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One of a series of studies on artificial intelligence and medical health industry: overview of application scenarios and regulatory policies of artificial intelligence in the field of medical health

Time:2022-07-21Source:Jingquan law firmViews:665

In recent years, with the breakthrough of the underlying algorithm of artificial intelligence, the improvement of computing power, the improvement of data quality and the accumulation of quantity, artificial intelligence (AI) has shown a trend of rapid development, and its integration with real industries and fields such as finance, retail, communication media and medical treatment has been strengthened and deepened. According to the prediction and analysis, the total value of the global AI application market is expected to reach US $127 billion in 2025, of which the medical industry will account for one fifth of the AI application market size. 1. In May 2022, the national development and Reform Commission issued the "14th five year plan" for bioeconomy development, which clearly mentioned to encourage the development of AI to assist in new drug research and development and support disease diagnosis and treatment. Artificial intelligence in the field of medical and health (hereinafter referred to as "medical AI") will play an important role in effectively reducing the cost of medical research and development and improving the efficiency and quality of medical services by assisting and supporting all links of medical and health.

New technologies bring new opportunities, but also impact and challenge the traditional regulatory model. We will launch a series of articles on the theme of AI and the medical and health industry, discussing the main application fields of AI in the medical and health field, the current regulatory practice, the challenges faced, and the Countermeasures of enterprises and regulators to these challenges. This article is the first in a series of studies on artificial intelligence and medical health industry. It will sort out and introduce the main application scenarios, development status, industry and regulatory policies of medical AI. In the follow-up, we will also combine JUNHE's accumulated business experience in the field of AI and medical health to launch a series of special articles on the subdivisions of AI drug research and development, AI medical software, AI and medical robots, intelligent diagnosis and treatment, as well as the legal issues such as data compliance, ethical compliance and intellectual property that are often involved in medical AI, with a view to discussing and communicating with readers.

1、 Main application scenarios and development status of medical AI

Since 2016, relevant national departments have issued a series of relevant policies, such as the three-year action implementation plan for "Internet +" artificial intelligence, the guiding opinions on promoting and standardizing the application and development of medical big data, and the outline of the "healthy China 2030" plan, to encourage and guide the integration of AI and all links of the medical and health industry, that is, with AI technology represented by computer vision, speech recognition, language processing and machine learning, Realize cost reduction and efficiency increase in drug research and development, diagnosis and treatment, health management and other scenarios, and empower all links before, during and after the hospital, so as to meet the needs of patients. After years of development, some application scenarios of medical AI have been commercialized, and some medical AI enterprises have also run through relevant business models, grown into Unicorn enterprises, and even completed IPO. At the same time, there are still a large number of medical AI application scenarios that are still in the exploration stage, and countless start-ups are working hard on various technologies and business models, looking forward to breakthroughs and innovations, pupating into butterflies.

Based on our observation of the medical AI industry and market, we classify the main application fields of AI in the medical and health field at this stage into the following five categories: ai+ new drug research and development, ai+ medical imaging, ai+ medical robots, ai+ health management, and ai+ Internet medicine.

1. Ai+ new drug development

The traditional research and development of new drugs has long research and development cycle and high cost, while AI technology helps to shorten the time of new drug research and development and save trial and error costs. According to research statistics, it takes 5-6 years for traditional new drug discovery to screen suitable lead compounds as candidates for clinical research, while with the help of AI technology, the process can be shortened to 1-2 years or even completed in a few months. 3.

AI can play its role in all stages of new drug research and development, including drug discovery, preclinical research, clinical trials and approval for marketing. Specifically: (1) in the drug discovery stage, AI can improve quality and efficiency in target discovery, compound screening, compound synthesis and other links by learning from massive medical data and materials; (2) In the preclinical research stage, AI can use its deep learning and computing ability to optimize the process of compound screening and drug crystal form and dosage form prediction; (3) In the clinical trial stage, AI can accurately recruit patients and optimize the design of clinical trial schemes through the analysis of patients and trial data; (4) In the commercialization stage, AI can use real-world data to further analyze the safety, effectiveness and quality controllability of products and monitor adverse reactions.

The leading enterprises with "ai+ new drug research and development" as their main business include Jingtai technology, insilico, yingsi intelligence, Iceland spar biology, etc. According to public information, many AI pharmaceutical enterprises have obtained financing of nearly hundreds of millions of dollars. 4. In addition, some large pharmaceutical enterprises and Internet leading enterprises are also actively deploying the business department of "ai+ new drug research and development".

2. Ai+ medical imaging

Medical imaging is the most mature application scenario of AI in the field of medical and health. The so-called medical image refers to the technology and processing process of obtaining internal tissue images of the human body or a part of the human body in a non-invasive way for medical treatment or medical research. AI can further optimize the medical imaging system and medical image processing based on medical images, and provide assistance for doctors to form a more accurate radiological assessment. Specifically, the application scenarios of AI in medical imaging mainly include: (1) focus recognition and labeling, that is, classifying and analyzing x-ray, CT, MRI and other images, finding detailed information that cannot be recognized by the naked eye, and assisting imaging doctors in diagnosis; (2) Target area delineation, that is, accurately delineating the diseased organs of patients to improve the quality and efficiency of radiotherapy; And (3) image reconstruction of imaging equipment, that is, presenting high-quality images of high-dose CT through algorithm mapping technology.

According to public information 5, as of June 2022, nearly 30 medical imaging AI products in China have obtained the registration certificate of class III medical devices issued by the food and drug administration. In addition, at present, many enterprises engaged in "ai+ medical imaging" have successfully listed or submitted prospectuses, including but not limited to Yingtong technology-b (02251.hk), Shukun technology, Fanxiang medical, Lianying medical, etc.


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