mHealth- Advances, Knowledge and Patient Engagement
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FDA Approval Now Seen As Essential Ally to Prove Value of mHealth Wearables

FDA Approval Now Seen As Essential Ally to Prove Value of mHealth Wearables | mHealth- Advances, Knowledge and Patient Engagement | Scoop.it

A new wave of wearable computing devices that detect and monitor serious diseases is moving from the laboratory to the market, potentially transforming the treatment of conditions ranging from epilepsy to diabetes and creating business opportunities estimated to be worth tens of billions of dollars. 


Unlike popular fitness-tracking devices, such as Fitbit Inc's Fitbit and Jawbone's UP wristbands, these so-called medical-grade wearables require approval from the U.S. Food and Drug Administration - a rigorous regulatory hurdle that first-generation wearables sought to avoid.


The FDA is preparing for the coming onslaught. 


Bakul Patel, FDA's associate director for digital health, told Reuters the agency is reviewing applications for three new senior health scientist positions focused on digital health.


Long criticized by some health-tech entrepreneurs as a barrier to innovation, the FDA is now seen as an important ally by companies eager to show that their devices can improve peoples' health - and eager to get heath insurers to cover them. 


"Consumers, doctors, payers all want to know if a product provides a clinical benefit," said Julie Papanek of the venture capital firm Canaan Partners, who invests in wearables startups. "Working with the FDA is the one way to get the ability to market that benefit."


A key driver in the new wearables wave is the push for so-called value-based healthcare that is part of the Affordable Care Act. The law gives doctors and hospitals financial incentives for keeping large groups of patients healthy. 


Under the old fee-for-service model, hospitals got paid when patients were hospitalized, noted Jody Ranck, a Washington, D.C.-based healthcare consultant. "Now, you can lose money," he said. Instead, healthcare providers are now eager to collect the data that can help keep people out of the hospital - especially those with chronic diseases. "These wearables are just tools to get the health data," said Ranck.


An avalanche of studies - many of them taking advantage of new data-gathering platforms such as Apple Inc's HealthKit, Google's Google Fit and Samsung's SAMI - are under way on a number of chronic diseases, especially in the area of diabetes. "We're going to see a lot of devices over the next couple of years for every chronic condition of mankind that are FDA-regulated because they all involve a treatment loop," Scripps' Topol said.


Via Pharma Guy, Philippe Marchal
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Pharma Guy's curator insight, December 18, 2015 7:47 AM

More than FDA approval is required. Download this presentation: "Mastering Mobile Social Media to Improve Health Outcomes"; http://sco.lt/8w7RTN 

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FDA scrutinises health app for the first time

FDA scrutinises health app for the first time | mHealth- Advances, Knowledge and Patient Engagement | Scoop.it
The US Food and Drug Administration (FDA) has for the first time written to a company because it needs regulatory clearance for a mobile health app. The FDA has been in touch with Biosense Technolo...

Via Sam Stern, dbtmobile
eMedToday's insight:

As you develop apps you need to review quidelines for FDA approval. This is a big deal so developers need to be careful

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Sam Stern's curator insight, May 29, 2013 12:19 PM

More of things to come?