[Ip-health] FOIA in 21st Century Cures Act revisited

Jamie Love james.love at keionline.org
Sat Dec 17 12:15:40 PST 2016


Interesting discussion about the impact of the 21st Century Cures Act on
FOIA rules from the FOI-L listserver.


---------- Forwarded message ----------
From: Bob Gellman <bob at bobgellman.com>
Date: Sat, Dec 17, 2016 at 11:32 AM
Subject: 21st Century Cures Act revisited
To: FOI-L at listserv.syr.edu


I earlier posted a note about a new (b)(3) statute in the 21st Century
Cures Act that just became law.  That one had to do with biomedical
research information about an identified or identifiable individual.

Turns out there is a second one in the same Act in a provision about
information blocking.  Information blocking has to do with health data
processed in non-standard ways that undermine interoperability of
electronic systems and exchange of electronic health data..

Perhaps interestingly, the two provisions are mildly different. The first
*allows* HHS to exempt information under (b)(3), while the second *mandates*
withholding under (b)(3) of information "that could reasonably be expected
to facilitate identification of the source of the information."  So the
goal of the second provision is to protect a source who tells HHS about a
violation of the information blocking provision.  The law says *source* and
not *confidential* source.

The text of both provisions follows.


*SEC. 2013. PROTECTION OF IDENTIFIABLE AND SENSITIVE INFORMATION.*



Section 301 of the Public Health Service Act (42 U.S.C. 241) is amended by
adding at the end the following:



(f)(1) The Secretary may* exempt from disclosure under section 552(b)(3) of
title 5*, United States Code, biomedical information that is about an
individual and that is gathered or used during the course of biomedical
research if—

   (A) an individual is identified; or

   (B) there is at least a very small risk, as determined by current
scientific practices or statistical methods, that some combination of the
information, the request, and other available data sources could be used to
deduce the identity of an individual.

(2)(A) Each determination of the Secretary under paragraph (1) to exempt
information from disclosure shall be made in writing and accompanied by a
statement of the basis for the determination.

   (B) Each such determination and statement of basis shall be available to
the public, upon request, through the Office of the Chief FOIA Officer of
the Department of Health and Human Services.

(3) Nothing in this subsection shall be construed to limit a research
participant’s access to information about such participant collected during
the participant’s participation in the research..





*SEC. 4004. INFORMATION BLOCKING. *



Subtitle C of title XXX of the Public Health Service Act (42 U.S.C.
300jj–51 et seq.) is amended by adding at the end the following:



SEC. 3022. INFORMATION BLOCKING.

(a) DEFINITION.—

   (1) IN GENERAL.—In this section, the term ‘information  blocking’ means
a practice that—

               (A) except as required by law or specified by the  Secretary
pursuant to rulemaking under paragraph (3), is likely to interfere with,
prevent, or materially discourage access, exchange, or use of electronic
health information; and

               (B)(i) if conducted by a health information technology
developer, exchange, or network, such developer, exchange, or network
knows, or should know, that such practice is likely to interfere with,
prevent, or materially discourage the access, exchange, or use of
electronic health information; or

               (ii) if conducted by a health care provider, such provider
knows that such practice is unreasonable and is likely to interfere with,
prevent, or materially discourage  access, exchange, or use of electronic
health information.

*****

 (d) ADDITIONAL PROVISIONS.—

   *****

   (2)* PROTECTION FROM DISCLOSURE OF INFORMATION*.—Any information that is
received by the National Coordinator in connection with a claim or
suggestion of possible information blocking and that could reasonably be
expected to facilitate identification of the source of the information—

               (A) shall not be disclosed by the National Coordinator
except as may be necessary to carry out the purpose of this section;

               (B) *shall be exempt from mandatory disclosure under*  *section
552 of title 5, United States Code, as provided by subsection (b)(3) of
such section*; and

               (C) may be used by the Inspector General or Federal Trade
Commission for reporting purposes to the extent that such information could
not reasonably be expected to facilitate identification of the source of
such information.


Bob


-- 
Robert Gellmanbob at bobgellman.com
Privacy and Information Policy Consultant
Washington, DC 202-543-7923 <(202)%20543-7923>
(landline)https://www.bobgellman.com



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