Currently, HIPAA and HITECH mandate clinical labs, as well as other healthcare systems, to report any cybersecurity breaches within 72 hours, while ransomware payments must be reported within 24 hours. Failure to comply with cybersecurity regulations may have adverse ramifications for clinical diagnostic labs. Hence, clinical diagnostic labs must consider deploying a Laboratory Information Management Systems (LIMS) that can uphold system flexibility without compromising security.
Compliance with HIPAA Security Rule
The HIPAA security rule requires that clinical laboratories have safeguards in place to ensure that protected health information (PHI) is always secure. It lays out administrative, technical, and physical safeguards that must be in place to ensure the confidentiality, security, and integrity of PHI. When selecting a Healthcare LIMS, it is important to ensure that the LIMS supports compliance with these safeguards especially as it relates to two key areas:: information access management and information access control.
Information access management
It is one of the tools of administrative safeguards that restrict access to data and information stored electronically. It follows a principle known as the “least privilege access” that limits access to data, only allowing employees, contractors, or third parties to access the data they need to carry out their roles effectively. Should a hacker access the password of an authorized user, they will only be able to access what that user is authorized to access. When employees switch roles, their access rights need to be changed with immediate effect. Similarly, system access rights should be terminated as soon as an employee leaves an organization. A healthcare LIMS chosen should support the least privilege access to minimize security breaches.
Information access control
This is a technical safeguard that protects PHI by covering the network hardware and structure as well as the instrumentation. HIPAA provides four specifications to help clinical diagnostic labs implement information access control:
Unique user identification: Unique logins are supported as opposed to generic logins. This makes it easier to detect and identify unusual access or activity in the system.
Emergency access procedures: This stipulates procedures to be followed in the event of an emergency, such as massive power failures or public health emergencies. It dictates how employees should access systems following such events.
Automatic log-off: This supports automatic log-off from the system after a certain duration of inactivity. Hence, the employee does not have to log off manually at every point. Should the employee forgets to log off, there will be no cause for alarm as they will be automatically logged off.
Encryption: Data encryption enables lab management to encrypt their data and hence prevents authorized people or hackers from making sense of it or altering it. Properly encrypted data will be of no value to hackers unless they can “decrypt” it.
Healthcare LIMS – Security Versus Flexibility & Scalability
Having tight security measures in place may limit the flexibility and scalability of a healthcare LIMS and hence undermine the lab’s performance. Fortunately, labs no longer need to choose between security and flexibility as modern LIMS have features that support both functions. A LIMS that can be configured as per the users’ requirements and maintains an audit trail and chain-of-custody will support investigation in case of a cyberattack while allowing flexibility in the system. Granular, role-based access control limits what type of information is accessible to employees and contractors. This is not only limited to role-based access but context-based access as well. In case of a breach, only a segment and not the entire system will be compromised. Lastly, a cloud-based healthcare LIMS solution improves the flexibility and accessibility of the system. It allows remote access and multiple users to access health information from different locations and at any time. At the same time, a cloud-hosted healthcare LIMS provides maximum data security by having off-site data backup for both current and legacy data as well as having in-built data encryption. Cloud solutions have automatic regular updates that mitigate against volumetric and slow attacks.
A cloud-based LIMS offers significant advantages when it comes to scalability. With a cloud-based healthcare LIMS, the ability to scale the number of users becomes seamless and efficient, ensuring smooth and uninterrupted operations for all users. As operations grow and more users need access to the LIMS, it allows for easy provisioning of additional resources, such as storage space and user accounts. This means that organizations can quickly and flexibly accommodate an increasing number of users without the need for significant infrastructure investments or complex software installations on individual devices. This scalability not only supports growth but also provides a cost-effective solution that can adapt to evolving business needs.
CloudLIMS – A Secure, Flexible & Scalable Healthcare LIMS
CloudLIMS, a clinical diagnostics LIMS,has been uniquely designed to address the security and flexibility needs of clinical diagnostic labs. It fully supports HIPAA and HITECH compliance by providing the following features:
Secure PHI cloud storage
Automatic data encryption
Role-based access control
Secure audit trail
At the same time, CloudLIMS also offers system configurability, scalability, and seamless integration with simple to highly complex instruments as well as automatic upgrades and backups. This ensures that the software remains flexible and secure at all times.