mhealth regulation

New Report Cites Lack of Standardization in Wireless Monitor Market

The lack of standards for wireless sensors and technologies used in mHealth devices and wireless patient monitors may threaten the growth of the sector according to a new report from…

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FDA May Limit Scope of mHealth Regulation

The Food and Drug Administration (FDA) may not be interested in taking on regulatory responsibility for the vast sea of 40,000 or so mobile health apps according to partner Silicon…

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HIPAA Overhaul Falls Short on mHealth Data Protection

The Department of Health and Human Services (HHS) has unveiled its long anticipated revision to the HIPAA (the Health Insurance Portability and Accountability Act). While the new rules tighten compliance…

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Trials of mHealth Tools for Disease Management and Behavioral Change Come up Short

A meta study of controlled trials of the use of mobile-based technology for disease management or behavior modification has underscored the need for high quality, unbiased research into the effectiveness…

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Heard at JP Morgan: Five Cocktail Party Trends

It feels like a fool’s errand to try to draw conclusions from the cocktail circuit during the JP Morgan Healthcare Conference being held this week in San Francisco. Any observations…

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Europe Puts Forth Plan to Ease the Way for mHealth

There is a lot of focus on how health care reform in the US is driving, or sometimes impeding, the progress of mobile health tools. But other markets such as…

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Survey Shows Spread of mHealth

A new survey from HIMSS and Qualcomm Life reveals that two-thirds of healthcare executives reported that their organizations have mobile health policies in place. That’s up from 38 percent of…

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Patients Seeking Access to Data from Devices

As the Wall Street Journal reports, more and more patients who are using implantable medical devices or health apps that collect medical data are seeking to get access to that…

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“Clear and Conspicuous” FTC Guidance on Marketing Mobile Apps

Guest Blog by Michael Esquivel, Partner, Fenwick & West
The Federal Trade Commission (FTC or Commission) recently published a guide, Marketing your Mobile App: Get it Right From the Start,…

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Report Shows Many mHealth Apps have Dubious Therapeutic Value

The absence of regulatory standards for mHealth apps has led many to worry that apps with little or no therapeutic value are being promoted by hucksters who aim to take…

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