
[Federal Register Volume 79, Number 73 (Wednesday, April 16, 2014)]
[Notices]
[Pages 21473-21475]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08653]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0406]


Proposed Strategy and Recommendations for a Risk-Based Framework 
for Food and Drug Administration Safety and Innovation Act Health 
Information Technology; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA) is announcing the following 
public workshop entitled ``Proposed Strategy and Recommendations for a 
Risk-Based Framework for Food and Drug Administration Safety and 
Innovation Act Health Information Technology.'' FDA, the Office of the 
National Coordinator for Health Information Technology (ONC), and the 
Federal Communication Commission (FCC) (collectively referred for the 
purpose of this notice as ``the Agencies'' \1\) seek broad input from 
stakeholders and experts on the proposed strategy and recommendations 
for a risk-based framework for the Food and Drug Administration Safety 
and Innovation Act (FDASIA) Health Information Technology (IT). The 
topic to be discussed is the FDASIA Health IT report that contains a 
proposed strategy and recommendations on an appropriate, risk-based 
framework for health IT that promotes innovation, protects patient 
safety, and avoids regulatory duplication.
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    \1\ ONC is not an agency, but an office, within the Department 
of Health and Human Services.

DATES: Dates and Times: The public workshop will be held on May 13-15, 
2014, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at National Institute of 
Standards and Technology, 100 Bureau Dr., Building 101, Red Auditorium, 
Gaithersburg, MD 20899-1070.
    Contact Person: Bakul Patel, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5456, Silver Spring, MD 20993, 301-796-5528, email: 
Bakul.patel@fda.hhs.gov.
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending this public 
workshop must register online by 4 p.m. on May 2, 2014. Early 
registration is recommended because facilities are limited and, 
therefore, FDA may limit the number of participants from each 
organization. Onsite registration on the day of the public workshop 
will not be available.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, Food and Drug Administration, Center for Devices 
and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 4321, 
Silver Spring MD 20993, 301-796-5661, email: susan.monahan@fda.hhs.gov 
no later than April 29, 2014.
    To register for the public workshop, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this public

[[Page 21474]]

workshop from the posted events list.) Please provide complete contact 
information for each attendee, including name, title, affiliation, 
email, and telephone number. Those without Internet access should 
contact Susan Monahan to register (see special accommodations contact). 
Registrants will receive confirmation after they have been accepted. 
You will be notified if you are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast. Persons interested in viewing the Webcast must 
register online by May 2, 2014, 4 p.m. Early registration is 
recommended because Webcast connections are limited. Organizations are 
requested to register all participants, but to view using one 
connection per location. Webcast participants will be sent technical 
system requirements after registration and will be sent connection 
access information after May 5, 2014. If you have never attended a 
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get 
a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site 
addresses in this document, but FDA is not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)
    Requests for Public Comment: This public workshop will include 
public comment sessions and topic-focused sessions. The Agencies have 
included topics for comment in this document. FDA will do its best to 
accommodate requests to make public comments. Individuals and 
organizations with common interests are urged to consolidate or 
coordinate their comments. The Agencies will post additional details on 
the meeting Web page.
    Comments: The Agencies are holding this public workshop to seek 
broad input from stakeholders and experts on the FDASIA Health IT 
Report that contains a proposed strategy and recommendations on an 
appropriate, risk-based framework pertaining to health information 
technology. In order to permit the widest possible opportunity to 
obtain public comment, FDA is soliciting either electronic or written 
comments on all aspects of the public workshop topics. The deadline for 
submitting comments related to this public workshop is June 12, 2014.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. In addition, when responding to specific 
questions as outlined in section II, please identify the question you 
are addressing. Received comments may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, 
and will be posted to the docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.govhttp://
www.regulations.gov/. It may be viewed at the Division of Dockets 
Management (see Comments). A transcript will also be available in 
either hardcopy or on CD-ROM, after submission of a Freedom of 
Information request. Written requests are to be sent to the Division of 
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 
Parklawn Dr., Element Bldg., Rockville, MD 20857. A link to the 
transcripts will also be available approximately 45 days after the 
public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public 
workshop from the posted events list).

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 618 of FDASIA (Pub. L. 112-144), requires that FDA, in 
consultation with ONC and FCC, develop and post on their respective Web 
sites ``a report that contains a proposed strategy and recommendations 
on an appropriate, risk-based framework pertaining to health IT, 
including mobile medical applications, that promotes innovation, 
protects patient safety, and avoids regulatory duplication.'' To assist 
the Agencies' efforts in developing this report, FDA in collaboration 
with ONC and FCC formed a new workgroup, referred to as the FDASIA 
Workgroup, under ONC's Health Information Technology Policy Committee 
(HITPC) to help HITPC provide appropriate input and recommendations to 
FDA, ONC, and FCC as suggested by section 618(b) of FDASIA. The 
``Proposed Strategy and Recommendations for a Risk-Based Framework for 
FDASIA Health IT'' report is available at FDA's Web site, http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm390588.htm or ONC's Web site, www.healthit.gov/FDASIA.
    The proposed strategy and recommendations in the report reflect the 
Agencies' understanding that risks to patient safety and steps to 
promote innovation can occur at all stages of the health IT product 
life cycle and must consider the complex sociotechnical ecosystem in 
which these products are developed, implemented, and used. The Agencies 
believe a limited, narrowly-tailored approach that primarily relies on 
ONC-coordinated activities and private sector capabilities is prudent. 
The Agencies' proposed strategy identifies three categories of health 
IT: (1) Administrative health IT functions, (2) health management 
health IT functions, and (3) medical device health IT functions. The 
Agencies proposed strategy and recommendations focus primarily on a 
risk-based framework for clinical health IT functionalities. Four key 
proposed priority areas are identified in the report for a risk-based 
framework for health management health IT functionality:
     Promote the use of quality management principles;
     Identify, develop, and adopt standards and best practices;
     Leverage conformity assessment tools; and
     Create an environment of learning and continual 
improvement.
    The Agencies also recommend the creation of a Health IT Safety 
Center that includes broad representation from public and private 
sector stakeholders. This public-private entity would be created by 
ONC, in collaboration with FDA, FCC, and the Agency for Healthcare 
Research and Quality (AHRQ), with involvement of other Federal 
Agencies, and other health IT stakeholders. The Health IT Safety Center 
would convene stakeholders in activities that promote health IT as an 
integral part of patient safety with the goal of assisting in the 
creation of a sustainable, integrated health IT learning system that 
avoids duplication and leverages and complements existing and ongoing 
efforts.

II. Topics for Discussion at the Public Workshop

    Public comment is sought on the following topics: The Agencies' 
proposed strategy identifies three categories of health IT: (1) 
Administrative health IT functions, (2) health management health IT 
functions, and (3) medical device health IT

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functions. The Agencies seek input on these three categories of health 
IT.

A. Promote the Use of Quality Management Principles

    The Agencies seek input on the following questions related to 
promoting the use of quality management principles in health IT:
    1. What essential quality management principles should apply to 
health IT? How should they apply to different stakeholders and at 
different stages of the health IT product lifecycle?
    2. How do we assure stakeholder accountability for adoption of 
quality management principles? Is there a role for a non-governmental, 
independent program to assess stakeholder adherence to quality 
management principles? Is there a role for government?

B. Identify, Develop, and Adopt Standards and Best Practices

    The Agencies seek input on the following questions related to 
identification, development, and adoption of standards and best 
practices in health IT:
    1. Are the identified priority areas for standards and best 
practices the proper areas of focus? If not, what areas should be 
prioritized?
    2. How can the private sector help facilitate the development and 
adoption of applicable health IT standards and best practices? Is there 
a role for a non-governmental, independent program to assess product 
and stakeholder adherence to standards and best practices? Is there a 
role for government?

C. Leverage Conformity Assessment Tools

    The Agencies seek input on the following questions related to 
clarifying the value and role of conformity assessment tools in health 
IT:
    1. What conformity assessment tools, if any, should be incorporated 
into a risk-based health IT framework? How should they apply to 
different stakeholders and at different stages of the health IT product 
lifecycle? How can adoption of and adherence to conformity assessment 
programs be promoted?
    2. Should interoperability be tested? How should tests to validate 
interoperability be conducted? Should interoperability standard(s) be 
adopted and used for conformity assessments (i.e. develop a functional 
standard that specifies interoperability characteristics that could be 
used for conformity assessment)?
    3. How should the intended user (e.g. health care provider, 
consumer, etc.) affect the type of conformity assessment performed?
    4. How should conformance assessment results be communicated to 
stakeholders?
    5. Is there a role for a non-governmental, independent health IT 
conformity assessment program? Is there a role for government? Should 
the ONC Health IT Certification Program be leveraged to protect patient 
safety through the use of conformity assessment tools?

D. Create an Environment of Learning and Continual Improvement

    The Agencies seek public input on the following questions related 
to creating an environment of learning and continual improvement:
    1. What should be the governance structure and functions of the 
Health IT Safety Center, in order for it to serve as a central point 
for a learning environment, complement existing systems, facilitate 
reporting, and promote transparent sharing of adverse events, near 
misses, lessons learned, and best practices?
    2. How can comparative user experiences with health IT be captured 
and made available to the health IT community and other members of the 
public to promote learning?
    3. How can the private sector help facilitate the development of a 
non-governmental process for listing selected health IT products? What 
types of products and information should be included? Should the 
results of conformity assessments, such as conformance with certain 
clinical or privacy and security standards, be included?
    4. In terms of risk management, what type of safety-related 
surveillance is appropriate for health IT products categorized as 
health management functionality? What continued or expanded role(s), if 
any, should the ONC Health IT Certification Program play in the safety-
related surveillance of health IT products?
    5. What role should government play in creating an environment of 
learning and continual improvement for health IT?

E. Clinical Decision Support

    The Agencies seek public input on the following questions related 
to clinical decision support (CDS):
    1. What types of CDS functionality should be subject to the health 
management health IT framework? Which types should be the focus of FDA 
oversight?
    2. How should the following priority areas identified in the health 
management health IT framework be applied to CDS categorized as health 
management health IT functionality?
    a. Quality management principles.
    b. Standards and best practices.
    c. Conformity assessments.
    d. Learning environment and continual improvement.
    3. Are there additional safeguards for CDS, such as greater 
transparency with respect to CDS rules and information sources that are 
needed to appropriately balance patient safety and the promotion of 
innovation?
    4. Does the certification of CDS functionalities, such as those 
functionalities currently certified under the ONC Health IT 
Certification Program, sufficiently balance patient safety and the 
promotion of innovation?
    5. How can the private sector help assure the facilitation of the 
development, application and adoption of high quality CDS with health 
management health IT functionality in lieu of a regulatory approach? 
What role, if any, should government play?

    Dated: April 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08653 Filed 4-15-14; 8:45 am]
BILLING CODE 4160-01-P


