Section 618 of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 directed the Secretary of Health and Human Services, acting through the Commissioner of the U.S. Food and Drug Administration (FDA), and in consultation with ONC and the Chairman of the Federal Communications Commission, to develop a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework for health IT, including medical mobile applications, that promotes innovation, protects patient safety, and avoids regulatory duplication.
FDASIA Health IT Report Proposed Risk Based Regulatory Framework
Read the report for public comment [PDF - 438 KB]. Additional activities related to the draft report, including public meetings and instructions on how to submit public comments will be made available on an ongoing basis.
Health IT Policy Committee Recommendations that informed the Section 618 Report
At the September 4, 2013 meeting, Health IT Policy Committee approved recommendations from the Food and Drug Administration Safety Innovation Act (FDASIA) Workgroup. View the recommendations provided to the National Coordinator for Health IT (Listed under “February 20, 2014” subheading).
Public Workshop – Proposed Risk-Based Regulatory Framework and Strategy for Health Information Technology
May 13-15, 2014
The FDA, ONC, and FCC seek broad input from stakeholders and experts. The topic to be discussed is the FDASIA health IT report [PDF - 438 KB] that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework for health IT that promotes innovation, protects patient safety, and avoids regulatory duplication.
This meeting will be held May 13-15, 2014, beginning at 8:00 a.m. (EDT) at the following location:
National Institute of Standards and Technology (NIST)
Building 101, Red Auditorium
100 Bureau Drive
Gaithersburg, Maryland 20899-1070
The workshop will be webcast. Persons interested in viewing the Webcast must register online by May 2, 2014, 4 p.m.