[Federal Register Volume 78, Number 104 (Thursday, May 30, 2013)]
[Notices]
[Pages 32390-32391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-12817]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Food and Drug Administration Safety and Innovation Act (FDASIA): 
Request for Comments on the Development of a Risk-Based Regulatory 
Framework and Strategy for Health Information Technology

AGENCY: Office of the National Coordinator for Health Information 
Technology, Department of Health and Human Services.

ACTION: Notice of public meeting and request for comments.

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SUMMARY: The Food and Drug Administration (FDA), Office of the National 
Coordinator for Health Information Technology (ONC), and Federal 
Communication Commission (FCC) seek broad input from stakeholders and 
experts on the elements we should consider as we develop a report that 
contains a proposed strategy and recommendations on an appropriate, 
risk-based regulatory framework for health IT, including mobile medical 
applications, that promotes innovation, protects patient safety, and 
avoids regulatory duplication. To that end, we are requesting comments 
on the topics identified in Section III.

DATES: This Docket on regulations.gov will remain open for public 
comments until 11:59pm Eastern Time, August 31, 2013.

FOR FURTHER INFORMATION CONTACT: Steven Posnack, Director, Federal 
Policy Division, Office of Policy and Planning, Office of the National 
Coordinator for Health IT, 202-690-7151.

SUPPLEMENTARY INFORMATION:

I. The Food and Drug Administration Safety and Innovation Act Workgroup 
Under ONC's HIT Policy Committee

    Section 618(a) of the Food and Drug Administration Safety and 
Innovation Act (FDASIA) of 2012 (Pub. L. 112-144) directs the Secretary 
of the Department of Health and Human Services (HHS), acting through 
the Commissioner of the Food and Drug Administration (FDA), and in 
consultation with the HHS Office of the National Coordinator for Health 
Information Technology (ONC) and the Chairman of the Federal 
Communications Commission (FCC), to publish a report that will offer a 
proposed strategy and recommendations for an appropriate risk-based 
Health IT regulatory framework that would include mobile medical 
applications and promotes innovation, protects patient safety, and 
avoids regulatory duplication.
    To assist the agencies' efforts in developing this report, the FDA 
in collaboration with ONC and FCC formed a new workgroup, referred to 
as the FDASIA Workgroup, under ONC's HIT Policy Committee to help the 
HIT Policy Committee provide appropriate input and recommendations to 
FDA, ONC, and FCC as suggested by section 618(b) of FDASIA. 
Accordingly, the FDASIA Workgroup is charged with providing input on 
issues relevant to the report FDA, ONC, and FCC will develop, which 
include:
     Types of risk that may be posed by health IT that impact 
patient safety, the likelihood that these risks will be realized, and 
the impact of these considerations on a risk-based approach;
     Factors or approaches that could be included in a risk-
based regulatory approach for health IT that also promote innovation 
and protect patient safety; and
     Approaches to avoid duplicative or overlapping regulatory 
requirements.
    The workgroup's membership includes agency officials and 
representatives from a wide range of stakeholders, including patients, 
consumers, health care providers, startup companies, health plans and 
other third-party payers, venture capital investors, information 
technology vendors, health information technology vendors, small 
businesses, purchasers, and employers.
    Through this request for comments, FDA, ONC, and FCC would like to 
provide an opportunity for broad public input on section 618 of FDASIA. 
Timely submitted written comments will inform the new FDASIA 
Workgroup's deliberations on the input it will provide to the HIT 
Policy Committee regarding the report required by section 618 of 
FDASIA. We seek input on a number of specific topics identified in 
Section III, but welcome any other pertinent information stakeholders 
wish to share. For commenters that wish to have their comments 
considered by the FDASIA Workgroup, we encourage you to submit your 
comments as early as possible and preferably before June 30, 2013.

 FDASIA Workgroup In-Person Meeting

    On May 30 and 31, 2013, in Washington, DC, the FDASIA Workgroup 
will hold an in-person meeting which will also be Webcast. Persons 
interested in attending the in-person meeting or viewing the Webcast 
can access information about doing so at this URL: http://www.healthit.gov/ policy-researchers-implementers/policy-fdasia-1.
    Interested parties may submit electronic comments to http://www.regulations.gov. Submit written comments to Office of the National 
Coordinator for Health Information Technology, Attention: FDASIA Report 
Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave. SW., 
Washington, DC 20201.

II. Background

    Health IT is being rapidly adopted by the health care industry and 
there is a growing need for the Federal government to develop a 
coordinated approach to its oversight of health IT that promotes 
innovation, protects patient safety, and avoids regulatory duplication. 
FDA, FCC, and ONC each have important roles with respect to the 
development and use of health IT that significantly impacts public 
health and welfare. Congress recognized the importance of a coordinated 
regulatory approach and through FDASIA, specifically tasked the FDA, 
ONC, and FCC with creating a report that includes a proposed strategy 
and recommendations for an appropriate, risk-based regulatory framework 
for health IT. To inform the report required by FDASIA, FDA, ONC, and 
FCC, in addition to receiving input from the HIT Policy Committee, 
intend to provide multiple opportunities, as appropriate, for input 
from other stakeholders at different stages throughout the report's 
development, including, if feasible, feedback on the draft framework 
prior to finalizing the report.

III. Topics for Discussion

    Public comment is sought on any or all of the following topics 
below.
1. Taxonomy
    a. What types of health IT should be addressed by the report 
developed by FDA, ONC, and FCC?
2. Risk and Innovation
    a. What are the risks to patient safety posed by health IT and what 
is the likelihood of these risks?
    b. What factors or approaches could be included in a risk-based 
regulatory approach for health IT to promote innovation and protect 
patient safety?

[[Page 32391]]

3. Regulation
    a. Are there current areas of regulatory overlap among FDA, ONC, 
and/or FCC and if so, what are they? Please be specific if possible.
    b. If there are areas of regulatory overlap, what, if any, actions 
should the agencies take to minimize this overlap? How can further 
duplication be avoided?

    Dated: May 23, 2013.
Jodi Daniel,
Director, Office of Policy and Planning, Office of the National 
Coordinator for Health IT.
[FR Doc. 2013-12817 Filed 5-29-13; 8:45 am]
BILLING CODE 4150-45-P