Wednesday, April 16, 2014

FDASIA Report on Healthcare Software Regulation Released - April 2014

"FDASIA" was the 2013 round of new funding for the FDA.   One of its mandates was the the FDA collaborate in a multi-stakeholder effort to develop best practices for the regulation of software in healthcare - whether electronic health records, software inside medical devices, decision-assistance software, or mobile apps.   This is an area where Congressional voices have weighed in, coalitions have struck position, and relatively little concrete action has occurred - yet.

The report, released in early April 2014, is relevant to stakeholders in a whole host of fields, from telemedicine to new horizons in healthcare self-help apps.

On our Foley Hoag website, see our full review of the new 2014 consensus report: go to our  full website here.   We also provide the text as a 4-page PDF.


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 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 publicworkshop 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. 

As additional context, both British and European authorities have released policy documents on medical software regulation and mobile health regulation, respectively. 
Attached is the summary of the Report with a focus on provisions that affect two key areas: electronic health records (EHR) and CDS software. 
Summary of the Report 

Division of Regulation by Functionality 
• Framework for the Oversight of Health Management Health IT 
• Clarity Regarding the Regulation of CDS 
• Continued Agency Interactions 

Continued at:   our FDASIA Health IT website here.