The document summarizes a request from an interagency working group composed of the FDA, ONC, and FCC seeking public comments on developing a risk-based regulatory framework for health IT that promotes innovation, protects patient safety, and avoids regulatory duplication. Specifically, the agencies are seeking comments on what types of health IT should be regulated, what risks health IT poses to patient safety and how to address them through a risk-based approach, and whether there are any current areas of regulatory overlap between the agencies. Comments may be submitted until August 31, 2013.

1. PattonBoggs.com Health Care Client Alert 1
JUNE 18, 2013
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PAUL BESOZZI
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MELODI GATES
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MARTIE KENDRICK
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KAREN SMITH THIEL
kthiel@pattonboggs.com
202.457.5229
ABU DHABI
ANCHORAGE
DALLAS
DENVER
DOHA
DUBAI
NEW JERSEY
NEW YORK
RIYADH
WASHINGTON DC
HEALTH CARE CLIENT ALERT
REQUEST FOR COMMENTS ON RISK-
BASED REGULATORY FRAMEWORK FOR
HEALTH IT
An interagency working group – composed of the Food and Drug Administration
(FDA), Office of the National Coordinator for Health Information Technology
(ONC), and the Federal Communications Commission (FCC) – is seeking public
comment on elements that should be considered in developing a risk-based
regulatory framework for health information technology (IT), which promotes
innovation, protects patient safety, and avoids regulatory duplication. This effort
is the outgrowth of several regulatory developments regarding mobile medical
applications and health IT in general.
Health IT significantly assists providers in clinical decision-making and empowers
patients to make informed decisions that improve the quality of their lives.
Equally, health IT has the potential to cause harm to patients if it is not properly
designed, developed, implemented or used. In July 2011, FDA issued draft
guidance, indicating its intent to regulate a subset of mobile medical applications
as medical devices under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Recognizing the importance of a coordinated regulatory approach, Congress
tasked FDA, ONC, and FCC with developing a proposed risk-based regulatory
framework for health IT. The agencies formed the Food and Drug
Administration Safety and Innovation Act (FDASIA) Workgroup to provide input
and recommendations on issues relevant to developing a health IT regulatory
framework.
In February, the Bipartisan Policy Center (BPC) released its recommendations for
a risk-based regulatory framework specific to health IT. BPC emphasized that
FDA’s current regulatory approach for medical devices is not well-suited for
health IT. Unlike medical devices, in which safety is largely dependent on
manufacturing, safety in health IT requires a shared responsibility among
designers, developers, implementers, and users. BPC’s recommendations received

2. PattonBoggs.com Health Care Client Alert 2
endorsements in March by health care industry representatives during a series of three House Energy and Commerce
(E&C) Committee hearings on health IT.
FDA, ONC, FCC, and the FDASIA Workgroup seek broad public comment on the following topics:
→ Taxonomy. What types of health IT should be addressed by the report developed by FDA, ONC, and FCC?
→ Risk and Innovation. What are the risks to patient safety posed by health IT and what is the likelihood of
these risks? What factors or approaches could be included in a risk-based regulatory approach for health IT to
promote innovation and protect patient safety?
→ Regulation. Are there current areas of regulatory overlap among FDA, ONC, and/or FCC, and if so, what
are they? Please be specific if possible. 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?
Comments may be submitted electronically (http://www.regulations.gov , ID: HHS-OS-2013-0003-0001)
until 11:59 p.m. Eastern Time, August 31, 2013. Comments submitted by June 30, 2013 will be considered by
the FDASIA Workgroup, who will make recommendations to FDA, ONC, and FCC.
For assistance in preparing your comments or additional background on the request for comments, please contact
Paul Besozzi, Mel Gates, Martie Kendrick, or Karen Thiel.