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once the medical app application needs to face a similar review of drug and medical devices, the cost and product iterations of the developer will increase. And that's a huge cost to some small medical app development teams.
, the industry's concerns have become reality. As Mr Obama formally signed the new Food and Drug Administration (FD) Security and Innovation Act in early July, the United States formally established FDA regulation of medical apps from the legal level.
reporters noted that the U.S. new deal has been quickly transmitted to the other side of the ocean in China. For Chinese developers, without a good understanding of US regulatory mechanisms, it may be difficult to sell apps to the US market in the future. Moreover, given that FD A's decision has always been the barometer of China's Food and Drug Administration (SFDA), will China "follow suit"?
Medical app developer has tens of thousands of
smartphone a PP application has become increasingly popular, has been changing people's previous treatment habits. As long as a sick, people first thought is to find a doctor to prescribe medicine, and nowadays, just pick up the phone, open some medical care to ask a PP, some common diseases and medication regimens, drug efficacy and adverse reactions, have been easy to download.
according to the Biological Valley Chairman Baosheng to reporters data, in China, is developing medical a PP company has 500~600 home to 20 people per company calculation, practitioners up to tens of thousands of people.
However, this fast-growing industry is ushering in a new test. Such a PP developed by Chinese companies, if they want to enter the U.S. market, is theoretically subject to the regulation of FD A in the US.
the new FD a Security and Innovation Act was signed by Obama in early July, and from the legal level, the United States has formally established the regulation of FD A on the medical type a pp.
in accordance with the draft regulation drafted by the country last year, a PP that has been used for diagnosis, treatment, and disease prevention in verbal or textual descriptions of labels, claims, advertisements, etc. will be covered.
In the opinion of one industry, the regulation of medical a PP will come sooner or later. At present, some smartphones in the support of Medical a PP, has been able to measure blood sugar and blood pressure, and on this basis through the network to achieve telemedicine, which has the risk of misdiagnosis. In his view, "mobile terminals do whatever they want to do, and they are bound to lose control." Strengthening regulation is therefore a trend. ”
because of the regulatory trend of FD A has been a SFDA vane, bio-valley, good doctors and many of the domestic companies involved in the medical app has given high attention to this matter. Because, in the long run, China has the possibility to follow up. The impact on the industry is obvious, according to the US counterpart, that a medical a PP is to be marketed under the control of FD A, "It takes about 72 months and an additional 75 million dollars to spend that roughly 77% of the total development cost".
China to follow "is premature"?
"You may not have the details of the profit model, but compared to the electricity industry and other industries, you burn less money." This is one of the factors that VCs are willing to invest in medical a pp. "A former agency that has provided financial services to a number of health care a PP companies in the country said in an interview with reporters in South China. It is clear that, in the light of the previous experience of the United States, the burning of money will become inevitable once it is brought under regulation.
Some companies in the industry are more willing to look for differences in the level of medical a PP's openness before China and the United States to prove that the current Chinese medical a PP industry does not need to be regulated.
"U.S. A PP walk in China, regulatory intervention is necessary." It's early on in China to talk about it. At present, the domestic medical a PP industry is still in its infancy, a lot of health is actually a pp. The real medical app for patients is currently very few in the country, as few of us are doing. For medical treatment A PP, doctors usually have their own professional judgment. "Good Doctor Online CEO Wang that.
The Baosheng of
's Biology Valley also holds a similar view, in his view, the domestic medical app is still "floating in the sky." App is linked to the cloud and terminal industry, but now the domestic medical a PP has no cloud and terminal, just to the information push mainly, or the simplest business model.
"It is necessary to strengthen regulation, but at this stage in China there is no need for regulation or for the value of regulation." It is necessary for the industry to develop to the level of the United States in the future. In Europe and the United States, they developed a lot of medical a PP has been used to protect the human body, is related to disease. For example, a can turn mobile phone into a medical thermometer of a PP, if the user's actual body temperature is 39 ℃, and show only 37 ℃, that will cause great risk. "Zhang Baofa said.
to the industry's attitude, the aforementioned institutions bare the industry's concerns, he admitted: "If the tube early, the industry will not develop." Do you see any emerging industry in China developed by regulation? ”
Wind cast Hot
in the institutional eye, China's medical app this market has the potential, as long as the global scale of the industry and the pace of development, you can see the future of this industry.
according to statistics from the Healthit now website, sales of medical apps in the App Store rose 250% from 2010 to 2011.
, a Manhattan capital chief who has focused on healthcare investments, has cited some international data research company reports that by 2015, medical a PP and its derivative market will reach more than 50 billion U.S. dollars, the industry will explode in the next few years.
in fact, because bullish on the development potential of this industry, in recent years, the investment in this field has already been surging.
The good doctor online, for example, the company had already entered the venture as early as 2007. And Clove Garden, Rui Medical companies have also got the money of venture capital.
according to the aforementioned institutional personage, clove garden and good doctor is optimistic, because these two companies and in the subdivision area of the second place has been 5 to 10 times times the distance. The two companies are so bull because patients and doctors have been using their products and their databases have been updated. This is an advantage that no one else can replicate.
policy is unknown "time bomb"
according to a domestic industry analyst who studies medical apps, medical a PP, an industry that is infinitely bullish, is in China where a single company does not have a company with a revenue exceeding 500 million, or a maximum of 200 million yuan.
in his view, China Medical a PP industry can develop to how far, mainly depends on how much the country can open.
"Compared to the United States, domestic medical a PP or there will be a certain gap." First, the terminal is already 10 months later than the United States, in addition, policy on medical a PP-related mobile medical policy is very tight. "In the opinion of the analyst, the reason why a good doctor can take a firm footing is that a good doctor is a platform that has been approved by the relevant departments." This kind of platform resources are scarce, because once free online registration platform application, there will be "inverted number" of the risk, then "online cattle" will be flying.
according to the industry, the domestic venture investment in the medical app, its target customers must be a habit of paying high-end users. Because of the imbalance of medical resources, the demand for high-end medical care for high-end people is always there. But it is not clear what the policy bias is for the industry. This kind of uncertain policy, in fact, for the industry, is tantamount to a time bomb.
at present, and medical a PP-related private Doctors policy is not clear, doctors more practice is also thunder, rain. However, according to foreign experience, strengthen supervision, medical a PP quality will be more and more high, from the long-term development point of view, is certainly positive.
"We look forward to standardize and innovate the industry development environment." "A practitioner who declined to be named expects the National Drug Administration to consider incorporating medical a PP into regulation after 2 years."
Domestic Medical app classification
According to industry insiders, the current domestic medical app can be divided into the following categories:
1. A medical app that has been developed by the traditional Internet or database company.
2. Mainly with a number of enterprise-class applications combined products, such as Case Management System a PP, with this a PP, doctors can use the ipad to rounds, the development of such a PP company directly to the hospital charges.
3. There are also a number of medical a PP to obtain traffic, and then in a PP implanted advertising products, of course, due to the low user and supervision of the reasons, such products are relatively small.
The above categories of companies, the general can be the wind to cast their sights, are the industry or subdivision of the field of the leaders.
(Responsible editor: Lu Guang)
