The life science industry is a significant contributor to the global market, with companies developing and manufacturing a wide range of medical products and devices. However, due to the complex and highly regulated processes that companies must follow, a significant volume of data is generated, which needs to be correctly managed and stored. This includes research and development documents, clinical trial data, and regulatory filings, which are often stored in electronic and hard-copy paper formats.
The life science industry, including pharmaceutical, biotechnology, medical device, and diagnostic companies, is heavily regulated by multiple regulators, such as the United States Fund and Drug Administration (USFDA), Medicines and Healthcare products Regulatory Agency (MHRA), World Health Organization (WHO), European Medicine Agency (EMA), Therapeutic Goods Administration (TGA), Department of Justice (DOJ), etc. It is often subject to legal disputes or regulatory requirements related to discovery, which is the process of gathering information in legal proceedings. Therefore, eDiscovery is an important solution for the life science industry to manage the vast amounts of data generated and respond efficiently to legal and regulatory challenges.
What is eDiscovery?
eDiscovery involves the identification, collection, processing, review, and production of electronically stored information (ESI) in response to a legal request or investigation, or regulatory matter. In the context of the life science industry, ESI can include emails, documents, communication records, laboratory notebooks, clinical trial data, manufacturing data, quality data, testing, and other digital records. The eDiscovery solution helps companies reduce time and costs compared to traditional paper-based discovery, as well as improve the accuracy and completeness of documents submitted as per the matter.
Some areas where eDiscovery solutions are used in the life science industry include:
- Litigation: Pharmaceutical and medical device companies may be subject to lawsuits from patients, competitors, or government entities.
- Product liability litigation: Companies may face lawsuits alleging harm caused by their products. The eDiscovery solution can be used to gather and examine information pertaining to the creation, testing, promotion, and favorable/unfavorable occurrences of the product under scrutiny.
- Intellectual Property (IP) or Patent litigation: Companies may engage in IP disputes related to their products or technologies. eDiscovery can be used to collect and review data related to the invention, development, and commercialization of the patented product or technology.
- Regulatory Investigations: Life science firms are accountable to regulatory bodies such as the Food and Drug Administration (FDA), Department of Justice (DOJ), and Security and Exchange Commission (SEC). eDiscovery can be used to quickly collect and review data related to compliance with regulations and to respond to agency requests for information.
- Compliance: Companies must comply with various regulations, such as the Federal Food, Drug, and Cosmetic Act and the Health Insurance Portability and Accountability Act (HIPAA). eDiscovery helps companies ensure they are complying with these regulations by allowing them to efficiently identify and produce relevant documents.
By implementing eDiscovery solutions, companies can more efficiently handle data and mitigate risk. However, eDiscovery solution implementation can be a challenging process and demands resources with specific skill sets who understand the technology, data, and business processes. Implementing and managing eDiscovery solutions comes with challenges.
Some of the challenges that companies face using the eDiscovery solution include:
Data Volume Management
The amount of electronic information produced by both individuals and organizations is rapidly increasing. For instance, pharmaceutical firms generate data throughout the drug development process, including clinical trials, regulatory submissions, and manufacturing procedures. In healthcare, electronic medical records (EMRs), emails, and instant messages are some examples of data sources. In medical device companies, data is generated throughout the product life cycle, such as design and development documentation, manufacturing and quality control records, clinical trial data, adverse event reports, labeling and marketing materials, and post-market surveillance data. Dealing with this significant volume of data, multiple data formats, and sources can create challenges in terms of identifying and collecting relevant data, as well as managing and analyzing large datasets.
By implementing an eDiscovery solution, companies can manage this data efficiently, reducing costs and improving accuracy. One effective strategy to begin with the eDiscovery solution is the identification of the relevant data and custodians dealing with that data. This can be achieved through interviews and questionnaires. This approach can save costs, assist with gaining business intelligence, and determine case strategy, especially in matters that involve any legal hold. Additionally, processing data through the eDiscovery platform with advanced analytics techniques (i.e., machine learning and artificial intelligence) helps in analyzing the data quickly and accurately. Also, the right eDiscovery platform and its infrastructure need to be implemented to handle different types of data formats, ensuring data is organized, making it easy to search, review, and download when required.
Data Privacy and Cross-Border Data Transfer Concerns
Data privacy is critically important in life sciences due to the sensitive and highly personal nature of the data involved, such as medical records, genetic information, and biometric data. Further, this information is used for a variety of purposes, including medical research and drug development.
Considering the sensitivity of the data, there are laws and regulations in some jurisdictions that life science companies need to follow. For example, in the European Union, the General Data Protection Regulation (GDPR) sets out strict requirements for collecting, using, and storing personal data, including medical records.
In the case where a life science company is facing cross-border litigation involving the transfer of personal data between different jurisdictions, managing, reviewing, and sharing information becomes a very complicated task. Also, any personal information shared may later cause damage to the company. To address these data privacy challenges, companies should take measures to identify, analyze, and secure data throughout the eDiscovery process.
The eDiscovery solution has machine learning (ML) and natural language processing techniques to identify and categorize sensitive data. For example, ML can be used to automatically identify personal data, such as names, addresses, and social security numbers, in large volumes of data. Further, this data can be redacted while sharing the information. Additionally, the solution has encryption and access control features that can help ensure that sensitive data is kept secure.
Speed and Accuracy in Litigation and Compliance Matters
The life science industry has experienced a significant increase in litigation and compliance matters, including patent disputes, data theft, regulatory investigations, financial fraud, and more. These matters are critical to the company, and management is under constant pressure to resolve/respond to them quickly, as they could potentially cause reputational or financial harm. These matters involve collecting, analyzing, and reviewing a vast amount of data from different sources, which can be a complex and time-consuming task. Additionally, the project team must ensure that there is no risk of evidence spoliation, and data must be reviewed efficiently to meet the necessary timelines.
The key to addressing these matters efficiently and expeditiously is to act swiftly by utilizing streamlined workflows and tools within the eDiscovery process. This will enable decision-makers and legal experts to navigate vast amounts of data quickly and efficiently.
Using eDiscovery time-consuming manual processes can be automated such as document review and data collection, making the entire process more efficient. Additionally, it helps in better collaboration among legal and investigation teams, enabling them to work together more effectively and efficiently. Furthermore, having automated processes and streamlining workflows is much more cost-effective compared to manual discovery methods.
For instance, companies worried about current or former employees stealing proprietary information can be identified quickly and efficiently by implementing eDiscovery procedures to detect any warning signs alongside proactive data leakage prevention (DLP). This can help in mitigating the risks associated with data privacy, security, and regulatory compliance.
In conclusion, as the life science industry continues to expand and generate vast amounts of data, it becomes increasingly important for companies to adopt efficient and effective solutions to manage their legal, regulatory, and compliance matters. The eDiscovery solution offers a streamlined approach to data volume management, data privacy concerns, and speed and accuracy in litigation and compliance matters. By utilizing advanced technologies like machine learning and natural language processing, eDiscovery can help identify and categorize sensitive data, automate manual processes, and improve collaboration among legal and investigation teams. Implementing eDiscovery can provide a cost-effective and efficient way to manage the associated risks, mitigate data privacy and security risks, and ensure compliance with regulatory requirements.
Therefore, it is imperative for life science companies to take appropriate steps to implement an in-house eDiscovery solution or collaborate with third-party eDiscovery experts who understand the industry and can make the process seamless. By doing so, companies can manage their matter workloads, budgets, and mitigate risks while maintaining their essential priorities, which ultimately contributes to their success and growth in the industry.
© Copyright 2023. The views expressed herein are those of the author(s) and not necessarily the views of Ankura Consulting Group, LLC., its management, its subsidiaries, its affiliates, or its other professionals. Ankura is not a law firm and cannot provide legal advice.