I 
112TH CONGRESS 
1ST SESSION H. R. 3239 
To provide certain legal safe harbors to Medicare and Medicaid providers 
who participate in the EHR meaningful use program or otherwise dem-
onstrate use of certified health information technology. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 21, 2011 
Mr. MARINO introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To provide certain legal safe harbors to Medicare and Med-
icaid providers who participate in the EHR meaningful 
use program or otherwise demonstrate use of certified 
health information technology. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Safeguarding Access 
For Every Medicare Patient Act’’. 
SEC. 2. COVERED ENTITIES. 
(a) COVERED ENTITIES.—For purposes of this sec-
tion, a covered entity means, with respect to certified 
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EHR technology (as defined in section 1848(o)(4) of the 
Social Security Act) and a year, any of the following: 
(1) MEANINGFUL EHR USERS.—Any of the fol-
lowing, with respect to such year: 
(A) An eligible professional (as defined in 
paragraph (5)(C) of section 1848(o) of the So-
cial Security Act) determined to be a meaning-
ful EHR user under paragraph (2) of such sec-
tion for the EHR reporting period (as defined 
in paragraph (5)(B) of such section) during 
such year. 
(B) In the case of a qualifying MA organi-
zation (as defined in paragraph (5) of section 
1853(l) of such Act), an eligible professional de-
scribed in paragraph (2) of such section of the 
organization who the organization attests under 
paragraph (6) of such section to be a meaning-
ful EHR user for such year. 
(C) In the case of a qualifying MA organi-
zation (as defined in paragraph (5) of section 
1853(l) of such Act), an eligible hospital de-
scribed in section 1853(m)(2) of such Act of 
the organization which attests under section 
1853(l)(6) of such Act to be a meaningful EHR 
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user for the applicable period with respect to 
such year. 
(D) An eligible hospital (as defined in 
paragraph (6)(B) of section 1886(n) of such 
Act) determined to be a meaningful EHR user 
under paragraph (3) of such section for the 
EHR reporting period (as defined in paragraph 
(6)(A) of such section) with respect to such 
year. 
(E) A critical access hospital determined 
pursuant to section 1814(l)(3) of such Act to be 
a meaningful EHR user (as would be deter-
mined under paragraph (3) of section 1886(n) 
of such Act) for an EHR reporting period (as 
defined in paragraph (6)(A) of such section) for 
a cost reporting period beginning during such 
year. 
(F) A Medicaid provider (as defined in 
paragraph (2) of section 1903(t) of such Act) 
eligible for payments described in paragraph (1) 
of such section for such year. 
(2) HEALTH
INFORMATION
EXCHANGE
ENTI-
TIES.—Individuals and entities (other than States or 
State designated entities) which during such year 
are health information exchange contractors (con-
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sisting of technology providers), health information 
exchange participants (consisting of organizations 
providing supportive technology to a health informa-
tion exchange), and other users of health informa-
tion exchanges (consisting of other entities that may 
be exchanging clinical or administrative data). Man-
ufacturers of EHR Software and other health infor-
mation technologies who participate in the reporting 
of adverse events or who otherwise contribute rel-
evant patient safety work product under section 3(a) 
of this Act. 
(3) CERTAIN
OTHER
EHR
USERS.—A health 
care professional who, during such year— 
(A) is a user of such certified EHR tech-
nology; 
(B) is not eligible for incentive payments 
based on meaningful use of such technology 
under title XVIII or XIX of the Social Security 
Act solely because the professional is not— 
(i) an eligible professional (as defined 
in paragraph (5)(C) of section 1848(o) of 
such Act); 
(ii) an eligible professional described 
in paragraph (2) of section 1853(l) of such 
Act, with respect to a qualifying MA orga-
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nization (as defined in paragraph (5) of 
such section); 
(iii) an eligible hospital described in 
section 1853(m)(2) of such Act, with re-
spect to such a qualifying MA organiza-
tion; 
(iv) an eligible hospital (as defined in 
paragraph (6)(B) of section 1886(n) of 
such Act); 
(v) a critical access hospital; or 
(vi) a Medicaid provider (as defined in 
paragraph (2) of section 1903(t) of such 
Act); and 
(C) attests, to the satisfaction of the Sec-
retary, that but for the reason described in sub-
paragraph (B), the professional would otherwise 
satisfy criteria to be eligible for such incentive 
payments during such year. 
SEC. 3. IMPROVING PATIENT SAFETY THROUGH ERROR RE-
PORTING AND REMEDIATION, AND CLARI-
FICATION OF AUTHORITY. 
(a) IN GENERAL.—A covered entity may submit to 
a Patient Safety Organization as defined in section 921. 
Title IX of the Public Health Service Act (42 U.S.C. 299 
et seq.) information on EHR-related adverse events with 
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respect to certified EHR technology as defined in section 
3001 of the Public Health Service Act (42 U.S.C. 300jj– 
11) used or provided by such entity, as applicable. The 
utilization of patient safety work product shall be for the 
purpose of providing direct feedback and assistance to cov-
ered entities to effectively minimize patient risk. Patient 
Safety Organizations may furnish the Office of the Na-
tional Coordinator de-identified reports of their findings 
for the purposes of tracking the number and nature of 
such adverse events. 
(b) APPLICATION OF SAFETY ORGANIZATION PRIVI-
LEGE AND CONFIDENTIALITY PROTECTIONS.—In the case 
of a covered entity that submits to such a body informa-
tion on such an adverse event and in the case of the collec-
tion and maintenance of such information by such a body, 
the provisions of section 922 of the Public Health Service 
Act shall apply to such information and to the body and 
the entity in the same manner such provisions apply to 
patient safety work product and a patient safety organiza-
tion and provider under part C of title IX of such Act. 
(c) 
CLARIFICATION
OF
AUTHORITY.—Certified 
EHR’s shall not be considered a device for purposes of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.). 
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SEC. 4. RULES RELATING TO E-DISCOVERY. 
In any health care lawsuit against a covered entity 
that is related to an EHR-related adverse event, with re-
spect to certified EHR technology used or provided by the 
covered entity, electronic discovery shall be limited to— 
(1) information that is related to such EHR-re-
lated adverse event; and 
(2) information from the period in which such 
EHR-related adverse event occurred. 
SEC. 5. LEGAL PROTECTIONS FOR COVERED ENTITIES. 
(a) GENERAL.—For a covered entity described in sec-
tion 2, the following protections apply: 
(1) ENCOURAGING
SPEEDY
RESOLUTION
OF 
CLAIMS.— 
(A) GENERAL.—A claimant may not com-
mence a health care lawsuit against a covered 
entity on any date that is 3 years after the date 
of manifestation of injury or 1 year after the 
claimant discovers, or through the use of rea-
sonable diligence should have discovered, the in-
jury, whichever occurs first. This limitation 
shall be tolled to the extent that the claimant 
is able to prove— 
(i) fraud; 
(ii) intentional concealment; or 
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(iii) the presence of a foreign body, 
which has no therapeutic or diagnostic 
purpose or effect, in the person of the in-
jured person. 
(B) TREATMENT OF A MINOR.—A health 
care lawsuit by or on behalf of a claimant under 
the age of 17 years at the time the injury was 
suffered may not be commenced after the date 
that is not later than 3 years after the date of 
the alleged manifestation of injury except that 
actions by a claimant under the full age of 6 
years shall be commenced not later than 3 
years after the date of manifestation of injury 
or prior to the claimant’s 8th birthday, which-
ever provides a longer period. In addition to 
subsection (1)(A)(i)–(iii), this limitation shall 
be tolled for claimants under the age of 17 
years for any period during which a parent or 
guardian and a health care provider or health 
care organization have committed fraud or col-
lusion in the failure to bring an action on be-
half of the claimant. 
(2) EQUITABLE
ASSIGNMENT
OF
RESPONSI-
BILITY.—In any health care lawsuit against a cov-
ered entity— 
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(A) each party to the lawsuit other than 
the claimant that is such a covered entity shall 
be liable for that party’s several share of any 
damages only and not for the share of any 
other person and such several share shall be in 
direct proportion to that party’s proportion of 
responsibility for the injury, as determined 
under clause (iii); 
(B) whenever a judgment of liability is ren-
dered as to any such party, a separate judg-
ment shall be rendered against each such party 
for the amount allocated to such party; and 
(C) for purposes of this paragraph, the 
trier of fact shall determine the proportion of 
responsibility of each such party for the claim-
ant’s harm. 
(3) SUBSEQUENT REMEDIAL MEASURES.—Evi-
dence of subsequent remedial measures to an EHR- 
related adverse event with respect to certified EHR 
technology used or provided by the covered entity 
(including changes to the certified EHR system, ad-
ditional training requirements, or changes to stand-
ard operating procedures) by a covered entity shall 
not be admissible in health care lawsuits. 
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(4) INCREASED
BURDEN
OF
PROOF
PROTEC-
TION FOR COVERED ENTITIES.—Punitive damages 
may, if otherwise permitted by applicable State or 
Federal law, be awarded against any covered entity 
in a health care lawsuit only if it is proven by clear 
and convincing evidence that such entity acted with 
reckless disregard for the health or safety of the 
claimant. In any such health care lawsuit where no 
judgment for compensatory damages is rendered 
against such entity, no punitive damages may be 
awarded with respect to the claim in such lawsuit. 
(5) PROTECTION FROM LIBEL OR SLANDER.— 
Covered entities and employees, agents and rep-
resentatives of covered entities are immune from 
civil action for libel or slander arising from informa-
tion or entries made in certified EHR technology 
and for the transfer of such information to another 
eligible provider, hospital or health information ex-
change, if the information, transfer of information, 
or entries were made in good faith and without mal-
ice. 
SEC. 6. DEFINITIONS. 
(a) CLAIMANT.—The term ‘‘claimant’’ means any 
person who brings a health care lawsuit, including a per-
son who asserts or claims a right to legal or equitable con-
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tribution, indemnity, or subrogation, arising out of a 
health care liability claim or action, and any person on 
whose behalf such a claim is asserted or such an action 
is brought, whether deceased, incompetent, or a minor. 
(b) COMPENSATORY DAMAGES.—The term ‘‘compen-
satory damages’’ means objectively verifiable monetary 
losses incurred as a result of the provisions of, use of, or 
payment for (or failure to provide, use, or pay for) health 
care services or medical products, such as past and future 
medical expenses, loss of past and future earnings, cost 
of obtaining domestic services, loss of employment, and 
loss of business or employment opportunities, damages for 
physical and emotional pain, suffering, inconvenience, 
physical impairment, mental anguish, disfigurement, loss 
of enjoyment in life, loss of society and companionship, 
loss of consortium (other than loss of domestic service), 
hedonic damages, injury to reputation, and all other non 
pecuniary losses of any kind or nature. Such term includes 
economic damages and noneconomic damages, as such 
terms as defined in this section. 
(c) ECONOMIC
DAMAGES.—The term ‘‘economic 
damages’’ means objectively verifiable monetary losses in-
curred as a result of the provisions of, use of, or payment 
for (or failure to provide, use, or pay for) health care serv-
ices or medical products, such as past and future medical 
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