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 demonstrate 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 Medicaid providers who participate in the EHR meaningful 

use program or otherwise demonstrate use of certified 

health information technology. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Safeguarding Access 

5 For Every Medicare Patient Act’’. 

6 SEC. 2. COVERED ENTITIES. 

7 (a) COVERED ENTITIES.—For purposes of this sec8 tion, a covered entity means, with respect to certified 


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1 EHR technology (as defined in section 1848(o)(4) of the 

2 Social Security Act) and a year, any of the following: 

3 (1) MEANINGFUL EHR USERS.—Any of the fol4 lowing, with respect to such year: 

5 (A) An eligible professional (as defined in 

6 paragraph (5)(C) of section 1848(o) of the So7 cial Security Act) determined to be a meaning8 ful EHR user under paragraph (2) of such sec9 tion for the EHR reporting period (as defined 

10 in paragraph (5)(B) of such section) during 

11 such year. 

12 (B) In the case of a qualifying MA organi13 zation (as defined in paragraph (5) of section 

14 1853(l) of such Act), an eligible professional de15 scribed in paragraph (2) of such section of the 

16 organization who the organization attests under 

17 paragraph (6) of such section to be a meaning18 ful EHR user for such year. 

19 (C) In the case of a qualifying MA organi20 zation (as defined in paragraph (5) of section 

21 1853(l) of such Act), an eligible hospital de22 scribed in section 1853(m)(2) of such Act of 

23 the organization which attests under section 

24 1853(l)(6) of such Act to be a meaningful EHR 


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1 user for the applicable period with respect to 

2 such year. 

3 (D) An eligible hospital (as defined in 

4 paragraph (6)(B) of section 1886(n) of such 

5 Act) determined to be a meaningful EHR user 

6 under paragraph (3) of such section for the 

7 EHR reporting period (as defined in paragraph 

8 (6)(A) of such section) with respect to such 

9 year. 

10 (E) A critical access hospital determined 

11 pursuant to section 1814(l)(3) of such Act to be 

12 a meaningful EHR user (as would be deter13 mined under paragraph (3) of section 1886(n) 

14 of such Act) for an EHR reporting period (as 

15 defined in paragraph (6)(A) of such section) for 

16 a cost reporting period beginning during such 

17 year. 

18 (F) A Medicaid provider (as defined in 

19 paragraph (2) of section 1903(t) of such Act) 

20 eligible for payments described in paragraph (1) 

21 of such section for such year. 

22 (2) HEALTH INFORMATION EXCHANGE ENTI23 TIES.—Individuals and entities (other than States or 

24 State designated entities) which during such year 

25 are health information exchange contractors (conVerDate Mar 15 2010 04:07 Oct 22, 2011 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3239.IH H3239

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1 sisting of technology providers), health information 

2 exchange participants (consisting of organizations 

3 providing supportive technology to a health informa4 tion exchange), and other users of health informa5 tion exchanges (consisting of other entities that may 

6 be exchanging clinical or administrative data). Man7 ufacturers of EHR Software and other health infor8 mation technologies who participate in the reporting 

9 of adverse events or who otherwise contribute rel10 evant patient safety work product under section 3(a) 

11 of this Act. 

12 (3) CERTAIN OTHER EHR USERS.—A health 

13 care professional who, during such year— 

14 (A) is a user of such certified EHR tech15 nology; 

16 (B) is not eligible for incentive payments 

17 based on meaningful use of such technology 

18 under title XVIII or XIX of the Social Security 

19 Act solely because the professional is not— 

20 (i) an eligible professional (as defined 

21 in paragraph (5)(C) of section 1848(o) of 

22 such Act); 

23 (ii) an eligible professional described 

24 in paragraph (2) of section 1853(l) of such 

25 Act, with respect to a qualifying MA orgaVerDate Mar 15 2010 04:07 Oct 22, 2011 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3239.IH H3239

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1 nization (as defined in paragraph (5) of 

2 such section); 

3 (iii) an eligible hospital described in 

4 section 1853(m)(2) of such Act, with re5 spect to such a qualifying MA organiza6 tion; 

7 (iv) an eligible hospital (as defined in 

8 paragraph (6)(B) of section 1886(n) of 

9 such Act); 

10 (v) a critical access hospital; or 

11 (vi) a Medicaid provider (as defined in 

12 paragraph (2) of section 1903(t) of such 

13 Act); and 

14 (C) attests, to the satisfaction of the Sec15 retary, that but for the reason described in sub16 paragraph (B), the professional would otherwise 

17 satisfy criteria to be eligible for such incentive 

18 payments during such year. 

19 SEC. 3. IMPROVING PATIENT SAFETY THROUGH ERROR RE20 PORTING AND REMEDIATION, AND CLARI21 FICATION OF AUTHORITY. 

22 (a) IN GENERAL.—A covered entity may submit to 

23 a Patient Safety Organization as defined in section 921. 

24 Title IX of the Public Health Service Act (42 U.S.C. 299 

25 et seq.) information on EHR-related adverse events with 


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1 respect to certified EHR technology as defined in section 

2 3001 of the Public Health Service Act (42 U.S.C. 300jj– 

3 11) used or provided by such entity, as applicable. The 

4 utilization of patient safety work product shall be for the 

5 purpose of providing direct feedback and assistance to cov6 ered entities to effectively minimize patient risk. Patient 

7 Safety Organizations may furnish the Office of the Na8 tional Coordinator de-identified reports of their findings 

9 for the purposes of tracking the number and nature of 

10 such adverse events. 

11 (b) APPLICATION OF SAFETY ORGANIZATION PRIVI12 LEGE AND CONFIDENTIALITY PROTECTIONS.—In the case 

13 of a covered entity that submits to such a body informa14 tion on such an adverse event and in the case of the collec15 tion and maintenance of such information by such a body, 

16 the provisions of section 922 of the Public Health Service 

17 Act shall apply to such information and to the body and 

18 the entity in the same manner such provisions apply to 

19 patient safety work product and a patient safety organiza20 tion and provider under part C of title IX of such Act. 

21 (c) CLARIFICATION OF AUTHORITY.—Certified 

22 EHR’s shall not be considered a device for purposes of 

23 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 

24 et seq.). 


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1 SEC. 4. RULES RELATING TO E-DISCOVERY. 

2 In any health care lawsuit against a covered entity 

3 that is related to an EHR-related adverse event, with re4 spect to certified EHR technology used or provided by the 

5 covered entity, electronic discovery shall be limited to— 

6 (1) information that is related to such EHR-re7 lated adverse event; and 

8 (2) information from the period in which such 

9 EHR-related adverse event occurred. 

10 SEC. 5. LEGAL PROTECTIONS FOR COVERED ENTITIES. 

11 (a) GENERAL.—For a covered entity described in sec12 tion 2, the following protections apply: 

13 (1) ENCOURAGING SPEEDY RESOLUTION OF

14 CLAIMS.— 

15 (A) GENERAL.—A claimant may not com16 mence a health care lawsuit against a covered 

17 entity on any date that is 3 years after the date 

18 of manifestation of injury or 1 year after the 

19 claimant discovers, or through the use of rea20 sonable diligence should have discovered, the in21 jury, whichever occurs first. This limitation 

22 shall be tolled to the extent that the claimant 

23 is able to prove— 

24 (i) fraud; 

25 (ii) intentional concealment; or 


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1 (iii) the presence of a foreign body, 

2 which has no therapeutic or diagnostic 

3 purpose or effect, in the person of the in4 jured person. 

5 (B) TREATMENT OF A MINOR.—A health 

6 care lawsuit by or on behalf of a claimant under 

7 the age of 17 years at the time the injury was 

8 suffered may not be commenced after the date 

9 that is not later than 3 years after the date of 

10 the alleged manifestation of injury except that 

11 actions by a claimant under the full age of 6 

12 years shall be commenced not later than 3 

13 years after the date of manifestation of injury 

14 or prior to the claimant’s 8th birthday, which15 ever provides a longer period. In addition to 

16 subsection (1)(A)(i)–(iii), this limitation shall 

17 be tolled for claimants under the age of 17 

18 years for any period during which a parent or 

19 guardian and a health care provider or health 

20 care organization have committed fraud or col21 lusion in the failure to bring an action on be22 half of the claimant. 

23 (2) EQUITABLE ASSIGNMENT OF RESPONSI24 BILITY.—In any health care lawsuit against a cov25 ered entity— 


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1 (A) each party to the lawsuit other than 

2 the claimant that is such a covered entity shall 

3 be liable for that party’s several share of any 

4 damages only and not for the share of any 

5 other person and such several share shall be in 

6 direct proportion to that party’s proportion of 

7 responsibility for the injury, as determined 

8 under clause (iii); 

9 (B) whenever a judgment of liability is ren10 dered as to any such party, a separate judg11 ment shall be rendered against each such party 

12 for the amount allocated to such party; and 

13 (C) for purposes of this paragraph, the 

14 trier of fact shall determine the proportion of 

15 responsibility of each such party for the claim16 ant’s harm. 

17 (3) SUBSEQUENT REMEDIAL MEASURES.—Evi18 dence of subsequent remedial measures to an EHR19 related adverse event with respect to certified EHR 

20 technology used or provided by the covered entity 

21 (including changes to the certified EHR system, ad22 ditional training requirements, or changes to stand23 ard operating procedures) by a covered entity shall 

24 not be admissible in health care lawsuits. 


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1 (4) INCREASED BURDEN OF PROOF PROTEC2 TION FOR COVERED ENTITIES.—Punitive damages 

3 may, if otherwise permitted by applicable State or 

4 Federal law, be awarded against any covered entity 

5 in a health care lawsuit only if it is proven by clear 

6 and convincing evidence that such entity acted with 

7 reckless disregard for the health or safety of the 

8 claimant. In any such health care lawsuit where no 

9 judgment for compensatory damages is rendered 

10 against such entity, no punitive damages may be 

11 awarded with respect to the claim in such lawsuit. 

12 (5) PROTECTION FROM LIBEL OR SLANDER.— 

13 Covered entities and employees, agents and rep14 resentatives of covered entities are immune from 

15 civil action for libel or slander arising from informa16 tion or entries made in certified EHR technology 

17 and for the transfer of such information to another 

18 eligible provider, hospital or health information ex19 change, if the information, transfer of information, 

20 or entries were made in good faith and without mal21 ice. 

22 SEC. 6. DEFINITIONS. 

23 (a) CLAIMANT.—The term ‘‘claimant’’ means any 

24 person who brings a health care lawsuit, including a per25 son who asserts or claims a right to legal or equitable conVerDate Mar 15 2010 04:07 Oct 22, 2011 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H3239.IH H3239

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1 tribution, indemnity, or subrogation, arising out of a 

2 health care liability claim or action, and any person on 

3 whose behalf such a claim is asserted or such an action 

4 is brought, whether deceased, incompetent, or a minor. 

5 (b) COMPENSATORY DAMAGES.—The term ‘‘compen6 satory damages’’ means objectively verifiable monetary 

7 losses incurred as a result of the provisions of, use of, or 

8 payment for (or failure to provide, use, or pay for) health 

9 care services or medical products, such as past and future 

10 medical expenses, loss of past and future earnings, cost 

11 of obtaining domestic services, loss of employment, and 

12 loss of business or employment opportunities, damages for 

13 physical and emotional pain, suffering, inconvenience, 

14 physical impairment, mental anguish, disfigurement, loss 

15 of enjoyment in life, loss of society and companionship, 

16 loss of consortium (other than loss of domestic service), 

17 hedonic damages, injury to reputation, and all other non 

18 pecuniary losses of any kind or nature. Such term includes 

19 economic damages and noneconomic damages, as such 

20 terms as defined in this section. 

21 (c) ECONOMIC DAMAGES.—The term ‘‘economic 

22 damages’’ means objectively verifiable monetary losses in23 curred as a result of the provisions of, use of, or payment 

24 for (or failure to provide, use, or pay for) health care serv25 ices or medical products, such as past and future medical 


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1 expenses, loss of past and future earnings, cost of obtain2 ing domestic services, loss of employment, and loss of busi3 ness or employment opportunities. 

4 (d) CERTIFIED EHR TECHNOLOGY.—The term ‘‘cer5 tified EHR technology’’ has the meaning given such term 

6 in section 1848(o)(4) of the Social Security Act. 

7 (e) EHR-RELATED ADVERSE EVENT.—The term 

8 ‘‘EHR-related adverse event’’ means, with respect to a 

9 provider, a defect, malfunction, or error in the certified 

10 health information technology or electronic health record 

11 used by the provider, or in the input or output of data 

12 maintained through such technology or record, that results 

13 or could reasonably result in harm to a patient. 

14 (f) HEALTH CARE LAWSUIT.—The term ‘‘health care 

15 lawsuit’’ means any health care liability claim concerning 

16 the provision of health care items or services or any med17 ical product affecting interstate commerce, or any health 

18 care liability action concerning the provision of health care 

19 items or services or any medical product affecting inter20 state commerce, brought in a State or Federal court or 

21 pursuant to an alternative dispute resolution system, 

22 against a health care provider, a health care organization, 

23 or the manufacturer, distributor, supplier, marketer, pro24 moter, or seller of a medical product, regardless of the 

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1 ber of claimants, plaintiffs, defendants, or other parties, 

2 or the number of claims or causes of action, in which the 

3 claimant alleges a health care liability claim. Such term 

4 does not include a claim or action which is based on crimi5 nal liability; which seeks civil fines or penalties paid to 

6 Federal, State, or local government; or which is grounded 

7 in antitrust. 

8 (g) HEALTH CARE LIABILITY ACTION.—The term 

9 ‘‘health care liability action’’ means a civil action brought 

10 in a State or Federal court or pursuant to an alternative 

11 dispute resolution system, against a health care provider, 

12 a health care organization, or the manufacturer, dis13 tributor, supplier, marketer, promoter, or seller of a med14 ical product, regardless of the theory of liability on which 

15 the claim is based, or the number of plaintiffs, defendants, 

16 or other parties, or the number of causes of action, in 

17 which the claimant alleges a health care liability claim. 

18 (h) HEALTH CARE LIABILITY CLAIM.—The term 

19 ‘‘health care liability claim’’ means a demand by any per20 son, whether or not pursuant to alternative dispute resolu21 tion, against a health care provider, health care organiza22 tion, or the manufacturer, distributor, supplier, marketer, 

23 promoter, or seller of a medical product, including third24 party claims, cross-claims, counter-claims, or contribution 

25 claims, which are based upon the provision of, use of, or 


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1 payment for (or the failure to provide, use or pay for) 

2 health care services or medical products, regardless of the 

3 theory of liability on which the claim is based, or the num4 ber of plaintiffs, defendants, or other parties, or the num5 ber of causes of action. 

6 (i) HEALTH CARE ORGANIZATION.—The term 

7 ‘‘health care organization’’ means any person or entity 

8 which is obligated to provide or pay for health benefits 

9 under any health plan, including any person or entity act10 ing under a contract or arrangement with a health care 

11 organization to provide or administer any health benefit. 

12 (j) HEALTH CARE PROVIDER.—The term ‘‘health 

13 care provider’’ means any person or entity required by 

14 State or Federal laws or regulations to be licensed, reg15 istered, or certified to provide health care services, and 

16 being either so licensed, registered, or certified, or exempt17 ed from such requirement by other statute or regulation. 

18 (k) HEALTH CARE ITEMS OR SERVICES.—The term 

19 ‘‘health care items or services’’ means any items or serv20 ices provided by a health care organization, provider, or 

21 by any individual working under the supervision of a 

22 health care provider, that relates to the diagnosis, preven23 tion, or treatment of any human disease or impairment, 

24 or the assessment or care of the health of human beings. 


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1 (l) MALICIOUS INTENT TO INJURE.—The term ‘‘ma2 licious intent to injure’’ means intentionally causing or at3 tempting to cause physical injury other than providing 

4 health care items or services. 

5 (m) MEDICAL PRODUCT.—The term ‘‘medical prod6 uct’’ means a drug, device, or biological product intended 

7 for humans, and the terms ‘‘drug’’, ‘‘device’’, and ‘‘biologi8 cal product’’ have the meanings given such terms in sec9 tions 201(g)(1) and 201(h) of the Federal Food, Drug, 

10 and Cosmetic Act (21 U.S.C. 321(g)(1) and (h)) and sec11 tion 351(a) of the Public Health Service Act (42 U.S.C. 

12 262(a)), respectively, including any component or raw ma13 terial used therein, but excluding health care services. 

14 (n) NONECONOMIC DAMAGES.—The term ‘‘non15 economic damages’’ means damages for physical impair16 ment, mental anguish, disfigurement, loss of enjoyment of 

17 life, loss of society and companionship, loss of consortium 

18 (other than loss of domestic service), hedonic damages, in19 jury to reputation, and all other nonpecuniary losses of 

20 any kind of nature. 

21 (o) PUNITIVE DAMAGES.—The term ‘‘punitive dam22 ages’’ means damages awarded, for the purpose of punish23 ment or deterrence, and not solely for compensatory pur24 poses, against a health care provider, health care organiza25 tion, or a manufacturer, distributor, or supplier of a medVerDate Mar 15 2010 23:25 Oct 24, 2011 Jkt 099200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H3239.IH H3239

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1 ical product. Punitive damages are neither economic nor 

2 economic damages. 

3 (p) STATE.—The term ‘‘State’’ means each of the 

4 several States, District of Columbia, the Commonwealth 

5 of Puerto Rico, the Virgin Islands, Guam, American 

6 Samoa, the Northern Mariana Islands, the Trust Terri7 tory of the Pacific Islands, and any other territory or pos8 session of the United States, or any political subdivision 

9 thereof. 

Æ 


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