[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2549 Introduced in House (IH)]
114th CONGRESS
1st Session
H. R. 2549
To amend the HITECH Act with respect to accessing, sharing, and using
health data for research purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 21, 2015
Mrs. McMorris Rodgers introduced the following bill; which was referred
to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the HITECH Act with respect to accessing, sharing, and using
health data for research purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. ACCESSING, SHARING, AND USING HEALTH DATA FOR RESEARCH
PURPOSES.
(a) In General.--The HITECH Act (title XIII of division A of Public
Law 111-5) is amended by adding at the end of subtitle D of such Act
(42 U.S.C. 17921 et seq.) the following:
``PART 4--ACCESSING, SHARING, AND USING HEALTH DATA FOR RESEARCH
PURPOSES
``SEC. 13441. REFERENCES.
``In this part:
``(a) The Rule.--References to `the Rule' refer to part 160 or part
164, as appropriate, of title 45, Code of Federal Regulations (or any
successor regulation).
``(b) Part 164.--References to a specified section of `part 164',
refer to such specified section of part 164 of title 45, Code of
Federal Regulations (or any successor section).
``SEC. 13442. DEFINING HEALTH DATA RESEARCH AS PART OF HEALTH CARE
OPERATIONS.
``(a) In General.--Subject to subsection (b), the Secretary shall
revise or clarify the rule to allow the use and disclosure of protected
health information by a covered entity for research purposes, including
studies whose purpose is to obtain generalizable knowledge, to be
treated as the use and disclosure of such information for health care
operations described in subparagraph (1) of the definition of health
care operations in section 164.501 of part 164.
``(b) Modifications to Rules for Disclosures for Health Care
Operations.--In applying section 164.506 of part 164 to the disclosure
of protected health information described in subsection (a)--
``(1) the Secretary shall revise or clarify the Rule so
that the disclosure may be made by the covered entity to only--
``(A) another covered entity for health care
operations (as defined in such section 164.501 of part
164);
``(B) a business associate that has entered into a
contract under section 164.504(e) of part 164 with a
disclosing covered entity to perform health care
operations; or
``(C) a business associate that has entered into a
contract under section 164.504(e) of part 164 for the
purpose of data aggregation (as defined in such section
164.501 of part 164); and
``(2) the Secretary shall further revise or clarify the
Rule so that the limitation specified by section 164.506(c)(4)
of part 164 does not apply to disclosures that are described by
subsection (a).
``(c) Rule of Construction.--This section shall not be construed as
prohibiting or restricting a use or disclosure of protected health
information for research purposes that is otherwise permitted under
part 164.
``SEC. 13443. TREATING DISCLOSURES OF PROTECTED HEALTH INFORMATION FOR
RESEARCH SIMILARLY TO DISCLOSURES OF SUCH INFORMATION FOR
PUBLIC HEALTH PURPOSES.
``(a) Remuneration.--The Secretary shall revise or clarify the Rule
so that disclosures of protected health information for research
purposes are not subject to the limitation on remuneration described in
section 164.502(a)(5)(ii)(B)(2)(ii) of part 164.
``(b) Permitted Uses and Disclosures.--The Secretary shall revise
or clarify the Rule so that research activities, including comparative
research activities, related to the quality, safety, or effectiveness
of a product or activity that is regulated by the Food and Drug
Administration are included as public health activities for purposes of
which a covered entity may disclose protected health information to a
person described in section 164.512(b)(1)(iii) of part 164.
``SEC. 13444. PERMITTING REMOTE ACCESS TO PROTECTED HEALTH INFORMATION
BY RESEARCHERS.
``The Secretary shall revise or clarify the Rule so that
subparagraph (B) of section 164.512(i)(1)(ii) of part 164 (prohibiting
the removal of protected health information by a researcher) shall not
prohibit remote access to health information by a researcher so long
as--
``(1) appropriate security and privacy safeguards are
maintained by the covered entity and the researcher; and
``(2) the protected health information is not copied or
otherwise retained by the researcher.
``SEC. 13445. ALLOWING ONE-TIME AUTHORIZATION OF USE AND DISCLOSURE OF
PROTECTED HEALTH INFORMATION FOR RESEARCH PURPOSES.
``(a) In General.--The Secretary shall revise or clarify the Rule
to specify that an authorization for the use or disclosure of protected
health information, with respect to an individual, for future research
purposes shall be deemed to contain a sufficient description of the
purpose of the use or disclosure if the authorization--
``(1) sufficiently describes the purposes such that it
would be reasonable for the individual to expect that the
protected health information could be used or disclosed for
such future research;
``(2) either--
``(A) states that the authorization will expire on
a particular date or on the occurrence of a particular
event; or
``(B) states that the authorization will remain
valid unless and until it is revoked by the individual;
and
``(3) provides instruction to the individual on how to
revoke such authorization at any time.
``(b) Revocation of Authorization.--The Secretary shall revise or
clarify the Rule to specify that, if an individual revokes an
authorization for future research purposes such as is described by
subsection (a), the covered entity may not make any further uses or
disclosures based on that authorization, except, as provided in
paragraph (b)(5) of section 164.508 of part 164, to the extent that the
covered entity has taken action in reliance on the authorization.''.
(b) Revision of Regulations.--Not later than 12 months after the
date of the enactment of this Act, the Secretary of Health and Human
Services shall revise and clarify the provisions of title 45, Code of
Federal Regulations, for consistency with part 4 of subtitle D of the
HITECH Act, as added by subsection (a).
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