Clinical Safety and Quality Management in Health IT

Abstract

This chapter describes the principle risks that are associated with the supply of healthcare information systems, services, and technologies and the emerging best clinical safety and quality management practices that are being adopted by both users and suppliers in order to mitigate or remove these risks. It states that there are two principle sources of risk: one derived from the potential harm that could be caused to patients and users in a care environment and the other derived from possible failures to achieve the specifications and service levels demanded by a buyer. It argues that for a health IT supplier, implementing industry best practices in an effective way not only provides a high level of protection from both sources of risk but has in any event now become a minimum expectation on the part of users such as the NHS Connecting for Health programme. The chapter concludes that although quality, safety and performance standards in health IT still lag behind other, more established sectors of healthcare innovation—such as pharmaceuticals and medical devices—new standards for clinical safety and quality management are rapidly emerging, introducing a new dimension into informatics standardisation and substantially but necessarily raising the barriers to entry into the health IT market place.