Part-7: Information Security and Privacy Frameworks in the Pharmaceutical Industry

Pharmaceutical companies manage some of the most sensitive data in the world. This includes patient records, clinical trial data, intellectual property, and regulated manufacturing information. As digital platforms, cloud systems, and global collaboration become standard, information security and privacy governance is no longer just an IT concern. It is a regulatory and business risk issue.

Information Security and Privacy Frameworks provide the structure needed to protect sensitive data while supporting compliance, operational continuity, and trust with regulators and patients.

Below are the key frameworks commonly used in the pharmaceutical industry, along with their importance.

ISO 27001 – Information Security Management System (ISMS)

What it is

ISO 27001 is a globally recognized framework for establishing, implementing, and maintaining an information security management system.

Why it matters in pharma

ISO 27001 helps pharma organizations systematically identify information security risks and apply appropriate controls. It supports protection of GxP data, clinical trial systems, and intellectual property, especially in outsourced and cloud-based environments.

It also strengthens audit readiness by demonstrating structured security governance rather than ad-hoc controls.

NIST Cybersecurity Framework (CSF)

What it is

The NIST CSF provides a practical model built around five core functions: Identify, Protect, Detect, Respond, and Recover.

Why it matters in pharma

Pharma companies are frequent targets for cyberattacks due to the value of their data. NIST helps organizations build resilience against ransomware, data breaches, and operational disruptions, especially across manufacturing and R&D systems.

It is often used alongside ISO 27001 to operationalize cybersecurity controls and incident response.

GDPR – General Data Protection Regulation

What it is

GDPR governs how personal data of EU residents is collected, processed, stored, and shared.

Why it matters in pharma

Clinical trials, pharmacovigilance, and patient support programs frequently involve EU personal data. GDPR requires strong governance around consent, data minimization, breach notification, and data subject rights.

Non-compliance can result in significant financial penalties and reputational damage, making GDPR governance a board-level concern.

HIPAA – Health Insurance Portability and Accountability Act

What it is

HIPAA sets standards for protecting protected health information (PHI) in the United States.

Why it matters in pharma

Pharma organizations working with healthcare providers, patient programs, or real-world evidence data may fall under HIPAA obligations. Governance ensures PHI is accessed only by authorized users and protected throughout its lifecycle.

HIPAA controls often overlap with GxP and data integrity requirements, making alignment critical.

Data Integrity and ALCOA+ Principles

What it is

ALCOA+ defines data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available.

Why it matters in pharma

Data integrity failures remain one of the most common causes of regulatory findings. Information security frameworks must support ALCOA+ by ensuring proper access control, audit trails, system security, and data retention.

Security and data integrity are tightly linked in regulated environments.

How REDE Consulting Supports Pharma Information Security Governance

REDE Consulting helps pharmaceutical companies design and operationalize information security and privacy frameworks that align with both regulatory and business needs.

We work across Quality, IT, and Compliance teams to ensure security controls are risk-based, inspection-ready, and scalable.

Our services include:

• Information security and privacy governance design

• ISO 27001 and NIST framework alignment

• GDPR and HIPAA compliance integration

• Data integrity and system access control strategy

• Security risk assessments for GxP and non-GxP systems

AI-Powered ServiceNow for Pharma Security and Compliance

REDE Consulting leverages AI-powered ServiceNow IRM and GRC solutions to help pharma organizations move from manual compliance to continuous risk monitoring.

Using ServiceNow, we help clients:

• Centralize security and privacy risks in one platform

• Automate control testing and evidence collection

• Monitor compliance across ISO, GDPR, HIPAA, and GxP requirements

• Gain real-time visibility into incidents, risks, and remediation

• Reduce audit preparation time through structured workflows

This enables pharma companies to strengthen security while maintaining speed and operational efficiency.

Ready to strengthen your information security governance?

If your organization is managing increasing regulatory scrutiny, expanding digital systems, or preparing for audits, REDE Consulting can help you build a practical, compliant, and scalable security governance model.

Connect with REDE Consulting { info@rede-consulting.com } to learn how our AI-driven ServiceNow solutions can support your information security and privacy objectives.