FDA to Regulate Healthcare Apps?

By Juli | July 22, 2011 | 2 comments

Share |

In the near future, the Food and Drug Administration could be in charge of monitoring your iOS devices, at least where healthcare is concerned. The FDA recently released a proposal that would allow it to regulate all smartphone and tablet applications relating to health and medical needs.

There are approximately 200 million medical apps in use, with the FDA predicting that 600 million will be available in the next few years. By 2015, the FDA expects that 500 million smartphone users across the world will be using some kind of healthcare app.

The FDA’s new rules won’t cover every healthcare app – just a small percentage, including apps that operate medical hardware, perform dosage calculations for doctors, and transform into medical devices with attachments, such as those used as electronic stethoscopes, glucose meters, and even accelerometers used for capturing sleep data.

Some apps, such as those that connect to home monitoring devices, are already regulated by the FDA. Several other medical apps have already been inspected by the FDA, including apps that are used as mobile monitoring software.

The FDA’s proposed guidelines will not extend to apps that are for general wellness or fitness. Online medical reference programs, electronic health records, and personal health record tools will also be excluded, along with those that deal with billing and administration.

The FDA wants to be sure that certain apps are safe to use in a medical capacity, which is a reasonable request. “There are advantages to using medical apps, but consumers and health care professionals should have a balanced awareness of the benefits and risks,” said FDA Policy Advisor Bakul Patel. Likely, the FDA’s proposed rules will not cause too many problems for medical app developers, because FDA approval will boost consumer confidence in the app, thereby increasing sales.

At this point, the FDA is seeking input on the proposal, from anyone who has an opinion. “We want to hear from as many consumers, advocacy groups, health care professionals, software creators and distributors as possible to help us finalize the proposed guidelines,” said Patel.

To provide feedback on the FDA’s proposal, submit comments online at http://www.regulations.gov. For more information, check out the FDA’s website and proposal here.

email

print

About Juli: Contact me via Twitter: @julipuli

Chris from Seattle

The article states:

The FDA wants to be sure that certain apps are safe to use in a medical capacity, which is a reasonable request.

Why is this an obviously “reasonable request?” I am sure we can all agree that medical apps should be safe. But what guarantee is there that the FDA will ensure that? If one looks at the expense and time to market for drugs under the FDA process, it is easy to conceive how that process has dramatically affected needy would-be customers. Delay and high cost are obvious barriers that can affect the lives (and deaths) of thousands.

Apps are an even more interesting case as they are dependent upon ubiquitous and inexpensive technology (smart phones and tablets) and rapid development cycles with short times to market. An FDA regime comparable to that of drugs will almost certainly result in technological obsolescence between submittal and approval and massive cost increase. These costs will lessen availability and discourage inventors. Who will this benefit? Does this improve safety? Why is inaction considered inherently safer than action? when it comes to medical technology?
Anonymous

More fiscally irresponsible regulation from the FDA. Big surprise.

Medical apps are a small proportion of our medical devices. 50% of our medical devices and 80% of our pharmaceuticals are imported according to the FDA themselves in their report Pathway to Global Product Safety and Quality. They also said themselves that “The safety of America’s food and medical products remains under serious threat… it would take 9 years just to inspect every high-priority pharmaceutical facility alone, let alone those of lower priority.” The FDA is lacking in resources and manpower. The FDA’s budget was slashed recently by 258 million. This new set of regulations is only one instance of new regulations that are taking away resources from more important areas. This lack of resources has made the 2011 Food Safety and Modernization Act reactionary instead of preventative as the FDA will need to establish a myriad of partnerships, coalitions and improved intelligence-gathering techniques. Even then, resources will still be deployed on “data-driven risk analytics.” Hardly all-inclusive, hardly preventative. By overregulating this new field of technology and handing over monopolies to big pharma, we crush innovation. Many companies, especially small tech startups cannot afford the increased research. For example since 1968 about 41 less new pharmaceuticals have been approved each year according to the Independent Institute and even more aren’t even researched due to the costs associated.

Initially, for the first 86 years of FDA’s existence, from 1906-1992the U.S. treasury department funded the FDA. In 1992 a law passed allowing pharmaceutical companies to provide funding for their own research that smaller companies could not put forth.