European standardization in the healthcare sector has traditionally been limited to medical devices and e-Health applications. Nevertheless, in recent years there has been an increasing level of demand from stakeholders in relation to the standardization of healthcare services.
In June 2012, CEN published a new standard on healthcare provision by chiropractors (EN 16224). This standard specifies requirements and recommendations in relation to the services provided by chiropractors and their education, as well as the facilities and equipment used. The main objective of the standard is to provide assurance to patients concerning the quality of care provided, including optimum levels of patient management, patient safety and ethical practice.
Currently CEN has Project Committees that are developing European Standards in relation to aesthetic surgery services and services provided by osteopaths. The market for aesthetic surgery interventions has increased dramatically in recent years. The Project Committee on Aesthetic Surgery Services (CEN/TC 403) is working to develop a European Standard covering aesthetic surgery as well as nonsurgical medical services in this field. The standard should be finalised and published in 2014. Among the specific aspects to be covered are: competences required by surgeons; information provided to the patient; requirements in relation to facilities; the need for a "cooling-off" period before commencing certain procedures; and a code of ethics for marketing and advertising.
Osteopathy is a distinct healthcare profession that is being practiced in many countries. However, there are no consistent standards of education, training and practice across Europe. This is the reason why CEN, with the support of the professional osteopathy organisations, was prompted to create a Project Committee on Services in Osteopathy (CEN/TC 414). This Project Committee is developing a European Standard on osteopathic healthcare provision including requirements on service provision, minimum competences and training, and a code of ethics. The standard should be finalised and published in 2015.
A quality management standard for healthcare services
CEN has published a new European Standard that specifies quality management requirements applicable to the provision of healthcare services, with a special focus on clinical processes. On 24 October 2012, CEN published the European Standard EN 15224:2012 'Health care services - Quality management systems - Requirements based on EN ISO 9001:2008'. This standard is intended for use by hospitals, nursing homes, hospices, mental health services, pharmacies and other bodies that need to ensure a high quality of healthcare service delivery. The new European Standard was developed by CEN/TC 362 'Project Committee - Healthcare services - Quality management systems'. It also aims at enhancing customer satisfaction through the continual improvement of the management system within the organisation, in line with the general requirements of EN ISO 9001:2008 'Quality management systems - Requirements'.
More information about European standardization activities in the healthcare sector can be found on the CEN website. All European Standards published by CEN are distributed by the members of CEN.
Source: "CONNECT", issue 11, January 2013