Federal Official Gazette
ORDINANCE GM/MS No. 12,301, OF OCTOBER 27, 2026 — LATE PUBLICATION OF THE PREVIOUS EDITION
The Ministry of Health established the National Digital Health and Information Policy (Política Nacional de Informação e Saúde Digital — PNISD), with the purpose of promoting the digital transformation of SUS, the unification of clinical records, telehealth, interoperability, and the safe use of data and emerging technologies.
The policy applies, where pertinent, to public and private health entities and providers, technology companies, professionals, and users. Its guidelines include:
- consolidation of the National Health Data Network (Rede Nacional de Dados em Saúde, RNDS) as an interoperability platform;
- exchange between public and private systems;
- protection of personal data and security by design;
- single capture and reuse of information;
- expansion of telehealth; and
- use of artificial intelligence with human oversight and risk management.
Health establishments must gradually make the adjustments necessary for interoperability with the RNDS, make the information required by SUS available, and ensure the protection, privacy, and confidentiality of data. The Transformation Action Plan for SUS Digital Health must be agreed upon within 180 days.
Analysis: the rule is relevant to vertically integrated operators, hospitals, laboratories, clinics, and technology companies. Although the policy was established within the scope of SUS, it expressly provides for the participation of private providers and the interoperability of their systems with the RNDS. The specific technical obligations will depend on the forthcoming action plan and on complementary rules. We recommend monitoring the definition of the mandatory data, interoperability standards, implementation timeline, responsibilities for data sharing, and compatibility with the LGPD (Brazilian General Data Protection Law) and with the TISS standard.
https://www.in.gov.br/web/dou/-/portaria-gm/ms-n-12.301-de-27-de-outubro-de-2026-740877901
ANS news
ANS holds international seminar on quality and value in supplementary health
The National Supplementary Health Agency (ANS) will hold the International Seminar on Quality and Value in Supplementary Health on Nov 17. The event will bring together experts and leaders of health institutions from Brazil and abroad to discuss experiences and perspectives on improving care and generating value in health. The seminar will take place from 8:45 a.m. to 6:00 p.m. at the Windsor Guanabara Hotel, in downtown Rio de Janeiro. Registration is open until Nov 13.
Brazilian Open Data Portal: ANS has 62 datasets on supplementary health
The National Supplementary Health Agency (ANS) reports that it has 62 datasets available on its page on the Brazilian Open Data Portal (Portal Brasileiro de Dados Abertos, PDA). Citizens, researchers, companies, and other interested parties can consult and reuse information on health plan operators and other topics in the sector.
Open public consultations
- CP 179. Subject: proposal to update Normative Instruction ANS – IN ANS No. ANS No. 31, of December 19, 2022, which provides for the monitoring and assessment of the guarantee of care to beneficiaries by health care plan operators. Deadline: from Oct 23, 2026 to Dec 7, 2026
Scheduled public hearings
There are no scheduled public hearings.
Open public calls for input
There are no scheduled public hearings.
Open public calls
There are no open public calls or targeted social participations.
Other news
– No updates.
Sources: Federal Official Gazette (DOU) and the ANS website. Press items link to the original article. This brief is for information only and does not constitute legal advice.