The health sector in the post-pandemic scenario has been marked by the emergence and consolidation of new components of digital life that are revolutionizing the sector.
Significant advances in the use of information and communication technologies in a wide range of areas are taking shape and reaching unprecedented proportions.
After all, we are living in a digital age, marked by an economic and social scenario based on information technology, which is transforming not only social interactions, but also the way health-related services and products are provided.
The strengthening of a set of health tools and services based on the use of digital technologies is a direct product of this phenomenon, giving rise to a field that has become popularly known as “digital health”, which encompasses topics such as telehealth and the use of artificial intelligence in procedures and diagnoses.
Understanding the regulatory challenges in this area is becoming increasingly urgent.
Any public debate in this regard leads to the recognition of the fundamental right to health as the main objective of regulation.
Perhaps the difficulty debated here lies precisely in the need to build a regulatory environment that is able to offer incentives for the development of new technologies that are beneficial to society and patients, while at the same time being able to establish the limits of new technologies with regard to the full protection of fundamental human rights.
In this sense, understanding the types of digital health goods, products and services is essential to ensure better protection of the right to health itself, guaranteed by the Federal Constitution.
On the other hand, it is undeniable that the regulatory challenges on the subject are diverse.
In Brazil, regulation of digital health is in its infancy.
The General Data Protection Law and Law No. 14.510/2022, for example, are important milestones on the subject, but they have not yet proved to be sufficient given the complexity of the matter.
The latter authorizes and disciplines the practice of telehealth, but does so in a way that does not take into account the complexities of the modality, assigning other regulatory bodies to determine the conditions for its operation.
However, albeit at a slow pace, the movement in this field in recent years has been promising.
Law No. 14.063/2020, which deals with electronic signatures in health, provides that documents signed by health professionals related to their area of expertise are valid when signed using the modalities listed therein.
In the same vein, CFM Resolution 2.299/2021 regulates the issuance of electronic medical documents through portals and platforms in face-to-face and remote consultations.
Within the context of the issue mentioned above, ANVISA itself, through technical note 31/2020, has taken the position that medicines that require the presentation of a medical prescription can only be purchased using digital prescriptions (with a digital signature certified by ICP-Brasil), provided that they are included in the permissive list contained therein and provided that the pharmaceutical establishment has the resources to consult the original electronic document. Also noteworthy are the initiatives of the Ministry of Health, which in 2020, through Ordinance No. 1,434, brought in the National Health Data Network (RNDS), within the context of the Connect SUS Program, a national platform created by the Department of Informatics of the SUS, with the aim of enabling the interoperability of health data between agents of this “ecosystem”, showing itself as a kind of repository and storage of health data, using blockchain as a support technology for security and performance purposes.
Throughout its evolution, the RNDS is becoming a highly available, secure and flexible information platform, so as to favor the ethical use of health data.
In short, the phenomenon of digital health holds great potential for society, and its need for regulation has been perceived and gradually addressed by various bodies, which are already working on it.
After all, such innovations, if not well regulated and parameterized, can also pose risks to a significant set of fundamental rights.
This being the case, the state’s regulatory functions are essential if we are to build a regulatory environment that is capable of providing the necessary foundations for the development of technologies, while establishing the necessary limits to safeguard citizens’ rights to privacy, health and freedom.
The future looks promising.
