H. R. 1591
IN THE HOUSE OF REPRESENTATIVES
April 17, 2013
Mr. Carter (for himself, Mr. Burgess, Ms. Speier, Mr. King of New York, Mr. McCaul, and Mr. Rangel) introduced the following bill; which was referred to the Committee on Energy and Commerce
To amend the Public Health Service Act to provide for the establishment and maintenance of an undiagnosed diseases network, and for other purposes.
This Act may be cited as the
Charles August Long Undiagnosed Diseases Research and
Collaboration Network Act of 2013
CAL Undiagnosed Diseases Research and Collaboration Network
Act of 2013
CAL Network of undiagnosed diseases
Title III of the Public Health Service Act ( 42 U.S.C. 241 et seq. ) is amended by inserting after section 317T the following:
The National CAL Network of Undiagnosed Diseases
The Secretary, acting through the Director
of NIH, shall establish and maintain an undiagnosed diseases patient network
(in this section referred to as the
The purposes of the CAL Network shall be to—
provide physicians who are handling cases of undiagnosed diseases with a means, consistent with applicable privacy laws, including HIPAA privacy and security law (as defined in section 3009(a)(2)), to search for similar cases and to network and collaborate with the physicians handling such similar cases in order to find a diagnosis and to improve patient care and outcomes;
better enable and examine cross-disease research whereby cases of undiagnosed diseases can be cross-referenced against attributes of common diseases and rare diseases to assist in the rendering of a diagnosis; elucidate commonalities; identify atypical presentations, rare subgroups, similar findings; and identify potential treatments;
better describe the types and prevalence of cases of undiagnosed diseases in the United States;
make necessary data available to elucidate appropriate factors (such as genetic, environmental, and occupational factors) that may be associated with the various types of cases of undiagnosed diseases reported by individuals specified by the Director of NIH;
better outline key demographic factors (such as age, race or ethnicity, gender, sex, geographic location, and family medical history) of individuals who are undiagnosed;
provide such data necessary to better understand the length of time for a diagnoses to be rendered in cases of undiagnosed diseases and to identify barriers to diagnoses and reasons for misdiagnosis of diseases; and
provide such information necessary to determine, in order to improve access of individuals with undiagnosed diseases throughout the United States (including those with severe illnesses which limit or restrict travel) to programs similar to the Undiagnosed Disease Program conducted at the National Institutes of Health, if the needs and number of such individuals support—
the expansion of such Undiagnosed Disease Program, as in existence as of the date of the enactment of this section, to include the establishment of additional undiagnosed diseases programs of like scope and nature at other locations throughout the United States; and
the establishment by entities other than the National Institutes of Health of separate undiagnosed disease programs of like scope and nature to the Undiagnosed Disease Program at locations throughout the United States under the guidance of and through grants provided by and through such Undiagnosed Diseases Program.
Content of the CAL Network
The Secretary shall include in the CAL Network such information respecting undiagnosed diseases as the Secretary deems appropriate for the purposes described in subsection (b) and other purposes to facilitate the early recognition, treatment, cure, and control of such diseases.
Subject to paragraph (2), for the purposes described in subsection (c) and consistent with applicable privacy laws, including HIPAA privacy and security law (as defined in section 3009(a)(2)), the Secretary shall ensure that the CAL Network is designed in such a manner as to—
make the information in the CAL Network available to appropriate health care professionals, patients, and other qualified individuals and organizations, as determined by the Secretary, who are registered to access such network in accordance with such process and requirements as specified by the Secretary;
make epidemiological and other types of information obtained through the CAL Network available to Federal agencies and health-related agencies;
provide for different levels and types of access to such network to be granted based on the circumstances and individuals involved; and
allow for an individual to have only the level and type of access to the network so granted.
Information which may not be publically disclosed
The design under paragraph (1) shall ensure that the following information is not publicly disclosed:
Individually identifiable information.
Trade secrets or commercial or financial information obtained from a person and privileged or confidential, as provided in section 552(b)(4) of title 5, United States Code.
The Secretary, acting through the Director of NIH, may award grants to, and enter into contracts and cooperative agreements with, public or private nonprofit entities for—
the collection, analysis, and reporting of data on cases of undiagnosed diseases and other disorders that can often go undiagnosed or be misdiagnosed as other diseases or disorders; and
the establishment of separate undiagnosed disease programs described in subsection (b)(7)(B).
In carrying out this section, the Secretary shall—
not later than 1 year after the date of the enactment of this section, complete any study, research, and development necessary to implement the CAL Network; and
complete the implementation of the CAL Network such that it is fully operational by not later than September 30, 2015.
Undiagnosed diseases defined
For purposes of this section, the term undiagnosed disease means a medically unexplained chronic multi-symptom disease that—
causes the decline of, limitations in, or cessation of a person’s developmental status, functional status, quality of life, or any combination thereof;
has not been diagnosed by a medical specialist in a tertiary medical center;
is defined by a cluster of signs or symptoms; which by history, physical examination, and laboratory tests cannot be attributed to any known clinical diagnosis;
is without conclusive pathophysiology or etiology;
is characterized by overlapping symptoms and signs; or
exhibits an inconsistent demonstration of laboratory abnormalities.
Authorization of appropriations
To carry out this section , there are authorized to be appropriated $5,000,000 for the period of fiscal years 2014 through 2019.
offset amounts appropriated pursuant to the authorization of appropriations in
paragraph (1), the Secretary shall reduce funds that would otherwise be
obligated and expended under the account heading
National Institutes of
Health–Office of the Director by $5,000,000 for the period of fiscal
years 2014 through 2019.