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New FDA Guidance Could Support Digital Transformation in Medical Devices

New FDA Guidance Could Support Digital Transformation in Medical Devices

The digital transformation sweeping across health care is moving quickly. Like most things regarding technology, regulation is slow to keep up, but the Food and Drug Administration’s perspective on regulating new wearable technology and mobile apps is getting a little clearer. The agency recently issued draft guidance stating that it wouldn’t regulate “low-risk” devices that are intended […]

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Patient Engagement and Data Protection: Complying with Regulations in a Digital Age

Patient Engagement and Data Protection: Complying with Regulations in a Digital Age

With ongoing developments in technology and software, there are many more opportunities to foster patient engagement, giving patients the tools to find out more about various medical issues, keep track of health-related measures, and chart the course of their own treatment. However, one of the critical concerns to deal with involves data protection. For example, […]

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Mobile Medical Apps- Which Ones are Regulated?

Mobile Medical Apps- Which Ones are Regulated?

The emergence of smartphones has changed the world. They have put a great impact on our lifestyle. One can do almost anything and everything using smartphone Apps ranging from playing games to shopping, paying bills etc. This digital technology has started approaching healthcare systems as well. The app designers are targeting the Healthcare industry in […]