Medical Mobile App Clearance Times Decrease

by Holly Shoemaker

The Emergo Group, a medical device consulting firm, has provided updated information that shows the time it takes for apps that undergo the 510(k) process has decreased.

Numbers at a Glance

The study shows that medical mobile apps that undergo the 510(k) process takes about 138 days to receive clearance from the Federal Food and Drug Administration (FDA) in 2011, which was down from 146 days in 2010.

The data analysis took submissions through the end of 2011 to look at a 12-month data set. The analysis showed that 95 to 97 percent of all 510(k) applications received FDA clearance within one year of submission.

What is 510(k)?

The 510(k) status is a pre-market submission made to the FDA to show that a device may be marketed as safe and effective. Introducing a new device or changing the usage are some reasons for needing this clearance. The FDA publishes further guidelines here.

Good News for Developers 

One of the hurdles for developers designing medical mobile apps was the time needed for clearance. Any additional delay meant using more time, money and other resources. What the study found was that many medical mobile apps have a shorter wait time for clearance when compared to other devices.

Another study by MobiHealth News found 76 cleared apps in the FDA’s 510(k) database, and the average clearance time was less than the time reported by Emergo Group. This study found the clearance time was 25 days shorter between 1997 and 2012, with an average time of 110 days.

Outstanding Issue

Developers continue to debate what the time for clearance actually means. The FDA’s data defines the dates as when the agency receives the 510(k) application and the official “decision date.” Some developers and companies say the wait for clearance is longer because discussions occur before the actual filing of the application.

While medical mobile apps requiring FDA clearance takes more planning, developers have many tools to assist them. I still recommend using Happtique guidelines to assist, as that app store dedicates itself to just health apps.

Concluding Thoughts

No matter which study patients believe has more validity, both show progress when it comes to medical mobile apps clearance. That is untimely good news for patients too because they gain access to better quality information. Once approved, the device is deemed safe and effective, which helps marketing efforts and branding.

NECIR Study: Many Medical Mobile Apps Still Offer False Promises

by Holly Shoemaker

The New England Center for Investigative Reporting (NECIR) has found that the Google Play Store and the iTunes Store continues to offer medical apps that do not follow proposed guidelines.

Background Information

The ongoing debate of how to regulate medical mobile apps and the role the Food and Drug Administration (FDA) should play came to the forefront last year when the Federal Trade Commission (FTC) became involved in helping to pull an app that claimed to cure acne.

Research2Guidance, a global market research firm, reports that apps range anywhere from free, $.69 to $999. The company expects about 247 million smartphone users to download health apps this year.

Ongoing Issues

NECIR examined 1,500 health apps available for purchase since June 2011. It found that more than one out of five apps claimed to treat and/or cure a medical issue.

The agency looked at 331 therapeutic apps and found that 43 percent of them relied on the sound a cellphone makes for treatment. Twelve more apps used the device’s light as a treatment and two others said the phone vibrations provided the treatment.

Light treatment is used to treat a variety of conditions, but typically under the guidance of a dermatologist or other medical professional. It is impossible to achieve professional results by using a phone as it lacks the needed light frequency.

Concluding Thoughts

While the debate continues regarding regulation, the credibility of certain apps will remain in question. Agencies continue to monitor and call out those who make false claims. Users may protect themselves by keeping in mind that apps cannot diagnose or treat a medical condition. For consumers, apps that monitor conditions or help keep track of things like weight, rate the highest. Apps that support doctors and hospitals also rank high. 

Developers who need assistance to ensure they follow the proper guidelines, should visit the ones posted by Happtique, as that store only houses medical apps.

Johns Hopkins Likely to Set Benchmarks for Medical Mobile Apps

by Holly Shoemaker

Johns Hopkins University has announced that as part of its Global mHealth Initiative it has started researching and analyzing current medical mobile apps. This is an impressive undertaking as Research2Guidance, a market research firm, estimated that there are over 40,000 mobile health apps on the market.

Research Overview

Johns Hopkins will conduct 49 studies. Its goals are to evaluate current health app offerings, and examine what strategies work best to assist doctors, medical professionals and consumers. The Global mHealth Initiative will compare how well the apps work against traditional methods such as clinic visits.

Alan Labrique, director of the Johns Hopkins Global Health Initiative, acknowledged that case studies only go so far. He said people need to have the willingness to use technology and follow advice for an app to work. In the end, patients will need to embrace technology so they better understand how to monitor and change behaviors that affect health.

Concluding Thoughts

While many apps come with disclaimers, doctors and patients will feel more secure by using apps recommended from a reputable university like Johns Hopkins. Its research will add to the legitimacy of medical mobile apps and likely help standardize best practices for developers.

FTC Regulates Medical Mobile Apps Too

by Holly Shoemaker

The Food and Drug Administration (FDA) has received attention for its guidelines regarding how to regulate medical mobile apps used as devices. There is another agency that has a stake in regulation too. The Federal Trade Commission (FTC) often works with the FDA to regulate mobile medical apps.

FTC or FDA Issue?

The FTC watches for unfair or deceptive practices. Basically, the agency looks at apps that promote false or misleading claims. If an app makes false promises to consumers, the FTC may become involved. The FTC only takes action if there is “no direct harm.” In this case, the FDA may ask the FTC to become involved or the FDA investigates the matter. The FDA also says it works with the FTC on issues where some overlap may occur.

Concluding Thoughts

It is logical that both agencies would oversee different areas or work together. Because the FDA received so much attention regarding regulation of health apps used as devices, it becomes easy to overlook the involvement of another agency. For developers, it means thinking in the end how any potentially false claims will impact consumers as another agency is watching too.