Legal Challenges for IT Service Providers in Pharmacogenomics

被引：1

作者：

Meier, Lea ^{[1
]}

Tippenhauer, Kevin ^{[1
]}

Sariyar, Murat ^{[1
]}

机构：

[1] Bern Univ Appl Sci, Inst Med Informat I4MI, Bern, Switzerland

来源：

IMPORTANCE OF HEALTH INFORMATICS IN PUBLIC HEALTH DURING A PANDEMIC | 2020年 / 272卷

关键词：

general data protection regulation; GDPR; data management; sensitive data; genetic data;

D O I：

10.3233/SHTI200490

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

IT providers offering services based on genetic data face serious challenges in managing health data in compliance with the General Data Protection Regulation (GDPR). Based on a literature research and our experiences, an overview of GDPR compliant processing of sensitive data is given. The GDPR requirements for processing sensitive data were specified for a use case concerning a service provider of a pharmacogenomic decision support system. Start-ups who want to enter into the health market also have to comply with the Medical Device Regulation (MDR). The associated efforts for legal compliance constitute an impediment for many start-ups. We created a comprehensive overview, which aligned the requirements of the GDPR with the life-cycle of a medical device. This overview shall help start-ups to grasp and overcome the regulatory hurdles faster.

引用

页码：47 / 50

页数：4

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