducting an audit of their audited procedures and practices to confirm how they maintain strong security standards.

Cloud migration can also be more complicated for regulated companies like those in the life sciences who have GxP systems with specific regulatory requirements. Having a cloud migration strategy and cloud governance plan to assess, plan, migrate, and confirm proper relocation of data can significantly assist in a company’s successful transition to the cloud. Healthcare and life science industries also have digital compliance requirements because of electronic Personal Health Information (ePHI). Challenges can range from data security, lack of strategy, bandwidth, downtime, and vendor lock-in.

Integrating Cloud Applications

Cloud-based applications can be supplemental in running business-critical functions but also aid in cloud compliance to enhance your security standing. If not adequately scrutinized, implementing new cloud applications into your sensitive network can expose you to severe security and compliance risks. Maintaining compliance in regulated organizations is essential, and having applications that do not integrate well may call for separate compliance for each application.

If the integration of cloud applications is a crucial component of your organization’s business transformation processes, it is necessary to know the implementation process when examining cloud applications. It is also imperative to know how these applications affect where data is kept, who has data accessibility, how long you are required to store the data and how the applications are kept secure.

When running sensitive GxP cloud systems, it is also beneficial to have proper strategies when migrating GxP applications to the cloud. A sound cloud design strategy for GxP applications can assist in the overwhelming task of maintaining digital compliance with regulatory requirements.

Compliance Programs are Meant to be Revised

Regulatory environments are complex, and as requirements evolve with technology, the challenge to maintain compliance increases the intricacy of cloud computing. Data security is now a critical component of a regulated organization’s compliance program, and it can be a challenging task for companies to integrate their security standards with their compliance goals.

Committing to a proactive monitoring regimen with a compliance program can assist in limiting risk, securing data, and increasing customer trust in your organization. Consistent compliance risk assessments are the framework for a reliable compliance program. As technology in the cloud evolves, our data security is affected, and regulatory risks change. An assessment process is then revised to address updated regulatory requirements. 

A regulated environment is never stagnant; therefore, a compliance program must be monitored and audited accordingly. Third-party audits are highly recommended to understand your compliance position and gaps. Furthermore, innovations in technology like artificial intelligence (AI) and machine learning (ML) are implemented as risk monitoring devices. Experts expect AI to further integrate with monitoring regimens, creating proactive compliance programs to address the challenges of strict regulatory environments. 

Conclusion

As technology in the cloud advances, security and compliance laws affecting confidential data changes. Although cloud host providers now offer security features and applications to recognize regulation affected organizations, the need to maintain compliance, avoid interruptions, protect customers, avoid fines and uphold reputation is the challenge of the organization. Remaining proactive, exploring third-party solutions and looking to advances in technology to assist in compliance, can assist us in alleviating challenges associated with strict regulatory environments.


 Kevin Grimes, Sr. is a Vice President at Arbour Group, which is a Pharmalex company.  He is a seasoned executive with over 30 years of experience and is responsible for multiple business areas, including Digital Transformation and Compliance, Regulatory and Validation, and Connected Health.  During his career, he has worked with many Fortune 50 Life Sciences companies to accomplish objectives such as Revenue Growth, M&A, Cost Savings, and Technology Innovation. His Healthcare and Life Sciences career has focused with him working with payers, pharma, medical products, devices, and clinical trials.  He has extensive experience in the Healthcare Value Chain, Cloud Integration, Hybrid Public Cloud (AWS, Azure, and GCP), the Internet of Things (IoT), Project and Program Management, Digital Transformation, Artificial Intelligence, Machine Learning, Big Data, Analytics, Agile Development, Scaled Agile Framework (SAFe), and ERP package implementation. Moreover, he has knowledge of FDA regulated environments, including GCP, GMP, and GAMP5.