The global mobile health applications market is expected to reach $4.1 billion by 2014 compared to $1.7 billion in 2010, according to a report published by research company Technavio.
The company's analysts said they expect the market to grow by an impressive compound annual growth rate (CAGR) of 24% percent until 2014.
The report indicates that the key drivers for growth are the increase in general diseases and population of patients. It adds that the main source of revenue in this field will comes from smartphones used by the healthcare professionals.
Technavio estimates that the United States has the largest market share and is expected to grow at a faster rate in the future. The authors said that in the coming years, due to increasing focus on patients in developing nations, mobile Health software providers and telecom companies may penetrate further in countries such as China and India.
The analysts noted that the U.S. Food and Drug Administration (FDA) intends to come up with proper rules for the approval of mobile health applications. This will, in turn, increase the productivity and the accuracy of these apps in the future.
At the same time, the analysts warned that there have not been proper or effective FDA rules and regulations yet. "FDA regulations seem to be more confusing than helpful to many vendors in the mHealth industry," Technavio wrote. "With the advent of numerous new Mobile Health applications being introduced in the market by various players, the FDA is finding it difficult to come up with any specific parameters for the Mobile Health applications".
The US Food and Drug Administration (FDA) outlined new draft guidelines, suggesting how it intends to regulate mobile medical applications.
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| Source: FDA |
The FDA announced that it seeks public input on the proposed approach for certain medicine and health mobile applications. The agency said that currently, mobile medical apps include a variety of functions, ranging from monitoring calorie intake, helping people maintain a healthy weight, and allowing doctors to view a patient’s radiology images on their mobile communications device.
The FDA's draft guidance defines a small subset of mobile medical apps that may impact the performance or functionality of currently regulated medical devices including apps that:
- Are used as an accessory to medical device already regulated by the FDA
- Transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices
"The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery," said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. "Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended."
We at Aerotel welcome FDA regulation of mobile medical apps. We believe that there is a real need to assure the stability, reliability and quality of all mHealth solutions so patients won't face any risk.
The U.S. Food and Drug Administration (FDA) long awaited rule regulating how hardware manufacturers can introduce new mobile medical devices for use by health care providers went into effect earlier this month.
It is yet to be seen what will be the impact of the new regulations on medical equipment developers and software vendors as it is too early to predict how it will influence the market.
The new Medical Device Data Systems (MDDS) rule now classifies most health-related IT devices as Class I or low-risk medical devices. The rule requires IT companies to register health care hardware and software that transfer, store, convert or display health care data.
"This rule is a common-sense regulatory approach that provides clarity and predictability for manufacturers of these data systems," Dr. Jeffrey Shuren, who heads the FDA center for review of medical devices M.D. said in a statement.
"This shows our flexibility in applying regulations for medical device data systems that are not overly burdensome for manufacturers, but continue to assure that data stored, transferred or displayed on these systems remain reliable," said Shuren.
The US Food and Drug Administration (FDA) intends to change regulations for medical device manufacturers in attempt to shorten approval time.
A report by news agency Bloomberg indicated that the FDA released proposed new requirements for the 510(k) program. According to Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, the FDA intends to grant device companies a more predictable process while asking them for additional safety data.
Shuren said device makers will be asked to provide a complete summary of all information about the safety of their products. This will include clinical studies relevant to a product.
The FDA intends to create a Science Council for its medical device unit to “assure quality and consistency” about “some of the tougher science questions,” Shuren said.
The agency also plans to streamline the application process for a category of devices that aren’t similar to earlier products and are deemed to have a low enough safety risk that human studies aren’t needed, Shuren said. The “de novo” process, a subject of frequent complaints by the device industry, has been plagued by “lengthy review timeframes and nontransparent data requirements,” Shuren said.
The agency expects to begin making the changes later this year after a 60-day public comment period, Shuren said.
