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

Workgroup Unveils Preliminary Health IT Regulation Proposals

This article was originally published in The Gray Sheet

Executive Summary

An HHS-sponsored workgroup issued its initial recommendations for a health IT regulatory framework, featuring risk-based oversight, adverse event reporting and better agency coordination.

You may also be interested in...



FDA Emphasizes “Deregulatory” Efforts In Mobile Medical Apps Final Guidance

In a long-awaited final guidance, FDA affirmed its plan to practice enforcement discretion for most mobile medical apps, except those applications that present the same risks as conventional FDA-regulated devices. Some digital health stakeholders praised the guidance, while others wished FDA had waited.

FDA Emphasizes “Deregulatory” Efforts In Mobile Medical Apps Final Guidance

In a long-awaited final guidance, FDA affirmed its plan to practice enforcement discretion for most mobile medical apps, except those applications that present the same risks as conventional FDA-regulated devices. Some digital health stakeholders praised the guidance, while others wished FDA has waited.

Health IT Workgroup’s Final Regulatory Recommendations Approved

The final recommendations from the FDASIA workgroup urge the government to focus regulatory attention on the highest risk products, while minimizing requirements for the large swath of health IT offerings that are lower risk. The recommendations, which largely align with a prior draft version, will inform a health IT regulatory framework proposal due to Congress in January.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT032322

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