Standards for Digital Homecare

Abstract

This chapter discusses requirements for digital homecare that are dictated by current international standards. The standards relate to services and devices. For digital homecare services, standards concern quality assurance (quality management system and indicators), information management (quality of data and information), supporting systems (calibration, instruction and system integration) and organization. For organizing, the start is to define the needs of clients in terms of health and quality of life: independence, self-reliance, participation and self-determination. Next, processes must be described that lead to these goals. Digital homecare devices (apparatus and software) are generally in the lowest risk class (Class 1) according to: the amended Medical Devices Directive of the European Union. Requirements for CE-marking are: 1) a quality assurance system, 2) a risk analysis, 3) clinical evaluation and 4) post-market surveillance. Certification for ISO 13485 (quality management systems) and ISO 14791 (risk management) can assist in complying with the requirements. Measures for implementation of standards in digital homecare are described.