The Legal WG aims to interact, analyze and monitor the decisions of the Executive, Legislative and Judiciary branches and also of regulatory agencies.
As part of its goal of lead the digital transformation process of the health sector, with ethics,Keeping up with regulatory developments and discussions related to the practice, Saúde Digital Brasil (Brazilian Association of Telehealth, Telemedicine and Health Technology Developers) has just created another working group. Coordinated by Caroline Ranzani, Executive Manager of Government Relations & ESG at DASA; and Analuza Lopes Nascimento, lawyer at TopMed, the Legal Working Group will focus on debating and monitoring issues related to the regulation of the digital health sector.
The approval of the Law 14,510, in December 2022, which auregulates and disciplines the practice of telehealth, broadly, throughout the national territory, It was the first milestone in digital health after the Covid-19 pandemic and was led by Saúde Digital Brasil, through its parliamentary advisory team.
This was, however, only the first step towards adapting Brazilian legislation to the digitalization of healthcare. There is still much to be done for the sector and to adapt regulations, whether the legislation itself or the rules of regulatory agencies, to the needs of the sector. The creation of the group is the result of efforts by Saúde Digital Brasil to meet the demands of its members and as a mechanism to encourage regulatory discussions to disseminate information among members and to improve the entity's performance in favor of its members, in the legislative, executive and even judicial spheres, highlights Michele Alves, executive manager of Saúde Digital Brasil.
According to Caroline, considering the current scenario, it is mandatory that an entity representing a sector has a group to analyze and support the positioning and decision-making involving regulatory aspects.
“It is necessary that all stakeholders are supported. In addition to security, the Legal WG brings legitimacy in the defense of interests, by allowing the SDB to speak on behalf of all companies that are part of the sector”, he emphasizes.
A preliminary agenda has already been drawn up, covering the various topics that need to be analyzed, monitored and debated with the Executive, Legislative and Judiciary branches, as well as with regulatory agencies. These include: electronic patient records; electronic prescriptions; artificial intelligence; tax reform and its impacts on healthcare service and technology providers; and LGPD, which has an exclusive chapter on the processing of healthcare data, the sanctions for which are already being applied by ANPD.
“This group aims to support the demands of its members. We are aware that technology advances much faster than the law. For example, the National Data Protection Agency (ANPD) regulated the use of data and, shortly after, artificial intelligence came along, and now it will be necessary to create a new project that contemplates its use. Therefore, it is essential that members have access to all this information to expand and develop their business. The Legal WG will analyze all these projects, laws, innovations and necessary regulations”, emphasizes Analuza.
Learn more about the coordinators
Caroline Ranzani
With over 20 years of experience in Institutional Relations in the healthcare sector, Caroline has worked in renowned consulting firms (Patri, Prospectiva, Speyside), in professional associations (FIESP, CNI) and in the federal government (Secretariat of Strategic Affairs of the Presidency of the Republic). She is currently the Executive Manager of Government Relations and ESG at Dasa. She holds a degree in Law (USP), International Relations (PUC/SP), a master's degree in Public Administration (FGV/SP) and training in Integrative Medicine (HIAE).
Analuza Lopes Birth
Lawyer, working in Corporate Law and Civil Litigation in favor of TopMed Assistência à Saúde Ltda. Graduated in Law from UNIP – Universidade Paulista and postgraduate in Criminal Law from Uniasselvi – Sociedade Educacional Leonardo da Vinci de Indaial/SC and in Business Law from PUCMINAS. In addition, Analuza has EXIN Privacy & Data Protection Essentials (PDPE) certification and courses in Compliance from Fundação Getúlio Vargas; LGPD – Essential and Rights of Holders and Duties of Processing Agents from Data Privacy Brasil; and General Data Protection Law in Practice from Escola Superior da Advocacia de Santa Catarina – ESA/SC. She is currently studying to obtain the Professional Certification in Data Protection (CPPD).
