DGBMT Calls for Mandatory Interoperability Standards in Medical Device Procurement
DGBMT-Positionspapier fordert verbindliche Standards bei Medizintechnik-Beschaffung
Summary
The German Association for Biomedical Engineering (VDE DGBMT) has called for the mandatory inclusion of 'interoperability' as a core procurement criterion when purchasing medical technology. The paper suggests that hospitals can leverage their market power and existing international standards to enforce compliance without needing new legislation.
Details
In its policy paper, the VDE DGBMT advocates for establishing interoperability as a binding procurement criterion, arguing that connected and intelligent medical technology should drive modern healthcare systems. They highlight that hospitals possess significant market power when purchasing IT and medical devices, which can be used to enforce adherence to standards. Technically, international standards for syntactic and semantic interoperability already exist, including HL7 FHIR, SNOMED CT, and LOINC. However, implementation is hampered by proprietary interfaces, incomplete semantic consistency, and insufficient cybersecurity and lifecycle concepts. Organizational hurdles—such as separated responsibilities between medical technology and IT, staff shortages, and lacking funding models—exacerbate the problem. The DGBMT specifically recommends setting FHIR-based interfaces as a minimum requirement, mandating the explicit mention of open international standards in tenders, and requiring proof of conformity rather than mere declarations of intent. Interoperability should be included as an elimination criterion and a weighted scoring criterion in procurement documents. Furthermore, the VDE ITG Beirat Qualifizierung HealthCare is developing a VDE application rule with binding minimum requirements for operators and manufacturers.
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