BRAZIL Trends and Developments Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
2026 in practical terms Taken together, the evidence suggests 2026 is likely to be defined more by execution quality than by regula- tory surprise. Trade liberalisation signals, an acceler- ated patent cliff, active industrial policy and dense regulatory agendas are unfolding simultaneously under different logics and speeds. This convergence heightens sequencing risk: misalignment in regulatory, operational, commercial or financial dimensions can produce disproportionate downstream effects. Com- petitive advantage is therefore unlikely to come from correctly predicting a single outcome. It will accrue to organisations that remain institutionally prepared, operationally integrated and strategically agile, being capable of adjusting priorities and execution as signals crystallise over the course of the year. For companies seeking to do business in Brazil, the year ahead offers significant opportunity, but it will reward those who approach the market not as a collection of isolated fil- ings or transactions, but as an interconnected system that demands co-ordination, timing and discipline. *Legal Disclaimer: This document has been reviewed with the assistance of Harvey AI for the purposes of grammar correctness, typographical error identifi - cation, and standardisation of terms and definitions throughout. All substantive content, analysis and con- clusions remain the sole work product of the authors.
initiatives, including the recently launched National Health Data Network ( Rede Nacional de Dados em Saúde – RNDS), are laying the groundwork for interop- erability and secure data exchange across SUS. The Brazilian Artificial Intelligence Plan 2024–28, backed by roughly BRL23 billion in investment commitments, further underscores the government’s intent to posi- tion AI at the centre of healthcare transformation. This regulatory convergence, however, comes with ris- ing compliance expectations. Regulators are recali- brating device and software rules, requiring sponsors to demonstrate robust data lineage, monitor real-world performance, and embed cybersecurity protocols and update pathways as core safety features rather than afterthoughts. Even as regulatory clarity improves, reimbursement continues to lag behind the technology itself. Digital diagnostics, therapeutics and remote monitoring still navigate fragmented payment pathways, making early payer alignment on units of value and supporting evi- dence a critical priority for market access. That frag- mentation extends to clinical trials as well, where the steady stream of continuous sensor data and algorith- mic assessments demands tighter governance over data quality, adverse event detection and mid-study model changes. Beyond these regulatory and reimbursement dynam- ics, industrial policy is reshaping competitive position- ing in ways that favour locally integrated capabilities. SUS procurement increasingly rewards end-to-end local presence spanning devices, cloud infrastructure and support services, effectively turning service infra- structure into a strategic lever. Public financing, mean- while, is beginning to treat digital rails, such as remote monitoring, hospital-at-home connectivity and secure data exchange, as essential health infrastructure in their own right, creating new opportunities for com- panies that can deliver integrated solutions at scale.
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