Ideally, compliance with a standard tells end users about the type of service and its quality. Certainly, in situations where patients can freely choose a doctor or facility across borders, they must be able to rely on information about the quality and price of the prospective treatment. However, there are serious doubts about the suitability of CEN standards to provide reliable help when making individual decisions on social and health services. In the worst case, a patient could be misled to believe that a facility that is certified according to a European standard is automatically ‘better’ than a facility that follows other quality assurance procedures. In reality, the patient must know and trust the health system of the country where he is receiving treatment. The European Directive on patients’ rights requires the establishment of national contact points which provide patients with access to the necessary information. Even though this is complex in practice and could be improved, this system contributes significantly more to patients’ understanding than simply fulfilling a technical standard.
If compliance with European Standards is of little help in making decisions, perhaps these standards would still be a suitable instrument for increasing the level of healthcare across Europe and improving patient safety, thus contributing to a more social and ‘healthier’ Europe. In fact, this argument is repeatedly put forward in the public debate, not least by representatives from ‘poorer’ Member States. However, this argument is quickly countered. The problematic level of healthcare in some Member States is not due to the lack of sophisticated formal technical standards and specifications, but to the lack of appropriate health budgets. In addition, it should be made clear: as far as patient safety is concerned, there is the danger that European Standards have only limited consensus and thus exert ‘pressure to adapt downwards’.
Position of the German Social Insurance: Where does it make sense to have standards and where not?
Standards can help make products safe. As such, product standards are also useful in the healthcare sector. Thus, the safety of medical devices is not only important for patient safety but also for the safety and health of the doctors and nurses who use these products.
Despite all of this, the German Social Insurance is critical of the European standardisation of social and healthcare services because, ultimately, this is an attempt to influence national social security systems via privately organised standardisation institutes and their members. This position was already stated in October 2015 with a detailed public statement. It called on standardisation institutes and the European Institutions to no longer pursue or support efforts to standardise healthcare services and social services. The latest developments confirm the criticism raised in the original position statement.