Medical Writing
Medical Devices
Medical devices in the disclosure era and the role of medical writers
Volume 26, Issue 2 - Medical Devices
Medical devices in the disclosure era and the role of medical writers
Author: Raquel Billiones
Abstract
Abstract
Increased transparency is one of the provisions of the Clinical Trial and Medical Device Regulations. This article discusses the impact of transparency and disclosure on medical devices. Many modern-day medical devices are software-driven. These, as well as the patients implanted with or wearing these devices, have become part of the so-called Internet of Things, and are therefore vulnerable to cyber attacks. Disclosure of information, data, and documents pertaining to medical devices will increase this vulner - ability. In the rapidly changing regulatory landscape, the role of medical writers in anonymisation of patient data takes on a whole new magnitude. It is not only about protecting patient privacy, it is about ensuring patient safety
Increased transparency is one of the provisions of the Clinical Trial and Medical Device Regulations. This article discusses the impact of transparency and disclosure on medical devices. Many modern-day medical devices are software-driven. These, as well as the patients implanted with or wearing these devices, have become part of the so-called Internet of Things, and are therefore vulnerable to cyber attacks. Disclosure of information, data, and documents pertaining to medical devices will increase this vulner - ability. In the rapidly changing regulatory landscape, the role of medical writers in anonymisation of patient data takes on a whole new magnitude. It is not only about protecting patient privacy, it is about ensuring patient safety
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References
- EMA Policy 0070 External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use. 02 Mar 2016; 16 Dec 2016; 12 Apr 2017 Available from: http://
- European Medicines Agency Clinical Data. Available from: https://clinicaldata.ema.europa.eu/
- Medical Device Regulation (EU) 2017/… of the European Parliament and of the Council of Europe on medical devices (draft 22 Feb 2017) Available from: http://data.consilium.europa.eu/doc/ document/ST-10729-2016-INIT/en/pdf
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