The standardizing of services is currently in vogue, and standards governing health and social services are increasingly becoming an issue. It is to be feared that standards in this area will conflict with proven social systems enshrined in legislation. In the view of KAN and the statutory accident insurance institutions, standardization activity in this area must therefore be monitored and scrutinized closely.
The standardization of products in the health sector is advantageous and its value generally acknowledged. Products such as safe and ergonomic hospital beds, heart-lung machines and hypodermic needles are in the interests of patients and medical personnel.
Efforts have increased in recent years to extend standardization beyond traditional product standardization to include services in the health and social security sectors. Health services are however not part of the market structure in the usual sense, and for this reason were excluded from the scope of the EU Services Directive (2006/123/EC). Despite this, the European Commission has referred to the relevance of standards governing health services in its annual work programmes since 2013. Support has been proposed for standards in the areas of eHealth and quality assurance in breast cancer screening.
DIN's Standardization Roadmap for Services (pdf) also envisages potential for the standardization of health and social security services. At the same time however, it acknowledges that standardization is not advantageous in all areas owing to the existence of numerous national statutory provisions. An advisory body at CEN is currently sounding out where standards could be beneficial in the area of health services. Standardization projects at ISO level are already in progress in this area, such as International Workshop Agreement 18 on "community-based integrated health and care services for aged societies".
Caution: standardization has its limits
According to Article 153 of the Treaty on the Functioning of the European Union, responsibility for health and social security systems lies primarily with the Member States. Standards governing health services are therefore problematic when they impact upon the safety and health of workers at work or upon the statutory accident insurance, which delivers health and social security services in accordance with specific national legislation and regulations.
Safety and health of workers at work
Employers have a duty to assess risks and to take protective measures, for example where nursing staff and doctors have contact with chemotherapeutic substances. The specific work situation is the deciding factor. A standard cannot and should not anticipate this situation. Accordingly, a working group comprising representatives of the stakeholders in OSH and headed by the German Federal Ministry of Labour and Social Affairs has set out in a policy paper (pdf) that standardization with a bearing upon the safety and health of workers at work is to be possible only in exceptional cases (refer also to the KAN position papers on this subject (pdf)). CEN supports this position: according to CEN Guide 15, the safety and health of workers at work is explicitly excluded from the scope of standardization.
Treatment following an occupational accident
Following an occupational accident, the accident insurance institutions provide medical services in accordance with specific statutory provisions and quality requirements. For example, they may specify the specialist competence to be possessed by the doctors and clinics working on their behalf. In conjunction with the medical associations and bodies representing the medical profession, they also draw up quality standards for the treatment and care of workers following occupational accidents. Standards developed by external European parties and embodying deviating provisions would lead to legal uncertainty in such cases, particularly where contradictions in their content arise.
The German Social Accident Insurance (DGUV) has a statutory mandate to use all suitable means to provide medical care to insured individuals. The patient's personal situation is the decisive factor. The quality requirements which must be formulated for this purpose lie outside the scope of standardization. The same applies to the care and the social and occupational rehabilitation services delivered by the German Social Accident Insurance.
The DGUV therefore rejects standardization of services delivered by the statutory accident insurance institutions (pdf, in german), and has joined with other organizations in formulating its criticisms in this respect.
Eva-Marie Höffer Angela Janowitz