Suchergebnisse

Data protection is an emerging field of law that is challenging for legislators and the actors from public and private sector. It establishes standards for processing personal information and sets certain requirements to any party which is handling one's personal data. The article is oriented on the issues regarding the security of data, namely to keep personal data safe and secure in an organization, public or private, if they are using such data. The emphasize is made on the features of organizational and technical security measures and on their role in processing operations. The aim of this article is to show that these measures are not only mere rules, instead, they deserve to be considered as the data processing principles alongside with the five universally acknowledged principles of data handling. Additionally, to reach the high standards of security, the government should prescribe the standards of security for both private and public actors.

Recently, there has been much open debate with the regulators around the use of ePRO in clinical drug submissions. US and European agencies have approved new drugs that have included ePRO data in the submission dossier, but there are many questions around the adoption of the technology that concern the community. Bill Byrom and Brian Tiplady's ePro addresses these questions, reviews the new FDA guidance, and provides a very contemporary view on this important subject

Introduction -- Uncovering the hidden asset -- An overview of data -- Common categories of business data -- Taking a value-based approach to data management -- Some current thinking on the value of business data -- Some business reasons to perform a data valuation -- The open framework for data valuation -- Summary