M-HEALTH By PHARMAGEEK
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M HEALTH...and Mobile marketing - Mobile, Ipad and Apps.. #mhealth #ehealth #healthapps
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Rescooped by Lionel Reichardt / le Pharmageek from Health Care Social Media And Digital Health
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Beyond fitness apps: patient-centric mobile health 

Beyond fitness apps: patient-centric mobile health  | M-HEALTH By PHARMAGEEK | Scoop.it
From pharmaphorum.com - August 18, 2016 2:57 AM
mHealth brings opportunities to better understand how conditions impact everyday life and develop solutions that work.

Via Marie Ennis-O'Connor
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Nilambari Mane's curator insight, August 17, 2016 11:05 AM
Interesting read on how patient-centric apps are gaining momentum and present great business opportunities for Pharma Companies.  
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Rescooped by Lionel Reichardt / le Pharmageek from New pharma
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Why clinical trials need mobile health tools - mHealthNews (blog)

Why clinical trials need mobile health tools - mHealthNews (blog) | M-HEALTH By PHARMAGEEK | Scoop.it
From www.mhealthnews.com - January 16, 2014 3:41 PM
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
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rob halkes's curator insight, January 16, 2014 5:33 AM

Well, I agree very much with David about the potential and the benefits of using mobile technology in trial studies.

Yet, I think that the very patients are entitled to not just that. I know of cases in which patients have been supported and guided on an intensive schedule to their participation in the trial. But, alas, when the trial was over, so the support and guidance disappeared.

Why not continue this in the very support at therapy? My take is that both FDA and EMA should take steps to guarantee that services rendered during trials should be continued, by  the participating institutes and business of care and research to the services for the participating patients. Isn't that self evident?

Please endorse this, by your comments! 

 
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Rescooped by Lionel Reichardt / le Pharmageek from New pharma
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FDA declines to scrutinize claims by “low risk” mhealth apps, devices. What’s the takeaway?

FDA declines to scrutinize claims by “low risk” mhealth apps, devices. What’s the takeaway? | M-HEALTH By PHARMAGEEK | Scoop.it
From medcitynews.com - August 2, 2016 2:58 AM

FDA said it will ease up vetting general health and wellness apps, but it will scrutinize clinical applications and devices. Does this mean the FTC will step up?

 

The U.S. Food and Drug Administration has issued final guidance on “low-risk” digital health apps and devices for general health management 18 months after it  came out with draft guidance.

The document offers information on the kinds of apps and devices for which it will and won’t take action. Apps promoting or maintaining a healthy weight or to assist with weight loss goals and healthy eating are OK.  The guidance says that companies can make claims that their apps and devices can help with healthy lifestyle choices to reduce the risk of chronic conditions such as Type 2 diabetes, high blood pressure and heart disease or improve their management. But those lifestyle choices have to be advocated by the likes of the American Heart Association or American Association of Clinical Endocrinologist or peer-reviewed medical journals.

So what are some examples of what’s not OK? Claims that a product will treat or diagnose obesity, an eating disorder, such as bullimia or anorexia, or an anxiety disorder. Digital health entrepreneurs are also encouraged to ask themselves the following questions:

Is the product invasive?
Is the product implanted?
Does the product involve an intervention or technology that may pose a risk to
the safety of users and other persons if specific regulatory controls are not applied, such as risks from lasers or radiation exposure?

If the answer is yes to any of the above, they need to assume their products are considered clinical applications, will be scrutinized and should act accordingly.

My takeaway from the guidance is twofold. It’s a question of resources. Although there are thousands of general wellness apps, more and more medical device and pharma companies are developing digital health devices and apps of their own.  Second, the Federal Trade Commission has shown it is willing to take action against companies that it deems to be making false health claims about their apps and devices.

 


Via rob halkes
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rob halkes's curator insight, August 1, 2016 4:50 AM

Health apps should do what they promise! At the moment they need to take a diagnostic feature and use personal physics to arrive at advice or conclusions about the health status of the person who uses the app, they are considered not to be 'just' an "app" but a medical device. At that condition they need to adhere to and be certified by several criteria attached to 'medical devices". Developers should know about this, which the more professional ones will. Rightly so!

PatientView has developed a website MyHealthApps that presents an inventory of the better Health Apps.
Pharma Guy's curator insight, August 1, 2016 8:38 AM

Also read “FDA Won't Regulate ‘Low-Risk’ mHealth Apps as Medical Devices. But Battle Looms Over Defining ‘Low Risk’"; http://sco.lt/5kkDyr
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Rescooped by Lionel Reichardt / le Pharmageek from Health on the Move > 2013
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New iPad Rep Report: Docs Who “Tablet Touch” During Details Have Significantly Better iPad Rep Experiences - Manhattan Research

From manhattanresearch.com - October 2, 2012 9:34 AM
Manhattan Research Releases New iPad Rep Report to Help Pharma Optimize Investments in 2012...

Via Thomas N. Burg
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