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.

Looking for Funding? Venture Capital Firms Tap into Medical Mobile App Market

by Holly Shoemaker

As the mobile medical app market continues to grow, developers need to find new ways to generate revenue streams. Recent reports indicate that developers may find venture capital firms willing to invest.

The National Venture Capital Association reported that from 2010 to 2011, investments in health IT companies increased by 78 percent. Mercom Capital Group estimated in Q1 2012, firms put in $184 million for 27 deals. This was the highest number reported since Mercom began collecting data in 2010.

Potential Roadblocks

For those developing apps to use as medical devices, the increasing regulation from the Food and Drug Administration (FDA) poses the greatest risk when it comes to receiving funding. While venture capitalists are embracing the healthcare market, they do not want the long development cycle to delay receipt of profits. To overcome the potential roadblock, developers should ensure they work with the latest guidelines from the FDA. Happtique, an app store dedicated to healthcare apps, provides easy-to-follow guidelines to ensure developers follow all stakeholder concerns.

Concluding Thoughts

 

While medical apps account for approximately one to two percent of the app market, the segment continues to grow faster than other areas. As more consumers look to medical mobile apps, and medical professionals continue to find ways to tap into the growing market, seeking out venture capital firms may assist developers in finding needed revenue.

Protecting Patient Privacy Remains at the Forefront of Medical Mobile Apps

by Holly Shoemaker

Patient privacy continues to remain a top priority and focus of concern regarding medical mobile applications. As the Federal Drug Administration (FDA), other government agencies and a medical app store drafted guidelines pertaining to aspects of eHealth applications, the Future of Privacy Forum (FPF) has provided its own input regarding how to best protect data collection and has also released best practices for app developers.

Overview of Best Practices

The FPF stresses that developers should embed privacy measures throughout the development lifecycle. The guidelines also stress the importance of using clear and simple language to ensure all users understand how data is collected and shared. Along with that, the FPF discusses the importance of securing data and having someone accountable for ensuring privacy measures are followed.

Concluding Thoughts

As mentioned before, guidelines will help developers streamline the development lifecycle and provide consumers with information on how to best protect their information. The challenge comes in when integrating all the feedback gathered from all sources to ensure all parties get what they need from regulatory measures - no developer wants to prolong an already long lifecycle for medical applications.

Medical App Store Drafts Guidelines for Developers

by Holly Shoemaker

In the past, I blogged about where developers store an app was just as important as the app itself. In particular, I discussed how Happtique, an app store dedicated to healthcare professionals, seemed like an ideal place to find apps for medical purposes. Now, in a move that follows the Food and Drug Administration (FDA), Happtique has announced its own guidelines regarding medical mobile app regulation. 

Overview of Guidelines

In addition to meeting security guidelines, apps will have to:

• Effectively run on mobile devices and connect to peripherals like WiFi.
• Follow certain speeds, although at this time, the guidelines do not specify particular ones.
• Identify who receives patient information before a consumer downloads them.
• Contain information written for laypersons. 
• Come from current and recognizable sources.

Concluding Thoughts

Happtique is dedicated to medical apps. By putting guidelines in place, the company shows that it wants to further differentiate itself as the marketplace leader for medical applications. Because of its narrow focus, it has the time to put together detailed guidelines, something the Apple App Store and the Google Play Store cannot do.

With all guidelines, they could hinder or help developers depending on how stringent everyone reviews the requirements. For some developers, it could mean a longer development cycle. At the same time, Happtique makes all the factors known upfront. Therefore, developers could use the information as a checklist when developing medical apps. The drafted guidleines also assign accountablity and make credibility focuses. These are factors that are needed considerations as the numbers of medical mobile apps continue to increase.

Happtique is currently accepting feedback from doctors, nurses, other medical professionals and consumers through Friday, August 17, 2012.

FDA to Move Forward with Medical Mobile Apps Regulation

by Holly Shoemaker

After weeks of debating the scope of how and what the Food and Drug Administration (FDA) should regulate when it comes to medical mobile apps, Congress has finally reached a decision – well somewhat of one. The FDA may move forward with defining regulations regarding medical mobile apps used as devices, but other agencies are now required to provide their input.

Overview of Action Taken and Next Steps

The FDA published its drafted guidelines in July 2011. Now, Congress modified a section of the FDA Safety and Innovation Act that will allow the FDA to progress on its planned regulation. However, Congress has asked for additional input. The Department of Health and Human Services (HHS) must draft a report using input from the FDA, the Federal Communications Commission (FCC) and the Office of the National Coordinator for Health IT (ONC), which is part of HHS.

The FDA has until the end of year to publish its findings. By the fall of 2013, the FDA must finalize regulations and implement a program within two years of the published date. The FDA and other agencies have 18 months to recommend a regulatory framework for mobile apps and IT-related software.

Concluding Thoughts

The action taken by the House and Senate allows stakeholders, including developers, to know where the issue stands. However, it still draws the process out and comes almost a year after the FDA published its drafted guidelines. The enhanced gathering process could go either way. It will either result in clarity for developers, users and agencies or even more questions and confusion.

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.