Search Results for Mobile Health

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Wearable Technologies and Mobile Health Devices: Changing Medical Research and Delivering Better Patient Outcomes By Dr Elin Haf Davies, Chris Tyson - Published 28 August 2017

This article discusses how wearable technologies and mobile health devices are changing medical practice and improving patient outcomes with the potential to lower research and development costs and impact reimbursement.

Categories: Features, FDA, Medical Devices

Tags: Wearables, Mobile Health, mHealth, Patient Reported Outcomes

Industry Calls for More Guidance From FDA on New Clinical Trials Technology By Zachary Brennan - Published 11 May 2016

The initiation of a new era of mobile health technology has erupted into industry calling on the US Food and Drug Administration (FDA) to offer more guidance on how best to use new technology, like Fitbits and mobile apps, in clinical trials, and to find ways that don’t restrict the development of novel tech products.

Categories: News, US, FDA, Clinical, Government affairs, Medical Devices, Research and development

Tags: Fitbit, mHealth, Medidata, Pfizer, GlaxoSmithKline, mobile health technology

FDA Collaborates With FTC on Mobile Health App Regulatory Tool By Zachary Brennan - Published 05 April 2016

The US Food and Drug Administration (FDA), the Federal Trade Commission (FTC) and other regulators are looking to help health-related mobile application developers comply with the Federal Food, Drug and Cosmetics Act (FD&C Act) and other applicable laws.

Categories: News, US, FDA, FTC, Business Skills, Compliance, Government affairs, Medical Devices

Tags: mHealth regulation, mobile health apps, health applications

EU Looks to Improve Data Quality of mHealth Apps By Zachary Brennan - Published 25 January 2016

The European Commission is bringing together a working group to develop guidelines by the end of 2016 for assessing the validity and reliability of the data that mobile health (mHealth) applications collect and process in order to make these ubiquitous apps more useful for public health.

Categories: News, Europe, US, EC, FDA, MHRA, Due Diligence, Government affairs, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: mHealth, mobile health apps, mobile health app data, mHealth regulations

Mobile App Regulation Focus of Upcoming Legislative Hearing By Alexander Gaffney, RF News Editor - Published 18 November 2013

Categories: US, FDA

Tags: SOFTWARE Act, Mobile Health App, Mobile App, Latest News, Jeffery Shuren, medical device

Experts Examine Regulation of Health-Related Mobile Apps, Software and Social Media By Zachary Brousseau, RAPS senior manager, communications - Published 29 October 2012

When it comes to the regulation of mobile apps, software and social media in the healthcare space, intent is key but absolute clarity is elusive, according to the expert presenters who spoke to attendees during a session at 2012 RAPS: The Regulatory Convergence in Seattle.

Categories: Under RAPS, FDA, MHRA

Tags: Center for Medicine in the Public Interest, 2012 RAPS, Mobile Apps, Software, Mobile Health, regulators, social media, annual conference, The Regulatory Convergence, regulatory

As Mobile Applications Cross Over Into FDA Regulatory Territory, New Frictions Emerge By Alexander Gaffney - Published 17 April 2012

Categories: FDA

Tags: Apps, Developers, Wireless, Mobile Health, App, House, FCC, mobile, Latest News, Congress

Congressmen Pressure FDA, FCC Over Wireless Health Regulation By Alexander Gaffney - Published 11 April 2012

Categories: FDA

Tags: Genachowski, Wireless, Mobile Health, Letter, House, FCC, mobile, Latest News, Hamburg, Congress