Last week, the Federal Council of Nursing (in Portuguese, “Conselho Federal de Enfermagem” or simply “COFEN”) approved the Resolution COFEN n°. 696/2022 governing the performance of Nursing in Digital Health. The so-called “Telenursing regulation” was published on May 23 in the Brazilian Official Gazette (in Portuguese, “Diário Oficial da União” or simply “DOU”), coming into force on the same date.
This Resolution rules the basics of rendering nursing services in the digital health arena – both within the Brazilian National Health System (in Portuguese, “Sistema Único de Saúde” or simply “SUS”) and the supplementary and private health – encompassing the activities related to nursing appointment; joint nursing appointment; nursing consulting services; monitoring; health education and spontaneous demand [i.e., all mediated by information and communication technology resources (in Portuguese, “TIC”)].
Bringing light to the main aspects of the Telenursing regulation, the provisions relate to:
- the protection of sensitive personal health data, especially regarding to the collection, recording, storage and processing, according to the Brazilian General Data Protection Law (in Portuguese, “Lei Geral de Proteção de Dados” or simply “LGPD”);
- the need for an informed consent from the patient or their legal representative; and
- off-site prescriptions and requests for off-site examinations necessarily through the use of certified electronic signatures, in accordance with the guidelines of the Brazilian Public Key Infrastructure (in Portuguese, “Infraestrutura de Chaves Públicas Brasileira” or simply “ICP – Brazil”), among others.
It is important to note that the practice of off-site nursing services had already been approved on an emergency status during the coronavirus pandemic (early 2020) and, between September and November 2021, a Public Hearing was rolling on the matter – which, in turn, resulted in the new Resolution n°. 969/2022.
The COFEN’s efforts towards this new regulation converges with our undisputed understanding that digital health will play an increasingly important role in the global economy, now alongside new technologies, based on a philosophy of patient access and readiness to collaborate with business competitors in service of the greater good.
The field of digital therapeutics has been home to an incredible variety of products since 2019, including telemedicine platforms, mobile health apps, virtual and augmented reality, artificial intelligence, and also wearable and ingestible sensors. Digital therapy for example has focused on a wide range of treatments, including mild depression and anxiety, insomnia, substance abuse, chronic pain, irritable bowel syndrome, Crohn’s disease, ulcerative colitis, diabetes type II and even schizophrenia.
It's the perfect storm for the stakeholders that make up the chain of healthcare services and systems worldwide to direct efforts in the development and strengthening of the digital health ecosystem in a timely, safe and innovative way. This also rings a bell in the sense that the companies operating in this industry through disruptive business models must protect and explore the opportunities that the technology offers behind their products and services.
This is indeed one of the greatest investment hubs, especially in this new era of digitalization and data monetization – even more in Latin America.
This article describes the current thinking at Campos Mello Advogados on these topics and should not be viewed as a legal opinion.
Campos Mello Advogados is a Brazilian law firm which has worked in cooperation with DLA Piper LLP across the globe since 2010.