We hear about AI and other emerging technologies daily, but how will these innovations impact regulatory affairs and especially our ability to navigate the regulatory landscape? As global compliance becomes increasingly complex, AI is beginning to reshape regulatory operations in the life sciences sector.
For organisations that embrace AI, it can provide significant competitive advantages and assist with various tasks. However, adopting this technology also presents its own set of challenges. As the saying goes, “Take risks, but don’t take reckless risks.” Achieving a clear understanding is crucial when adopting new technologies. For example, industries such as finance have begun to use AI for transparency, prediction, and analysis. At the end of this article we hand out an AI hack you may use already today, with a validated and tested prompt dialogue to process regulatory documents.
Short definition of AI and what models that is covered in this article
There are several AI models, with differences in how they learn and how to operate them. In this article we will only look at NLPs (Natural Language Processing) and GTP´s (Generative Pre-trained Transformer).
Rewards of AI in Regulatory Intelligence
1. Automated Summaries and Translations
AI tools like ChatGPT and Gemini streamline the summarisation and translation of regulatory documents, enabling organisations to quickly extract key information and overcome language barriers. This enhances access to critical regulatory updates, improves communication, and supports compliance efforts across diverse regions. Additionally, AI assists in navigating extensive content relevant to your product. By facilitating precise queries, it significantly enhances the ability to identify relevant information and efficiently distil complex documents. While AI boosts productivity by managing large volumes of data, human oversight remains essential to ensure accuracy and contextual understanding.
2. Enhanced Document Review for Regulatory Compliance
AI technologies can greatly assist in reviewing and interpreting newly released regulations and guidelines from authorities like the FDA, EMA, and WHO. By extracting key information, AI enables rapid identification of relevant changes that may impact operations, streamlining the review process for greater efficiency. However, the effectiveness of AI in document review relies on the quality of algorithms and the context of the documents. Organisations must recognise that AI may overlook critical details or misinterpret complex language. Thus, integrating human expertise with AI insights is essential for comprehensive compliance and risk mitigation.
3. Targeted Data Analysis for Regulatory Intelligence
AI technologies can analyse data from various regulatory sources, helping organisations identify trends and compliance gaps. This can greatly benefit organisations in staying ahead of evolving requirements. By leveraging AI for insights, organisations gain a deeper understanding of compliance landscapes. The combination of AI-driven insights and human expertise empowers teams to navigate compliance issues and make informed strategic decisions.
Risks of AI in Regulatory Intelligence
1. Data Integrity Concerns
While AI models for NLP and GPT excel at summarising and reflecting on information, the quality of the data fed into these systems is paramount. If AI is trained on inaccurate or outdated information, it can yield misleading insights. Regulatory professionals must ensure rigorous oversight of information sources. It is crucial for organisations to enhance their knowledge and ensure they have the right tools and expertise to validate the data used in AI systems.
2. Cost Implications
The adoption of AI technologies often requires significant investment in software and training. Smaller organisations may face challenges in justifying these expenses, necessitating a careful assessment of long-term benefits versus initial costs. Try out free of use tools to try out a good fit with your operations to justify the value!
3. Job Displacement?
The increasing use of automation in regulatory affairs raises concerns about potential job displacement as AI takes over routine tasks traditionally performed by humans. While AI can streamline operations, human oversight and expertise remain crucial in areas requiring critical thinking, judgement, and contextual understanding. These elements are vital for maintaining an effective and balanced regulatory strategy. Although we can only speculate on where this technology will lead us, it’s clear that AI is here to stay and will continue to evolve. Recognising its potential and adapting to its growth will be essential for future success.
Conclusion
As AI continues to reshape regulatory affairs, understanding its capabilities and limitations is crucial for organisations navigating the complex landscape of global compliance. While AI assists with tasks like summarising, translating, and analysing documents, critical decisions still require human judgement, as regulatory professionals provide insights and contextual understanding that AI cannot replicate. While AI offers competitive advantages, organisations must remain aware of data integrity, financial barriers, and job displacement concerns. Ultimately, effective collaboration between human expertise and AI is essential for navigating compliance challenges and adapting to the evolving regulatory landscape.
A Practical Hack: How to Get Started Today
The Problem: Summarise and Interpret a new guidance
Regulatory documents are often lengthy and intricate, making them challenging to navigate. This complexity can lead to inefficiencies, with professionals spending excessive time reading and analysing texts that contain critical information relevant to their operations.
Illustrative Step-by-Step Guide - Summarising and Analysing Articles with AI
In this example we use a rather short guideline from MHRA, feel free to try with any guideline, regulation, amendment etc that feels important to you. To get implications we need to use product and company data in the prompt. In this example we use a fiction product called Blood plasma analysis machine, an IVD product by Plasma Inc.From the guideline, one usually wants the following:
A short summary for internal distribution, perhaps in a weekly regulatory newsletter.
Implications in relation to the product and company for compliance and planning reasons. I.e. a checklist.Follow the steps below to try this on your own of AI (In this example we use ChatGTP 4.1)
Step 1: Select an ArticleThe first step is to select and find the article you wish to summarise and get interpretations of. In our example we selected the following regulatory news from MHRA (UK)
Example Article:
Source: MHRA Transparency for machine learning-enabled medical devices: guiding principles
URL: https://www.gov.uk/government/publications/machine-learning-medical-devices-transparency-principles/transparency-for-machine-learning-enabled-medical-devices-guiding-principles
Step 2 (VIDEO): Create a Summary Prompt
Prompt used in the video: Summarise the key points of the regulatory document on transparency guidelines for machine learning-enabled medical devices in a concise, executive style suitable for a regulatory newsletter. Focus only on the essential points without elaboration. [Paste the article text here]
Step 3 (VIDEO): Identify potential implication for compliance
Prompt used in the video (insert your product data): Provide the implications of this guideline for our product that is, a Blood analysis machine, product type is IVD by Plasma Inc. The product contains vital components and material such as; internet connection and software, batteries, bluetooth, glucose metre and electrical engine and comes with a software. [Paste the article text here]
Step 4 (VIDEO): Review and enhance the Summary and Implications generated by AI
Our results generated for the example article were pleasing in terms of a summary and implications on a higher level. Though, it is a good idea to continue the dialogue with the AI model to get further details when needed. Let's have a look at how we pinpointed some findings regarding implications to get a more detailed response.
Prompt used in the video (insert your specific area): What applicable standards regarding User interface should we consider to reach compliance regarding this part?
Conclusion:
Making use of AI to summarise and interpret regulatory changes can be very effective, especially if the regulatory change is in another language than one of the ones you master.
With Hoodin, you can easily access global articles, concise summaries, and translations relevant to your interests. Start your 14-day free trial today and simplify your journey to understanding regulatory implications. If you have any questions or need assistance, we're here to help!
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