AbstractIncreased 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