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Mobile Medical Apps

FDA Finalizes Guidance on Medical Device Data Systems

[02/10/15]

Posted on February 10, 2015 in Health Information Technology

Written by: Mark R. Dahlby

On February 6, the Food and Drug Administration (the “FDA” or “Agency”) released a finalized guidance (the “Guidance”) informing the public that the Agency does not intend to enforce any regulatory requirements applicable to several types of devices and software that transfer, store, convert, format and display medical data, specifically including medical image storage (“MIS”)... READ MORE

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New Guidance Documents from FDA Seek to Clarify Regulation for Wellness Devices and Medical Device Accessories

[02/10/15]

Posted on February 10, 2015 in Health Information Technology

Published by: Hall Render

On January 20, 2015, the Food and Drug Administration (the “FDA” or “Agency”) published two draft guidance documents designed to fulfill promises it made in the multi-agency Food and Drug Administration Safety and Innovation Act (“FDASIA”) Health IT report. The first draft guidance is intended to promote the innovation of general wellness devices and... READ MORE

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Report Details Safety Issues with Health IT

[02/09/15]

Posted on February 9, 2015 in Health Information Technology

Written by: Mark R. Dahlby

In November 2014, the ECRI Institute¹ issued a report discussing issues of patient safety and adverse events linked to health information technology (“IT”) products. The report comes in the form of an annual list of top ten health technology safety hazards. According to the ECRI Institute, although many facets of health IT have a... READ MORE

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New FTC Guidance Addresses Social Media Advertising; Could FDA Be Next?

[03/28/13]

Posted on March 28, 2013 in Health Information Technology

Written by: Mark R. Dahlby

On March 12, the Federal Trade Commission (“FTC”) published new guidance detailing how advertising disclosures should be made online.  Disclosures are necessary to qualify or limit advertising claims that would otherwise be deceptive, unfair or give misleading impressions. READ MORE

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FTC Issues Mobile Privacy and Security Publications

[02/22/13]

Posted on February 22, 2013 in Health Information Technology

Written by: Mark R. Dahlby

On February 1, 2013, the Federal Trade Commission (FTC) issued two publications recommending ways that key players in the mobile marketplace, such as operating system providers, application developers, advertising networks and analytics companies, can promote mobile privacy and security. READ MORE

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ECRI Institute Publishes Top 10 Health Technology Hazards for 2013

[02/22/13]

Posted on February 22, 2013 in Health Information Technology

Written by: Mark R. Dahlby

ECRI Institute has released its list of the Top 10 Health Technology Hazards for 2013.  The annual report is based on the prevalence and severity of incidents reported by health care facilities and information found in the Institute’s medical device problem reporting databases. READ MORE

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Opinions about Mobile Device Privacy and Security Due to ONC by March 30, 2012

[03/29/12]

Posted on March 29, 2012 in Health Information Technology

Written by: Alisa C. Kuehn

The public comment period regarding securing health information while using mobile devices ends on March 30, 2012. Information regarding ONC’s Mobile Device Roundtable discussion and a link to provide comments can be found here. Should you have any questions, please contact Alisa Kuehn at 317.977.1475 or akuehn@wp.hallrender.com.   READ MORE

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