Strategies for Securing Pharma Manufacturing’s Fast-expanding Data Landscape

AI: The key to protecting life sciences data from cyber criminals

Cybersecurity has become increasingly critical in the life sciences industry, where sensitive data such as patient information, research findings, and intellectual property (IP) are at risk from sophisticated cyberattacks. This data is extremely valuable, especially when related to the development of blockbuster drugs, as it can often be a company’s most valuable asset.

Cybercriminals have become increasingly sophisticated in orchestrating attacks to access this critical data or disrupt a company’s ability to harness it. In addition to IP theft, they may carry out ransomware attacks, which have the potential to cripple a life sciences company’s operations.

Traditional cyber security measures are no longer sufficient to protect against sophisticated cyberattacks. The same digitalization and integration of data systems that have increased the speed and efficiency of drug development can also leave companies vulnerable if they fail to adopt a more comprehensive approach to security, incorporating the latest technologies.

Artificial intelligence (AI) has a crucial role to play not just when it comes to enhancing the effectiveness and value of life sciences data management but also in ensuring an organization’s cyber security is fit for the future. AI can be used to detect and respond to cyberattacks in real-time, and it can also be used to identify and mitigate vulnerabilities in IT systems. By leveraging the power of AI, organizations in the life sciences industry can significantly improve their cyber security posture.

But, as with any new technology, companies face challenges when integrating AI into their cyber security strategy.

The state of cyber security in the life sciences industry

In recent years, the pharmaceutical industry has made significant strides in data protection and cyber security. According to a recent study, the cost of a pharma data breach decreased from $5.01 million in fiscal year 2022 to $4.82 million in 2023. Furthermore, the time taken to detect (189 days) and contain (66 days) data breaches is now shorter than the global average of 204 days and 73 days, respectively.

Malicious attacks (45%), followed by human errors (28%) and IT failures (27%), are the most common root causes of pharma data breaches. Phishing-compromised credentials and cloud misconfigurations are the primary attack vectors employed by threat actors. On-premises storage and private clouds are less frequently breached than public clouds, while multi-cloud environments are the least secure and incur the highest breach costs.

The consequences of these data breaches for the life sciences industry extend beyond mere inconvenience. Cyberthreats can disrupt critical operations and manufacturing processes, affecting the supply chain and product distribution. They can result in the theft of IP as well as patient data. The former can lead to significant loss of profit, while the latter can result in costly regulatory and legal repercussions.

The pharmaceutical industry is subject to strict regulatory requirements regarding data protection and privacy, such as  Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and data privacy regulations (e.g., the EU’s General Data Protection Regulation [GDPR] or the U.S. Health Insurance Portability and Accountability Act [HIPAA]. Cybersecurity breaches can lead to non-compliance with these regulations, resulting in legal actions, fines, and damage to the company's reputation. The average HIPAA penalty has reached $1.5 million, with penalties ranging from $137 to $68,928 per violation, depending on the level of culpability. 17 October 2024 is also the deadline for EU Member States to transpose the NIS2 Directive into applicable law. For specific industry sectors, failure to comply with the NIS2 Directive and applicable laws could result in company fines up to €10m or 2% of total global annual revenue for essential entities or up to €7m or 1.4% of total global annual revenue for important entities, whichever figure is higher.

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