Should The Government Oversee Health Apps?

A fast-growing number of software applications offers doctors the chance to view X-rays or monitor heart rates from iPads or smartphones, prompting U.S. health officials on Tuesday to propose government oversight for some of the more complex health apps.

A portion of the apps perform tasks that mimic the work of medical devices and could cause harm if they failed to perform as promised, Food and Drug Administration officials said.

New FDA guidelines state that in some cases software developers would have to show their apps worked as well as non-mobile devices for the same use. The agency would have to provide clearance for those apps before they could be sold.

FDA officials said they recognized the potential benefits from mobile medical apps and aimed to encourage future development. "At the same time, we need to make sure these things are also safe and effective," Dr. Jeffrey Shuren, head of the agency's medical device center, said in an interview.

Medical apps are sold for devices such as Apple Inc's iPad and iPhone, Blackberry phones sold by Research In Motion, and phones run with Google Inc's Android software.

Only a small number of the thousands of mobile apps would face FDA scrutiny under new draft guidelines, agency officials said. They fall into two categories: apps that serve as an accessory to an FDA-regulated device, and apps that turn a mobile platform into a medical device.

Examples are apps that allow a doctor to view X-ray or MRI images on a smartphone or tablet computer, or see vital signs displayed on a patient's bedside monitor from another location.

Others may allow connection of heart sensors on a patient's chest to a mobile device, or provide a way to use a smartphone like a stethoscope.

One concern is that smaller screen sizes and lower contrast ratios could affect the quality of images on a mobile device.

Regulators hope the guidelines provide clarity on their expectations and will spark new app development, said Bakul Patel, policy adviser in the FDA device center. The agency aims to "strike that fine balance between promoting innovation and assuring safety and effectiveness," Patel said.

Apps for consumers that count calories or provide medical reference materials would not draw FDA oversight.

The FDA already has cleared a handful of medical apps after developers sought the agency's blessing. In February, for example, an app that lets doctors view CT, MRI and other scans on Apple's iPhone or iPad won FDA clearance.

The agency is taking public comment the proposed guidelines for 90 days.

Copyright 2011 Thomson Reuters. Click for Restrictions.

Comments

[buttonq]

10:29 AM on 08/11/2011

I understand there are irresponsible, harmful and trying to earn quick buck professionals, people and others in our society/world. Who made these rats preying on the public? Unknown sources or let us say this we will not point our fingers at anyone because that is another issue. Yes, we need to contain and possible jail these individuals if harm is cause by their product. Guess who will know before the Government? The society and their voices are louder than the Government. Society does not swipe anything under the rug or in corners and do no play hide or seek/the guess games. The truth will be prevailed with society and everyone is aware of it faster through society.

The government tends to delay the treatments, medication and procedures for years to help people that are dying. We do not need people going to the extreme to obtain an application that the government does not want to approve or delaying. The government needs to deal with bigger problems such as their outrageous spending, creating large debts for our society to pay back, taking care of home first and the deal with our problems, etc. The government cannot handle the political aspect, what do you think they handle the social aspect? Threatening and placing people in jail is not a solution here in the USA and they cannot resolve our social problems...until they stop their negative behavior. Rest my case.

[Jesse EngAmer]

04:42 PM on 07/19/2011

To regulate apps that make suggestions regarding a patient’s diagnosis or treatment is risky. There are plenty of instances where social media has saved lives. But here’s one example where a Facebook thread saved an infant’s life. With it came correct and incorrect suggestions but it lead to a diagnosis that qualified doctors had not reached.
http://today.msnbc.msn.com/id/43757155/ns/health-slate_c


Furthermore, many doctors themselves consult medical apps.
http://mobihealthnews.com/7990/95-of-doctors-with-smartphones-use-medical-apps/
Furthermore, there is a definite contradiction here. The draft states that:

“Mobile apps that allow the user to input patient-specific information and – using formulae or processing algorithms – output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions.”

Yet digital copies of textbooks offering the same algorithms are mysteriously absent. The FDA shouldn’t be able to regulate the dispersion of medical knowledge.