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E-HEALTH - E-SANTE - PHARMAGEEK

Is it OK for digital health tools to exclude vulnerable populations?

From www.hcanews.com

Digital health is rapidly changing our lives. Almost every day, new developments using data, artificial intelligence and smartphones to improve health, on individual and population levels, are entering the market. In 2015, there were more than 40,000 healthcare apps on Apple's U.S. App Store alone. And the number has kept growing.

But in the process of delivering the next revolutionary technology, health-tech innovators have often neglected to include usability in their apps so that they may also benefit people with disabilities, research suggests 


“People with disabilities have a particularly hard time, as they are often overlooked in the design of new technology, both regarding tools and content,” noted a report titled, “Health Inequalities in eHealth Context,” by the European Commission.

“Due to their impairment, the notion of them being proficient (information and communications technology) users is often sidelined.”

So, what does this issue look like in the real world?

In August, the U.S. Food and Drug Administration approved the marketing of the first mobile health (mHealth) app for contraception: Natural Cycles. The app allows women to avoid pregnancy by monitoring their resting body temperature — known as the basal body temperature — and recording their data so that an algorithm can determine their daily fertility.

With “perfect use,” the app’s creators say the failure rate is 1.8 percent, which means that 1.8 in 100 women annually will become pregnant despite using the technology.

But although the app meets the FDA’s guidelines governing mHealth apps, Natural Cycles poses problems for some nontraditional eHealth users, including women who have disabilities or irregular periods.

 

read the whole story at https://www.hcanews.com/news/natural-cycles-is-the-first-fdaapproved-contraception-app-but-its-not-for-all-women
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nrip's curator insight, October 3, 2018 12:08 AM

In the process of delivering the next revolutionary technology, health-tech innovators often neglect to look at usability in their apps for a wide variety of users. This is true for revolutionary technologies in all verticals. 

 
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Mobile medical apps need to be regulated for patient safety, FDA official tells House panel

From www.fiercemobilegovernment.com

Mobile medical apps need to be regulated because patient safety is at risk when they are used to diagnose or treat a disease, said Jeffrey Shuren, director of the Food and Drug Administration's Center for Devices and Radiological Health at a Nov. 19 House Energy and Commerce Committee subcommittee on health hearing.


The FDA's regulation of software as a medical device is based on risk and function, Shuren told the panel, and the FDA treats devices that perform the same function the same way regardless of the platform on which it is used.


"It's not about the platform. It's about the function," said Shuren.

Software becomes a medical device through intended use and diagnosis of disease and conditions or treatment cure mitigation of disease, he said.


"All we are saying is, the functions, when they stay the same, treat them the same, because the impact and the risk to patients is the same," Shuren said. "Simply because they got smaller and I can pick it up and walk out of the room with it, doesn't change the risk to the patients. Why for that reason alone would we treat it differently?"


The FDA issued nonbinding guidance Sept. 25 with their plan of how to regulate mobile apps as medical devices.

If, for instance, an app illuminates an LED light, like prevalent flashlight apps do, the FDA wouldn't consider it a medical device. But if the developer labels and markets it as a light source for doctors to examine patients, the FDA would approach it as it would an ophthalmoscope, the guidance says.


But the FDA might not need that guidance if Congress passes a bill that's currently sitting in the House Energy and Commerce Committee.

The bill (H.R.3303) would amend the Food, Drug and Cosmetic Act to regulate medical software. It would establish three categories of software--clinical, health and medical--with the two former software types not subject to FDA regulation.


But Shuren told the subcommittee that the bill undermines the FDA's authority to assure the safety and effectiveness of high risk medical devices.


The FDA would no longer be able to regulate blood glucose meters and software that is used to analyze pap smear slides, Shuren said.


"It's very confusing to us what this actually accomplishes," he said.



Read more: http://www.fiercemobilegovernment.com/story/mobile-medical-apps-need-be-regulated-patient-safety-fda-official-tells-hou/2013-11-27

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Avraham Harris's curator insight, June 29, 2014 7:43 AM

Medical Apps - FDA's standpoint overkill - or proposed bill is risky?

If you ask me, probably the latter. Health apps are fun, easy to make, distribute and can effect misuse if risk controls and information for safety are not required. Can't they?

What do you think?

Avraham 
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