How AI is changing the game

Last Tuesday I touched back home after a busy week at several events related to one theme: artificial intelligence (AI) in healthcare and, in particular, regulatory medical writing.

First stop was the Intelligent Health event in Basel on the 13th and 14th September, where attendees discovered the latest trends from robotic surgery and virtual reality-assisted international collaborations, to using AI for health equality and real-world evidence initiatives. Ethics and data ownership were debated in panel sessions and several workshops harnessed the diversity and excitement of those attending the event to progress ideas in these innovative fields.

Monday 18th then took me to Copenhagen to present to a surprisingly large crowd from the Danish Medical Writer’s Network. We started with an excellent talk on lean writing initiatives in regulatory medical writing: an eye opener at the amount of time we can already save by leaning up the documents we write and helping our readers at the same time. After coffee and networking, I was up to talk about AI in regulatory medical writing. What it is, why we need it, and how we should think about implementing it within our companies.

It was great to see that so many pilot initiatives are already in place within pharma and device companies. We should bear in mind that there is a lot of excitement around generative AI, but we are just at the start of this, there will likely be a sense of disappointment before true foundations are built in establishing workable solutions.

Where we are today

Recently, the healthcare field has been seeing a major disruption. One of the key players in this transformation is AI, which has found its place in various aspects of healthcare, including medical writing. Let’s take a closer look at how AI is reshaping medical writing and communication.

AI’s Impact on Medical Writing

Polishing the language

Ever read a medical document that is so hard to read that you end up re-reading the same sentence time and again? AI can help by catching grammar mistakes and ensuring documents are simple, clear and error-free. You are probably already using some of these AI tools without realising it.

Streamlining the manual work

Traditionally, medical writing used to involve a ton of manual work – reviewing data, reusing text, creating in-text tables and figures, and acronym lists. AI has stepped in to make this process easier by handling tasks like summarizing research findings and formatting documents. This not only saves time but also reduces errors.

Making sense of data

AI can chew through enormous datasets, which helps researchers and medical writers extract insights from clinical trials, other studies, and the literature. These insights can then be turned into research-backed regulatory documents.

AI in Action: Practical Applications

Clinical reports made simple

Creating clinical study reports used to be a tedious task. AI simplifies it by automating the process, ensuring reports meet regulatory standard templates and accurately reflect trial results, leaving the writer to the more skilled task of ensuring on-target messaging and a report that is fit for purpose.

Educating patients

AI-powered chatbots and virtual assistants help patients access reliable medical information. Medical writers can team up with tech experts to create patient-friendly content that also follows medical guidelines.

Challenges and Ethical Concerns

AI, however, isn’t without its limitations. Privacy issues, biases in AI algorithms, hallucination and the need for human oversight are important aspects to keep in mind when adopting AI in healthcare.

The Road Ahead for AI in Medical Writing

As technology continues to evolve, AI’s role in medical writing is set to expand. Expect more advanced language generation, better data analysis capabilities, and improved patient engagement tools in the future. Let’s ensure we, as medical writers, are prepared for the future. But let’s ensure we also do not forget how we used to analyse data and write reports. If your cloud service is down, if the system has been hacked, or simply if your internet access is not at its best, you’re going to need to write like you used to – manually (well, on a computer still). If you’re interested in hearing more, please contact me.


Integrating AI into regulatory medical writing isn’t just a trend; it’s a smart move in a rapidly changing healthcare landscape. Embracing this technology can lead to more efficient, accurate, and patient-focused communication in healthcare. So, keep an eye out for AI – it’s here to stay and shape the future of medical writing!