Law No. 15,524, published on September 29, 2026 and already in force, creates the National Strategy for Control and Assessment of the Quality of Healthcare Provided by the Private Sector. In practice, private hospitals, clinics and other providers will be assessed against standards set by the Brazilian Health Regulatory Agency (Anvisa), with results periodically disclosed to the public. Providers that fail to meet the standards face a daily fine that may reach BRL 500,000.
What does the law create?
The strategy is an action plan built on three pillars: setting quality standards, assessing the services provided and periodically publishing the results. Anvisa will define the standards by type of provider and lead the strategy, with possible support from states and municipalities.
Although the strategy targets the private sector by name, the same standards will also apply to public healthcare facilities, which will likewise be assessed and have their results disclosed.
What will be assessed?
The law sets minimum guidelines for the standards. These include patient safety, through scientifically proven treatments; sufficient staff, infrastructure and processes to avoid long waits; patient-centered care; equity, with no distinction based on sex, religion, ethnicity, geographic location or socioeconomic status; and effective compliance with the rules of Anvisa and the National Supplementary Health Agency (ANS).
External accreditation also gains ground: certifications granted by accrediting bodies may be considered in the assessment, under requirements to be set by Anvisa. They do not, however, replace visits, inspections and enforcement actions.
What if the standards are not met?
The law also amends Law No. 9,782/1999, which created Anvisa, to impose a BRL 5,000 daily fine on private providers that fail to meet the standards. The amount may be increased up to 100 times, depending on the provider’s economic situation, where necessary to ensure the penalty is effective. The fine does not exclude civil liability for harm to patients or sanctions for violating consumer protection and ANS rules.
Next steps
Implementation depends on regulations. Anvisa will detail the quality standards by type of provider, the assessment method, the requirements for relying on accreditation and how results will be disclosed. With assessments made public, quality of care is likely to carry more weight as a driver of reputation and differentiation in the healthcare market.