With the continuous evolution of the ecology of the mobile medical industry, various businesses with network light consultation and chronic disease management have been greatly developed, especially in the past two years, they have gradually entered the daily life of ordinary people. Although in terms of regulating medical behavior, China has “Regulations on the Administration of Medical Institutions†and “Interim Measures for the Administration of Individual Physicians and Chinese Physiciansâ€, there is no explicit provision for the regulation of policy and regulation in the mobile medical industry , although the Health Planning Commission has Some of the guidelines were published publicly, but without de facto regulation, how will this change in the future? Let's first learn about the differences in international regulatory policies for mobile health.
International regulation of mobile medical apps
In addition to the United States, other regions are also committed to regulating the growing mobile health arena. Some countries, such as China and India, have not regulated mobile health care in any form, but other countries have clearly chosen temporary deregulation: For example, in March 2014, South Korea decided not to mandate the medical devices and mobile health components of Samsung mobile phones. At the same time, the EU is establishing a clear mobile health regulatory framework.
The EU's mobile health certification process is more open and efficient than the US. The EU has more than 70 certification bodies throughout its member countries. Once the medical device is approved by one of the agencies, the device is licensed for sale throughout the European Union. Unlike the United States, the EU does not have the scope of law enforcement discretion. Medical applications are either within or outside the scope of regulation. As a result, the EU regulates certain equipment more closely than the United States, but the scope of regulation is small: a new US equipment may be immediately classified as Category III, while the EU automatically categorizes equipment before providing the opposite evidence. Class I.
Although this regulatory framework theoretically jeopardizes consumer safety, in the past five years, the EU's medical device recalls have remained the same as in the United States, and new medical devices have been approved more quickly. As a result, many mobile healthcare developers first launch products in the European Union to receive funding to respond to more stringent US regulations. Just like MIMvista, Samsung Health, Fitbix Flex and CardioMem, they have been on the European market for many years before they landed in the US.
In fact, the United States should pay attention to the development of international mobile medical supervision. First, you can learn from the European model: When regulators exercise their powers appropriately, openness and selective regulation can inspire more innovation, and consumers do not have to bear any costs. Secondly, in the past few years, the international standardization of supervision has been continuously strengthened, and the future results can be mutually recognized in theory.
In October 2013, at the international forum of Medical Equipment regulatory agencies, it was indicated that medical software regulation will develop towards standardization in the next five years. The EU is moving towards a more standardized testing system. This standardization will help reduce certification costs and reduce regulatory uncertainty. Given the difficulty of distinguishing online users through geolocation, this standard consistency will be popular in the mobile medical arena. The current regulatory changes affect not only the markets of each country, but also the expectations and expectations of mobile healthcare investors around the world.
The future trend of US-China mobile medical supervision
Despite the continuous development of international standardization, the US mobile medical supervision is still unpredictable. Legislators in the US House of Representatives and the Senate have drafted bills that could revolutionize mobile health care. In October 2013, in the House of Representatives, the two parties jointly proposed the Sensible Oversight for Technology which Advances Regulatory Efficiency Act. In the Senate, the Preventing Regulatory Overreach to Enhance Care Technology Act was jointly proposed by Republicans and non-partisan in February 2014. These bills are similarly worded and attempt to achieve a common purpose: to limit the scope of FDA regulation in the mobile medical arena.
At the same time, these bills distinguish between clinical, health and medical software. Clinical software users are professional medical health providers, such as doctors or nurses, who can recommend courses or clinical operations, and health software functions to carry out medical health-assisted management for a wide range of people, including patients. According to the new bill, these two categories are outside the scope of FDA regulation. The FDA's focus will be on the diagnostic software for specific patients. These bills have been submitted to the relevant subcommittee for discussion, and the debate surrounding FDA regulation will continue regardless of whether it is passed or not. But in any case, it is impossible for the FDA to completely withdraw from the regulation of mobile medical care in the future.
Then China’s mobile medical supervision work is already in the pipeline. At present, it seems that the Health Planning Commission will be the main body of supervision and guidance. However, Dr.2 believes that from the perspective of governing the country according to law, it is very likely that it will be in the long run. Referring to the United States, the SFDA partially exercises approval and regulatory powers to review mobile medical apps against medical devices, involving specific diseases, and requiring long-term interventions, and will certainly conduct clinical validation data collection and statistical analysis, but procedures. And the content will be much simpler.
At the same time, the doctor-patient communication platform like Spring Rain, Quick Question Doctor and Good Doctor, like the Zocdoc in the United States, should not belong to the scope of SFDA regulation, because they only do the combination and are not medical institutions themselves. After the large-scale implementation of the free practice of our national physicians, doctors have the right to work under the conditions of medical treatment that they believe to be safe and reliable, and there is no longer a legal problem called “must be diagnosed in medical institutionsâ€, and the risk will be Each doctor is responsible for it, and the state will conduct medical quality control through the data analysis system. It should also introduce insurance companies to support the “compulsory medical liability insuranceâ€.
Mobile medical care also has a branch of medical e-commerce, which will be subject to strict supervision. The first step is to start the regulation. According to the steps of implementing the new policy in our country, it is very likely that we will first pilot the local area and conduct business on a small scale. I think that at the beginning, the country may first list the "white list" for window guidance. When the business develops better, the "blacklist" system will be used to express the prohibited varieties. This will in turn promote the whole The development of mobile medical ecology!
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