During an exclusive panel on Digital Health Brazil, held at the Global Summit Telemedicine Digital Health APM, coordinators of the working groups addressed important topics involving electronic prescription notifications, digital dispensing, electronic medical records, interoperability, information security and data privacy
In Brazil, digital health regulation is in its early stages. Despite important milestones such as the General Data Protection Law and Law No. 14,510/2022, there is still a lack of comprehensiveness given the complexity of the sector. The latest legislation, for example, establishes parameters for the practice of telehealth, but does not offer a comprehensive approach to dealing with the various nuances of this modality, leaving the determination of the conditions for its operation to other regulatory bodies and there are still many gaps to be filled.
Aiming to clarify the upcoming regulatory challenges involving the sector, Saúde Digital Brasil brought together the coordinators of three of its Working Groups to discuss the main aspects of this framework. The panel, moderated by Michele Alves, executive manager of the entity, included the participation of Marina Jacob, coordinator of the Electronic Health Documents and Dispensing WGLegal Director, Government Relations and Public Policy at Memed; Rafael Yoneta, coordinator of the Interoperability WG and Product Manager and Product Data Manager at Grupo Fleury; and Victor Prata, coordinator of the Information Security and Data Protection WG, Saúde Digital Brasil and DPO, Data Protection, Compliance and Regulatory Affairs Coordinator of Grupo Conexa.
Michele highlighted the role of Digital Health Brazil in promoting positive agendas and working towards the development of the sector. She pointed out how the discussions planned for the panel could highlight the need to promote regulatory adjustments for existing public bodies and also for new entities, such as ANPD.
According to Marina, electronic documents are increasingly present in the concept of health, being part not only of services that take place in the digital environment, but also in the physical environment, which is even safeguarded by the law regulated at the end of last year. However, there are still several challenges to be overcome in the construction of an ethical sector and some points that are of concern beyond the status quo, as she herself mentioned.
“There are usability challenges and several gaps. For example, there is a lack of a system to connect the platforms and send the prescription book number to the pharmacy, to the doctor and back to the regulatory agency. How can we encourage medical boards to go one step further so that we can issue prescriptions for the blue and yellow modalities in the digital environment? How can we design a digital experience for the patient that makes sense from end to end? It makes sense to have technical limitations that are neither scientific nor legal. Regulation needs to make sense, and the regulatory challenge cannot hinder the development of the sector”, emphasizes the executive.
From the perspective of data security and protection, the coordinator of the WG responsible for discussing this topic explained that the legislation being recent increases the area of uncertainty. Another aggravating factor, in addition to the great specificity that involves the sector, is the fact that health and digital health are not on the most urgent agenda of the National Data Protection Agency (ANPD). Saúde Digital Brasil has even been working to establish these guidelines. Thus, based on international standards and numerous other sources, it has compiled some guidelines in its Good Practices Manual.
“We have heard a lot about the 'what', but the 'how' has been little addressed. This is a big challenge. There are several standards and frameworks, but none of them address what needs to be done in digital health and it is important to consider that the ANPD does not understand the pain points of the sector, so it needs to be a joint proposition. The association has a role in helping to standardize and propose all these aspects that are important”, reinforced Prata.
Since it is impossible to think about advancing telehealth without thinking about interoperability, this was another aspect addressed during the panel. Yoneta, who leads the group responsible for addressing this issue, emphasized that there are a variety of contexts in which data can be generated, as well as models that could be adopted. However, there are also difficulties in implementing it and specific challenges. There is a lack of understanding of the concepts of what interoperability really is and how to promote a public agenda to make it happen. “Interoperability is not about centralizing data,” emphasized the executive, who reinforced SDB’s participation in these discussions. “There are a huge number of opportunities for solutions that can generate value for the patient.”
A single medical record, which is an important step in this process of interoperating data, was also highlighted by participants as a challenge, not only due to systemic integration, but also due to the standardization of information and terminology. Although the CPF grants uniqueness, there is a step before that, which is to align the registration of information. Another point highlighted is the divergence of understanding between the councils, including regarding the data that must be included and the storage time, and the tendency is for sectoral regulations to be created by the councils themselves. stakeholders.
