/ image alliance, dts agency
Berlin – The Federal Ministry of Health (BMG) wants to greatly strengthen legal requirements for providers of practice management systems (PVS). Among other things, a soft change to the PVS should become binding and medical practices should have a legal right to compensation if they incur costs as a result. In the future, an updated Gematik should also be able to certify the ease of use of the PVS and impose fines on service providers in the telematics infrastructure (IT).
This emerges from the bill to create a digital health agency (Health Digital Agency Act, GDAG), which German medical journal is present. In essence, the project defines the conversion of the previous “Gesellschaft für Telematik (Gematik GmbH)” into a “Gematics – Digital Agency for Health”, which should be equipped with significantly more powers and assume sovereign functions.
The draft also addresses the regulation of the PVS in detail and provides regulations that aim to improve the change process and ensure that doctors can fully comply with their documentation and archiving obligations, even after a change. The same should apply to the insured’s right to disclose data in an interoperable format.
“If the manufacturer does not fulfill its obligation to make the data available to the service provider in an interoperable format, the latter is entitled to compensation for the damage caused”, says the project.
The amount of damages refers to the actual costs incurred, for example, through the use of external services for data migration or measures necessary to archive data and locally transfer data to a cloud computing service provider.
Statutory health insurance associations (KVen) should also take action: they should be given the opportunity to offer more offers related to digitalization, which explicitly also include general advice on changes to the PVS. This could explain what steps are needed for a change in PVS and what can be expected.
Criteria-based comparison options with regard to key product properties, such as ease of use and cost structures, are also possible “to enable management service providers to make informed decisions to modernize their practices”.
Competence Center for Interoperability
Furthermore, Gematik will receive additional competencies for PVS certification. With the entry into force of the Digital Law (DigiG), a uniform conformity assessment procedure was introduced to verify interoperability requirements, which is carried out by the Gematik interoperability coordination office. The law intends to transform the coordination office into a competence center for interoperability and also give it new responsibilities.
The newly assigned tasks are intended to ensure that information technology systems in healthcare “can not only communicate with each other at a technical, semantic and syntactic level, but can also be used as intended by users in practice”.
The objective is to ensure compliance of information technology systems with all relevant requirements, “so that, particularly with regard to qualitative and quantitative functionalities, it can be guaranteed that in the future service providers will only use systems that, e.g. , has sufficient performance and ensures that service providers, for example ePA [elektronische Patientenakte, Anm.d.Red.] to serve your patients smoothly and efficiently.”
In a certification process, the competence center – or an accredited body that commissioned it – must confirm that an information technology system meets the Gematik specifications not only in terms of interoperability, but also in terms of qualitative and quantitative functions.
The certificate must then be published on the competence center platform. The goal is to create transparency about the performance and ease of use of PVS. If a manufacturer does not meet the requirements, they will not receive the certificate.
“To ensure interoperability and standardization, as well as increase the quality of information technology systems, they can only be maintained on the market in the future if they not only meet the interoperability requirements (IOP), but also meet other requirements relating to quality and quantitative functions”, continues in the bill.
The digital health agency should be responsible for clearly defining the scope of application in relation to binding requirements that result from a specification and that have been defined for mandatory implementation.
This should also apply if significant changes are made to existing systems that affect not only interoperability, but also the requirements for qualitative and quantitative functions. A new compliance check is then necessary, but this may possibly be carried out through a modified accelerated procedure.
Compliance with all these requirements is “crucial for seamless PVS integration and effective exchange of health data, thus improving the quality of healthcare towards modern, data-driven medicine”, he continues. Gematik itself must determine which standards apply for ease of use, but must also take into account existing standards such as DIN standards.
Furthermore, it has been demonstrated in the past that suppliers do not always follow Gematik’s binding instructions to eliminate or avoid IT outages. But Gematik had no way of enforcing instructions by force. Component and service failures and security risks could therefore not have been corrected as quickly as necessary to ensure IT security and functionality.
Fines for PVS providers
Here too, BMG wants to make adjustments: it wants to give Gematik the opportunity to punish suppliers’ failure to comply with binding instructions with fines and thus ensure that the instructions are followed. This will help strengthen IT as a secure digital platform in the healthcare sector for exchanging sensitive health data.
Additionally, the National Association of Statutory Health Insurance Practitioners (KBV) will provide in the future a central and uniform interface that can be used for direct data retrieval, through which the master data of the fee table and the data necessary for the invoicing of the contracts necessary for the creation of the invoicing of medical services can be made available and accessed automatically.
To date, KBV and KVen have made fee schedule master data available via a web-based platform. Master data therefore has to be retrieved manually and prepared in a complex way, which leads to high implementation costs and lost time. “With the new central interface being created, these difficulties will be resolved and costs will be saved”, promises the project.
The KBV must agree on the details of the interface with the umbrella association GKV no later than six months after the law comes into force and make the interface available no later than twelve months after the law comes into force.
Concept for the future development of the APE until 2026
Furthermore, Gematik shall carry out the ongoing conceptual development of the ePA towards a personal health data space that enables secure and data protection-compliant processing of structured health data. To this end, an implementation concept must be presented to BMG by July 1, 2026.
The National Association of Statutory Health Insurance Funds, in turn, with the participation of BMG and the Federal Ministry of Labor and Social Affairs (BMAS), should analyze whether and under what conditions the medical certificate of incapacity for work – including the employer’s certificate – can be issued by a suitable electronic equivalent with the same high probative value in the EPA and can be replaced. The association must present a proposal in this regard.
In general, Gematik should continue to control the development and delivery of digital applications in the future, but should be able to take on different roles. It should be permitted to develop and operate components and services that can only be available centrally and only once under your own responsibility. Applications with a variety of offers and the possibility of competition would be specified by it, but developed in different degrees by the market.
“The components, services and applications that constitute the backbone of digital healthcare can be purchased and provided by the Digital Health Agency in a controlled market model through tender processes”, it continues.
“This package of offerings and the associated contractual control options from the digital health agency will significantly improve the quality, cost-effectiveness and timely delivery of products, as well as increase the stability of the overall system by reducing complexity.”
It has been shown in the past that the previous structure of the pure market model created a high degree of complexity due to a large number of different components, services and applications, according to the project. This had a negative impact on operational stability and service quality.
The new authorization to be able to tender not only operation services for the core infrastructure, but also the development and operation of IT components and services, as well as selected applications and make them available to IT users should “transform the approval model in a so-called provider model can be created.” Gematik then assumes “a controlling role in a controlled competitive environment”.
Gematik will have freedom over which components, services and applications it wishes to maintain in the current approval model and which components, services and applications should be acquired through procurement procedures. In case of a centralized award decision, the consent of BMG is required.
In an initial reaction today, the KBV welcomed the fact that the digital agency could implement measures aimed at increasing the stability of the telematics infrastructure. “This is urgently needed because there are still many failures and interruptions,” said KBV board member Sibylle Steiner.
The fact that Gematik should define qualitative and quantitative requirements for the PVS in the future was also approved: “We have been demanding this for a long time and now it has been included in the project”.
However, when it comes to authorizations, it is necessary to critically question what the role of medical and psychotherapeutic self-administration will be, he warned. “Resident colleagues know best which requirements are crucial for digital processes to truly facilitate work in practices.” © lau/bee/aerzteblatt.de