Tag Archive | "mhealth regulation"

mHealth Debate Puts Congress on Opposite Side of FDA

mHealth Debate Puts Congress on Opposite Side of FDAThe FDA is in the middle of a disagreement with Congress. The issue at hand? mHealth regulation.

Specifically, the debate boils down to whether mobile health-related software should be regulated as a medical device would ordinarily be.

The debate was elevated to a new level this week during Tuesday’s hearing by the House Energy and Commerce Subcommittee on Health.
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Congresswoman Calls for More mHealth Regulation

Congresswoman Calls for More mHealth RegulationRep. Marsha Blackburn (R-Tenn.) recently revealed at the Telecommunications Industry Association conference that she plans to introduce a bill that would potentially mandate the FDA to regulate all mHealth apps.

No timeline was given as to when the Tennessee lawmaker would introduce such legislation, the effect of which would empower the FDA and provide it with the resources necessary to more closely monitor and govern this emerging industry.

“There are 97,000 health-related mobile apps in the Apple App store, and health providers and patients are turning to mobile devices more and more,” Rep. Blackburn said at the conference.

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FDA Issues Draft Guidance for Pharma & Medical Device Makers’ Use of Social Media

The Food and Drug Administration recently published draft guidelines for pharmaceutical and medical device companies on the use of “emerging electronic media,” A.K.A. social media marketing and communication.

Though the FDA notes the proposed guidelines aren’t comprehensive and rather the “first of many planned guidance initiatives,” the move marks the first time the FDA has clearly addressed rules for Pharma and medical device makers’ digital communication via social media and other channels — even specifically mentioning services like Twitter, Facebook and YouTube.

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echoBase Debuts Secure Mobile Interface for Healthcare Systems Using Gazzang Encryption

EchoBase, a provider of “mobile interface” solutions for the healthcare industry, has announced a new integration with Gazzang to power secure access to clinical systems — providing physicians and clinicians mobile access to things like patient medical records and other internal systems while limiting the risk of sensitive data breach or exposure.

Through its “Resonate” solution, echoBase provides a single mobile interface to electronic medical record, practice management, clinical and financial systems that allows clinicians to interact with electronic patient data in real-time, with or without an Internet connection.  The solution currently works on both Apple iPads and iPhones/iPod Touches.

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Washington, DC Based Law firm Offers In-Depth Regulatory Guidance on Telehealth

Telehealth vendor inTouch Health recently commissioned legal guidance from Washington, DC-based law firm Epstein Becker Green, which was subsequently made public and now provides an excellent resource for any organization providing or leveraging telehealth solutions.

The guidance relates to U.S. Food and Drug Administration (FDA) regulation as it applies to telehealth, and was made public to help other users and vendors “understand the regulatory framework within which telehealth may fall, as FDA rules progress.”  The 10-page document covers everything from risk-based regulation of medical devices to recent mhealth regulatory trends and even clinical decision support software as it relates to telehealth.

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mHealth Regulatory Coalition Says FDA’s Intended Use Approach for Mobile Medical Apps is Too Broad

The FDA has had plenty of input as it works to draft guidelines for regulating mobile medical apps, but the mHealth Regulatory Coalition (MRC) in particular has maintained a leading voice since the guidelines were introduced.

Following initial comments on the proposed guidelines submitted October 19th, the MRC just submitted additional comments related to the FDA’s definition of “intended use,” which has been surrounded in debate since it was introduced.  Among more specific comments to the FDA, the MRC said its approach for evaluating intended uses of mobile medical applications was “too broad and would result in unnecessary regulation of mHealth technologies.”

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Austria’s Orange Mobile Operator Set to Expand Remote Patient Monitoring Solution Following Successful Trial

Mobile operators have a huge role to play in the future of mHealth technologies, not to mention being huge players in helping spur adoption of new age concepts given their immense reach.

Orange Austria, the nation’s third largest operator with more than 20% market share, is a perfect example of the role carriers can play in this burgeoning industry.  The company has been successfully distributing its own proprietary remote patient monitoring solution since June of last year, following a successful 12-month trial prior to the official launch.  The solution has been so successful, in fact, that Orange is presenting on its mHealth experience at the Connected World Forum in October.

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