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, standardsconcern 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 I) 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.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
Similar content being viewed by others
References
Bergeijk, A.E., van Kokswijk, J., Wijnen, E.: Visiedocument ICT-standaardisatie en Wonen Versie 2.0. NEN and Ministerie EZ (May 2008)
EN 1041:2008 Information supplied by the manufacturer of medical devices
EN13606. Health informatics – Electronic healthcare record communication – Parts 1-5
EN ISO 9000
EN ISO 9001:2008
EN ISO 9004:200O Quality management systems – Guidelines for performance improvements
EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes, 2nd edn.
EN ISO/TR 14969:2004 Medical Devices - Quality management systems – Guidance on the application of ISO 13485:2003
EN IS0 14971:2007 Medical Devices - Application of Risk Management to Medical Devices
European Council. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Oviedo, 4 IV (1997)
ISO/IEC 7498-1 Open Systems Interconnection – Basic Reference Model
ISO/IEC 8348 Open Systems Interconnection – Network service definition
ISO/IEC 9126-1:2001 Software engineering – Product quality – Part 1: Quality model
ISO 14155-1:2003 Clinical investigation of medical devices for human subjects
ISO/TR 16056-1:2004 Health informatics – Interoperability of telehealth systems and networks - Part 1: Introduction and definitions
ISO/TR 16056-2:2004 Health informatics – Interoperability of telehealth systems and networks – Part 2: Real-time systems
ISO/TS 16058:2004 Health informatics – Interoperability of telelearning systems
ISO 16484 Building automation and control systems
ISO/IEC 18028 Security techniques
ISO/TS 18308:2004 Health informatics – Requirements for an electronic health record architecture
ISO/IEC 27001:2005 Information technology - Security techniques - Information security management systems - Requirements
Medical Device Directive of the European Union: Directive 93/42/EEC amended by Directive 2007/47/EC, Official Journal of the European Union L 247/21, http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:247:0021:0055:EN:PDF
Meijer, W.J., Ragetlie, P.L.: Empowering the Patient with ICT-tools: the Unfulfilled Promise. The Journal on Information Technology in Healthcare 5(5), 313–323 (2007)
NTA 8028: 2007 Health Informatics – Telemedicine The Netherlands, Delft; NEN (2007i)
Wichelecki, S.: Understanding ISO 13485 Editorial, Quality Magazine (January 2008), http://www.qualitymag.com/Articles/Feature_Article/BNP_GUID_9-5-2006_A_10000000000000225133
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2009 Springer-Verlag Berlin Heidelberg
About this chapter
Cite this chapter
Meijer, W.J. (2009). Standards for Digital Homecare. In: Yogesan, K., Bos, L., Brett, P., Gibbons, M.C. (eds) Handbook of Digital Homecare. Series in Biomedical Engineering. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-01387-4_4
Download citation
DOI: https://doi.org/10.1007/978-3-642-01387-4_4
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-01386-7
Online ISBN: 978-3-642-01387-4
eBook Packages: EngineeringEngineering (R0)