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Medtech compliance : abordagem regulatória com foco em cibersegurança e proteção de dados
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Resumo(s)
O grande avanço das tecnologias disruptivas diante da chamada 4ª Revolução Industrial, vem favorecendo o setor de healthcare, que atualmente apresenta um crescimento exponencial no que tange aos dispositivos médicos inteligentes. Devido a este crescimento avassalador, observamos a existência de alguns pontos de grande preocupação em relação à utilização de tais dispositivos, seja individualmente, seja através de sistemas, no que concerne à assuntos relacionados à ciberseguranca e proteção de dados. Tais assuntos envolvem algumas incertezas para as empresas deste setor, uma vez que tanto falhas de ciberseguranca quanto de proteção de dados podem acarretar prejuízos imensos e/ou até fatais aos pacientes/consumidores dos produtos e, consequentemente às próprias empresas. Por esta razão, este trabalho se presta a esclarecer, especificamente para as empresas de healthcare, a relevância em possuir um programa de compliance devidamente estruturado para ambos os tópicos mencionados e quais as possíveis consequências em caso de inexistência ou falha desse programa, bem como alguns impactos que podem ser produzidos na esfera nacional quanto na internacional.
The great advance of disruptive technologies in the so-called 4th Industrial Revolution has been favoring the healthcare sector, which currently presents an exponential growth in terms of smart medical devices. Due to this overpowering growth, we can observe the existence of some points of main concern in relation to the use of such devices, either individually or through systems, regarding issues related to cybersecurity and data protection. Such issues involve some uncertainties for companies in this sector, since both cybersecurity and data protection failures may cause huge and even fatal losses to patients/consumers of the products and, consequently, to the companies themselves. For this reason, this study aims to clarify, specifically for healthcare companies, the relevance of having a compliance program properly structured for both topics mentioned and which are the possible consequences in case of inexistence or failure of this program, as well as some impacts that may be produced in the national and international sphere.
The great advance of disruptive technologies in the so-called 4th Industrial Revolution has been favoring the healthcare sector, which currently presents an exponential growth in terms of smart medical devices. Due to this overpowering growth, we can observe the existence of some points of main concern in relation to the use of such devices, either individually or through systems, regarding issues related to cybersecurity and data protection. Such issues involve some uncertainties for companies in this sector, since both cybersecurity and data protection failures may cause huge and even fatal losses to patients/consumers of the products and, consequently, to the companies themselves. For this reason, this study aims to clarify, specifically for healthcare companies, the relevance of having a compliance program properly structured for both topics mentioned and which are the possible consequences in case of inexistence or failure of this program, as well as some impacts that may be produced in the national and international sphere.
Descrição
Palavras-chave
Cibersegurança Cuidados de saúde Protecção de dados Regulação Compliance Teses de mestrado - 2023