Ensuring Robust Data Privacy and Protection: An Overview of the MMS Framework

In today’s digital age, data privacy and protection have become paramount concerns for organizations across various industries. Last year alone, the HIPAA Journal reported that a record-breaking 133 million individuals had their healthcare data compromised across 655 breaches, and new research from this outlet shows that this trend is not slowing down.

This, coupled with regulatory imperatives, means that implementing stringent data protection measures is crucial for maintaining the highest standards of information security.

Information Security Management System (ISMS) explained!

A robust Information Security Management System (ISMS) is essential for maintaining high levels of data security and protection needed in today’s healthcare and pharmaceutical landscape. An organization, like MMS, that is certified to the ISO 27001:2022 standard underscores an organization’s commitment to information security. This encompasses various security capabilities and controls designed to protect sensitive data.

Key components of the ISMS, include the following:

• Physical and Logical Security Standards: Adhering to ISO 27001-compliant physical and logical security standards is crucial. These standards include multiple layers of information security and data protection, from firewall and intrusion prevention systems to real-time virus, malware, and phishing protection.
• Ongoing Education and Training: Continuous education and communication to all stakeholders in an organization are critical components of a security strategy like this one. Conducting phishing simulations and training raises awareness among employees about potential cyber threats should occur regularly and unexpectedly.
• Multi-Factor Authentication (MFA) and Device Registration: Implementing MFA and device registration for accessing cloud services, including SharePoint Online, OneDrive, Exchange Online (Email), and VPN, ensures that only authorized personnel can access sensitive information.
• Redundancy and Fault Tolerance: Employing redundancy and fault tolerance mechanisms across servers, networks, and internet access points ensures business continuity. This includes real-time server, application, network, and access event monitoring.
• Business Continuity and Disaster Recovery: A robust business continuity and disaster recovery process is essential. This includes secure data exchange policies and tools, as well as backup and restore capabilities to support all services and client deliverables. For the ISMS, include the following:
  

Management of Protected Health Information

Protecting and managing protected health information (PHI) requires well-defined standard operating procedures (SOP). Recently completing an ISO audit with no findings or necessary remediations, MMS has employed an SOP titled “QA-SOP-016 Protection of Private Data and Privacy Breach Management.”

Within, this SOP outlines the processes for safeguarding private data and managing privacy breaches. Additionally, it provides employees with the proper resources needed to respond to Sponsor inquiries regarding privacy policies and data management practices.

In response to the European Court of Justice’s Schrems II ruling, MMS has successfully completed the self-certification process for the EU-US Data Privacy Framework (EU-US DPF), with an updated Privacy Policy and Privacy Notice and the company is now in the active list of certified companies for Data Privacy Framework. This certification ensures that MMS complies with the EU-US DPF, the UK Extension to the EU-US DPF, and the Swiss-US DPF, facilitating reliable personal data transfers between the US and the EU, UK, and Switzerland.

The dedication of MMS and its colleagues to data privacy and protection for Sponsors, patients, and people across the globe is evident. A comprehensive information security framework and adherence to international standards is a must for every CRO in this everchanging pharmaceutical industry. By continually enhancing its security measures and compliance practices, MMS ensures the highest level of data protection to keep us focused on what is most important – positively improving lives worldwide.

Authored by: Seetharaman Sankaran, Associate Director, IT, Quality and Compliance