Software legal regulation

Database Integrity. Integrity of the database must be assured particularly if the data are to be used to meet government regulations or used as legal evidence. Several things can be done to secure the data against user errors and hardware or software failures. 

GxP regulations require that access to the software and relevant associated documentation should be preserved for a number of years after the system or software has been retired (see Chapter 4 and Chapter 11 for more details). Software licenses do not entitle pharmaceutical and healthcare companies to ownership of the software products they have purchased. All that has been purchased is a license, an official permission or legal right to use it for some period of time under defined conditions of use. Accordingly, some companies have established escrow (third party) accounts with suppliers to retain their access to software, but this is not mandatory. Access agreements directly... 

PACS software must address four issues confidentiality, integrity, reliability, and availability. From the legal point of view mandated by various federal and state regulations, these issues are paramount in the operation of a healthcare institution. 

We have seen in the previous chapter that, as well as an obvious moral duty, systems designers and software engineers may have legal responsibilities under statutes such as the Health and Safety at Work Act to ensure that other people are not put at risk by their acts or omissions. Despite its apparently specific subject area, the general approach to safety matters contained in the Health and Safety at Work Act and associated regulations need not be confined to workplace safety. Indeed, the sequence— assess, control and monitor—found in the Control of Substances Hazardous to Health Regulations and the European regulations is capable of application to... 

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