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

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
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References

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