M-HEALTH By PHARMAGEEK

The Food and Drug Administration (FDA), which regulates everything from heart monitors to horse vaccines, will soon have its hands full with consumer health apps and devices.

 

The vast majority of the health apps you’ll find in Apple’s or Google’s app stores are harmless, like step counters and heart beat monitors. They’re non-clinical, non-actionable, and informational or motivational in nature.

 

But the next wave of biometric devices and apps might go further, measuring things like real-time blood pressure, blood glucose, and oxygen levels.

 More clinical apps

The FDA is charged with keeping watch on the safety and efficacy of consumer health products. Lately, that includes more clinical apps as well as devices you might buy at the drugstore, like a home glucose testing kit.

 

“It’s these apps that the FDA says it will regulate,” David Bates of Brigham and Women’s Hospital and Physicians Organization told VentureBeat in June. These apps will have to go through the full 510(k) process,” he said.

 

Dr. Bates chaired a group to advise the FDA on how to review health apps for approval, and on how the FDA should advise developers.

“It was intended to help them think through the risk factors involved with these products and then give guidance on how to stay within the guidelines,” he said.

 

“The device makers were asking from some guidance from The FDA on what types of things would be accepted and what wouldn’t,” Bates said.

Bates believes the FDA wants to use a light regulatory touch when looking at new medical devices. “The FDA definitely wants innovation to continue in clinical devices,” he said. “In general the FDA knows that the vast majority of apps are just informational.”

 

The FDA’s final guidance focuses on a small subset of mobile apps that present a greater risk to patients if they do not work as intended.

 

Health apps go mainstream

The big software companies (Apple, Google, and Samsung) have brought attention to, and lent credibility to, apps and devices that do more than count steps. These companies are building large cloud platforms designed to collect health data from all sorts of health apps and devices.

 

more at http://venturebeat.com/2014/07/21/health-apps-are-changing-so-must-the-fda/

 

Via nrip, Clara Hamelin

Why clinical trials need mobile health tools
mHealthNews (blog)
Pfizer used social media to recruit patients for a clinical trial of Detrol.

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CROs (clinical  research organization, "an organization that provides support to the pharmaceutical and biotechnology industries in the form of research services outsourced on a contract basis")  as we know them today started in the late 1970s and early 1980s and have grown as a part of Pharma R&D budgets from 4 percent in the 1990s to close to 50 percent in the mid 2000s. In a previous post on why Pharma needs mobile apps, I briefly mention their potential role in clinical trials. I would like to discuss this in more detail now. The cost of performing clinical trials is increasing significantly. Technology including mobile technology and analytics can decrease these costs, but the challenge is for both business models and the research processes to adapt around them. This presupposes that the technologies can perform trials well.

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Both the European Medicines Agency and the FDA have endorsed centralized monitoring of trials via technology on a real-time basis.

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Recruitment of patients is another aspect of digital technology in clinical trials. Pfizer used social media to recruit patients for a clinical trial of Detrol. One company hosting 200,000 patients in online communities which gather data on 150,000 disease states, PatientsLikeMe has signed agreements with pharmaceutical companies to match patients with trials using its clinical trial search tool.

Other advantages of mobile clinical trials, as I see them, include less biased recruitment via crowdsourcing, a dramatic reduction in costs, better medication tracking via pill sensor technology (Proteus Digital Health), and faster reporting of adverse events (which can potentially save lives and stop negative studies earlier via transmission to the Data Safety Monitoring Board), and more timely analytics and trial reporting. In addition, they might lend themselves to more comprehensive or efficient audits, and will strengthen the assistance of caregivers (who can receive and transmit data with/for the patient) in the trial.

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While I do not believe that mobile technology will replace CROs, I do believe that it will significantly reduce costs and improve procedural inefficiencies and accuracy. The digitalization of clinical trial data represented a significant step in improving process and quality of trials. Making it mobile will take it to an even higher level.

 

David Lee Scher, MD, FACP, FACC, FHRS, is a clinical associate professor of medicine at the Pennsylvania State University College of Medicine,

 

Via rob halkes