Hospital.Help

Berlin – The Federal Ministry of Health (BMG) wants to massively tighten the legal requirements for providers of practice management systems (PVS). Among other things, a smooth change of the PVS should become binding, and medical practices should be given a legal right to compensation if they incur costs as a result. In the future, an upgraded Gematik should also be able to certify the user-friendliness of the PVS and impose fines on providers of services in the telematics infrastructure (TI).

This emerges from the draft law to create a digital agency for health (Health Digital Agency Act, GDAG), which German medical journal is present. In essence, the draft defines the conversion of the previous “Gesellschaft für Telematik (Gematik GmbH)” into a “Gematik – Digital Agency for Health”, which should be equipped with significantly more competencies and take on sovereign tasks.

The draft also deals in detail with the regulation of PVS and provides for regulations that are intended to improve the switching 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 person’s right to release the data in an interoperable format.

“If the manufacturer does not fulfill its obligation to make data available to the service provider in an interoperable format, the latter has the right to compensation for the damage caused,” the draft says.

The amount of damage relates to the actual costs incurred, for example through the use of external services for data migration, or for necessary measures to archive data and the local transfer of data to a cloud provider.

The statutory health insurance associations (KVen) should also take action: They should be given the opportunity to offer further offers relating to digitalization, which explicitly also include general PVS change advice. This could explain which steps are necessary for a PVS change and what can be expected.

Criteria-based comparison options with regard to essential product properties such as user-friendliness and cost structures are also possible “in order to enable management providers to make well-founded decisions to modernize their practices”.

Competence center for interoperability

In addition, Gematik is to receive further competencies for the certification of PVS. With the entry into force of the Digital Act (DigiG), a uniform conformity assessment procedure for checking the interoperability requirements was introduced, which is carried out by the coordination office for interoperability at Gematik. The law is intended to expand 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 on a technical, semantic and syntactic level, but can also be used as intended by users in practice”.

The goal is to ensure the conformity of the information technology systems with all relevant requirements, “so that, specifically with regard to the qualitative and quantitative functionalities, it can be guaranteed that in the future service providers will only use systems that, for example, have sufficient performance and with which ensures that service providers, for example the ePA [elektronische Patientenakte, Anm.d.Red.] to serve their patients smoothly and efficiently.”

In a certification process, the competence center – or an accredited body that has commissioned it – should 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 should then be published on the competence center platform. The aim is to create transparency about the performance and user-friendliness of the PVS. If a manufacturer does not meet the requirements, he will not receive a certificate.

“In order to ensure interoperability and standardization as well as increase the quality of information technology systems, they may only be kept on the market in the future if they not only meet the interoperability requirements (IOP), but also meet the other requirements regarding qualitative and quantitative functions,” says it continues in the draft law.

The digital agency for health should be responsible for the clear definition of the scope of application in relation to the binding requirements that result from a specification and that were set 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 required, but this could possibly be carried out using a modified fast-track procedure.

Compliance with all of these requirements is “crucial for a seamless integration of PVS and effective exchange of health data, thereby improving the quality of health care towards modern and data-driven medicine,” it continues. Gematik itself should determine which standards apply to user-friendliness, but should also take existing standards such as DIN standards into account.

In addition, it has been shown in the past that providers do not always follow Gematik’s binding instructions to eliminate or avoid TI disruptions. But Gematik had no way of forcibly enforcing instructions. Failures of components and services and security risks could therefore not have been remedied as quickly as was necessary to ensure the security and functionality of the TI.

Fines for PVS providers

Here too, the BMG wants to make adjustments: It wants to give Gematik the opportunity to punish providers’ failure to follow the binding instructions with fines and thus ensure that the instructions are followed. This will help strengthen TI as a secure digital platform in the healthcare sector for the exchange of sensitive health data.

In addition, the National Association of Statutory Health Insurance Physicians (KBV) will in future provide a central, uniform interface that can be used for direct data retrieval, through which the master data of the fee schedule and the data required for the billing of contracts necessary for the creation of billing for medical services will be provided and automated can be accessed.

To date, KBV and KVen have made the master data of the fee schedule available via a web-based platform. The master data therefore has to be retrieved manually and prepared in a complex manner, which leads to high implementation costs and time losses. “With the new central interface to be created, these difficulties will be addressed and costs will be saved,” the draft promises.

The KBV should agree on details of the interface with the GKV umbrella association 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 further development of the ePA until 2026

In addition, Gematik should carry out the continuous conceptual development of the ePA towards a personal health data space that enables data protection-compliant and secure processing of structured health data. To this end, it should submit an implementation concept to the BMG by July 1, 2026.

The National Association of Statutory Health Insurance Funds, in turn, with the participation of the BMG and the Federal Ministry of Labor and Social Affairs (BMAS), should examine 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 can be replaced. The association should submit a proposal for this.

In general, Gematik should continue to control the development and provision of digital applications in the future, but should be able to take on different roles. It should be allowed to develop and operate components and services that can only be available centrally and only once on its own responsibility. Applications with a variety of offers and the possibility of competition would be specified by it, but developed in different gradations by the market.

“Components, services and applications that form the backbone of digital healthcare can be procured and provided by the Digital Agency for Health in a controlled market model through tendering processes,” it continues.

“This bundling of offers and the associated contractual control options of the digital agency for health will significantly improve the quality, cost-effectiveness and timely provision of the products as well as increase the stability of the overall system through reduced complexity.”

It has been shown in the past that the previous structure in the pure market model created a high degree of complexity due to a large number of different components, services and applications, according to the draft. This had a negative impact on operational stability and service quality.

The new authorization to be able to tender not only operating services for the central infrastructure, but also the development and operation of TI components and services as well as selected applications and make them available to TI users should “turn the approval model into a so-called provider model can be created”. Gematik then takes on “a controlling role in a controlled competitive environment”.

Gematik will be given discretion as to which components, services and applications it wants to stick to the current approval model and which components, services and applications should be procured through procurement procedures. In the event of a decision for central awarding, the consent of the BMG is required.

In an initial reaction today, the KBV welcomed the fact that the digital agency should be able to implement measures with the aim of increasing the stability of the telematics infrastructure. “This is urgently needed because there are still far too many failures and disruptions,” said KBV board member Sibylle Steiner.

The fact that Gematik should define qualitative and quantitative requirements for the PVS in the future also met with approval: “We have been demanding this for a long time and it has now been taken up in the draft.”

When it comes to authorizations, however, it is necessary to critically question what role medical and psychotherapeutic self-administration will play, she warned. “The resident colleagues know best which requirements are crucial so that digital processes really make work in the practices easier.” © lau/bee/aerzteblatt.de