The introduction
At present, many countries attach great importance to medical informationization. With the integration of medical informatization and communication technology, more and more mobile communication technologies and services are applied to medical activities, thus mobile Medical Application (MMA) emerges as The Times require. As a combination of mobile software and medical technology, MMA is a medical application software based on mobile terminals. It can provide services such as seeking medical consultation, booking registration, purchasing medical products and inquiring professional information. Currently, MMA can be divided into five categories according to the demand: e-commerce application of pharmaceutical products; Applications that meet the needs of professionals for professional information and medical reference; Applications that meet the needs of medical consultation; Booking registration and medical guidance, consultation and comment service platform; Subdivide functional products and so on.
Shenzhen Longde Biotechnology Co., LTD. Research found that, with the continuous development of MMA, on the one hand, they provide convenience for people's medical health, on the other hand, also brought hidden worries to people, these MMA in some times as a medical device, they will not bring risks? Does it need to be supervised by the drug administration? Should it be regulated? This paper will discuss the above problems one by one.
1. The background
1.1. International MMA background
In recent years, with the popularization of 3G service and the integration of medical treatment and information communication technology, the development of mobile medical treatment has provided an opportunity. Mobile medicine has been widely used in developed countries, including disease surveillance, monitoring, diagnosis and treatment and health management. In Europe, the United States, Japan, Taiwan and other countries and regions, mobile medical applications have entered the stage of refined service.
In addition, the world health organization and the international telecommunication union and launched the "mobile health plan", aimed at using SMS and mobile phone application technology, encourage governments and relevant institutions, against smoking, alcohol abuse, unhealthy diets and lack of exercise cause noncommunicable diseases such as way of life, the use of mobile phone technology promote the lifestyle can damage, to help countries to fight non-communicable diseases.
In the UK, there is clearly a broad market for mHEALTHCARE strategies. The number of mobile users using mobile devices to visit websites has risen from 3,000 a month in the past year to 155,000 in 2011, according to NHS statistics. Mobile devices have rapidly become a consumer necessity, with clear benefits for both doctors and patients.
According to the prediction of The New York Times, the number of users of mobile medical services will reach 500 million in 2015, and more than 20% of doctors in the United States own aN Ipad and use it in their daily diagnosis and treatment of patients. The GSMA predicts that the growth of the global mobile healthcare market will generate $23 billion in revenue by 2017. At present, 62% of physicians in the world use tablets, 50% of doctors use tablets for clinical diagnosis, 71% of nurses use smart phones at work, and mobile terminals have reached a certain popularity among medical workers.
In Japan, the construction of mobile medical system has been issued on a scale. The first is to digitize home health equipment. With the help of NFC (near Field communication technology) and smart phones, medical devices + smart data management App can help doctors obtain patients' information. Such as changes in weight and blood pressure in the last 3 months. Second, the cloud computing model is used to build personal healthcare databases. Individuals can view medical information stored in the cloud anytime and anywhere through the network. Hospitals no longer keep the medical data of patients, but they can view the medical information saved in the cloud with the consent of patients and add new contents. Individuals can also view their medical health data at any time through mobile devices.
1.2. MMA background in China
In China, with the continuous improvement of hospital information construction, the functions of fixed information points such as doctor station and nurse station can no longer meet the growing demand, and the demand for mobile medical service is more and more prominent. In addition, with the gradual improvement of the technology of mobile phone intelligent system, the demand for expanding medical services to mobile phones naturally arises at the right moment.
Most of the existing mobile medical models in China are progressive improvement models that implant mobile functions into existing products and enhance their attractiveness. At present, China's mobile medical model is to implant mobile functions into hospital information system (HIS). MMA mainly includes the following aspects:
1.2.1. Electronic medical records and wireless ward rounds
Through wireless technology and portable mobile devices such as tablets, doctors can get rid of paper cases, access electronic medical records anytime and anywhere, quickly and accurately obtain relevant diagnosis and disposal information and issue new medical orders. For example, in 2011 the PLA 309 Hospital began using smart tablet devices for mobile ward rounds and nursing among its doctors and nurses. Some hospitals in Wuxi city, Jiangsu Province use mobile phones with PDA function to interact with HIS, so as to record information, write medical records and issue doctors' orders in real time.
1.2.2. Mobile nursing workstation application
Connected to the hospital's entire information system via tablet computers and 3G networks, nurses can tap into a patient's medical history, temperature, medication intake and other information. Nurses scan the barcode between the patient's wrist band and the medicine bag or infusion bag through the mobile terminal, automatically check and sign with the doctor's order, and the system reminds the mismatched information to ensure the correctness of administration, which can not only improve the work efficiency of nurses but also prevent errors.
1.2.3. Mobile remote diagnosis and treatment
Using telemedicine technology, doctors can go beyond geographic boundaries to conduct remote consultations for patients with high-definition cameras, and share medical records and diagnostic photos. The China-japan Friendship Hospital fully borrows advanced telemedicine technology from Japan and other countries, realizing the rapid, accurate, efficient and economical extension of high-quality medical resources and medical technical assistance. Some hospitals in Wuxi use mobile phones with PDA function, which can realize remote mobile consultation by sharing medical examination pictures.
1.2.4. Application of community health management
With the increasing maturity of 3G(the third generation of mobile communication) technology, it will become a reality to provide high rate of mobile digital transmission bandwidth. Meanwhile, more and more users have mobile communication terminals, and wireless communication will become the mainstream channel of information communication among people. China Mobile in Dongguan, Guangzhou, has established a smart medical management system. This system provides residents with mobile phone appointment, health information services, video visits to ICU wards or neonatal rooms, remote monitoring of the elderly with mobility difficulties, tracking patients' health records through the mobile community health information management platform built, and sending the medical examination results to mobile phones or email addresses according to user needs.
1.2.5. Other
RFID (Radio Frequency Identification) system is used to realize the positioning, tracking and real-time management of the equipment, so as to simplify the workflow and improve the overall work efficiency. Such as drug management, distribution infusion, specimen collection and treatment. An RFID tag ring worn by an infant can identify the infant and prevent theft. At the same time, there are an endless number of medical apps in the market, which can provide doctors' recommendation, appointment booking and other services.
As mentioned above, As the most populous country in the world, With the rapid development of Mobile Internet technology in China, MMA has also witnessed rapid development. According to statistics from IMedia Consulting, there are now more than 2,000 mobile medical apps in China. Meanwhile, China's mobile medical market reached 1.86 billion yuan in 2012, up 17.7% over the previous year. It is predicted that the scale of China's mobile medical market will reach 12.53 billion yuan in 2017. The explosive growth of mobile medical apps is closely related to the development of mobile Internet technology and China's medical environment.
2. Risk and regulatory thinking of MMA
Mobile medical treatment has been the trend of the world, the domestic has also set off a boom. However, as well as bringing convenience, various mobile medical applications also bring risks. The biggest reason is that the medical industry is a cautious and special industry with strong professionalism, high risks and many disputes. Some experts pointed out that, if it involves the specific consultation for medical advice, because of the hidden dangers of the network, there may be a wrong diagnosis delay treatment, the consequences are unimaginable. If a doctor misdiagnoses a patient, it not only harms the patient, but also may lead to medical disputes and even lawsuits and claims.
In order to strengthen the management of medical mobile applications, some countries have introduced some regulations to regulate them. Investigation by Shenzhen Longde Biotechnology Co., Ltd. found that the United Kingdom and the United States have developed regulatory strategies for MMA.
In March 2013, for example, the British national health launched its own recommended library, it is a specifically for patients and medical professionals to establish a website, website recommendation about 90 mobile phone applications, both by the British national health security review, the basic information of the related web pages and applications and user reviews. In addition, app developers can upload their apps and, once approved, appear on the site. In addition, the NHS clinical Safety team is working closely with application developers to ensure that their applications meet the agency's safety standards for review and publication on the site. The clinical safety team is composed of a number of doctors, nurses and medical safety experts with considerable authority.
In the early 1990s, the U.S. Department of Health introduced the Health Insurance Portability and Accountability Act (HIPAA). Since 1989, FDA began to regulate medical software as a medical device [14]. In 2011, THE US FDA summarized two types of apps with potential risks in the draft guidance on mobile healthcare Apps: one is to turn mobile platforms into medical devices. For example, apps that turn mobile devices into stethoscopes through sensors, or apps that measure blood sugar and electrocardiograms and present the results on smartphones; The other is to control the use, function, mode and energy of existing medical devices. For example, the insulin pump controls the delivery of insulin. These two types of apps may generate new risks because they connect or control the already standardized medical devices, so they need to be supervised. In 2013, the guidance document named "Mobile Medical Apps" was finally finalized. According to the guidance, the FDA said it would regulate mobile Apps based on risk. The attachment's developers, licensees, modifiers and hardware manufacturers will be regulated as manufacturers. The U.S. Food and Drug Administration (FDA) has been regulating MMA in recent years.
There has been a mixed reception to the regulation of medical devices, with some arguing that strict regulation of mobile healthcare applications could stifle innovation in the sector, while others point to fake or flawed applications that are in desperate need of regulation. However, according to the use of MMA, the risk level of classification management, and corresponding to the idea of strict supervision is worthy of our reference.
3. Possible schemes for MMA supervision
How to regulate mobile health apps? FDA2013's Draft Mobile Healthcare Application Guidelines give us clear examples and guidelines.
3.1. Specific model of MMA regulated by FDA
FDA stipulates that mobile medical applications must meet the relevant requirements and the applicable device classification. Mobile health applications, like other devices, may be classified as either category 1 (general controls), level 2 (special controls in addition to generic controls), or category 3 (pre-market approvals). If the mobile medical application belongs to a medical device classification by itself, it must meet the requirements related to the classification.
According to the characteristics and safety of mobile medical applications, FDA regulates them according to different requirements. There are mainly the following three types of patterns:
1.
Part of the FDA's focus on mobile medical devices
As an extension of one or more medical devices, mobile applications are connected to medical devices for the purpose of controlling or displaying, storing, analyzing and transmitting patient-specific medical device data; Mobile applications that convert mobile platforms into regulated medical devices by using attachments, displays, and sensor attachments; Become a supervised medical device (software) by performing patient-specific analyses and providing patient-specific diagnostic or therapeutic recommendations; And so on. These types of mobile health applications are the focus of FDA regulation because of their safety concerns
2.
For most mobile health applications, the FDA exercises discretion (meaning it is not required by the FD&C Act). Provide or assist with additional clinical care, by coach or prompt, to help patients manage their own health in their daily environment; Providing patients with simple tools to organize and track their health information; Provide easy access to information about the patient's health or treatment (in addition to providing an electronic "replication" of the medical reference); Specifically marketed to help patients document, display, or communicate potential medical conditions; Perform simple calculations that are often used in clinical practice; Provide individual interaction with Personal Health Record (PHR) or Electronic Health Record (EHR) Systems; And so on.
3.
There are also some mobile medical applications that FDA does not regulate as medical devices: for example, providing electronic "copies" of medical textbooks or other reference materials (such as e-books or audio books) and generic text search functions; For use by health-care providers as an educational tool, as medical training or prior training; Commonly used reference information for general patient education and facilitating patient access; (b) Office automation in a health care environment, not for the diagnosis of disease or other diseases, or for the treatment, remission, treatment or prevention of disease; Generic help or generic product. And so on.
3.2. Implications of MMA regulation in China
In 2010, health it companies grew by 78%, and smartphone apps accounted for 41%. There is no relevant regulatory system in China. In this context, relevant authorities in China should take precautions in the supervision of mobile medical apps to prevent possible market chaos and health care risks in the future.
As the largest market for medical devices and mobile applications, the consumer group of mobile medical applications in China has the potential to grow continuously, and puts forward higher and more detailed requirements for corresponding management. Shenzhen Longde Biotechnology Co., Ltd. believes that in today's booming MMA application community, Chinese regulatory authorities can also develop MMA regulatory methods that are in line with China's medical market and national conditions according to different situations and on demand management. For example, according to the regulatory model of FDA, MMA is divided into three major modules of key regulation, discretionary regulation, and not as medical device regulation. Different rules and guidelines are formulated in each module to provide guidance and specifications for manufacturers and drug regulatory departments.
4. Conclusion
Based on its own characteristics, MMA can better meet the needs of diagnosis and treatment. Better meeting care needs; Better meeting management needs. With the deepening of medical system reform, how to make better use of MMA, so as to realize the mobility of hospital internal information and develop into hospital and hospital