The Ministry of Health published, on May 4th, 2024, Ordinance GM/MS 3.232/24, which alters Consolidation Ordinance GM/MS 5/17 and launches a new digital health program within the Brazilian Publica Health System (“SUS Digital Program”). The initiative seeks to promote digital transformation in the SUS in areas such as:

  • comprehensive health care;
  • health surveillance;
  • training and continuing education of health workers and professionals;
  • management of the SUS (at all levels and spheres); and
  • planning, monitoring, evaluation, research, development and innovation in health.

The SUS Digital Program will be implemented by the Federal Government, states, the Federal District and municipalities, with the possibility of participation of higher education institutions, technological institutes and research institutions.

Concepts and definitions

The new ordinance brings important concepts and definitions for understanding the objectives, development stages and actions/projects of the SUS Digital Program. Among them, the following stand out:

  • Sensitive personal health data: any data relating to a data subject's health or health care provided to him or her that reveals information about your physical or mental health in the present, past, or future. It is important to note that this is a complementary definition to the concept of sensitive personal data, relating to health or sex life, genetic or biometric data, brought by Law 13.709/18 (General Data Protection Law – LGPD);
  • Digital health ecosystem: system with technical objects, techniques and technologies organized on a physical basis (connectivity, equipment and auxiliary devices), structures (networks, systems and databases), instruments (electronic medical records, self-applied records and protocols), operational processes (programs, applications and routines) and applications of digital techniques, for problem solving or interventions in health situations;
  • National Digital Health Maturity Index (INMSD): representation of the results of metrics used for the diagnosis, monitoring and evaluation of digital maturity, including the most important indicators to demonstrate the sustainability of digital health actions and services;
  • Digital health: a set of knowledge, techniques, practices, attitudes, ways of thinking and values related to the use of digital technologies in health and the growth of the digital space.

Objectives

Among the objectives of the SUS Digital Program, we highlight:

  • foster the appropriate, ethical, and critical use of new digital technologies in the SUS;
  • support the proposition of collaborative and free digital solutions that improve the provision of services, the management of care by health professionals and the quality of health care;
  • encourage training and continuing education in digital health;
  • promote sensitization, awareness and engagement for the use of digital technologies and adequate data processing by SUS actors, fostering the culture of digital health and the protection of personal data;
  • promote the interoperability of health data;
  • reduce inequality in access to digital health solutions and services in the different regions of the country.

Development Steps

The SUS Digital Program will be divided into three stages of development:

  • Step 1: preparation of the Action Plans for the Transformation of Digital Health (PA Saúde Digital) by the states, the Federal District and municipalities that adhere to the SUS Digital Program, according to the following phases (Ordinance GM/MS 3.233/24):
  • diagnosis of the territory situation, considering the health macro-region to which the plan refers and establishment of the degree of digital maturity based on the application of the INMSD – according to guidelines to be released by the Secretariat of Information and Digital Health by April 3rd of this year; and
  • analysis of the territory situation diagnosis and the recommendations resulting from the application of the INMSD.

The execution of the three phases related to the preparation of the Digital Health PA must meet the following deadlines – under penalty of suspension of the financial incentives (transfers) provided for in Ordinance GM/MS 3.233/24:

  • by April 3 of this year – states, the Federal District and municipalities must submit a request to join the SUS Digital Program;
  • within 90 days from the Ordinance publication date – diagnosis of the territory situation must be sent; and
  • within 120 days from the date of submission of the territory situation diagnosis – PA Digital Health by macro-region must be sent.
  • Step 2: Implementation of the respective Digital Health Transformation Action Plans, elaborated in the form of Step 1.
  • Stage 3: evaluation of the actions implemented as a result of the program, with reference to the INMSD.

The Ministry of Health will publish other ordinances with guidelines on stages 2 and 3 of the SUS Digital Program and its actions.

Actions and projects

According to Ordinance GM/MS 3,232/24, the digital transformation actions and projects resulting from the SUS Digital Program must be based on one or more of the following axes of action:

  • Axis 1: digital health culture, training and continuing education in health, which covers initiatives such as:

  • training and continuing education in digital health;
  • strengthening the digital health ecosystem by promoting open innovation; the structuring of a collaborative network for the sharing of experiences, knowledge, culture and practices among actors; and co-creation with citizens and organised civil society;
  • strengthening the use of studies and evidence for the incorporation of digital technologies in health;
  • fostering a culture of protection of personal and sensitive health data; and
  • improvement of health records.

Axis 2: technological solutions and digital health services within the scope of the SUS, which covers initiatives such as:

  • support for the computerization of the SUS and the adoption of electronic medical records that meet the interoperability standards of the RNDS;
  • supporting the improvement of infrastructure for digital and connectivity systems;
  • strengthening security mechanisms for access to health systems, data, and information;
  • encouraging the structuring and use of technological solutions and digital health services within health establishments and services;
  • strengthening digital health for health care for neglected, vulnerable, and geographically isolated populations and indigenous peoples; and
  • expansion of the offer of telemedicine and telehealth within the scope of the SUS in the national territory.
  • Axis 3: Interoperability, analysis and dissemination of health data and information, which covers initiatives such as:
  • promoting the interoperability of health data with the RNDS;
  • management and governance in the sharing of health data;
  • elaboration of technical studies, guidelines and protocols, analysis and dissemination of data to support digital health strategies and innovation in health;
  • standardization of national information models, as well as health vocabularies and terminologies;
  • promotion of the dissemination of health data and information, maintaining confidentiality, privacy, data protection and security of personal health information; and
  • preservation of the authenticity, integrity, traceability and quality of health information.

The following guidelines must be observed for the execution of digital transformation actions and   projects:

  • universality and equity in access to digital health products and services, at all levels of health care;
  • recognition of the National Health Data Network (RNDS) as the digital platform for interoperability, innovation, information and health services for all of Brazil;
  • active transparency in the availability of data and information that enable the monitoring and participation of society in the social control of digital health services and policies, with cooperation between federated entities;
  • use of information and communication technologies to support the decentralization of health activities, observing regional and local specificities;
  • recognition of access to quality internet as essential to promote digital inclusion and reduce inequalities in access to information and communication technologies necessary for the realization of digital health;
  • guarantee of the safe use of information, in compliance with the rules on data protection provided for in the legislation;
  • prioritizing digital health in the training and continuing education in health of SUS health professionals and workers; and
  • association of the program's digital health actions with the SUS health care model, to guide its conduction.

Our Life Sciences & Healthcare practice can provide more information on the topic.