The FDASIA Health IT Report

more+
less-
more+
less-

On April 7, 2014, the Food and Drug Administration (FDA) released a report entitled “FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework” (the “Report”). The Report was mandated by section 618 of the Food and Drug Administration Safety and Innovation Act (FDASIA), which required the FDA consult with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC). These three agencies were tasked to work together to prepare a report containing “a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health IT [information technology], including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.” The Report emerged in substantial part from meetings of the FDASIA workgroup.

The 32-page Report is open to public comment until July 7, 2014 via a public docket (FDA-2014-N-0339). Comments may be submitted through www.regulations.gov. The agencies seek public comments on whether the Report addresses the appropriate focus areas, and whether the proposed next steps are appropriate. The Report itself also poses questions for the public throughout, seeking input on specific recommendations. Additionally, on May 13-15 FDA will hold a public workshop to discuss the following topics raised in the Report: use of quality management principles, standards and best practices, conformity assessment tools, creating an environment of learning and continual improvement, and clinical decision support (CDS) software.

Please see full alert below for more information.

LOADING PDF: If there are any problems, click here to download the file.

Topics:  Data Protection, FCC, FDA, FDASIA, Technology

Published In: Communications & Media Updates, Health Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Foley Hoag LLP | Attorney Advertising

Don't miss a thing! Build a custom news brief:

Read fresh new writing on compliance, cybersecurity, Dodd-Frank, whistleblowers, social media, hiring & firing, patent reform, the NLRB, Obamacare, the SEC…

…or whatever matters the most to you. Follow authors, firms, and topics on JD Supra.

Create your news brief now - it's free and easy »