Cyber security in the pharma sector: the scenario, risks and future challenges
SAFE CORE
Reference context
The increase in the digitization of companies has led to the birth of the sector Pharma 4.0 and the IoMT (Internet of Medical Things) , which describes thedigital evolution of the pharmaceutical and medical devices sector, with the aim of improving the efficiency, quality and customization of production processes through the adoption of new technologies and data analysis. It is based on the principles of Industry 4.0, which refers to the fourth industrial revolution characterized by the integration of digital technologies, automation and interconnection between devices and systems.
The digital evolution is bringing many innovations to the pharmaceutical sector, improving the research, production and marketing of medicines and patient health all over the world.
Unfortunately, however, no less important is the flip side as the pharmaceutical industries are often the target of cyber attacks due to the huge amount of sensitive data that is collected and processed by them, including patient information, research and development information of medicines and information on marketing activities.
Technological evolution in the pharma sector
Technological evolution in the pharmaceutical sector it is an unprecedented evolution, with the adoption of new technologies that are fundamentally changing the way medicines are developed, produced and distributed.
- Artificial Intelligence (AI) and Machine Learning: AI and Machine Learning are revolutionizing pharmaceutical research, accelerating the identification of new drug compounds and improving understanding of disease mechanisms
- Data analytics and Big Data: Data analytics and the use of Big Data are enabling pharmaceutical companies to gain a deeper understanding of patients, diseases and drugs, improving the precision and effectiveness of therapies.
- Advanced manufacturing technologies: New manufacturing technologies, such as 3D printing and robotics, are improving the efficiency and quality of drug production, reducing production lead times and improving supply chain flexibility.
- Wearables and IoT devices: Wearables and IoT devices are enabling patients to monitor their health in real time, improving understanding of their needs and responses to medications, and enabling physicians to deliver more personalized therapies.
- Health and telehealth apps: Health and telehealth apps are revolutionizing the way patients interact with healthcare professionals, enabling greater autonomy and better adherence to therapies.
In summary, the technological evolution in the pharmaceutical sector is bringing many innovations that are optimizing the efficacy, safety and efficiency of the production and distribution of medicines, and improving the quality of life of patients.
The vulnerability of the sector
The pharma 4.0 sector is subject to numerous cyber attacks, as pharmaceutical companies manage a large amount of sensitive data on patients, scientific research and the production of medicines.
Health information is highly valued in the dark web market and its value is very high compared to other types of information. According to some reports, the value of health information on the dark web market can be between 20 and 50 times higher than other information, such as credit card information.
Pharmaceutical information can be used for blackmail or fraud, such as to obtain confidential information about a pharmaceutical company's marketing strategies, or to obtain information about a drug's clinical trials.
Furthermore, they can be used for the production and marketing of counterfeit or unauthorized medicines, which pose a serious risk to the health of patients.
Some of the top cyber vulnerabilities in the pharmaceutical industry include:
- Phishing attacks: Phishing attacks are very common in the pharmaceutical industry and can have disastrous consequences. Cybercriminals send deceptive emails that appear to come from trusted sources, such as business partners or suppliers, to trick employees into opening attachments or clicking on malicious links.
- Ransomware: Ransomware are computer programs that block access to data and ask for payment in exchange for decryption. Pharmaceutical companies can be particularly vulnerable to this type of attack, as the information they handle is very valuable and vital to their business.
- Data theft: Data theft can be caused by cybercriminals or malicious employees and can lead to the disclosure of sensitive information about patients, drug patents or drug research and development.
- Unauthorized access: Unauthorized access to sensitive data can be caused by malicious employees or external hackers, and can lead to the disclosure of sensitive information or data loss.
- Medical device safety issues: Medical devices, such as pacemakers or insulin pumps, are increasingly connected and integrated into the computer network of pharmaceutical companies. However, these devices can be vulnerable to cyber attacks, which can cause harm to patients or compromise data security.
In summary, cyber vulnerabilities in the pharmaceutical sector are numerous and can cause serious damage to companies and patients. Pharmaceutical companies must take the protection of data and sensitive information seriously, adopting appropriate cybersecurity measures and training personnel to prevent unauthorized disclosure of sensitive information.
Cyber security in the pharma sector: guidelines
General recommendations for cybersecurity in the pharmaceutical industry, which can be adapted based on specific needs and local regulations, include:
- Protect sensitive data: Pharmaceutical companies must take measures to protect sensitive patient data, such as personal data and health records. It is important to adopt information security policies to ensure that data is adequately protected, including the use of encryption, strong passwords and two-factor authentication.
- Manage data access: Pharmaceutical companies must limit access to sensitive data to only employees who need it to do their jobs. This can be done by creating user roles with limited access rights and managing access through a strong authentication system.
- Train staff: Pharmaceutical company personnel must be trained on cyber risks and threats, and on the need to maintain high standards of cyber security. It is important to make staff aware of the risks associated with phishing and other cyber attacks, and how to recognize and report such attacks.
- Regularly update your software and systems: Pharmaceutical companies need to keep their software and information security systems up-to-date to protect against the latest threats. This includes regularly updating your antivirus software and firewalls, and implementing security patches to fix any security holes.
- Constantly monitor systems: Pharmaceutical companies must constantly monitor their computer systems for any suspicious activity or anomalies. This can be done by implementing monitoring and alerting systems that warn of any security breaches.
In addition, it is important that pharmaceutical companies comply with local regulations and the guidelines of regulatory agencies, such as the GDPR in Europe and the Health Insurance Portability and Accountability Act (HIPAA) in the United States, to protect patient privacy and Protected Health Information (PHI) by ensuring regulatory compliance and the protection of sensitive patient data.
To help protect against cyber risks in the pharmaceutical sector, regulations have also been issued GAMP 5 guidelines (Good Automated Manufacturing Practice). They are a set of guidelines published by the ISPE (International Society for Pharmaceutical Engineering) to provide a systematic approach to the validation of information systems in the pharmaceutical sector.
The GAMP 5 guidelines are used by pharmaceutical companies as a reference for the validation of information systems and compliance with local and international regulations and also include the definition of software categories, based on their importance for safety and their complexity.
Software categories are used to determine the level of validation required for a particular computer system.
In summary, the GAMP 5 guidelines are used by pharmaceutical companies to ensure that information systems used for the research, development, manufacturing and distribution of medicines comply with local and international regulations, and that they meet established functional and non-functional requirements. The GAMP 5 guidelines provide for a series of validation activities that must be performed during the life cycle of the information system to ensure system security and compliance.
Cyber security in the pharma sector: the challenges
The pharmaceutical sector will face numerous future cyber challenges adopting appropriate IT security measures to protect sensitive patient data and prevent cyber-attacks.
To improve cybersecurity in the pharmaceutical industry, pharmaceutical companies can take a variety of measures, including:
- Implement an information security policy: Pharmaceutical companies should develop and implement an information security policy that outlines procedures for protecting data and sensitive information, including protocols for managing data access, mobile device management, password management, backup management and staff training.
- Use encryption: Encrypting access to sensitive patient and research data, both in transit and on file, helps prevent unauthorized disclosure of sensitive information.
- Adopt a strong authentication strategy: Pharmaceutical companies should adopt a strong authentication strategy, such as two-factor authentication, to ensure that only authorized people can access sensitive data.
- Implement an endpoint security solution: The implementation of an endpoint security solution, such as software
- advanced antivirus, aims to protect corporate devices and networks from malware and cyber attacks.
- Constantly monitor the network: Continuous monitoring of the network for any suspicious or anomalous activity helps to identify and prevent any cyber threats before they cause damage.
- Implement a backup solution: Pharmaceutical companies should implement a regular backup solution to protect sensitive data and ensure it is available in case of any ransomware attack or data loss.
In addition, pharmaceutical companies should regularly train staff on cyber risks and threats, and on the procedures to follow in the event of a security breach. It is important that personnel are aware of the risks and consequences of any security breach, and that they are able to recognize and report any cyber-attacks.
