The new medical record of the electronic medical record activates the two billion-dollar market of medical informationization, how should the hospital meet the standard?

Recently, the State Health and Health Commission Medical and Medical Administration issued the "Notice on Further Promoting the Informatization Construction of Medical Institutions with Electronic Medical Records as the Core" (hereinafter referred to as the "Notice"). Because it involves the core issues of hospital ratings and compliance, it is highly concerned by hospitals at all levels.

After an in-depth investigation, the Arterial Network found that the impact of the Notice on the medical information market will be extraordinary. The rigid demand brought by the policy will bring huge benefits to this market.

At the same time, the arterial network also found that there are many types of products in this market. The products lack a unified standard from name to function, and the price is quite different. Those hospitals that carry out informatization construction must meet the requirements of the Notice and need to proceed carefully from their own needs.

CDSS and integration platform in the market space of tertiary hospitals

The arterial network estimates that the launch of this new deal will activate two major 10 billion yuan markets.

There is no reason for it. The Notice gives three established time nodes:

First, by 2020, tertiary hospitals must reach grade 4 or higher, that is, to achieve information sharing in the hospital and have medical decision support functions. Second, by 2020, tertiary hospitals must realize information interconnection in various hospitals. Interoperability, to achieve the level of maturity assessment of hospital information interconnection and integration level 4; Third, by 2020, tertiary hospitals must achieve full coverage of electronic medical record information diagnosis and treatment services.

Although these three time points are based on the current application of electronic medical records in tertiary hospitals. But what is particularly striking is the medical decision support and interoperability maturity evaluation.

Let me talk about medical decision support:

As we all know, the reason for the application of CDSS in domestic medical institutions is not entirely the improvement of the quality of medical services, but also the promotion of some other factors. There are two main aspects: first, the state's policy promotion for primary health care development; second, the informationization rating requirements of large medical institutions (HIMSS, electronic medical record grading evaluation). This point can be clearly seen from the announcement of the Clinical Support Decision Support System (CDSS) procurement project issued by the People's Hospital of Jiangsu Province on July 4, 2018:

1. Project Name: Procurement Project of Clinical Assistant Decision Support System (CDSS) of Jiangsu Provincial People's Hospital

2. Project Overview: Through the project, the level of informatization construction of the hospital will be improved, and the hospital will pass the National Interconnection Maturity Evaluation Level 5 and the electronic medical record application level evaluation level 5 review. We will build a library of clinical knowledge shared by clinical departments at the hospital level, vigorously improve medical quality and clinical efficiency, meet the knowledge base's support for hospital clinical business, increase the hospital's core competitiveness, and provide patients with better medical services.

In the "Electronic Medical Record System Function Application Level Evaluation Method and Standards (2018 revised consultation draft)", the clinical decision support (CDSS) was clearly defined, taking 5 levels as an example:

Level 5: Unified data management, intermediate medical decision support.

1. Partial requirements: Each department can use the unified integrated information and knowledge base of the whole hospital to provide a unified knowledge base of clinical diagnosis and treatment specifications, rational drug use, and clinical pathways, and provide integrated display and decision support functions for the department.

2. Overall requirements:

(1) The system data of the whole hospital can be integrated according to the unified clinical data management mechanism, and provide cross-department integrated display tools.

(2) It has a complete intelligent data collection tool to support structured and intelligent writing of medical records and reports.

(3) Based on integrated patient information, the knowledge base is used to implement decision support services, and data mining functions can be provided for clinical research work.

Among the evaluation criteria of HIMSS EMRAM, CDS (Clinical Decision Support) is also one of the core evaluation points. Starting from the second level of EMRAM, almost every level has requirements for CDS. The entire 0-7 level is actually a process of progressive and escalating CDS functions until the final level of comprehensive clinical decision support (full CDS).

电子病历新政激活医疗信息化两大百亿市场,医院达标应如何选择

Source: HIMSS Analytics official website

After the publication of the Notice, the construction of the CDSS was also put on the agenda of the tertiary hospital. Then we can't help but ask, by 2020, how big is the market space of CDSS?

According to the number of national medical and health institutions issued by the National Health and Health Commission's Statistical Information Center at the end of June 2018, as of the end of June 2018, the number of domestic tertiary hospitals was 2,439, compared with 2,286 at the end of June 2017. 153 homes. If we increase the number of 160 calculations per year, by 2020, the number of domestic tertiary hospitals will be about 2,606.

电子病历新政激活医疗信息化两大百亿市场,医院达标应如何选择

Source: National Health and Wellness Commission Statistical Information Center

In the bidding data of the Chinese government procurement network, we found the product prices of the clinical decision support systems of some hospitals from 2017 to 2018, as shown in the following figure. According to estimates, the average unit price of CDSS in China is about 450,000 yuan.

电子病历新政激活医疗信息化两大百亿市场,医院达标应如何选择

Source: China Government Bidding Network

However, according to industry experts, many products in the market are not real clinical decision support systems, but some literature on the annual payment based on library e-book materials, also known as evidence-based knowledge base, which is not essentially a CDSS. It’s going on. Because in the past few years, the review of the top three hospitals has been required for clinical decision support, but at that time big data applications have not been popularized, so the basic default knowledge base is also a decision support tool. But the core is just a query documentation tool for doctors.

Therefore, according to industry insiders, the real difference in the price of CDSS is relatively large. Normally speaking, about 500,000 yuan to 1 million yuan is the normal state, and high even has about 4 million products (rarely). And sometimes, CDSS is packaged into a large project and not sold separately. Therefore, after the trade-off, the arterial network estimates that the average price of CDSS in the current market is about 750,000 yuan.

Combined with the above information, the arterial network estimates that in 2020, the market space for CDSS in tertiary hospitals is about 1.9 billion yuan.

At first glance, the market space does not seem to be big. However, if you consider the horizontal expansion of the company around the department, such as CDS based value-added services, according to different clinical departments, the introduction of specialist disease CDSS, then in the original market scale, almost multiply by 10 is the potential market Space, that is 19 billion yuan.

This is not impossible, from the emergency CDSS launched by Mijian based on the critical care system and emergency medical treatment norms and guidelines, and the demand for decision support from different medical institutions based on different levels of medical treatment. This trend can be seen in hospitals, emergency department CDSS and grassroots CDSS products in large hospitals. These scenes of CDSS are all products of the horizontal market expansion of enterprises.

In the same way, we analyze the market opportunities and space brought about by interconnection.

The “National Medical and Health Information Hospital Information Interconnection Standardization Maturity Assessment Program (2017 Edition)” is used as the standard, and the infrastructure construction in the assessment content is mentioned:

The standardization of interconnection and intercommunication is mainly aimed at hospital information platforms or information management systems based on electronic medical records. The evaluation indicators standardized in the interconnection include three aspects: technical architecture, interconnection service functions and platform operation performance. Among the functions of the interconnection service, the construction of the integration platform is particularly critical.

Similarly, in the bidding data of the Chinese government procurement network, we reviewed the product prices of some hospital integrated platforms in 2018, as shown in the following figure. We estimate that the average unit price of the integrated platform in China is about 5.4 million yuan.

电子病历新政激活医疗信息化两大百亿市场,医院达标应如何选择

Source: China Government Bidding Network

Therefore, the approximate market space for the construction of the integrated platform for tertiary hospitals in 2020 is well estimated, about 10.9 billion yuan.

The significance and status of electronic medical records and interconnection ratings in hospitals

The National Medical and Hospital Administration has issued a new policy, and the hospital is naturally the first to bear the brunt and become a directly affected party.

In this regard, Lu Huijing, director of the Information Department of the Second Affiliated Hospital of Guangzhou Medical University, believes that the importance of this Notice is self-evident. In the past, many hospitals may still hesitate to go through the review rating. But this time, tertiary hospitals have to consider the electronic medical record rating and interoperability maturity review.

According to Director Lu, the management of general hospitals varies widely, and it is impossible for each hospital to distribute its resources equally to each subject. Therefore, the hospital will consider its most powerful 2-3 disciplines and make key investments. As a result, many of the hospital's processes are based on their own priorities. Because of this difference in process and regulatory mechanisms, the demand for information products such as HIS and LIS varies from hospital to hospital.

There are too many differences between hospitals, so starting with data and sharing documents, it is necessary to promote connectivity and electronic medical record ratings.

Regarding the expansion of the electronic medical records of the tertiary hospitals mentioned in the Notice, the director of the Information Center of Peking University Cancer Hospital gave his opinion. At present, the electronic medical records, medical orders and pharmacies of the tertiary hospitals The degree of care, anesthesia, imaging, testing, and pathology are relatively high; most hospitals started to establish these clinical systems around 2005, so the use is more optimistic; but the outpatient electronic medical records are mostly well-known reasons, most hospitals are especially large Many hospitals are blank.

Regarding the importance of CDSS, Director Heng said that the function of clinical decision support is needed when early medical orders and electronic medical records are on the line, but the technological development at that time was not enough to support more advanced decision support. With the rapid development of big data technology, the function of CDSS has been greatly improved, and it is no longer just a simple reminder. Therefore, the 2018 version of the requirements for the level 5 electronic medical record has been upgraded to the intermediate level.

In addition, CDSS is a system with an embedded architecture that can be embedded with any system. Therefore, the hospital does not need to replace the past electronic medical records. But at present, the most important factor hindering the development of CDSS is the authority and integrity of the knowledge base system.

Similar to Director Heng's point of view, Director Lu also believes that how to ensure the standardization and authority of basic data is a key issue. The medical industry has not yet produced a sufficiently authoritative clinical knowledge base and rule base.

The reason is that CDSS requires a large amount of medical literature and clinical data support, including basic medical knowledge, clinical guidelines, evidence-based medical evidence, real-world data, medical dictionaries, medical maps and other massive data. However, the internal data of the hospital are independent of each other, and information sharing between hospitals is difficult, resulting in these resources not being well integrated. Due to the lack of a real and authoritative clinical knowledge base and rule base, it is difficult for CDSS to obtain clinical real-world medical record data, which also makes the question of the practicality of the company's CDSS products questionable.

In addition, Director Lu also talked about his own concerns about the point in time in the Notice. She believes that there are a large number of tertiary hospitals. By 2020, all hospitals will pass the electronic medical record level 5 and interconnection level four. How to complete the review process in a limited time will be a big challenge.

Taking the electronic medical record rating as an example, the usual process is that the hospital declares its own form, below level 4, and is reviewed by the provincial level, level 4 or above, and is directly reviewed by the state. First, the hospital needs to take a screenshot of the function according to the review item, and note the implementation method and submit the online review. After the online review, the review experts went to the hospital for on-site audit, and passed the on-site audit, and the hospital was awarded the review level. And this whole set of online and offline processes is almost half a year. Due to the limited number of review experts, it will be very difficult to have more than 2,600 tertiary hospitals in 2020.

How should the hospital's CDSS be selected?

As can be seen from the foregoing, the price of CDSS purchased by different hospitals is relatively large, ranging from 200,000 to more than 1 million. In order to understand the reasons for the price difference, the arterial network consulted relevant industry experts.

According to the person in charge of each technology product, the electronic medical record grading evaluation requires the clinical decision support function. The clinical decision support function is not equivalent to the knowledge base. It is an application more artificial intelligence, such as the ability to deal with non-institutions. The multi-dimensional clinical data can automatically predict the list of diseases to be identified based on the patient's clinical data and automatically recommend personalized treatment plans. Advanced decision support not only covers all medical sessions, but also requires an evidence-based, real-time updated medical knowledge base. The authority of the knowledge base, the ability to process unstructured data, and the ability to predict models are the reasons for the difference in CDSS prices.

Take the CDSS developed by Science and Technology as an example. The knowledge base of this product comes from Mayo, and there is an algorithm team composed of machine learning engineers and clinicians. Using deep learning technology, it can unstructure the patient clinical data. And model prediction, can fully meet the electronic medical record information classification evaluation requirements.

This point is basically consistent with what Mr. Heng said.

According to Director Heng, primary clinical decision-making is mainly for reminders of simple conditions, such as rational drug use, contraindications for drugs, and a knowledge base for diagnosis and treatment. Intermediate decision support can handle relatively complex conditions, such as: past history. The diseases, diagnosis, age, gender and other conditions mentioned in the paper provide a taboo reminder for drug use, providing evidence-based medicine-based knowledge systems; advanced decision support, through big data processing, machine learning, guidance-based, evidence-based medical knowledge systems, and Real-world data, early warning of clinical behavior, prognostic analysis, and similar medical record recommendations.

In addition, in the new edition of the "Medical Device Classification Catalogue", the definition support software is also defined and divided. However, it is understood that since the CDSS products that are not mandatory for purchase by the hospital must pass the medical device classification catalogue, even the second-class certificates, the CDSS products obtained in the market are hard to find in the market. However, from the situation of domestic mainstream CDSS companies, each family is able to take the lead in obtaining the second or even third-class certificates in the process of submitting applications, or it will become the key to the company's emergence in the market.

电子病历新政激活医疗信息化两大百亿市场,医院达标应如何选择

Source of information: Announcement of the General Administration on the issuance of a catalogue of medical devices (No. 104, 2017)

In the face of various products with different functions and prices, each hospital can only make appropriate choices based on its actual needs.

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