Digitalization of health systems, especially the use of data, is a worldwide trend. Depending on how they are used, new technologies may offer great potential or pose immense risks to the health sector. Which of these two opposing scenarios finally play out would be determined by the extent to which digitalization processes are shaped by and comply with the right to health.
The right to health is a complex concept whose definition varies with the shifting meanings of health and the related duties that fall upon states and third parties to fulfill this right. The World Health Organization (WHO) Constitution defines health as a state of complete physical, mental, and social wellbeing, an abstract definition which accommodates different perspectives depending on the context one is looking at.
The United Nations Council for Economic, Social and Cultural Rights (CESCR) on its General Comment No. 14 presents a useful framework for understanding the basic dimensions of the right to health, and the related state duties to fulfill it, including respecting, protecting, and ensuring this right. In this framework, the right to health has two dimensions: individual and collective. The individual dimension encompasses the right to self-determination over a person’s own body, which in turn includes the right to information in the context of healthcare. The collective dimension includes the provision of services and policies to enable the highest attainable level of health, from ensuring healthcare to improving social determinants such as potable water, education, access to information, adequate food, and an adequate work environment.
Healthcare and public health actions, according to this framework, should fulfill the requirement of availability, meaning that these should exist, be accessible, acceptable, and meet quality standards. Here, accessibility implies not just physical access but also non-discrimination, affordability, and proper information. Acceptability includes the need to meet the specific expectations of people in a certain cultural context.
Finally, the document acknowledges the community as a key component of the right to health. The fulfillment of this right is contingent on democratic participation and consideration of the views of all actors interested in the realization of the highest attainable health status, especially healthcare users.
Social participation in health is also one of the main principles of the Declaration of Alma-Ata on Primary Healthcare. This document was a milestone in the global discussion around the right to health, approved in 1978 in a conference held by the WHO and the United Nations International Children’s Emergency Fund (UNICEF) in the then Soviet city of Alma-Ata. The conference reaffirmed health as a right and introduced integral primary healthcare as its foundation.
This essay discusses how the digitalization of health systems could comply with the key elements of the right to health, as defined by these frameworks, by offering a theoretical presentation and a case study of Brazil’s health system. The first part of the essay (section 2) maps the key components of the right to health against emerging digitalization-related issues. The next section explores these issues through a case study of Brazil, which not only has one of the largest universal access health systems in the world, but also a powerful insurance-based private healthcare sector. Based on the conclusions drawn from the case study, the final section of the essay then outlines policy recommendations for a digitalization process that takes into account the right to health.
2. Digitalization and the Right to Health
Advances in digital health and the possibilities of exploring personal data for generating economic value raises fresh questions for the health agenda. On the one hand, technologies like Big Data and artificial intelligence (AI) offer great potential for improving health outcomes. Big Data, for instance, could blur the traditional boundaries between clinical fields, which deal with practices aimed at understanding individual health, and epidemiological perspectives, which are concerned with the health of specified populations. This could facilitate the use of electronic health records to shape public health interventions or to assess health interventions.
On the other hand, there are several risks associated with these technologies, mainly arising out of their reliance on the collection of massive amounts of personal data. There has been a dramatic expansion in the concept of health data over the past two decades, from data collected and processed by standard health sources such as health services (e.g., electronic health records), public health agencies (diseases surveillance and immunization records), and researchers (e.g., biobanks and clinical trials records), to include data gathered from a wider range of sources such as environmental records, lifestyle, economics, and behavior. According to the WHO, a very relevant risk in this scenario is the so-called repurposing of data, which is the use of collected health data for aims other than health-related ones such as surveillance of private life or economic exploitation.
The three subsections below, present an overview of three emerging issues associated with the digitalization of health and how they are related to the right to health framework.
2.1 Digitalization of Health that Centers People’s Interest
Health data can potentially be used to optimize health systems, and the WHO has already taken some steps in this direction. In a recently released guidance document, the WHO identifies opportunities for the use of AI in diagnosis, including predictive analysis and the transition from hospital-based care to home-based care models, through monitoring devices that can collect and share data on sleeping patterns, heart rate, blood sugar levels, etc., in real-time. The same report also makes a case for deploying AI to improve healthcare access through telehealth, which allows users and healthcare professionals to communicate through a device1These possibilities were further explored in a mapping study by Sadoughi, which discussed mainly the perspectives around Internet of Things (IoT) in medicine. Connected devices through IoT represent new possibilities in terms of health data collecting.
Like drugs and medical devices, applied technologies on digitalization of health have significant potential for saving lives and improving health conditions, and it is the duty of the state to incorporate these advances into public health systems with the aim of ensuring the right to health.
Digitalization can play an important role in another key component of the right to health, namely, access to information. This can be done by developing interfaces which allow users to access their health records and/or reduce their waiting time for accessing a healthcare procedure. Likewise, digitalization can also allow for the sharing of information with universities and civil society organizations (CSOs) interested in better understanding the outcomes of health policies.
The incorporation of these technologies into health systems should follow the principle of acceptability and give due consideration to the socio-economic environment of the population. Their development needs to be people-oriented and take into account the local context. This is currently missing, for instance, in machine-learning algorithms for diagnosis which are trained on populations in Global North countries and may, therefore, be less efficient and produce biased outcomes when used on people located in other geographies and socio-economic contexts. Such biases can have particularly discriminatory impacts on specific ethnic groups.
2.2 Exploitation of Health Data
If health data can be used to optimize health systems, it also carries a corresponding risk by allowing companies to generate value at the expense of users. How health data is used is, therefore, a key concern under right to health frameworks. Digitalization can be detrimental to users’ interest when companies collect, exploit, and benefit from personal health data without user consent and in the absence of any benefit-sharing mechanisms. A 2019 article found at least 12 different business models applying AI to healthcare apparatuses being put in place by start-ups, pointing this out as an emerging field for companies.
To safeguard the right to health of individuals, the use of health data must, therefore, be regulated, including against corporate power. Particularly, the CESCR’s right to health framework emphasizes the principles of confidentiality and non-discrimination in the provision of health services. In the context of digitalization, at least four levels of protection can be envisaged based on these two guiding principles, namely, transparency, safety, protection against economic discrimination, and protection against economic exploitation.
Transparency demands proactive efforts by data holders to share how they use and store health data. Users must be provided with accessible and clear information on the usage of such data to ensure that there is no discrimination. To safeguard confidentiality and prevent misuse of data by third parties, the data holder is also duty bound to ensure the highest possible level of security against data breaches, as well as timely and sufficient response to any such incidents.
Besides transparency, safety is another oft-discussed topic on debates around personal data protection. Health data, in particular, contains sensitive information with potential for discriminatory use. Regulations such as the European Union’s General Data Protection Regulation (GDPR) and Brazil’s General Data Protection Law (Lei Geral de Proteção de Dados, or LGPD) have specific rules for both parameters and give personal health data a specific status, making repurposing of such data harder.
Big Data, could blur the traditional boundaries between clinical fields, which deal with practices aimed at understanding individual health, and epidemiological perspectives, which are concerned with the health of specified populations. Data can further shape public health interventions or to assess health interventions. But there risks with respect to collection of massive amounts of personal data persist.
The other two protective dimensions are economic status-related and are based on the non-discrimination component of right to health which expresses that the state, through regulation, shall protect people against economic discrimination and economic exploitation. Economic discrimination refers to the financial barriers that prevent users from accessing a product or service. One instance of this is the practice of risk selection in the health insurance sector which is biased towards healthy individuals, thereby denying access to care to those who need it the most, because doing so would entail greater costs for the insurance company.
Large-scale collection of personal data allows companies and governments to gain extensive knowledge about people and build profiles aimed at understanding the financial risks that they would pose by being sick. The insurance sector leverages this data either to avoid insuring high-risk users or to compel them to pay higher premiums. As far back as 1995, the health economist William Hsiao had suggested that to charge each individual a different insurance premium based on their own risk of having a health condition that will result in costs for the insurer, was an important but technically unfeasible goal.
What the risk selection practice suggests is that despite their highly advanced technical possibilities, massive treatment2 There is a discussion regarding the use of the word treatment in English in the expression data treatment. The word is currently used in Latin languages, like Portuguese, Spanish and French. In some of these contexts, it means more than only data processing. For instance, in the Brazilian legislation, data treatment means “any operation carried out with personal data, such as those relating to collection, production, reception, classification, use, access, reproduction, transmission, distribution, processing, archiving, storage, elimination, evaluation or control of information, modification, communication, transfer, of health data holds the potential for abuse when seen from a rights-based perspective. Through this practice, insurance companies and governments not only leverage people’s data against them, but also hold people responsible for their own health without considering the influence of social determinants, thus contradicting the core principles of the right to health expressed in the CESCR framework, the Alma-Ata Declaration, and the WHO Constitution. This is the exact opposite of equity as it punishes those who are already vulnerable, such as the elderly and the sick.
In risk selection practices, insurance companies and governments not only leverage people’s data against them, but also hold people responsible for their own health without considering the influence of social determinants, thus contradicting the core principles of the right to health. This is the exact opposite of health equity as it punishes those who are already vulnerable, such as the elderly and the sick.
What these practices also suggest is that price is not a good parameter to regulate people’s health-related behavior as it impedes access to essential services and might lead to a worsening of health conditions. A few regulations, such as the one in Brazil, have addressed this issue (more on this in section 3) but a larger debate is needed around what type of care humanity will pursue in the digital age.
2.3 Datafication of Health and Innovation
As mentioned earlier, a blurring of the boundaries between clinical studies and epidemiology allows health professionals and researchers to have a clear view of what is happening on points of care and use this data to better understand the effects of health interventions. This trend is likely to grow with Internet of Things devices and improved internet connection, portending an intensifying datafication of health.
It offers a great potential for the development of new technologies in different contexts, such as algorithms that are trained with health data. As mentioned in the previous section, emerging business models relies on health data collection and processing to train algorithms.
There is also potential for drug development. Extensive databases with health records can help researchers identify potential participants for clinical trials, which is an expensive and essential task on the pharmaceutical innovation process. Additionally, these databases could show patterns that help researchers to identify drug effects and outcomes. This information is the so-called real world data or real world evidence.
The WHO offers a whole section on the publication about AI on how health data can be applied to the pharmaceutical sector. This states how the use of real world evidence can speed up innovation as computing can process large amounts of data and find patterns that suggest that a specific compound has potential as a new treatment. This is acknowledged by other authors as well. AI has also been used extensively for detection and diagnosis during the Covid-19 pandemic.
However, innovation does not necessarily translate into access. For instance, every time a new drug, developed after years of research involving public institutions and using public resources, enters the market, intellectual property rights and other sorts of barriers create a monopoly-driven market, resulting in high prices that hamper affordability.3There are many references to issues related to access to medicines and drug prices. A comprehensive compendium that addresses the topic is the Report of the United Nations Secretary-General’s High-Level Panel on Access to Medicines Report: Promoting Innovation and Access to Health Technologies. For a pharmaceutical company, registering an innovative drug, especially with monopolistic commercialization, generally translates into high profits. However, while profits from the innovation are thus privatized — meaning, only one company benefits from it — the risks are socialized, as many public institutions (and public funds) are involved in the development of the drug and access to it is limited due to financial barriers.
At its simplest, the process of developing a new drug includes pre-clinical research and clinical trials with human beings. These participants have rights, such as the right to information and the right to be treated with dignity. They also have the right to post-trial access, 4 The World Medical Association’s Declaration of Helsinki, which is the cornerstone document for Ethics on Clinical Research states: “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial.”which acknowledges their participation and obliges the drug developer to provide treatment, if needed, after the clinical trials. This can be understood as a benefit-sharing mechanism, which seeks to ensure that people who participated in an innovation process also benefit from it. From that perspective, the use of personal health data in research and development would mean that the natural owners of that data should benefit as well. This perspective could be expanded to geopolitics as datafication also entails Global North companies benefiting from data collected in the South.
The challenge in developing a benefit-sharing model under digitalization is that, unlike the participants of clinical trials, it is not possible to identify the owners of the data that served to develop a new technology. In this context, the experience of the Nagoya Protocol and the Pandemic Influenza Preparedness (PIP) Framework may be instructive.
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity (CBD) is an agreement created in 2014 to ensure fair and equitable sharing of benefits arising out of the utilization of genetic resources. It provides some institutional pathways for benefit sharing on research and development using genetic resources. These pathways might be monetary or non-monetary and include, for example, joint ownership of intellectual property rights between the company who is commercializing the new technology and the state or funds aimed at fostering conservation initiatives.5 This mechanisms are found at the Protocol’s Article 5 – Fair and Equitable benefit sharing and at its annex
Likewise, in the health sector, a new technology, like a drug or an AI solution, developed at least partially upon large personal health databases should not turn into an exclusive product of a company. This company could be obliged, for instance, to share its patents with countries’ governments where data holders live, enabling local production or to make it available to the public healthcare system at a lower price.
If health data can be used to optimize health systems, it also carries a corresponding risk by allowing companies to generate value at the expense of users. How health data is used is, therefore, a key concern under right to health frameworks.
Another interesting experience to explore is the PIP Framework, a WHO-led mechanism that ensures that companies using shared samples of the influenza virus from countries contribute financially to the funds aimed at providing their populations access to the vaccines thus developed. The framework was created in 2006 after Global South countries, especially Indonesia, refused to share virus samples with the WHO on the grounds that the resultant vaccines would remain unaffordable to them.
Notwithstanding their differences, the right to post-trial access, the measures enabled by the Nagoya Protocol, and the experience of the PIP Framework point to a common conclusion — that any innovation should necessarily lead to access, especially for those who contributed the most towards its development. Free flow of health data and its utility in bringing new technologies to the market should draw from this perspective for ensuring the right to health.
Until this point, we discussed the ways in which the right to health can be used to shape policies and regulations around the digitalization of health. The next section examines some of these issues by situating them in the context of the health system in Brazil.
3. Concrete Issues around Right to Health and Digitalization: A Case Study of Brazil
With over two hundred million people, Brazil is the most populated country in Latin America, and the largest economy in the region. It is classified as an upper-middle-income country by the World Bank (2020) and comes under the category of a developing country. Brazil has a complex dual health system that combines private and public sector involvement. Several ongoing transformations in the country’s health system would be interesting to address.
3.1 Brazilian Health System: A Brief Description
Brazil’s Federal Constitution of 1988 acknowledges health as a right for all people, emphasizes the duty of the state to uphold this right, and establishes a universal access healthcare system known as the Unified Health System (Sistema Único de Saúde, or SUS).
The SUS is a taxpayer-funded public system similar to the National Health Service (NHS) in the United Kingdom. Its principles are universality and integrality of care, and it provides free-of-charge care to any person living in Brazil. It is governed by various actors operating under the guidelines of territory-oriented decentralization and social participation. The decentralization approach is based on territory-specific socioeconomic features, but considers the federation as the main network for health policies. Under this approach, states and municipalities are primarily involved in service delivery while the federal government’s main responsibility is to establish guidelines, protocols, and funding. Social participation refers to the tools of participative democracy which include, among other things, health councils formed by managers, workers, and users, as well as the health conferences held in the country once every four years.
Beyond healthcare, the SUS includes key national capacities on public health, such as epidemiology-based policies and surveillance of health-related products, including medicines and food. It also encompasses workforce capacity-building and manufacturing of essential technologies such as vaccines and medicines. Brazil is one the few countries with state-owned pharmaceutical laboratories.
Since its creation, the SUS has played a significant role in improving health conditions in Brazil by expanding healthcare services and improving access to health technologies, including medicines. However, it is plagued by issues such as underfunding, workforce shortages, long waiting periods for accessing medium- and high-complexity procedures (e.g., surgeries), and growing costs of health technologies.
The private health sector also plays an important role in Brazil. According to the Brazilian Institute for Geography and Statistics (IBGE), 9.6% of the country’s gross domestic product (GDP) was spent on healthcare in 2019. Of this, 5.8% of the GDP was spent on private health services by companies which offer their employees health insurance, by families with health insurance, and in the form of out-of-pocket spending by individuals The remaining 3.8% was spent on public health services or the SUS.
These numbers reflect Brazil’s dual healthcare system, which also includes a private health insurance sector covering about 25% of the population. The private insurance market is largely linked to employment. More than half of the users of private health insurance have access to it as part of their work benefits.6 Source: National Agency of Supplementary Health (Agência Nacional de Saúde Suplementar – ANS) Thus, the private health sector captures more resources than the public system in spite of its lower coverage.
3.2 Sanitary Reform and Collective Health: Principles for Right to Health
The creation of the SUS was an outcome of the so-called Sanitary Reform, a heterogeneous political process that included grassroots social movements led by local associations, health workers, and scholars, and culminated in the right to health being affirmed by the 1988 Constitution. As Amélia Cohn, one of the main social scientists working in the field of health studies in Brazil puts it, the creation and consolidation of the SUS was a victory over neoliberal policies.
Through most of the 20th century, health policy in Brazil was highly influenced by a technocratic and centralized approach. Healthcare was provided through a public insurance scheme, centralized at the federal level and reliant on the private sector for service delivery. The system excluded informal workers as well as the elderly and rural workers, and was deemed expensive and susceptible to corruption.
The Sanitary Reform, which was part of a larger ongoing struggle for democracy in Brazil at the time, questioned this model. After a protracted period of dictatorship between 1964 and 1985 came democracy with the formulation of the so-called citizen’s Constitution of 1988 that recognized individual and social rights, including the right to health.
The shift in health policy was accompanied by an important shift in academia. A new perspective that would broaden the discussion on health beyond infectious diseases replaced the earlier epidemiology-oriented approach for public health. This new scientific field, called Collective Health, considers health to be highly determined by socioeconomic factors, and includes inputs from social sciences and political and planning studies in the analysis of public health.
3.3 Pandemic and Digital Health in Brazil
More than three decades later, Brazil’s response to the Covid-19 pandemic has been marked by serious mishandling, with over 600,000 confirmed deaths as of May 2022. A study by the Health Law Research Centre of the University of São Paulo points out that the responsibility lies squarely with the federal government whose decision to pursue a so-called herd immunity approach resulted in an amplification, rather than a containment, of the spread of the virus. In addition, the unchecked circulation of misinformation about Covid-19 treatments and the government’s backing of drugs with unproven efficacy further worsened the crisis.
One of the few national policies that has worked relatively well during this period is immunization, mainly due to Brazil’s decades-long experience of the National Immunization Program (Programa Nacional de Imunizações, or PNI), which works on the basis of central procurement and public manufacturing, and has facilitated two technology transfer agreements for local production of the AstraZeneca and Sinovac vaccines.
There have been important shifts in digital health during this health crisis that have raised concerns on the fulfillment of the right to health. The pandemic has stimulated distant care solutions and accelerated the collection of personal data, including for public health purposes such as contact tracing and assessment of non-pharmaceutical measures (quarantine, physical distancing, reduction of circulation in public places, etc.). For instance, a partnership between the government of the State of São Paulo and the four main telecommunications companies in the country created a system to monitor circulation of people and send automatic warning messages on high Covid-19 incidence areas. The dataset was largely used to analyze the effectiveness of the non-pharmaceutical measures adopted to tackle the pandemic.
Health data can be applied to the pharmaceutical sector to speed up innovation and breakthroughs. For instance AI has also been used extensively for detection and diagnosis during the Covid-19 pandemic. However, innovation does not necessarily translate into access.
The pandemic has also prompted the lifting of prohibitions on telehealth, especially telemedicine, and led to the design of new solutions for validation of prescription recipes, especially for drugs and platforms used for distant care. This, despite opposition from the Federal Medicine Council which has historically argued that telemedicine would decrease quality of care.
Yet another instance of government mishandling of the pandemic can be found in the information systems of the Ministry of Health which has faced critical breaches and often failed to display up-to-date statistics on Covid-19 cases. The first incident of breach exposed health data of over 243 million Brazilians over six months and was eventually detected by a CSO known as Open Knowledge Brazil. A group of CSOs then filed a civil inquiry against the ministry.
Besides the health emergency itself, this period also witnessed crucial follow-up discussions on the implementation of the General Data Protection Law (LGPD) and the National Network for Data and Health (Rede Nacional de Dados e Saúde, or RNDS). The following two sections focus on these two legislations/policies as they reflect the tensions between the right to health and state and corporate power.
3.4 Impact of the LGPD: Use of Personal Identification by Pharma Retailers
As the national legislation that safeguards personal data, Brazil’s LGPD is the equivalent of the European GDPR. It is one of the main parliamentary acts that regulates the digital environment in Brazil. It came into full effect in August 2020 during the pandemic. The LGPD is based on two important principles: self-determination and the idea that personal data protection is a part of personality rights. It defines two categories of personal data, regular and sensitive, and outlines the types of information that fall under each. Under the law, treatment of sensitive data is only possible with the unequivocal consent of the owner for a specific purpose.
The LGPD deems personal data about health, sexual life, and genetics as expressly sensitive, but also makes room for exceptional situations when such data can be treated or used without unequivocal consent. When personal health data can be used as such, only healthcare practitioners and health authorities are allowed to treat it, and only for the sake of healthcare. However, lack of further clarification on this gives rise to questions which should be addressed by the authority established with the LGPD, namely, the National Data Protection Authority (Autoridade Nacional de Proteção de Dados or ANPD).
It has been a common practice in Brazil, for some years now, to collect the national identification number of healthcare users in exchange for a lower price on health services or products. This number, known as the Natural Person Record (Cadastro de Pessoa Física, or CPF), is a unique personal number issued by the country’s tax authority. Even though CPF is not sensitive data, it might become so when combined with information on consumption of health products. Buying a drug, for instance, might indicate a specific health condition. Since the approval of the LGPD, organizations and authorities that protect consumer rights have questioned and even fined retailers for use of personal health data. However, this is done in the absence of clear guidelines on transparency of health data sharing which could better regulate the sector.
As explained in sections 2.2 and 2.3, there are many ways in which health data can be used by businesses, some of them against users’ interest, such as risk profiling. Health data also can be used for discrimination and for repurposing. Retailers’ practice of collecting the national identification number of healthcare users is one such instance, reiterating the lack of transparency on how collected data is treated in Brazil’s health system.
3.5 Information Systems and the National Network for Data and Health
The RNDS is an interoperability platform which aims to integrate all health information systems in Brazil, including those of the private sector, in order to build an electronic medical records system. The ambitious project would work with a blockchain security net, with one knot at each one of the 27 federal divisions in the country. This mechanism is expected to address the challenge of integrating hundreds of information systems in the country and ensure the safety of this information.
As researchers Giliate Coelho and Arthur Chioro point out, the Ministry of Health alone has over 50 active health information systems, each serving a different purpose. In addition, each one of the 27 federal units and some of the municipalities run their own information systems, taking the total number to well over 5,000. This tally rises even further with the inclusion of the private sector information systems, as there are over 700 health insurance companies that provide medical assistance.
The RNDS project is due to be completed in 2028. However, the specifics of its implementation, including governance, infrastructure, safety, and the use of its datasets by the private sector, are already under discussion.
In their review of health information systems conducted from the perspective of developing countries in general, and Brazil’s Sanitary Reform in particular, Marcelo Fornazin and Luiz Antonio Joia conclude that the success or failure of their implementation is a matter of political articulation rather than a result of technical barriers. In other words, it is more important to acknowledge and engage the actors, such as different public bodies, that will be crucial for the success of these information systems, rather than resolving their technical issues, they argue.
As mentioned above, the principles of Sanitary Reform emphasize the ideas of decentralization, which values local experiences in health informatics as potentially innovative, and social participation, which invites the proactive engagement of all relevant actors, including users, workers, and public managers, on healthcare-related issues. Neither of these principles seem to be accounted for in the implementation of the RNDS.
The actors responsible for its implementation include: a) the Manager Committee for Digital Health (Comitê Gestor da Saúde Digital), a council formed by representatives of the Ministry of Health and state- and municipal-level health secretaries, including the three levels of the Brazilian federation; b) the National Supplementary Health Agency (ANS) which is responsible for regulation of the health insurance sector in the country; and c) the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária or Anvisa). As is evident, the composition of the committee is limited only to public managers, and excludes CSOs, unions, and scientific organizations. Yet, it is common for the committee to invite the information technology units of the main private hospitals in Brazil to execute the committee’s decisions.
Additionally, Brazil’s Department of Information Technology of the Ministry of Health (DATASUS) relies on Amazon Web Services (AWS), one of the world’s biggest technology companies for cloud computing, which means that all RNDS data is stored on AWS servers. While the contract was justified on the grounds that it was the most cost-effective and scalable choice, in 2022, concerns were raised about potential conflicts of interest, as a former DATASUS director-in-charge left the ministry to work as a development manager in AWS.
A solid information and informatics health policy should rely on resilient technological solutions such as servers and data centers. However, the implementation of the RNDS project in Brazil demonstrates an emerging trend of developing countries hiring multinational companies for services such as cloud computing, thus creating technological dependency. Overcoming this dependency should be an important agenda for developing countries. This is because the information and communications technology (ICT) industry is a key area of economic development currently, and carries great potential for generating value in various sectors, including health, thereby boosting domestic income. Besides, technological dependency reduces the room to develop localized, country-oriented solutions, and private innovation mostly meets the needs of high-income countries.
These problems are commonplace in the pharmaceutical sector and determine access to medicines in developing countries. Monopoly-driven policies adopted by private companies in the form of patents and industrial secrets allow them to charge high prices. In addition, the health needs of vulnerable communities are seldom tackled through privately-controlled innovation as there is little interest in doing so from a profit-making perspective.
In order to reduce the reliance on private companies, the state-owned laboratories could be motivated to chart a path for innovation and industrial policies. The need for digital health solutions on a wide-reaching system like the SUS is high, making the Ministry of Health a potentially strong buyer. Instead of simply hiring multinational private companies, the public sector could try to meet these needs with local capacities, which would also strengthen the country’s research and development sector.
3.6 Use of Personal Health Data by the Insurance Sector
Using personal data to develop individual health profiles and applying risk analysis for new customers is strictly prohibited by both the LGPD and the ANS. Yet, the health insurance sector has, for some time now, lobbied for tailored products based on the use of personal health data, and many manuals released by the sector deem this legal. Such products necessitate data collection on a massive scale in order to assemble identifying health records of users and build digital profiles that can then be used to apply the partial coverage rule. According to current regulation, insurance companies can offer partial coverage for up to two years if a consumer has known pre-existing health conditions or lesions. That the insurance industry’s demands have garnered support is evident from the guides produced by company associations such as the National Insurance Confederation.
Despite criticism by academia and CSOs, the Brazilian health minister, in early 2022, proposed the creation of the so-called Open Health mechanism which would allow insurance companies to access personal data to understand consumption patterns and financial information, thus paving the way for tailored products. The RNDS would provide the necessary infrastructure for this project.
4. Towards a Right to Health Agenda for Digital Health
The Brazilian case illustrates how digitalization simultaneously presents opportunities for, and jeopardizes the right to health. Against this backdrop, a revamped healthcare agenda that includes the views of policymakers, civil society, and social movements is urgent and necessary. This agenda should safeguard users against corporate abuse and incorporate digital technologies in ways that take into account public interest.
The first axis of action is to incorporate transparency in the digitalization of health, which means regulating how data is collected and treated. Transparency mechanisms must specifically address the private sector and reverse the opaque practices of pharmacy retailers.
The second axis of action is to ensure that digitalization of health systems balances technical solutions with good governance so as to ensure safety and interoperability of health data. Effective digitalization makes use of existing resources, like the RNDS system that seeks to bring together scattered information systems. The experience of the RNDS also points to the relevance of creating spaces that allow political debates and shared solutions.
The third axis is to acknowledge the immense potential of health data for value generation by the private sector, and recognize the ways in which it might be used by companies to exacerbate inequalities. Risk-based profiling is a crucial concern in this context. This practice undermines the foundations of the right to health by holding healthcare users entirely responsible for their health, ignoring the fact that health status is socially determined, as pointed out by the field of Collective Health and the frameworks drawn from the CESCR recommendations and the Alma-Ata Declaration.
A fourth pillar of action would be to ensure that innovation results in effective access. The perspective of benefit sharing is a useful starting point in this direction. However, states could also use their procurement power to manage innovation. The Brazilian health system has a history of successfully combining public procurement and public manufacturing of vaccines. On digital health, however, the government turned to a Big Tech company based on a cost-effectiveness criterion. The choice of support services for digitalization, such as cloud computing, should go beyond merely choosing the most cost-effective option in the short term and include concerns like sovereignty, national development, and access to new technologies in an equitable and sustainable way.
All these concerns should be part of a national strategy for digital health aimed at ensuring the right to health. As researcher Sara Leila Margaret Davis notes, when discussing the use of these technologies, if they are put out of place they might turn into a Trojan horse. With the Covid-19 pandemic accelerating the digitalization of health systems, the need for a revamped strategy is more urgent than ever.
One of the key people of the Sanitary Movement in Brazil, Sérgio Arouca, the president of the historical VIII National Health Conference of 1986 that laid the foundations for the SUS, once stated that this reform, that was almost considered merely administrative, was actually a key political moment. This is in keeping with one of the mottos of the movement: Health is democracy and democracy is health. Perhaps a clever motto to inspire the future could be that digital health is digital democracy in all possible ways.