EU Member States are at liberty to organize their healthcare systems as they themselves see fit. At the same time, numerous European and international standards currently seek to harmonize this area more closely. Will forms of medical treatment be determined in future less by the specifications of national social insurance agencies and medical associations, and more by standardized European healthcare? A fictitious case study illustrates one possible development.
The European Commission plans to use European standards among other things to promote cross-border eHealth, telemedicine, harmonized cancer registries and the quality of health apps1. It also aims to gain experience of value for other areas by standardizing the quality assurance of breast cancer treatment. Harmonized requirements for medical laboratories have existed since 2012, in the form of EN ISO 15189.
One possible scenario: The electronic data of a radiographer who has developed breast cancer are transferred across national borders between healthcare providers, and her x-ray images and tissue samples analysed in another country. Her breast cancer is treated by means of quality-assured procedures in accordance with European standards. The treatment is monitored by a standardized health app, which for example records the patient's physiological data.
Medical services are finding their way into standardization: EN 16372, Aesthetic surgery and aesthetic non-surgical medical services, conflicts with German medical law to the extent that it continues to be rejected by Germany. Services provided by doctors with a supplementary qualification in homoeopathy are governed by EN 16872. International series of standards exist governing traditional Chinese medicine (TCM), such as ISO 18668.
The patient is operated on by a plastic surgeon who is certified in accordance with the standard but does not satisfy the German medical regulations. Supplementary homoeopathic and TCM treatments are based upon the requirements of standards.
CEN/TC 450 is planning a European standard governing patient involvement in person-centred care. EN ISO 22870 standardizes Point-of-care testing (POCT) – Requirements for quality and competence.
The patient receives person-centred care and support and is party to decisions, in accordance with the standard. Certain examinations, for example for determining the kidney function values in an emergency, are based upon EN ISO 22870.
The new ISO/TC 304 aims to standardize administration in healthcare. EN 15224, governing quality management, has been in existence since 2012. A current DIN project is concerned with cleaning in hospitals.
Hospitals, convalescence centres and doctors' surgeries are managed and cleaned in accordance with European and international standards.
Who is behind this trend?
The European Commission formally accepts that in accordance with Article 168 of the TFEU2, responsibility for national healthcare systems lies with the Member States themselves. At the same time, the Commission is seeking to use standards to enhance cross-border healthcare and the rights and safety of patients (and thus also of workers).
CEN and ISO are exploiting this tailwind. Following preliminary work by the CEN Strategic Advisory Group on Services3, the "Health care services" focus group is now drawing up recommendations for the CEN Technical Board4. The focus group's aim is to find common objectives and language for topics such as processes, buildings and equipment, management and guidance documents in the area of healthcare5.
In response to an initiative by Poland, Germany and several other countries have voiced their opposition to this standardization activity in the EU Council of Ministers6. In the CEN focus group, the German stakeholders are engaged in damage limitation, despite considerable opposition from the proponents of this activity. The German stakeholders are attempting for example to keep training in medical vocations or rules for treatment out of standards. Do certain areas need to be declared off-limits for standardization activity, or should compromises be reached? Could certain standards promote innovation (for example in quality management) or serve as benchmarks for Europe-wide invitations to tender? Which strategy holds the prospect of success in the long term (such as participation, adoption of a position or non-participation) is currently being debated by the most diverse of stakeholders, such as the medical associations, health ministries, and the European Social Insurance Platform (ESIP). The outcome is still open.
3 SAGS; www.cen.eu/work/areas/services/Pages/default.aspx
4 CEN Technical board (BT); https://boss.cen.eu/TechnicalStructures/Pages/BT.aspx
5 Mirror committee of the CEN focus group: DIN Commission on Health