Understanding risks related to
Information Systems
Carrying out a risk mapping of its information system is expected for any healthcare institution, as it allows identifying vulnerabilities and defining all the necessary actions to achieve a residual risk level that can be knowingly accepted. Therefore, an approach based on the evaluation of human, technical, and regulatory risks is essential to ensure effective management of computerized systems. This article explores the main types of risks and proposes strategies to mitigate them.
Information Systems Security in Healthcare – definition and challenges
In the healthcare sector, information systems (IS) play a central and strategic role. An information system is characterized by the use of digital technologies serving the organization to facilitate each key stage of the processes implemented, from preclinical and clinical studies, through drug or medical device manufacturing, to patient data collection. Consequently, it carries new kinds of risks.
As a reminder, a risk can be defined as a feared event due to different threats (causes), for which one must assess the level of severity depending on the impacts (consequences), combined with the likelihood of the event occurring.
Risks related to the human factor
Humans are the most unpredictable factor, and the errors resulting from them must not be underestimated. They can have major impacts on the security and integrity of data and information systems.
Causes and Impacts of human-factor risks
These errors may stem from inadequate data handling, carelessness, lack of training, or negligence in applying security protocols by users. With technologies continuously evolving, the skills required may be lacking internally, whether for choosing suitable solutions or for performing IT management and maintenance tasks.
One can no longer ignore deliberate, malicious actions with lucrative or ideological goals, carried out through various cyberattacks. The ANSSI (French National Cybersecurity Agency) has published a report on the rise of incidents and alerts, from 2.87% in 2020 to 11.4% in 2023.
In the pharmaceutical and medical device sectors, such errors can lead to severe operational and legal consequences, including production downtime, loss of data integrity leading to incorrect product release decisions or wrong medical diagnoses, or leaks of confidential information.
How to prevent risks related to the human factor?
Regularly raise awareness and train personnel in best practices for information system management, regulatory requirements, specific data integrity risks, and ensure technology updates are addressed for administrators.
Quality culture
Promote an organizational culture where data quality and security are top priorities.
Use of advanced technologies
Leverage advanced technologies, such as artificial intelligence to detect intrusions or anomalies, or blockchain to ensure secure and traceable data exchanges.
Access management
Implement strict access control measures over system and network rights in order to prevent unauthorized manipulations and malicious acts.
Information Systems Technical Risks
Technical risks include failures and breakdowns, service interruptions, or issues related to system integration and interoperability.
Causes and Impacts of Technical Risks
These incidents may result from hardware defects, software development flaws, or environmental issues and tool incompatibilities. Technological innovation, although essential to remain competitive, can introduce new risks.
These risks may disrupt critical processes, such as drug manufacturing, clinical trials management, or the use of connected medical devices, resulting in delays, financial losses, impacts on product quality, or even direct impacts on patient health.
How to prevent technical risks?
Design reviews
Thoroughly analyze potential security or compatibility flaws.
Standards and protocols
Adopt recognized standards and follow strict security protocols to support integration and interoperability.
Preventive maintenance
Implement regular maintenance programs to reduce unexpected breakdowns.
System redundancy
Plan backup systems to ensure business continuity in the event of failure.
Regular testing
Qualify your infrastructure, test your backup and recovery processes, and run performance and resilience tests to identify and correct system weaknesses.
Business continuity and disaster recovery plans
Develop strong plans ensuring the maintenance of critical services in case of failure, in order to minimize the impact of interruptions.
Security in third-party contracts
Include security and compliance clauses for the protection of shared data.
These measures strengthen the reliability, security, and resilience of systems, limiting risks related to breakdowns, cyberattacks, or human errors. A proactive approach is essential to ensure business sustainability and the protection of sensitive data.
Information Systems Legal Risks
Life sciences companies are subject to strict regulations that are regularly updated by national or supranational agencies. For example, one can cite the GDPR (General Data Protection Regulation), ISO 14971 (risk management for medical devices), ISO 27001 (information security management), and FDA 21 CFR Part 11 (electronic records and signatures across GxP) which set out specific regulatory expectations.
Causes and Impacts of legal risks
Non-compliance may result from misunderstanding or lack of awareness of diverse regulatory texts, variable in scope depending on the international context. It may also stem from a lack of traceability or digital signature tools, often revealed during audits or inspections. Patient complaints may also highlight non-conformities concerning information system use and generated data.
Non-compliance can lead to financial penalties, loss of certification, damage to company reputation, or even a complete ban on production and sale. Data integrity and traceability are essential to prove compliance during audits.
Warning letters and recall notices from regulatory bodies such as ANSM (France) or the FDA provide concrete examples of significant impacts on patient health. These include massive recalls of cardiac monitoring devices due to cybersecurity rule violations and software validation failures, or product recalls prompted by falsified analytical data released via insufficiently validated computerized systems. The resulting legal, logistical, and market losses can total tens of millions of dollars.
How to prevent legal risks?
- Compliance audits: Conduct regular audits to verify that systems meet current standards and regulations.
- Define compliance remediation action plans
- Rigorous documentation: Maintain complete, up-to-date documentation of processes and controls in place.
- Legal oversight: Work with legal experts to anticipate and respond to regulatory developments.
Conclusion
Risks associated with information systems in healthcare are numerous. Poor risk management can harm patient health and compromise privacy. Regardless of the cause, a company could face sanctions from health authorities, financial losses, temporary business disruptions, data loss, and damage to its reputation.
Although varied and constantly evolving, risks can be effectively managed through proactive strategies. Among these are cybersecurity policies, system validation, staff education, and business continuity policies after an incident or attack.
By understanding and mitigating these risks, and maintaining high security standards, decision-makers can continue to invest in emerging technologies to improve the quality of their products.
Efor Group, your trusted partner
- Performing compliance audits of installations and information systems
- Defining and implementing risk analysis methodologies adapted to the context / IT risk management
- Conducting risk mapping and process analysis
- Carrying out criticality analyses and risk analyses of company information systems, and validating associated systems (“VSI link”)
- Defining and drafting Business Continuity Plans (BCP) and Disaster Recovery Plans (DRP)
- Designing training programs and delivering Data Integrity training adapted to business contexts