[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