Editorial - Regulatory impact analysis in healthcare: an evidence-based approach
Vigil Sanit Debate, Rio de Janeiro, 2026, v.14: e02643| Published on: 2026-03-30
DOI:
https://doi.org/10.22239/vcxzq879Keywords:
Análise de Impacto Regulatório, RegulaçãoAbstract
Regulation in the healthcare sector represents one of the most intricate challenges for contemporary public administration. This is a field where technological innovation is advancing rapidly. Society's expectations for access to effective and safe treatments are growing, and the risks inherent in regulatory failure and the misuse of real data can have direct consequences on citizens' lives.
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1. Jarow JP, LaVange L, Woodcock J. Multidimensional evidence generation and FDA regulatory decision making: defining and using
“real-world” data. JAMA. 2017;318(8):703-4.https://doi.org/10.1001/jama.2017.9991
2. Brasil. Lei Nº 13.848, de 25 de junho de 2019. Dispõe sobre a gestão, a organização, o processo decisório e o controle social das agências reguladoras. Diário Oficial União. 26 jun 2019.
3. Brasil. Decreto Nº 10.411, de 30 de junho de 2020.Regulamenta a análise de impacto regulatório. Diário Oficial União. 1 jul 2020.
4. Saab FM, Silva MT. Qual a qualidade da análise de impacto regulatório elaborada por agências reguladoras do Brasil? Rev Admin Publ. 2022;56(4):415-34.https://doi.org/10.1590/0034-761220220111
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