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

Mobile medical apps need to be regulated for patient safety, FDA official tells House panel | 1- E-HEALTH by PHARMAGEEK - E SANTE par PHARMAGEEK | Scoop.it

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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PatientView's curator insight, November 30, 2013 10:41 AM

Yes but the FDA meeting also stated that software does not count as a medical app ??

Avraham Harris's curator insight, June 29, 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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Which mHealth Apps Are Doctors Prescribing?

Which mHealth Apps Are Doctors Prescribing? | 1- E-HEALTH by PHARMAGEEK - E SANTE par PHARMAGEEK | Scoop.it
This week, HealthTap, a fast-growing mobile health platform that connects users with a network of more than 40,000  doctors - rolled out something called

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Smartphone images measure up to desktop views in neurology study

Smartphone images measure up to desktop views in neurology study | 1- E-HEALTH by PHARMAGEEK - E SANTE par PHARMAGEEK | Scoop.it

Researchers at the Mayo Clinic have given a boost to telemedicine proponents with the publication of a new study that highlights smartphones' efficacy and quality in capturing medical images to evaluate stroke patients.  The study, published in the September issue of Stroke is the first to test the effectiveness of smartphone teleradiology applications in a real-world telestroke network, according to Mayo Clinic officials.


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Adherence app MediSafe to boost medication adherence up to 81 percent

Adherence app MediSafe to boost medication adherence up to 81 percent | 1- E-HEALTH by PHARMAGEEK - E SANTE par PHARMAGEEK | Scoop.it

MediSafe is a cloud-based app system — the patients get a reminder to take their meds on their Android or Apple smartphone app, and are then prompted to record it if they do. If they don’t indicate that they’ve taken their dose, a graduated series of friends and family is informed and can take action.

“It pushes you a notification when its time to take your meds,” MediSafe CEO Omri “Bob” Shor told MobiHealthNews in January. “The first one is a quiet one, like a text message. The second one is a louder one. The third one you can’t ignore, and the fourth one goes to your wife.”

The company will use the money to build up strategic partnerships with pharma companies, pharmacies, HMOs, employers and hospitals. MediSafe hopes to be valuable to those stakeholders because it not only can increase patients’ medication adherence, but it also collects de-identified aggregate data about patients’ adherence.


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FDA Device Surveillance to Tap App

FDA Device Surveillance to Tap App | 1- E-HEALTH by PHARMAGEEK - E SANTE par PHARMAGEEK | Scoop.it
The FDA is creating a largely automated surveillance system to monitor safety of high-risk medical devices, and has authorized a cellphone app for doctors to simplify reporting deaths and injuries to the agency.

Via Seth Bilazarian, MD
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Seth Bilazarian, MD's curator insight, April 24, 2013 4:25 PM

"There's an app for that."  Physicians are often criticized for not doing a better job reporting adverse events and this is largely because the method for reporting to the FDA has been burdensome and difficult. An easy to use reporting strategy from a smartphone will increase my reporting dramatically.  The speed of reporting and analysis by FDA for actionable items should be significantly shortened.

Seth Bilazarian, MD's comment, April 24, 2013 4:27 PM
#app, medical app, #chealth, #mHealth, FDA, adverse event reporting, Bilazarian
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New iPhone app can detect atrial fibrillation

New iPhone app can detect atrial fibrillation | 1- E-HEALTH by PHARMAGEEK - E SANTE par PHARMAGEEK | Scoop.it

Take Home: UMass Medical School and WPI have developed an app that can detect atrial fibrillation.  This moves connected and mobile health closer to reality.  The really important development with this approch might allow us to treat patients who have AF intermittently (paroxysmal) differently than we currently do.  Because we are worried about stroke, patietns now get blood thinners all the time because we are concerned that they will have recurrences without knowing about it.  With this technology, in the future, we might see validation of a strategy that allows use of blood thinners when patients are in AF only, sometimes called a pill in the pocket.


Via Seth Bilazarian, MD
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