The new Gesundheits-IT-Interoperabilitäts-Governance-Verordnung or (IOP Governance-Verordnung, GIGV for short) will come into force on October 01, 2021. A draft bill has already been published by the German Federal Ministry of Health (BMG). It does not need to be passed by parliament.
This article will explain what the regulation requires and whether you will be affected by it.
The healthcare system suffers from a lack of integrated processes. This leads, for example, to:
One necessary, but not on its own sufficient, prerequisite for integrated (i.e., cross-sector as well) processes is the interoperability (IOP) of the products and systems involved in healthcare delivery. Interoperability is the ability of a system (e.g., a medical device or a piece of software) to work with other systems.
This short article on interoperability(german) presents an interoperability model. Classification into different levels makes the differences between semantic and syntactic standards easier to understand.
The IOP Governance-Verordnung (GIGV) aims to solve this problem.
Even if it is not clearly stated: The legislator - specifically the Federal Ministry of Health (BMG) - wants to use the GIGV to curb the proliferation of interoperability standards. A new body will be established at gematik for this purpose:
“a coordinating body to promote interoperability and open standards and interfaces, and to support processes for the coordination of requirements for interfaces in information technology systems for cross-sector information exchange in healthcare”
GIGV § 2(1)
The task of this coordinating body is to:
The IOP Governance-Verordnung (GIGV) states that the coordinating body must utilize several groups of people:
External stakeholders have at least two options for interacting, indirectly at least, with the new coordinating body, expert circle and IOP working group structure:
While §7 of the GIGV (“Recommendation of standards, profiles and guidelines for information technology systems in healthcare”) still uses the word “recommendation”, §8 is clearer.
Information technology systems in healthcare that are used in the context of the provision of health-related services or are financed in whole or in part from public funds of the Federal Ministry of Health must be designed in such a way that the recommendations made in accordance with §7 included on the information platform in accordance with §10 must be fully taken into account within 24 months of the recommendation.
GIGV § 8(1)
This means that manufacturers of medical information systems, DiGA manufacturers and certain medical device manufacturers must design the data interfaces of their products in such a way that they comply with the established IOP standards. This will affect manufacturers of hospital information systems (HIS), patient data management systems (PDMS), practice information systems (PIS) and radiology information systems (RIS).
It is obviously still too early to evaluate the new GIGV. But we can make some initial observations.
It is obvious that there is currently a confusing array of interoperability standards. Simply listing these standards in a directory is not enough to ensure sufficient interoperability.
So, the desire for a body responsible for restoring some order is understandable.
However, the new regulation can also be a real headache:
Unnoticed by many, the BMG has issued the IOP Governance-Verordnung (GIGV). It would be a mistake to think that this will only affect the BMG's own gematik. In fact, this regulation will also affect a lot of manufacturers of medical devices (e.g., of DiGA) and medical information systems, e.g., through new bureaucratic and additional costs for development and regulatory affairs.
Hopefully, the benefits of the new regulation will outweigh the negatives.
But it would be nicer if we didn't have to hope and already had evidence that this was the case.
Regulatory science is a branch of research that aims to formulate regulatory requirements based on evidence-based knowledge. The Johner Institut is one of many organizations conducting research on this. You can find out more on the issue of regulatory science in our