Monday 26 July 2021
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Regulation Of All mHealth Medical Devices and the Impact

Regulation Of All mHealth Medical Devices and the Impact

During the three days of subcommittee hearings last week with the House Energy and Commerce Committees, mHealth was the main topic of discussion. This was highly unusual to hold three days of hearing on a single topic. This suggests that some within Congress are serious with moving forward on legislation impacting mHealth.


The Question is What is going to happen to the mHealth pioneers? Are they going to be restricted too much by the U.S. Government regulations to stop innovation? Innovation in this domain is the key to the best products and services available to doctors and patients, and they are supposed to be the beneficiaries of the mHealth products.

Articles by a few have delved into this subject with the detail that might help us decide what we can do to help guide the regulations to help and not hinder the development.


After FDA’s mobile medical apps final guidance, what’s next? By: Bradley Merrill Thompson, Member of the Firm Epstein Becker & Green.


Does your mobile health app need FDA clearance? Checklist gives guidance for

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digital health entrepreneurs

by: Stephanie Baum


Congressional Panels Hold Hearings on Mobile Health : AAMI (Advancing Safety in Medical Technology)


mHealth Congressional Hearings: Day Two- by: Lt. Dan


Health Information Technologies: Administration Perspectives on Innovation and Regulation—Testimony of the FDA before the subcommittee on Oversight and Investigations of the Energy

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and Commerce Departments U.S. House of Representatives.

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