Are Regulators Ready For The Robot Era? ChatGPT Weighs In On EU Regulation

Artificial intelligence model’s comments signal the likely start of computer-generated comments to the US FDA’s public notices.

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Artificial intelligence is already writing for comments on proposed regulations.

“The medical device regulation was intended to improve the safety and quality of medical devices and to bring a harmonized regulatory framework for medical devices across the EU,” starts a commenter on the European Commission’s rollout of the Medical Device Regulation.

“However, the implementation of the MDR has caused disruptions in the medical device industry, with some manufacturers raising prices or discontinuing certain devices due to the added costs and regulatory burdens,” according to public comments published 18 January.

The commenter, based in the US, listed its size as “micro” meaning 1 to 9 employees. But the commenter is not a company, trade organization, patient advocacy group, or individual. It is allegedly the artificial intelligence language “model” ChatGPT.

Assuming it’s true that the comments were generated by ChatGPT, the remarkable development means the US Food and Drug Administration and other global regulators and government agencies should be prepared to receive comments generated by AI on information requests, guidances, rules and regulations moving forward.

While this particular comment relates to the medical device field, the readthrough to drug and biologics is easy to see.

In addition, ChatGPT appears capable of advocating while handling highly complex topics.

The topic in this particular case is related to “transfer period extension,” which aims “to gradually extend the transition period for medical devices and in vitro diagnostics,” according to the EU. The proposal also proposes to “abolish the ‘sell-off’ deadline” after which devices, placed on the market before or during the transition period and still in the supply chain, would have to be withdrawn.

The EU says it expects to adopt the proposed initiative through a fast-track procedure.

What’s more, the ChatGPT flourishing prose is more nuanced and detailed compared to some of the other comments from more experienced humans and trade groups.

For example, AdvaMed, the medical device trade group, submitted the following comments:

“The Advanced Medical Technology Association (AdvaMed) would like to highlight the utmost importance of ensuring the continuity of patient care in Europe and underscores the comments submitted by MedTech Europe, which highlight the importance for adoption of this legislative proposal as swiftly as possible, as follows – MedTech Europe takes note of the European Commission's proposal to amend the transitional measures in the Medical Devices Regulation (EU) 2017/745 and welcomes its recognition of the ongoing urgent risks of medical device shortages in Europe stemming from the regulation implementation challenges. It is now of utmost importance that the European Parliament and Council of the European Union adopt this legislative proposal as swiftly as possible to restore an acceptable regulatory pathway that enables all categories of medical devices to remain available to patients and the healthcare system.”

Nothing wrong with brevity. By comparison, ChatGPT lists eight lessons – eight! – the European Commission “could learn” from the “challenges and disruptions” caused by the rollout of the Medical Device Regulation:

1. The importance of stakeholder engagement: The commission could learn the importance of engaging with stakeholders, including manufacturers, healthcare providers, and patients, early on in the regulatory process to ensure that their perspectives and concerns are taken into account.

2. The need for realistic timelines: The commission could learn the need to establish realistic timelines for implementation of new regulations, taking into account the complexity of the medical device industry and the resources required for compliance.

3. The importance of providing guidance and resources: The commission could learn the importance of providing clear guidance and resources to manufacturers, particularly small and medium-sized manufacturers, to help them understand and comply with the new regulations.

4. The need for monitoring and flexibility: The commission could learn the need for monitoring the impact of the regulation, and being open to changes as necessary to ensure that the intended goals are met without creating undue burden on the industry.

5. The importance of collaboration: The commission could learn the importance of collaboration between regulators, industry, and other stakeholders to find solutions that will benefit everyone.

6. The need for a phased-in approach: The commission could learn the need for a phased-in approach, which allows manufacturers more time to adapt to the new regulations.

7. The importance of addressing the challenges faced by small and medium-sized manufacturers: The commission could learn the importance of addressing the challenges faced by small and medium-sized manufacturers, which are different than those faced by large manufacturers.

8. The need for a clear and consistent communication: The commission could learn the need for a clear and consistent communication throughout the process, which will help to reduce confusion and uncertainty

“Overall, the implementation of the MDR has been a challenging process, but by learning from the mistakes, the European Commission and other stakeholders can work to improve the regulatory process and ensure that the MDR is effective and efficient for all involved,” ChatGPT says.

Apparently, the European Commission has a lot to learn. One can imagine that very soon, the FDA and Centers for Medicare and Medicaid Services, particularly with kickoff of the Inflation Reduction Act around the corner, are going to get a lot of comments, maybe an infinite amount, from ChatGPT and the next iterations of the chat-bot.

Those agencies should at least be prepared to “learn” from the AI.