Why Every Manufacturer Needs a Robust Information Security Program

Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators sharpen their focus, and threat actors grow more sophisticated, a comprehensive information security program is no longer optional—it’s essential.

What Is an Information Security Program?

An information security program is a structured framework of policies, procedures, and controls designed to protect the confidentiality, integrity, and availability of an organization’s data and systems. For life sciences companies, this includes everything from clinical trial data and manufacturing systems to employee records and protected health information (PHI). Frameworks that are used to help structure these programs include NIST, SOC 2, HITRUST CSF, ISO 27001, and CIS Controls, among others.

Why It Matters

The life sciences sector is uniquely vulnerable. Companies manage sensitive data across complex ecosystems involving R&D, supply chains, third-party vendors, and a variety of cloud-based platforms. A breach can lead to regulatory investigations, product recalls, reputational damage, litigation, commercial impact, and even patient harm.

U.S. laws and rules such as the Health Insurance Portability and Accountability Act (HIPAA), the Federal Trade Commission (FTC) Act, and Food and Drug Administration (FDA) cybersecurity guidance—as well as the EU’s General Data Protection Regulation (GDPR), European Union Data Act, and Medical Device Regulation (MDR)—impose strict obligations on manufacturers to ensure data protection, cybersecurity, and system resilience. Regulators increasingly expect companies to demonstrate proactive security measures, including risk assessments, incident response plans, and vendor oversight.

Even if your company is not regulated directly by HIPAA, other rules such as the FTC Act and various state laws still require reasonable security measures, especially for health information and other sensitive data.

Core Components of a Strong Program

A well-designed information security program should include:

• Governance and Accountability: Establish clear roles and responsibilities, including executive sponsorship and cross-functional oversight. Identify where and what data is collected, maintained, and used by the company.
• Risk Management: Perform regular assessments across the enterprise to identify and mitigate vulnerabilities in both IT and operational environments.
• Access Controls: Implement policies and measures to ensure only authorized users can access sensitive systems and data.
• Incident Response: Document and routinely test procedures for detecting, reporting, and responding to security incidents.
• Training and Awareness: Educate employees and contractors upon hiring and regularly thereafter on security best practices and regulatory requirements.
• Vendor Management: Establish contractual and operational controls to ensure third-party partners meet your security standards.
• Business Continuity and Disaster Recovery: Ensure company operations can continue in spite of disasters or other significant disruptions, including maintaining backups for critical information or systems.
• Vulnerability and Patch Management: Continuously track, assess, and manage vulnerabilities within the company’s technology assets and information infrastructure.
• Cyber Insurance: Ensure there is adequate coverage for any potential incidents based on the company’s risk profile and size.

An effective program needs to account for all company information and the systems and partnerships entrusted with it: cloud platforms, mobile applications, manufacturing systems, printers and other connected devices, vendor and consultant relationship, among other potential vulnerabilities. As companies scale or begin to handle PHI, their security programs must evolve too. A mature information security program enables innovation, builds trust with regulators and customers, and protects the core of your business. For life sciences manufacturers, cybersecurity investment is a core business function.

Paul Rothermel, Senior Attorney at Gardner Law: “Cybersecurity is not just a compliance issue—it’s a strategic requirement. Companies without robust information security programs are vulnerable not only to bad actors, but to market demands, as customers increasingly expect strong cybersecurity postures from vendors and technology partners.”

How Gardner Law Can Help You

Gardner Law works with drug and device manufacturers to operationalize regulatory expectations, develop information security program policies and procedures, and ensure adherence to compliance frameworks including HIPAA and other privacy and security laws and regulations. Whether you’re in a research phase or fully commercialized, now is the time to evaluate your security posture, identify gaps, and build or enhance your security measures to protect your company’s critical information assets. Contact us to get started.