Tag Archive | "FDA"

FDA Plans to Take a Hands Off Approach to Apple Watch


FDA Plans to Take a Hands Off Approach to Apple Watch   wearables mobile FDA Apple Watch apple With Apple Watch set to launch on April 24th, questions have swirled around how the FDA might intervene to somehow regulate the first-ever wearable released by Apple.

But this week, the FDA is making their position on the matter very clear. They want very little, if anything, to do with putting up regulatory hurdles for Apple Watch.

“We are taking a very light touch, an almost hands-off approach,” Bakul Patel, the FDA’s associate director for digital health, is quoted by Bloomberg. “If you have technology that’s going to motivate a person to stay healthy, that’s not something we want to be engaged in.”

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FCC and FDA Team Up for Joint Workshop


FCC and FDA Team Up for Joint Workshop   Workshop FDA FCC In a joint statement released to the media this week, the FCC and FDA have announced their agenda for a joint workshop on medical technology innovation and wireless test beds.

We’re told that Chairman Tom Wheeler and Commissioner Mignon Clyburn of the FCC, and Dr. William Maisel, Deputy Director, Center for Devices and Radiological Health, FDA, will address workshop participants.

The workshop is set for next Tuesday, March 31st.
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FDA Launches ‘Drug Shortages’ Mobile App


FDA Launches Drug Shortages Mobile App   mobile healthcare Mobile Apps iOS FDA Drug Shortages Android The U.S. Food and Drug Administration has just launched what’s being called the agency’s first mobile application “specifically designed to speed public access to valuable information about drug shortages.”

Conveniently, the app identifies current drug shortages, resolved shortages and discontinuations of drug products.

Drugs in short supply can delay or deny needed care for patients. Drug shortages may also lead health care professionals to rely on alternative drug products, which may be less effective or associated with higher risks than the drug in shortage.

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FDA Green Lights Promising New Continuous Glucose Monitoring System


FDA Green Lights Promising New Continuous Glucose Monitoring System   FDA Dexcom G4 PLATINUM Continuous Glucose Monitoring System On Monday, DexCom, Inc. — a provider of glucose monitoring solutions for patients with diabetes — announced that it has received U.S. Food and Drug Administration’s approval for its Dexcom G4 PLATINUM Continuous Glucose Monitoring System with Share.

According to a statement provided to mHealthWatch, the Dexcom Share receiver uses a secure wireless connection via Bluetooth Low Energy (BLE) between a patient’s receiver and an app on the patient’s smartphone to transmit glucose information to apps on the mobile devices of up to five designated recipients.

This can happen, the company says, without the need for a dedicated docking cradle.
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FDA Yet to Review and Approve the Vast Majority of mHealth Apps


FDA Yet to Review and Approve the Vast Majority of mHealth Apps   Mobile Apps FDA App regulation Currently there are over 100,000 mHealth apps available for immediate download. The apps range from managing general health and fitness, to monitoring and recording vitals. While mHealth apps are designed to be preventative, proactive, and even utilized for treatment and care, only 1 out of every 1,000 mHealth apps has been approved by the FDA.

This is not to say that an app lacking approval is not going to help individuals to achieve their health goals, just that their claims have not been verified. What consumers must keep in mind, is that just because an app is placed on a reputable mobile or online store such as iTunes that iTunes makes no efforts to verify the validity of mHealth apps.

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The FDA Professes to Support The Development of mHealth Apps


The FDA Professes to Support The Development of mHealth Apps   OpenFDA mobile health mHealth FDA There are strong feelings of both acceptance and opposition in the healthcare industry when it comes to the adoption of mHealth apps. However, the term “mHealth” is so broad that it can be used to describe technology that is beneficial individually to patients and healthcare professionals, as well as patients and healthcare professionals.

Regardless of the pros and cons, mHealth apps continue to be developed at a feverish pace and the FDA is taking notice. Recently the FDA publicly shared datasets and reports with the intent of helping mHealth app developers create and improve their heath-centric apps. This publicly shared information is called the OpenFDA initiative.

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Feds Pitch Risk-Based Health IT Regulatory Framework


Feds Pitch Risk Based Health IT Regulatory Framework   mHealth HHS healthcare IT FDA On Thursday, the U.S. Department of Health and Human Services released a draft report that puts forward a proposed strategy and recommendations for a health information technology (health IT) framework.

Per the details shared during a joint media briefing yesterday, the framework in question aims to promote “product innovation” while maintaining “appropriate patient protections” and avoiding regulatory duplication.

The report, which exists to “clarify oversight of health IT products based on a product’s function and the potential risk to patients who use it,” was developed by the U.S. Food and Drug Administration (FDA) with the assistance of two other federal agencies: HHS’ Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC).
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