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Publication compliance in 2026 is evolving: Here’s what to consider

Written by Dana Dena on Thursday, May 7, 2026

The publication teams I work with are tracking multiple compliance aspects throughout the publication development process. During my time at ISMPP, it was apparent that there are additional considerations to build into your plan. AI was at the heart of discussions and is generating new questions about authorship and peer review integrity. The critical planning around simultaneous publications and how we are addressing the recent additions to the ICMJE author guidance recently added were also part of discussions.

Simultaneous publication needs a governance framework, not just a timeline

Simultaneous publication, the coordinated release of pivotal data in journals and congress presentations, is increasingly common and increasingly demanding. Case data shared at ISMPP showed simultaneous publications achieving an average 89% higher Altmetric score compared with non-simultaneous releases, with one paper reaching an Altmetric score of 1,452 within 25 days.

But ensuring compliance is real. Managing embargo integrity across journals, congress organizers, corporate affairs teams, and authors requires senior leadership alignment and early coordination with publishers. Last-minute requests after acceptance typically cannot be accommodated. There was also a clear message from publishers in the room: missing declarations, incomplete ethics approvals, and absent author information add weeks to timelines. Publication teams that get everything in upfront protect both the timeline and the strategy.

AI disclosure: The compliance question without a standard answer

The “AI or Nay” plenary session made clear that the industry needs to continue the discussion on uniform guidance on disclosing AI use during manuscript development. Practices vary by publisher, by journal, and by the type of AI use involved. And the underlying question, When does assistive AI become generative AI? does not have an agreed answer.

Consider a scenario raised at the session: a non-native English speaker writes in their first language and asks an AI to translate and generate a paragraph from their notes. Is that assistive or generative? There is no consensus. Add to this the compliance risk of authors and freelancers using third-party AI tools that may compromise data security, and the gaps in current detection methods for AI-generated peer review content, and the exposure becomes clear.

Publication functions need an internal position before they need an external one. A proposed AI disclosure box, analogous to financial disclosures in journal submissions, was discussed as a potential path toward standardization. We are not there yet. But organizations that have already defined their internal standards will be better positioned when publisher requirements do solidify.

ICMJE: Track the changes, update the processes

During an interactive and engaging roundtable discussion, we focused on compliance-critical conversations around new ICMJE guidance related to author responsibilities, data access and AI transparency and specifically how new guidance was being added to author agreements. This has direct implications for how authorship decisions are structured and how GPP compliance is maintained across publication programmes. There were mixed operational updates to author agreements across the group. Session highlights focused on planning early to ensure compliance is obtained and upheld in these new evolving areas.

The single action I would prioritize following ISMPP

If I had to identify one action based on what I heard at ISMPP 2026, it would be this: continue to review your publication policy against the evolving compliance considerations that are impacting our industry.

We work with Publication and Medical Affairs teams across the ecosystem to build policies that are genuinely fit for the current compliance environment. If this is a conversation your organization needs to have, we would welcome the opportunity.

About the author

Dana Dena is EVP, Account and Operations at OPEN Health. She has been involved in the Medical Publications industry since the inception of ISMPP and has been an active contributor to the ISMPP community throughout her career, including serving as a committee member for the inaugural launch of the ISMPP Academy. Dana joined OPEN Health in 2019 and leads a team focused on delivering robust, compliant publication programmes for pharma and biotech organizations.

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