Is Your Clinical and Biobank Data Compliant and Secure with a Cloud-based LIMS?


In this era of digital communication, every sector is compelled to evolve in order to keep pace with the technological advancements. Clinical laboratories and biobanks are no exceptions to it. Considering the enormous amount of data handled by clinical laboratories and biobanks on a day-to-day basis, managing data manually is a big challenge, taking a toll on everyone’s time. Additionally, data management using spreadsheets and paper-based methods is error-prone and antiquated.

Laboratory data management using a cloud-based LIMS is emerging as one of the most viable options, both economically and operationally. However, clinical research laboratories and biobanks are subjected to a number of ethical and legal restrictions because they deal with human biological samples and Protected Health Information (PHI) of patients. Inappropriate disclosure of sensitive patient information may jeopardize patient privacy and may have adverse ramifications on a patient’s access to insurance and employability. Data security in the cloud is a prime concern of clinical laboratories and biobanks. Therefore, a cloud-based LIMS raises concerns with respect to data security and compliance.

A cloud-based LIMS has not only made managing a large amount of data feasible but has also enabled secure storage of sample data and the associated patient data. A cloud-based LIMS addresses data security concerns by collaborating with trusted cloud service providers. However, the responsibility of security in the cloud falls on both, the cloud service providers and the LIMS vendor. Cloud service providers use a two-factor authentication, biometric-controlled locks, video surveillance, and regular access reviews to ensure the physical integrity of their servers where LIMS or other applications are hosted. Besides, some LIMS vendors take adequate measures to prevent data breaches caused by multi-tenancy, besides sharing of storage and computing resources. Cloud deployment negates expensive information security upgrades for individual laboratories. Data security is addressed using a layered approach by applying different encryption and intrusion-detection mechanisms, while network security is addressed by implementing the best industrial practices such as firewall/route tables, IP spoofing, port scanning, packet sniffing, VPN gateway, etc. Stringent server and auditing guidelines, in addition to SLAs, are enforced to provide foolproof security and privacy, 99.95% uptime and multi-tenancy. The data transmission between the client and the server is through SSL/TLS 1.2 and is 256-bit encrypted to provide a secure access to users. The data stored in the cloud is encrypted as well. A LIMS vendor also ensures that the data is backed up at regular intervals, and a disaster recovery mechanism is in place to retrieve the data in the event of man-made and natural disasters.

Other essential criteria for clinical laboratories and biobanks are being HIPAA and 21 CFR Part 11 compliant. Every employee has a specific role in an organization. Based on the role, certain privileges are given to each employee, which are required to perform his or her job responsibilities diligently. One of the best ways to safeguard PHI is by restricting its access based on the employee role in an organization. This is called role-based access. Role-based access prevents unauthorized data access as only authorized individuals have access to sensitive patient information. A cloud-based LIMS helps laboratories follow HIPAA guidelines by enabling laboratory managers or administrators to assign role-based PHI access privileges, safeguarding sensitive patient data from unauthorized personnel. Additionally, it helps laboratories follow 21 CFR part 11 guidelines, which mandates authentication of various laboratory activities using electronic signatures. Furthermore, a LIMS helps in maintaining an automated audit trail to retain a granular history of the laboratory activities performed by all users along with a date and time stamp.

The operational workflow of clinical laboratories and biobanks necessitates a LIMS which governs user access, inhibits data breaches, and permits secure protocols for data backups. A cloud-based LIMS has advanced from sample accessioning, sample storage, to securing data management. It has enhanced its competitiveness by constantly building and safeguarding features which are data-centric and protected in the cloud. The security measures adopted by a cloud-based LIMS are of global standards and implementable by biobanks or clinical laboratories across the globe. The concerns related to data breaches, hijacking of accounts, or data loss which were significant once, are now obsolete. The advantages of switching to a cloud-based LIMS are numerous, which includes enhanced data security, multi-tenancy, automatic data backups, real-time data sharing, high scalability, and zero-IT requirements. Clinical laboratories and biobanks can leverage the advantages of a cloud-based LIMS to seamlessly manage data, minimize expenses, streamline laboratory operations, and automate workflows.