Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


Bipartisan House Bill Introduced To Curb FDA Health IT Oversight

This article was originally published in The Pink Sheet Daily

Executive Summary

The SOFTWARE Act, introduced in the House by Rep. Marsha Blackburn, R-Tenn., with support from House members on both sides of the aisle, attempts to redefine regulation of health information technology, and, in particular, limit FDA’s oversight to “products that pose a potential risk to human health.”

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 has waited.

Pending Mobile Medical Apps Guidance Provokes Heated Controversy

An impassioned debate brewing about FDA’s planned timing for finalizing mobile medical apps guidance bubbled to the surface at a recent meeting of the HHS workgroup tasked with recommending a health IT regulatory framework. Despite pressure to delay the guidance, FDA says it is still pushing ahead.

Draft Bill Aims To Clarify FDA Regulation Of Mobile Medical Apps

Draft legislation obtained by “The Gray Sheet” that seeks to restrain FDA’s oversight of mobile apps is being circulated for stakeholder comment by Rep. Marsha Blackburn, R-Tenn., and colleagues.

Related Content





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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