[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1101 Reported in Senate (RS)]
<DOC>
Calendar No. 409
114th CONGRESS
2d Session
S. 1101
To amend the Federal Food, Drug, and Cosmetic Act to provide for the
regulation of patient records and certain decision support software.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 27, 2015
Mr. Bennet (for himself and Mr. Hatch) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
April 4, 2016
Reported by Mr. Alexander, with an amendment and an amendment to the
title
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to provide for the
regulation of patient records and certain decision support software.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Medical Electronic Data
Technology Enhancement for Consumers' Health Act'' or the ``MEDTECH
Act''.</DELETED>
<DELETED>SEC. 2. REGULATION OF MEDICAL SOFTWARE.</DELETED>
<DELETED> Section 520 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360j) is amended by adding at the end the
following:</DELETED>
<DELETED> ``(o) Regulation of Medical and Certain Decision Support
Software.--</DELETED>
<DELETED> ``(1) Exclusions from the category of devices.--
The term `device', as defined in section 201(h), shall not
include the following:</DELETED>
<DELETED> ``(A) Software that is intended for
administrative and operational support of a health care
facility or the processing and maintenance of financial
records, appointment schedules, business analytics,
communication, information about patient populations,
and laboratory workflow processes.</DELETED>
<DELETED> ``(B) Software that is intended for the
purpose of maintaining or encouraging a healthy
lifestyle and are unrelated to the diagnosis, cure,
mitigation, prevention, or treatment of a disease or
disorder.</DELETED>
<DELETED> ``(C) Except for software intended to
interpret or analyze medical image data for the purpose
of diagnosis, cure, mitigation, prevention, or
treatment of a disease or condition, electronic patient
records, to the extent that such records are intended
to transfer, store, convert formats, or display the
equivalent of a paper medical chart, which may include
patient history records if--</DELETED>
<DELETED> ``(i) such records were created,
stored, transferred, or reviewed by health care
professionals, or by individuals working under
supervision of such professionals;
and</DELETED>
<DELETED> ``(ii) such records are part of
health information technology that is certified
under section 3001(c)(5) of the Public Health
Service Act as being in compliance with
applicable certification criteria adopted under
subtitle A of title XXX of such Act.</DELETED>
<DELETED> ``(D) Except for software intended to
interpret or analyze clinical laboratory test data,
software that is intended to transfer, store, convert
formats, or display--</DELETED>
<DELETED> ``(i) clinical laboratory test
report data, results, or findings prior to
analysis or interpretation by a health care
professional; or</DELETED>
<DELETED> ``(ii) clinical laboratory test
report data, results, or findings, or related
patient education information with respect to
such data, to a patient.</DELETED>
<DELETED> ``(E) Except for a device accessory and
software that is intended to acquire, process, or
analyze a medical image or a signal from an in vitro
diagnostic device or a pattern or signal from a signal
acquisition system, software that--</DELETED>
<DELETED> ``(i) is intended to display,
analyze, or print medical information about a
patient or other medical information (such as
peer-reviewed clinical studies and clinical
practice guidelines);</DELETED>
<DELETED> ``(ii) is intended to support or
provide recommendations to a health care
professional about prevention, diagnosis, or
treatment; and</DELETED>
<DELETED> ``(iii) enables the health care
professional to independently review the basis
for each recommendation that the software
presents such that it is not the intent that
the health care professional rely solely on any
specific recommendations or results provided by
such software to make a clinical diagnosis or
treatment decision.</DELETED>
<DELETED> ``(2) Multiple functionality products.--In the
case of a product with multiple functionality that contains a
software function that is excluded under paragraph (1) from the
definition of a device under section 201(h) and a function that
meets the definition of device under section 201(h), the
Secretary shall not regulate the excluded software function of
the product as a device, but the Secretary may assess such
software function for the purpose of determining the safety and
effectiveness of the device function of the product.</DELETED>
<DELETED> ``(3) Rules of construction.--Nothing in this
subsection shall be construed as limiting the authority of the
Secretary to--</DELETED>
<DELETED> ``(A) exercise enforcement discretion as
to any device subject to regulation under this Act;
or</DELETED>
<DELETED> ``(B) regulate software devices used in
the manufacture and transfusion of blood and blood
components to assist in the prevention of disease in
humans.''.</DELETED>
<DELETED>SEC. 3. QUALITY AND STANDARDS.</DELETED>
<DELETED> The Secretary of Health and Human Services shall ensure
that software described in subparagraphs (C), (D), and (E) of
subsection (o)(1) of section 520 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j) (as amended by section 3) is consistent
with appropriate quality principles and standards for software
development and validation.</DELETED>
<DELETED>SEC. 4. CLASSIFICATION OF ACCESSORIES.</DELETED>
<DELETED> Subsection 513(b) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360c(b)) is amended by adding at the end the
following:</DELETED>
<DELETED> ``(9) The Secretary shall classify an accessory
under this section based on the intended use of the accessory,
notwithstanding the classification of any other device with
which such accessory is intended to be used.''.</DELETED>
<DELETED>SEC. 5. CONFORMING AMENDMENT.</DELETED>
<DELETED> Section 201(h) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(h)) is amended by adding at the end ``The term `device'
does not include medical and decision support software described in
section 520(o).''.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Medical Electronic Data Technology
Enhancement for Consumers' Health Act'' or the ``MEDTECH Act''.
SEC. 2. REGULATION OF MEDICAL SOFTWARE.
(a) In General.--Section 520 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j) is amended by adding at the end the
following:
``(o) Regulation of Medical and Certain Decisions Support
Software.--
``(1) Regulation of certain software.--The term `device',
as defined in section 201(h), shall not include a software
function that is intended--
``(A) for administrative support of a health care
facility, including the processing and maintenance of
financial records, claims or billing information,
appointment schedules, business analytics, information
about patient populations, admissions, practice and
inventory management, analysis of historical claims
data to predict future utilization or cost-
effectiveness, determination of health benefit
eligibility, population health management, and
laboratory workflow;
``(B) for maintaining or encouraging a healthy
lifestyle and is unrelated to the diagnosis, cure,
mitigation, prevention, or treatment of a disease or
condition;
``(C) to serve as electronic patient records,
including patient-provided information, to the extent
that such records are intended to transfer, store,
convert formats, or display the equivalent of a paper
medical chart, so long as--
``(i) such records were created, stored,
transferred, or reviewed by health care
professionals, or by individuals working under
supervision of such professionals;
``(ii) such records are part of health
information technology that is certified under
section 3001(c)(5) of the Public Health Service
Act as being in compliance with applicable
certification criteria adopted under subtitle A
of title XXX of such Act; and
``(iii) such function is not intended to
interpret or analyze patient records, including
medical image data, for the purpose of the
diagnosis, cure, mitigation, prevention, or
treatment of a disease or condition;
``(D) for transferring, storing, converting
formats, or displaying clinical laboratory test or
other device data and results, findings by a health
care professional with respect to such data and
results, general information about such findings, and
general background information about such laboratory
test or other device, unless such function is intended
to interpret or analyze clinical laboratory test or
other device data, results, and findings; or
``(E) for the purpose of--
``(i) displaying, analyzing, or printing
medical information about a patient or other
medical information (such as peer-reviewed
clinical studies and clinical practice
guidelines);
``(ii) supporting or providing
recommendations to a health care professional
about prevention, diagnosis, or treatment of a
disease or condition; and
``(iii) enabling such health care
professional to independently review the basis
for such recommendations that such software
presents so that it is not the intent that such
health care professional rely primarily on any
of such recommendations to make a clinical
diagnosis or treatment decision regarding an
individual patient;
unless a function described in subparagraph (E) is
intended to acquire, process, or analyze a medical
image or a signal from an in vitro diagnostic device or
a pattern or signal from a signal acquisition system.
``(2) Multiple functionality products.--In the case of a
product with multiple functions that contains--
``(A) at least one software function that meets the
criteria under paragraph (1) or that otherwise does not
meet the definition of `device' under section 201(h);
and
``(B) at least one function that does not meet the
criteria under paragraph (1) and that otherwise meets
the definition of a `device' under section 201(h),
the Secretary shall not regulate the software function of such
product described in subparagraph (A) as a device.
Notwithstanding the preceding sentence, when assessing the
safety and effectiveness of the device function or functions of
such product described in subparagraph (B), the Secretary may
assess the impact that the software function or functions
described in subparagraph (A) have on such device function or
functions.
``(3) Exception.--
``(A) In general.--Notwithstanding paragraph (1), a
software function shall not be excluded from the
definition of `device' under section 201(h) if--
``(i) the Secretary determines that the
software function meets the criteria under
subparagraph (C), (D), or (E) of paragraph (1);
``(ii) the Secretary makes a finding that
use of such software function would be
reasonably likely to have serious adverse
health consequences; and
``(iii) the software function has been
identified in a final order issued by the
Secretary under subparagraph (B).
``(B) Procedures.--Subparagraph (A) shall apply
only if the Secretary--
``(i) publishes a notification and proposed
order in the Federal Register;
``(ii) includes in such notification the
Secretary's finding, including the rationale
and identification of the evidence on which
such finding was based, as described in
subparagraph (A)(ii); and
``(iii) provides for a period of not less
than 30 calendar days for public comments
before issuing a final order or withdrawing
such proposed order.
``(C) Considerations.--In making a finding under
subparagraph (A)(ii) with respect to a software
function, the Secretary shall consider the following:
``(i) The likelihood and severity of
patient harm if the software function were to
not perform as intended.
``(ii) The extent to which the software
function is intended to support the clinical
judgment of a health care professional.
``(iii) Whether there is a reasonable
opportunity for a health care professional to
review the basis of the information or
treatment recommendation provided by the
software function.
``(iv) The intended user and user
environment, such as whether a health care
professional will use a software function of a
type described in subparagraph (E) of paragraph
(1).
``(4) Rules of construction.--Nothing in this subsection
shall be construed as limiting the authority of the Secretary
to--
``(A) exercise enforcement discretion as to any
device subject to regulation under this Act;
``(B) regulate software used in the manufacture and
transfusion of blood and blood components to assist in
the prevention of disease in humans; or
``(C) regulate software as a device under this Act
if such software meets the criteria in section
513(a)(1)(C).''.
(b) Report.--The Secretary of Health and Human Services (referred
to in this subsection as the ``Secretary''), after consultation with
agencies and offices of the Department of Health and Human Services
involved in health information technology, shall publish a report,
every 2 years beginning after the date of enactment of this Act, that--
(1) includes input from outside experts, such as
representatives of patients, consumers, health care providers,
startup companies, health plans or other third-party payers,
venture capital investors, information technology vendors,
health information technology vendors, small businesses,
purchasers, employers, and other stakeholders with relevant
expertise, as determined by the Secretary;
(2) examines information available to the Secretary on any
risks and benefits to health associated with software functions
described in section 520(o)(1) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j) (as amended by subsection (a) of
this Act); and
(3) summarizes findings regarding the impact of such
software functions on patient safety, including best practices
to promote safety, education, and competency related to such
functions.
(c) Classification of Accessories.--Subsection 513(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended by
adding at the end the following:
``(9) The Secretary shall classify an accessory under this
section based on the intended use of the accessory,
notwithstanding the classification of any other device with
which such accessory is intended to be used.''.
(d) Conforming Amendment.--Section 201(h) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321(h)) is amended by adding at the
end the following: ``The term `device' does not include software
functions excluded pursuant to section 520(o).''.
Amend the title so as to read: ``A bill to amend the
Federal Food, Drug, and Cosmetic Act to provide for the
regulation of patient records and certain decision support
software.''.
Calendar No. 409
114th CONGRESS
2d Session
S. 1101
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to provide for the
regulation of patient records and certain decision support software.
_______________________________________________________________________
April 4, 2016
Reported with an amendment and an amendment to the title