Part of Odelle Technologies submission to the Board of Review in Germany for the KHZG.
in understanding that Robotics is part of Digitisation.
Some suggested amendments from Odelle Technology
Table of Contents
I. Summary 1
II. Necessary need for regulation 2
III. Suggested changes 2
1. Article 1: Amendment of the Hospital Financing Act 2
2. Article 2: Amendment of the Hospital Structure Fund Regulation 4
3. Article 2 Part 3: Funding according to section 14a of the Hospital Financing Act 6
From Odelle’s point of view, the (KHZG) contains numerous good approaches for reducing the investment backlog in hospitals in Germany. We consider the promotion of medical technology capital goods, especially those with a digital function, to be suitable for making hospital care in Germany sustainable.
Since many different solutions and methods already exist on the market, the funding criteria must be designed as openly as possible so that the hospitals receive support that meets their needs.
However, the measures contained in the KHZG are neither suitable for closing the investment gap, which has been increasing for decades, nor ensuring sustainable financing for the digitization of hospitals. It is also unclear what will happen after the funds have been exhausted.
By means of clear guard rails at federal level, it is necessary to harmonize the funding direction for the federal states more closely and to align it with relevant future technologies, where added value can be created for doctors and patients in a timely manner. It is not enough to measure the degree of digitization in hospitals alone. Its effects on improving patient care, both in terms of outcome and treatment quality and efficiency, must also be included in the outcome measurements.
The deductions provided for in Article 4 of the Act can worsen the already problematic financing of operating costs in cases through no fault of their own and do not constitute an incentive mechanism if the existing large investment cost gap is not closed at the same time.
As a result, the proposed measures in their current version can even lead to a further deterioration in the financing of operating costs in hospitals and, due to increasing innovation costs (e.g., co-financing of hospitals, discounts), also worsen the supply of high-quality, innovative medical products.
II. Necessary need for regulation
In the present draft version of the Hospital Future Act (KHZG) for modern technical and digital equipment in hospitals, robotic assistance systems and high-tech medicine are not considered in the implementation.
Odelle is of the opinion that progressive medical technologies make a significant contribution to ensuring that patient treatment is feasible if necessary. For example, robotic assistance systems in the operating room as well as digitized navigation and operation process systems form a supporting pillar for progressive, safe, and patient-friendly surgical treatment.
Robotic assistance systems in the operating theatre are not specifically mentioned in the draft, but only robotics in connection with small systems without any significant influence on patient care are provided. This is a mistake in the draft of this law since robotic assistance systems can also make a positive contribution to improving care in the short term. Finally, Odelle outlined the extensive potential and advantages in its position paper “Investment offensive for robotic assistance systems in the operating theatre”. It is therefore just as important to promote conventional medical products. In emergency care in particular, the necessary materials are missing completely, are insufficiently available and / or are out of date due to the investment backlog.
We demand a future-proof and sustainable solution beyond the term stipulated in the law to finance the necessary maintenance and regular updates. “Internal digitization” in hospitals also requires, against the background of necessary inter-sectoral care concepts, further integration / financing of a counterpart with a statutory health insurance contract and uniform cross-sector digital interfaces.
III. Proposed changes
1. Article 1: Amendment of the Hospital Financing Act
1.1. Number 1: section 1 principle
section 1 is amended as follows:
In Section 1, Paragraph 1, after the word “efficient” and the following comma, the word “digital” and a comma, the words “medically relevant to progress” and a comma are inserted.
Takes part in numerous digital health applications that affect medical progress and patient care 1.2. Number 4: section 14a Hospital Future Fund
1. Section 14a (1) sentence 1 is supplemented as follows:
In paragraph 1 sentence 1, after the word “better”, the words “and future-proof medical-technical-apparatus as well as” and after the word “high-tech medicine” the words “in patient treatment” are inserted.
The future program for hospitals aims to improve health care: For comprehensive technical and digital equipment in hospitals – also in the context of progressive patient care – modern, digital medical products such as robotic assistance systems must be given special consideration.
2. Section 14a (2) is amended as follows:
In paragraph 2, sentence 2, the year is changed from “2021” to “2022”.
3. In section 14a paragraph 3, the following sentence is inserted after sentence 5:
“The federal states are examining the decision to award funding, subject to the provision of a local supply structure for all citizens of the respective federal state, which corresponds to the objective in accordance with paragraph 1 sentence 1.”
4. Section 14a (4) is amended as follows:
In paragraph 4 sentence 1, the year is changed from “2018” to “2019”.
Reason for 2, 3, 4:
With the funding from this law, patient care close to home in times of crisis and in regular operations is to be made sustainable and improved over the long term. For this purpose, separate funds must be made available specifically for the procurement and modernization of medical equipment and robotic assistance systems. Modern medicine, with the aim of improving the quality of treatment and care, cannot be implemented without advanced medical technology systems. This also includes robotics-assisted operating systems.
1.3. Number 4: section 14b Evaluation of the digital maturity level of the hospitals
section 14b is supplemented as follows:
In sentence 1, after the word “digital”, the words “and robotic medical technology and apparatus” and after the word “hospitals” the words “with the aim of creating a hospital infrastructure that is advanced in terms of information technology” are added.
In sentence 2, the year is changed from “2021” to “2022” and from “2023 to 2024” and after the word “recognized” the words “structural and apparatus” and after the word maturity models the words “to assess the procedural quality and patient treatment quality “added.
The hospital future program focuses on improving and digitizing patient care. This mechanism of action should be measured and evaluated directly, including based on longitudinal data.
In addition to evaluating the digital maturity level of the hospitals, the Federal Ministry of Health should commission an independent expert opinion based on routine SHI data to demonstrate the positive effects of the investments and to gain knowledge of which investments have worked better which are less good. The focus here should be on indicators for the quality of the results, such as revision rates or the process quality, measured by the length of stay. Particular attention should be paid to a long-term view with patient-specific follow-up and a consistent patient perspective, for example quality of life and functional outcomes, such as mobility after surgical interventions.
To enable this appraisal, projects and their goals, elements and timeframes should be recorded in a standardized manner across countries by the Federal Social Security Office and made available to the appraiser. The report should be created and published in two parts: Part 1 by November 30, 2022 and Part 2 by November 30, 2024. Part 1 should describe the approach, hypotheses and initial results, Part 2 results of the projects with patient follow-up via the statutory health insurance – routine data.
1.4. Number 4: section 14a Hospital Future Fund & Number 8: Funding according to section 14a of the Hospital Financing Act
1. Number 4: section 14a Paragraph 1 Clause 4 is amended as follows:
In paragraph 2, sentence 4, the percentage is changed from “15” to “10”.
2. Number 8:
Section 22 (2) sentence 1 is amended as follows:
In paragraph 2, sentence 1, point 2, the percentage is changed from “15” to “10”.
Section 22 (5) sentence 1 is amended as follows:
In paragraph 5, sentence 1, the percentage is changed from “15” to “10”.
The obligation of 15% of the expenditure of each project on IT security focuses too much on this topic and greatly reduces the feasibility of specific projects or means that applications must plan practically fictitious IT security budgets, which are then missing elsewhere and not directly benefit the patient. We suggest reducing the minimum requirement to 10%. this is a clearly realistic value and less restricts possible projects.
2. Article 2: Amendment of the hospital structure fund regulation
2.1. Number 2: section 11 Eligible projects
Section 11 (1) sentence 1 is amended as follows:
In number 4 letter b), the words “the telematics infrastructure in the healthcare system according to Section 291a of the fifth book” are replaced by the words “and applications of the telematics infrastructure according to the fifth book” and the comma at the end is replaced by the words “and Share in the interoperability of the telematics infrastructure have replaced “.
When implementing modern medical equipment that is connected to the hospital network, data processing takes place only in certain cases within the meaning of Section 11 (1) sentence 1 KHSFV in conjunction with section 291a SGB V takes place. Here the legislature must delimit the cases in which data processing remains in the internal relationship between the service provider and the operator of the medical-technical equipment.
2.2. Number 8: Funding according to section 14a of the Hospital Financing Act
Section 19 (1) sentence 1 is supplemented as follows:
In Section 19 (1) sentence 1, the words “medical technology modernization and” are added after the words “in particular for”.
Modern medical technologies, together with digitization, lead to more patient safety and better treatment outcomes.
Section 19 (1) sentence 1 no.2 is supplemented as follows:
In section 19 Paragraph 1 Clause 1 No. 2 Hospital Structure Fund Regulation, discharge management is deleted and inserted after admission “Discharge and follow-up management as well as postoperative therapy”.
The establishment of patient portals for digital admission, discharge, and aftercare management as well as postoperative therapy, which enable a digital exchange of information between service providers and service recipients before, during and after treatment in the hospital, should be guaranteed.
In Section 19, Paragraph 1, Clause 4, point 4 is supplemented and reformulated as follows:
“Partially or fully automated” or robot-based “clinical” and surgically operative “decision support and” treatment systems “with the aim of” standardizing and “increasing the quality of care,” “for patients as well as integrating the operating theatre and increasing the Interoperability of OR systems with hospital information systems (HIS) and image management systems (PACS), “
With the integration of all necessary devices, people and hospital IT systems, a consistent and seamless surgical practice can be guaranteed, sources of error and process inefficiencies can be reduced and a high data quality can be ensured in the documentation. Doctors and nursing staff gain valuable time by reducing manual data entry and data transfers. At the same time, IT and data security and the protection of sensitive patient data are increased.
Ultimately, secure, and integrated data sets are created with which hospitals can develop and use decision-making systems.
3. Article 2 Part 3: Funding according to section 14a of the Hospital Financing Act
section 19 Hospital Structure Fund Ordinance – Eligible Projects
Section 19 (1), sentence 1
In number 4 the words “decision support systems” are added after the word
“Also, with AI-supported solutions” inserted.
Notes on artificial intelligence (AI) can only be found in the special part of Section 19 (1) number 4 regarding future extensions. Such solutions are already available today and should therefore be included in the legal text at the appropriate point.
AI systems are already able to support the doctor’s diagnosis with an even more targeted treatment. This makes it necessary to include diagnostic statements from the AI systems in the documentation and to incorporate them into the diagnostic question. This is the only way to ensure and improve quality.
Section 19 (1) number 5 is supplemented as follows
“End-to-end digital medication and treatment management to increase therapy safety, in which all treatment information about the entire treatment process is available in the hospital. This also includes robot-based systems for medication and medical product management. “
Therapy safety is important not only in the pharmaceutical sector, but also in the supply of medical devices. Digital management systems significantly improve the security of supply and compliance for drug and medical product-related treatment information.
In section 19 paragraph 1 sentence 1, the following number 7 is inserted after point 6:
“An operational infrastructure corresponding to the hospital’s degree of specialization with robotic assistance systems, their procurement and installation with the necessary structural changes, “
The numbering of the serial numbers 7 to 11 becomes 8 to 12.
In Section 19 (1) sentence 1, point 9 (of the previous draft) is supplemented as follows:
In section 19 Paragraph 1 Point 9, a point is inserted after the word “Procedure” and the paragraph “Eligible are also spatial measures”.
In Section 19 (1) sentence 1, point 10 (of the previous draft) is supplemented as follows:
In section 19 Paragraph 1 Clause 1 Point 10, the words “information technology” are used after the word
“Medical technology and apparatus” added.
In section 20 paragraph 1 sentence 1 the following is added:
In Section 19, Paragraph 1, Clause 1, Point 10, the words “medical-technical-apparatus” are added after the words “information technology and”.
The following is added to Section 20 (3) sentence 2:
In paragraph 3 sentence 2 the percentage is changed from “10” to “15”.
Justification of section 19 and 20:
2016, the European Economic and Social Committee identified robotics as an area with expected increases in performance. In many surgical procedures, such as for example, the implantation of total knee endoprostheses or the removal of the uterus in benign neoplasms, risk-adjusted differences in length of stay, complication and revision probabilities are reported. This can lead to follow-up treatments to improve the quality of care and to avoid high costs. Against the background of Covid 19 keeping hospital capacities free seems attractive. In some studies, robotic assistance systems also show more stable and higher quality results in relation to manual interventions. This potential for better patient care in the health system must be used. Only through a large-scale implementation can further potential for improvement be uncovered, developed and integrated and network effects achieved.
We suggest that a specific budget share of the economic stimulus package be earmarked for robotic assistance systems in patient treatment. To further digitization in specialist centres, maximum care providers and university research centres.