Healthcare Services European Standardization Activities Cinzia Missiroli & Maitane Olabarria CEN-CENELEC Management Center Sustainability & Services 1 Who we are and what we do European Standards Organisations Electricity – Electrotechnical Chemistry Material Food Energy European Committee for Electrotechnical Standardization Electronic Communications Services Mechanical engineering HVAC Transport Metrology Healthcare Construction Environment European Telecommunications Standards Institute Information society Security and defence European Committee for standardization CEN (& CENELEC) Members http://www.cen.eu/cen/Members/Pages/default.aspx What is a Standard? • Document meant for a common and repeated use • It is produced by all interested parties through a transparent, open and consensus based process • tool for self-regulation but also a tool to underpin legislation, e.g. European directives • Voluntary in their use • A European standard is automatically transposed in national standards and therefore conflicting national standards are to be withdrawn European Standard A fact to remember 1 European Standard... ... replaces 33 different national standards in Europe Standards developed by experts CEN CENELEC Technical Bodies National Standardisation Body National Standardisation Body National Standardisation Body Experts in a specific field representing: industry, professional associations, government, consumers, academia, patients, etc Finding and measuring consensus WG draft TC enquiry at national level WG improve draft TC formal vote of national members standard Types of publications European Standard (EN) – the same everywhere Technical Specification (TS) – try it out and/or compete Technical Report (TR) – give information CEN-CENELEC Workshop Agreement (CWA) – agreement between parties Standardization Healthcare Services © CEN-CENELEC 2010 10 Standardization in healthcare sector • Traditionally: medical devices, eHealth • Recently: increasing number of initiatives in the area of healthcare services • Started at the request of specific stakeholders (health professionals, patients…) Published documents • EN 15927:2010 Services offered by hearing aid professionals • EN 16224:2012 Healthcare provision by chiropractors • CWA 16642:2013 Health care services- Quality criteria for health checks • EN 15224:2012 Health care services - Quality management systems - Requirements based on EN ISO 9001:2008 • CEN/TR 15592:2007 Health services- Quality management systems- guide for the use of EN ISO 9004:2000 in health services for performance improvement • EN ISO 15189:2012 Medical laboratories - Requirements for quality and competence Under development • CEN/TC 403 “Project Committee-Aesthetic surgery and aesthetic non-surgical medical services” • FprEN16372 Aesthetic surgery services to be voted in April 2014 and (if approved) published in August-Sep 2014 • Standard to be developed on aesthetic non-surgical medical services • CEN/TC 414 “Project Committee- Services of osteopaths” • prEN 16686 Osteopathic healthcare provision under public enquiry until 7 April 2014 Recently initiated • CEN/TC 424 “Project Committee- Care services for cleft lip and/or palate” • Technical report on early care services for babies born with cleft lip and/or palate to be published in 2015 • CEN/TC 427 “Project Committee- Services of medical doctors with additional qualification in homeopathy” • First meeting 9-10 January 2014 Context and reasons behind the proposals • Increasing mobility of patients • Patients look for better financial deals • Cheap flights make them mobile • Increase patient safety • Build trust and confidence of patients • Improved service quality • Minimum requirements, benchmark & best practices • Mobility of health professionals • Mutual recognition of qualifications • Level playing field at European level • Complement legislation where it exists, or provide reference document where it does not Added value of standards • Developed in a neutral platform by all interested parties • Responds to specific request from stakeholders • Transparent and open process • Written by experts in a specific field • Everybody is entitled to comment on draft standards through a public enquiry • Reached through consensus • Common reference document in 33 countries • Possibility of integration with international standardization work (cooperation agreement between CEN and ISO) Requirements & Recommendations What currently the ENs cover: Quality of service provisions before – during – after intervention Information to patients, patient management/safety Good and best practices Requirements on facilities and equipment Education and trainings, competences code of conducts and ethical framework marketing and advertising ! Thank you for your attention! Questions? Cinzia Missiroli [email protected] Maitane Olabarria Uzquiano [email protected] www.cen.eu www.cenelec.eu www.cencenelec.eu CEN-CENELEC Management Centre Avenue Marnix 17, B-1000 Brussels
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