AI in health and pharma in Mexico: the use case to start with and the one to defer
A regulatory and pharmacovigilance assistant for laboratories; an administrative assistant for hospitals. No clinical records.
High value, available data, no decisions about people
A regulatory and pharmacovigilance assistant for laboratories (standards, filings, literature) and an administrative assistant for hospitals, both without patient data.
Any use with clinical records or diagnostic support: sensitive data, a possible medical device before COFEPRIS and a decision about people.
What is already happening in the sector
The digital health reform (General Health Law, chapter VI Bis, Official Gazette, January 15, 2026) requires digital clinical records with traceability. The health regulator (COFEPRIS) has no AI guidance, and Mexico had the highest medical inflation in the world in 2026 (Aon, January 2026), which pushes to automate claims reviews.
What the committee will review
Data the first use case touches
Regulatory documents, standards, procedures. No patients.
Regulator and obligation
Health data is sensitive: express written consent and fines that can double. Software with a clinical function requires sanitary registration as a medical device.
Who decides the purchase
Medical or regulatory director, with technology and Legal.
What health and pharma leaders ask
Is an assistant that drafts clinical notes a medical device in Mexico?
COFEPRIS has not published a criterion. An assistant that only drafts or summarizes without a diagnostic function does not automatically qualify as software as a medical device; if it predicts or recommends a diagnosis or treatment, it does. That is why the first project does not touch clinical records.
Other industries: Insurance · Financial services · Telecom and media · Fintech and payments
Discovery sessions, no commitment
With technology, compliance and two process owners. Includes an offline demonstration prepared for your sector, without using your company’s data.
Inventory and obligations
Data in four levels and a first review of what your sector requires.
Three candidate use cases
And the Assessment proposal. The Discovery is credited against the Assessment.
Founding clients program
Three seats, with an explicit discount in exchange for a publishable case and a reference.
Terms
Discovery and evidence pilot at no cost, Assessment at a discount, in exchange for a publishable case, a reference and feedback. Continuous operation is always paid at list price.