Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Digital Health Regulation Debate Continues At mHealth Summit

This article was originally published in The Gray Sheet

Executive Summary

Federal officials took pains at this year’s mHealth Summit in Washington, D.C., to describe their excitement for the digital health field and their plans to minimize the “touch” of federal regulation. But it was also clear at the meeting that a significant component of the health information technology space still looks skeptically at FDA and its long-term intentions.

You may also be interested in...



Active Months Ahead For mHealth Regulatory Policymaking

Multiple guidances, frameworks and legislative activity on mHealth are expected to surface this fall and could have major implications on how the emerging industry is regulated.

McKesson Tagged With Rare Class I Recall For Clinical Decision Support Software

McKesson Corp.’s McKesson Anesthesia Care clinical decision support system was the subject of a class I recall, a rarity in the health information technology sector that could offer insights into FDA oversight of the space going forward.

Representatives Grill Shuren, Advance SOFTWARE Act

Tennessee Republican Rep. Marsha Blackburn’s SOFTWARE Act advanced to the Health Subcommittee of the House Energy & Commerce Committee Nov. 19, where representatives grilled CDRH Director Jeffrey Shuren on health information technology regulation.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT032683

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel