Interoperability in healthcare in Brazil: trends and challenges

Maira Materagia Imperatriz
Lefosse Advogados, São Paulo
maira.materagia@lefosse.com

Lucas Barreto
Lefosse Advogados, São Paulo
lucas.barreto@lefosse.com

Interoperability of health information faces significant challenges in Brazil due to the structure of the national healthcare system, a complex regulatory framework, and socio-economic issues.

Healthcare actions and services are carried out through both public and private initiatives, involving multiple players and authorities. The combination of healthcare actions and services provided by federal, district, state, and municipal public facilities constitutes the Unified Health System (Sistema Único de Saúde or SUS), which is a decentralised system with a network of health services distributed across the above-mentioned levels.

Private health facilities provide healthcare actions and services accessed through private hospitals, laboratories, medical clinics, etc, and the admission to these facilities is primarily through health plans and insurance offered by health maintenance organisations.

Private entities may provide services to SUS through certain partnerships, agreements, or specific health programmes. Health maintenance organisations are required to reimburse SUS for health services provided to their beneficiaries in public health facilities.

To that extent, interoperability and health information standards are the minimum set of assumptions, policies and technical specifications which govern the exchange of information between all involved players and authorities.

The configuration of the national healthcare system poses the primary barrier to widespread health information interoperability in Brazil, as the fragmentation of health data across various locations and services is inherent to the system.

Nevertheless, Brazil’s plans, public policies, and strategies over the last few years have demonstrated significant progress in the dissemination of interoperability within its health system, although they still face major challenges in this regard, as will be explored below.

Brazil’s plans, public policies, and strategies

In the mid-2000s, the Ministry of Health (MoH) began making the first moves to enhance and integrate the flow of health information. In 2011, the MoH took a significant step by regulating the use of health information standards and interoperability among SUS information systems, as well as within private and supplementary health systems.

The MoH determined the use of certain information standards by public and private agents aiming at enhancing the quality and efficiency of the health ecosystem, thereby advancing the well-being of the population.^[1]

Among the information standards established are the National Health Card System and the Supplementary Health Information Exchange Standard (TISS Standard). The National Health Card System aims to provide unique identification of patients within the scope of SUS through a nationally valid number and is supported by other information standards for the patient track record. TISS Standard is designed for the exchange of healthcare data among Brazil’s Health Supplementary Agency (ANS), health maintenance organisations, healthcare providers, and contractors and beneficiaries of healthcare plans and insurances.^[2] TISS Standard encompass the registration and documentation of medical procedures carried out by beneficiaries of private health plan and insurances. This enables not only patient tracking, but also minimises the possibility of fraud and operational hold-ups.

In 2015, the MoH took another step towards the implementation of interoperability through the Policy for Information and Informatics in Health. ^[3] It set out principles and guidelines for both public and private sectors to foster innovation, advance the digital transformation of health work processes and bolster governance in the use of information, technology solutions and digital health.

To encourage interoperability among various systems, the Policy recommends: (1) implementing basic security standards in electronic medical records systems; (2) standardising vocabularies, terminologies, and nomenclatures; and (3) managing patient’s clinical history documents effectively to ensure continuity in the healthcare.

In 2020, there was a greater investment in implementing initiatives to promote the flow of health information. It was launched the Health Data Network (RNDS), Connect SUS Programme and Digital Health Strategy for Brazil 2020-2028 (ESD28), among others.

The RNDS is a national platform aimed at integrating and interoperating health information between public and private health entities. It integrates various types of information, including those relating to healthcare attention, surveillance, and management. This information can be used for several purposes, such as: (1) epidemiological and health surveillance; (2) statistical and research; and (3) management in health. The data has been progressively integrated into the RNDS, with the goal of making it the central hub for national health information interoperability, incorporating other related national initiatives into its architecture.^[4]

The Connect SUS Programme, now known as ‘Meu SUS Digital’, is a digital health solution (app) which aims to facilitate the access of health information by the patient. Users can track their medical history, vaccination records, test results, medication, place in the transplant queue, among other services. Meu SUS Digital is powered by the information provided in the RNDS.

The Digital Health Strategy for Brazil 2020-2028 (ESD28) is a public initiative with the overarching objective of guiding digital health actions for the period 2020 to 2028. ESD28 envisages elevating the RNDS by 2028 to become the foremost digital platform for innovation, information, and health services, benefiting users, citizens, patients, communities, managers, professionals, and healthcare organisations.^[5]

In 2022, discussions about the implementation of an Open Health System in Brazil began to emerge. Inspired by Open Banking and foreign Open Health models, the MoH and ANS published a report on the Open Health of the supplementary health sector in Brazil. It seeks to promote transparency of open data, improve user experience, and secure data sharing. The integration of the supplementary health data into the RNDS is one of the proposals to enhance healthcare across both the public and private sectors.^[6]

In 2023, the Secretariat of Information and Digital Health (SEIDIGI) was established and incorporated into the organisational structure of the MoH, with the purpose of formulating guiding public policies for digital health management.^[7]

Under the coordination of SEIDIGI, the SUS Digital Programme was recently launched for improving the digital transformation within the scope of SUS. It is based on several pillars and stages, one of which is related to interoperability, analysis, and dissemination of health data and information. This pillar encompasses initiatives such as promoting interoperability of health data with the RNDS, managing and governing the sharing of health data, preserving the authenticity, integrity, traceability, and quality of health information, among others.^[8] Pursuant to the National Council of Health Secretaries (CONASS), SUS Digital Programme has been adopted by all Brazilian States and 3,874 municipalities, representing over 70 per cent of Brazilian municipalities.^[9]

Trends and challenges

Brazil currently has significant initiatives regarding interoperability of health information. However, the effective implementation of such systems and technologies is still progressing at a slow pace.

This is likely to have been caused by several factors. Despite the legislation and initiatives that have been in place, there is still no effective normative act at national level which establishes interoperability as mandatory for the entire healthcare system. As a result, many initiatives remain subject to the individual interests of sector players.

In addition, Brazil is a country with marked social inequality in certain regions, which may affect the widespread dissemination of fundamental electronic systems and technologies, such as access to internet or electronic devices. This aspect further exacerbates the difficulty of achieving nationwide interoperability throughout the healthcare ecosystem.

Furthermore, it is not solely a matter of possessing suitable systems and technologies for the implementation of interoperability in healthcare. It is also imperative to have well-structured regulatory compliance by the entities involved, given that the matter entails the sharing of individuals’ personal health data.

In this regard, there are some specific rules which aim to protect patient data that shall be followed when exchanging patient data. For example, the Brazilian General Data Protection Law (LGPD), establishes that sharing of health data must occur, as a general rule, through (1) the consent of data holder, or (2) without the consent of the data holder only under the following circumstances: (a) for compliance with a legal or regulatory obligations; (b) for the execution, by the public administration, of public policies provided for in laws or regulations; or (c) for the protection of health in procedures carried out by healthcare professionals, healthcare services providers, or health authorities.^[10]

Government bodies and associations of healthcare professionals also provide for specific and complementary rules addressing the protection of patient data, including provisions regarding professional confidentiality, violation of patient privacy, and respective potential imposition of disciplinary penalties for professionals involved.

These data protection rules give rise to some discussions regarding liability for data breaches in cases involving artificial intelligence tools, which contribute to the challenges surrounding the interoperability in healthcare.

Despite the challenges, it is notable that both the public and private healthcare systems have been advancing more definitively and diligently in achieving the interoperability of their users’ data. Driven by the Covid-19 pandemic, which compelled a rapid digitisation of health records, technological trends are imperative for the sustainability of Brazil’s healthcare system. Debate and leadership on the topic from all industry players and authorities are essential to progress towards a nationally interconnected, innovative, efficient, transparent, democratic, and enduring healthcare system.