Tag Archive | "FDA"

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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HealthInterlink Clears Integral FDA Hurdle


HealthInterlink Clears Integral FDA Hurdle   U.S. Food and Drug Administration mobile health mHealth HealthInterlink FDA On Wednesday, HealthInterlink – a medical software company specializing in remote patient monitoring – finally received the good news for which it had been waiting for quite some time.

According to a statement provided to mHealthWatch, the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Beacon version 2.0.

The platform in question is billed as a “flexible, affordable, and scalable” software-based remote patient monitoring solution.

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Lawmakers Fighting to Keep FDA Out of mHealth


Lawmakers Fighting to Keep FDA Out of mHealth   USA Today mobile health news mobile health mHealth news mHealth apps FDA Two prominent federal lawmakers are going public in their fight to keep the FDA from fiddling too much in the mHealth space.

Senators Deb Fischer (R-Neb.) and Angus King (I-Maine) published an unapologetic op-ed in the pages of USA Today this week, urging the creation of a new, less intrusive framework for FDA oversight.
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FDA To Require Electronic Reporting of Medical Device Errors


FDA To Require Electronic Reporting of Medical Device Errors   mobile medical devices mHealth MDRs FDA regulations FDA Last week, The U.S. Food and Drug Administration published a final rule in the Federal Register which requires that both device makers and importers document negative event reports for medical devices electronically.

“Upon the effective date of this final rule, manufacturers and importers are required to submit MDRs to the Agency in an electronic format that FDA can process, review, and archive,” the FDA announced.

The new rule formally takes effect August 14th, 2015.
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CEA Supporting Education for Health App Development


CEA Supporting Education for Health App Development   Mobile Medical Apps (MMA) Roadshow: Managing App Development under FDA Regulation mobile health apps mHealth FDA Consumer Electronics Association CEA apps app development app developer While the announcement itself largely flew beneath the radar in recent days, the impact of this development could reverberate well into the future.

Last week, the Consumer Electronics Association (CEA) announced its sponsorship of an educational program series called the “Mobile Medical Apps (MMA) Roadshow: Managing App Development under FDA Regulation.”

In this effort, the CEA joins a consortium of six leading universities, more than a dozen industry trade associations and professional societies, and the U.S. Food & Drug Administration (FDA).

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FDA Lifts Restrictions on Social Media Ads


FDA Lifts Restrictions on Social Media Ads   social networking social media news social media marketing social media mobile ads internet FDA Advertising It’s safe to expect an increase in pharmaceutical ads on social networking sites resulting from a new FDA draft guidance document.  Many in the industry feel the announcement is a good start.

As far as the FDA’s reporting requirements for ads, the guidance is not as far reaching as some have hoped.  That could change in July when it is required that the FDA issues guidance that elaborates on the policy.

Wayne Pines, president of regulatory services and healthcare at APCO Worldwide, praised the draft.

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FDA Issues Draft Guidance on Mobile Blood Glucose Meters


FDA Issues Draft Guidance on Mobile Blood Glucose Meters   U.S. Food and Drug Administration Mobile Devices Mobile Blood Glucose Meters mHealth news mHealth FDA This week, the U.S. Food and Drug Administration published draft guidance on the matter of blood glucose meters – meters that are increasingly going mobile.

The guidance strives to separate prescription meters for use in point-of-care healthcare environments and over-the-counter meters for consumers.

The draft guidance is available now through the Federal Register for public comment.
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