II 

109TH CONGRESS 

1ST SESSION S. 544

To amend title IX of the Public Health Service Act to provide for the 

improvement of patient safety and to reduce the incidence of events 

that adversely effect patient safety. 

IN THE SENATE OF THE UNITED STATES 

MARCH 8, 2005

Mr. JEFFORDS (for himself, Mr. GREGG, Mr. ENZI, Mr. BINGAMAN, Mr. 

FRIST, and Mrs. MURRAY) introduced the following bill; which was read 

twice and referred to the Committee on Health, Education, Labor, and 

Pensions 

A BILL

To amend title IX of the Public Health Service Act to 

provide for the improvement of patient safety and to 

reduce the incidence of events that adversely effect patient safety.

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 ‘‘Patient Safety and 

5 Quality Improvement Act of 2005’’. 
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1 SEC. 2. FINDINGS AND PURPOSES. 

2 (a) FINDINGS.—Congress makes the following find3 ings: 

4 (1) In 1999, the Institute of Medicine released 

5 a report entitled To Err is Human that described 

6 medical errors as the eighth leading cause of death 

7 in the United States, with as many as 98,000 people 

8 dying as a result of medical errors each year. 

9 (2) To address these deaths and injuries due to 

10 medical errors, the health care system must identify 

11 and learn from such errors so that systems of care 

12 can be improved. 

13 (3) In their report, the Institute of Medicine 

14 called on Congress to provide legal protections with 

15 respect to information reported for the purposes of 

16 quality improvement and patient safety. 

17 (4) The Health, Education, Labor, and Pen18 sions Committee of the Senate held 4 hearings in 

19 the 106th Congress and 1 hearing in the 107th Con20 gress on patient safety where experts in the field 

21 supported the recommendation of the Institute of 

22 Medicine for congressional action. 

23 (5) Myriad public and private patient safety ini24 tiatives have begun. The Quality Interagency Coordi25 nation Taskforce has recommended steps to improve 

26 patient safety that may be taken by each Federal 
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1 agency involved in health care and activities relating 

2 to these steps are ongoing. 

3 (6) The research on patient safety unequivo4 cally calls for a learning environment, rather than a 

5 punitive environment, in order to improve patient 

6 safety. 

7 (7) Voluntary data gathering systems are more 

8 supportive than mandatory systems in creating the 

9 learning environment referred to in paragraph (6) as 

10 stated in the Institute of Medicine’s report. 

11 (8) Promising patient safety reporting systems 

12 have been established throughout the United States 

13 and the best ways to structure and use these sys14 tems are currently being determined, largely through 

15 projects funded by the Agency for Healthcare Re16 search and Quality. 

17 (9) Many organizations currently collecting pa18 tient safety data have expressed a need for legal pro19 tections that will allow them to review protected in20 formation and collaborate in the development and 

21 implementation of patient safety improvement strat22 egies. Currently, the State peer review protections 

23 are inadequate to allow the sharing of information to 

24 promote patient safety. 

25 (b) PURPOSES.—It is the purpose of this Act to—
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1 (1) encourage a culture of safety and quality in 

2 the United States health care system by providing 

3 for legal protection of information reported volun4 tarily for the purposes of quality improvement and 

5 patient safety; and 

6 (2) ensure accountability by raising standards 

7 and expectations for continuous quality improve8 ments in patient safety. 

9 SEC. 3. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT. 

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

11 299 et seq.) is amended—

12 (1) in section 912(c), by inserting ‘‘, in accord13 ance with part C,’’ after ‘‘The Director shall’’; 

14 (2) by redesignating part C as part D; 

15 (3) by redesignating sections 921 through 928, 

16 as sections 931 through 938, respectively; 

17 (4) in 934(d) (as so redesignated), by striking 

18 the second sentence and inserting the following: 

19 ‘‘Penalties provided for under this section shall be 

20 imposed and collected by the Secretary using the ad21 ministrative and procedural processes used to impose 

22 and collect civil money penalties under section 

23 1128A of the Social Security Act (other than sub24 sections (a) and (b), the second sentence of sub25 section (f), and subsections (i), (m), and (n)), unless 
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1 the Secretary determines that a modification of pro2 cedures would be more suitable or reasonable to 

3 carry out this subsection and provides for such 

4 modification by regulation.’’; 

5 (5) in section 938(1) (as so redesignated), by 

6 striking ‘‘921’’ and inserting ‘‘931’’; and 

7 (6) by inserting after part B the following: 

8 ‘‘PART C—PATIENT SAFETY IMPROVEMENT 

9 ‘‘SEC. 921. DEFINITIONS. 

10 ‘‘In this part: 

11 ‘‘(1) NON-IDENTIFIABLE INFORMATION.—

12 ‘‘(A) IN GENERAL.—The term ‘non-identi13 fiable information’ means, with respect to infor14 mation, that the information is presented in a 

15 form and manner that prevents the identifica16 tion of a provider, a patient, or a reporter of 

17 patient safety data. 

18 ‘‘(B) IDENTIFIABILITY OF PATIENT.—For 

19 purposes of subparagraph (A), the term ‘pre20 sented in a form and manner that prevents the 

21 identification of a patient’ means, with respect 

22 to information that has been subject to rules 

23 promulgated pursuant to section 264(c) of the 

24 Health Insurance Portability and Accountability 

25 Act of 1996 (42 U.S.C. 1320d–2 note), that the 
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1 information has been de-identified so that it is 

2 no longer individually identifiable health infor3 mation as defined in such rules. 

4 ‘‘(2) PATIENT SAFETY DATA.—

5 ‘‘(A) IN GENERAL.—The term ‘patient 

6 safety data’ means—

7 ‘‘(i) any data, reports, records, memo8 randa, analyses (such as root cause anal9 yses), or written or oral statements that 

10 are—

11 ‘‘(I) collected or developed by a 

12 provider for reporting to a patient 

13 safety organization, provided that they 

14 are reported to the patient safety or15 ganization within 60 days; 

16 ‘‘(II) requested by a patient safe17 ty organization (including the con18 tents of such request), if they are re19 ported to the patient safety organiza20 tion within 60 days; 

21 ‘‘(III) reported to a provider by a 

22 patient safety organization; or 

23 ‘‘(IV) collected by a patient safe24 ty organization from another patient 
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•S 544 IS 

1 safety organization, or developed by a 

2 patient safety organization; 

3 that could result in improved patient safe4 ty, health care quality, or health care out5 comes; or 

6 ‘‘(ii) any deliberative work or process 

7 with respect to any patient safety data de8 scribed in clause (i). 

9 ‘‘(B) LIMITATION.—

10 ‘‘(i) COLLECTION.—If the original 

11 material from which any data, reports, 

12 records, memoranda, analyses (such as 

13 root case analyses), or written or oral 

14 statements referred to in subclause (I) or 

15 (IV) of subparagraph (A)(i) are collected 

16 and is not patient safety data, the act of 

17 such collection shall not make such original 

18 material patient safety data for purposes 

19 of this part. 

20 ‘‘(ii) SEPARATE DATA.—The term ‘pa21 tient safety data’ shall not include infor22 mation (including a patient’s medical 

23 record, billing and discharge information 

24 or any other patient or provider record) 

25 that is collected or developed separately 
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1 from and that exists separately from pa2 tient safety data. Such separate informa3 tion or a copy thereof submitted to a pa4 tient safety organization shall not itself be 

5 considered as patient safety data. Nothing 

6 in this part, except for section 922(f)(1), 

7 shall be construed to limit—

8 ‘‘(I) the discovery of or admissi9 bility of information described in this 

10 subparagraph in a criminal, civil, or 

11 administrative proceeding; 

12 ‘‘(II) the reporting of information 

13 described in this subparagraph to a 

14 Federal, State, or local governmental 

15 agency for public health surveillance, 

16 investigation, or other public health 

17 purposes or health oversight purposes; 

18 or 

19 ‘‘(III) a provider’s recordkeeping 

20 obligation with respect to information 

21 described in this subparagraph under 

22 Federal, State, or local law. 

23 ‘‘(3) PATIENT SAFETY ORGANIZATION.—The 

24 term ‘patient safety organization’ means a private or 
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1 public entity or component thereof that is currently 

2 listed by the Secretary pursuant to section 924(c). 

3 ‘‘(4) PATIENT SAFETY ORGANIZATION ACTIVI4 TIES.—The term ‘patient safety organization activi5 ties’ means the following activities, which are 

6 deemed to be necessary for the proper management 

7 and administration of a patient safety organization: 

8 ‘‘(A) The conduct, as its primary activity, 

9 of efforts to improve patient safety and the 

10 quality of health care delivery. 

11 ‘‘(B) The collection and analysis of patient 

12 safety data that are submitted by more than 

13 one provider. 

14 ‘‘(C) The development and dissemination 

15 of information to providers with respect to im16 proving patient safety, such as recommenda17 tions, protocols, or information regarding best 

18 practices. 

19 ‘‘(D) The utilization of patient safety data 

20 for the purposes of encouraging a culture of 

21 safety and of providing direct feedback and as22 sistance to providers to effectively minimize pa23 tient risk. 
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1 ‘‘(E) The maintenance of procedures to 

2 preserve confidentiality with respect to patient 

3 safety data. 

4 ‘‘(F) The provision of appropriate security 

5 measures with respect to patient safety data. 

6 ‘‘(G) The utilization of qualified staff. 

7 ‘‘(5) PERSON.—The term ‘person’ includes Fed8 eral, State, and local government agencies. 

9 ‘‘(6) PROVIDER.—The term ‘provider’ means—

10 ‘‘(A) a person licensed or otherwise author11 ized under State law to provide health care 

12 services, including—

13 ‘‘(i) a hospital, nursing facility, com14 prehensive outpatient rehabilitation facil15 ity, home health agency, hospice program, 

16 renal dialysis facility, ambulatory surgical 

17 center, pharmacy, physician or health care 

18 practitioner’s office, long term care facility, 

19 behavior health residential treatment facil20 ity, clinical laboratory, or health center; or 

21 ‘‘(ii) a physician, physician assistant, 

22 nurse practitioner, clinical nurse specialist, 

23 certified registered nurse anesthetist, cer24 tified nurse midwife, psychologist, certified 

25 social worker, registered dietitian or nutri-
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1 tion professional, physical or occupational 

2 therapist, pharmacist, or other individual 

3 health care practitioner; or 

4 ‘‘(B) any other person specified in regula5 tions promulgated by the Secretary. 

6 ‘‘SEC. 922. PRIVILEGE AND CONFIDENTIALITY PROTEC7 TIONS. 

8 ‘‘(a) PRIVILEGE.—Notwithstanding any other provi9 sion of Federal, State, or local law, patient safety data 

10 shall be privileged and, subject to the provisions of sub11 section (c)(1), shall not be—

12 ‘‘(1) subject to a Federal, State, or local civil, 

13 criminal, or administrative subpoena; 

14 ‘‘(2) subject to discovery in connection with a 

15 Federal, State, or local civil, criminal, or administra16 tive proceeding; 

17 ‘‘(3) disclosed pursuant to section 552 of title 

18 5, United States Code (commonly known as the 

19 Freedom of Information Act) or any other similar 

20 Federal, State, or local law; 

21 ‘‘(4) admitted as evidence or otherwise disclosed 

22 in any Federal, State, or local civil, criminal, or ad23 ministrative proceeding; or 

24 ‘‘(5) utilized in a disciplinary proceeding 

25 against a provider. 
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1 ‘‘(b) CONFIDENTIALITY.—Notwithstanding any other 

2 provision of Federal, State, or local law, and subject to

3 the provisions of subsections (c) and (d), patient safety 

4 data shall be confidential and shall not be disclosed. 

5 ‘‘(c) EXCEPTIONS TO PRIVILEGE AND CONFIDEN6 TIALITY.—Nothing in this section shall be construed to 

7 prohibit one or more of the following uses or disclosures: 

8 ‘‘(1) Disclosure by a provider or patient safety 

9 organization of relevant patient safety data for use 

10 in a criminal proceeding only after a court makes an 

11 in camera determination that such patient safety 

12 data contains evidence of a wanton and criminal act 

13 to directly harm the patient. 

14 ‘‘(2) Voluntary disclosure of non-identifiable pa15 tient safety data by a provider or a patient safety 

16 organization. 

17 ‘‘(d) PROTECTED DISCLOSURE AND USE OF INFOR18 MATION.—Nothing in this section shall be construed to 

19 prohibit one or more of the following uses or disclosures: 

20 ‘‘(1) Disclosure of patient safety data by a per21 son that is a provider, a patient safety organization, 

22 or a contractor of a provider or patient safety orga23 nization, to another such person, to carry out pa24 tient safety organization activities. 
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1 ‘‘(2) Disclosure of patient safety data by a pro2 vider or patient safety organization to grantees or 

3 contractors carrying out patient safety research, 

4 evaluation, or demonstration projects authorized by 

5 the Director. 

6 ‘‘(3) Disclosure of patient safety data by a pro7 vider to an accrediting body that accredits that pro8 vider. 

9 ‘‘(4) Voluntary disclosure of patient safety data 

10 by a patient safety organization to the Secretary for 

11 public health surveillance if the consent of each pro12 vider identified in, or providing, such data is ob13 tained prior to such disclosure. Nothing in the pre14 ceding sentence shall be construed to prevent the re15 lease of patient safety data that is provided by, or 

16 that relates solely to, a provider from which the con17 sent described in such sentence is obtained because 

18 one or more other providers do not provide such con19 sent with respect to the disclosure of patient safety 

20 data that relates to such nonconsenting providers. 

21 Consent for the future release of patient safety data 

22 for such purposes may be requested by the patient 

23 safety organization at the time the data is sub24 mitted. 
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1 ‘‘(5) Voluntary disclosure of patient safety data 

2 by a patient safety organization to State of local 

3 government agencies for public health surveillance if 

4 the consent of each provider identified in, or pro5 viding, such data is obtained prior to such disclo6 sure. Nothing in the preceding sentence shall be con7 strued to prevent the release of patient safety data 

8 that is provided by, or that relates solely to, a pro9 vider from which the consent described in such sen10 tence is obtained because one or more other pro11 viders do not provide such consent with respect to 

12 the disclosure of patient safety data that relates to 

13 such nonconsenting providers. Consent for the fu14 ture release of patient safety data for such purposes 

15 may be requested by the patient safety organization 

16 at the time the data is submitted. 

17 ‘‘(e) CONTINUED PROTECTION OF INFORMATION

18 AFTER DISCLOSURE.—

19 ‘‘(1) IN GENERAL.—Except as provided in para20 graph (2), patient safety data that is used or dis21 closed shall continue to be privileged and confiden22 tial as provided for in subsections (a) and (b), and 

23 the provisions of such subsections shall apply to 

24 such data in the possession or control of—
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1 ‘‘(A) a provider or patient safety organiza2 tion that possessed such data before the use or 

3 disclosure; or 

4 ‘‘(B) a person to whom such data was dis5 closed. 

6 ‘‘(2) EXCEPTION.—Notwithstanding paragraph 

7 (1), and subject to paragraph (3)—

8 ‘‘(A) if patient safety data is used or dis9 closed as provided for in subsection (c)(1), and 

10 such use or disclosure is in open court, the con11 fidentiality protections provided for in sub12 section (b) shall no longer apply to such data; 

13 and 

14 ‘‘(B) if patient safety data is used or dis15 closed as provided for in subsection (c)(2), the 

16 privilege and confidentiality protections pro17 vided for in subsections (a) and (b) shall no 

18 longer apply to such data. 

19 ‘‘(3) CONSTRUCTION.—Paragraph (2) shall not 

20 be construed as terminating or limiting the privilege 

21 or confidentiality protections provided for in sub22 section (a) or (b) with respect to data other than the 

23 specific data used or disclosed as provided for in 

24 subsection (c). 

25 ‘‘(f) LIMITATION ON ACTIONS.—
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1 ‘‘(1) PATIENT SAFETY ORGANIZATIONS.—Ex2 cept to enforce disclosures pursuant to subsection 

3 (c)(1), no action may be brought or process served 

4 against a patient safety organization to compel dis5 closure of information collected or developed under 

6 this part whether or not such information is patient 

7 safety data unless such information is specifically 

8 identified, is not patient safety data, and cannot oth9 erwise be obtained. 

10 ‘‘(2) PROVIDERS.—An accrediting body shall 

11 not take an accrediting action against a provider 

12 based on the good faith participation of the provider 

13 in the collection, development, reporting, or mainte14 nance of patient safety data in accordance with this 

15 part. An accrediting body may not require a provider 

16 to reveal its communications with any patient safety 

17 organization established in accordance with this 

18 part. 

19 ‘‘(g) REPORTER PROTECTION.—

20 ‘‘(1) IN GENERAL.—A provider may not take an 

21 adverse employment action, as described in para22 graph (2), against an individual based upon the fact 

23 that the individual in good faith reported informa24 tion—
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1 ‘‘(A) to the provider with the intention of 

2 having the information reported to a patient 

3 safety organization; or 

4 ‘‘(B) directly to a patient safety organiza5 tion.

6 ‘‘(2) ADVERSE EMPLOYMENT ACTION.—For 

7 purposes of this subsection, an ‘adverse employment 

8 action’ includes—

9 ‘‘(A) loss of employment, the failure to 

10 promote an individual, or the failure to provide 

11 any other employment-related benefit for which 

12 the individual would otherwise be eligible; or 

13 ‘‘(B) an adverse evaluation or decision 

14 made in relation to accreditation, certification, 

15 credentialing, or licensing of the individual. 

16 ‘‘(h) ENFORCEMENT.—

17 ‘‘(1) PROHIBITION.—Except as provided in sub18 sections (c) and (d) and as otherwise provided for in 

19 this section, it shall be unlawful for any person to 

20 negligently or intentionally disclose any patient safe21 ty data, and any such person shall, upon adjudica22 tion, be assessed in accordance with section 934(d). 

23 ‘‘(2) RELATION TO HIPAA.—The penalty pro24 vided for under paragraph (1) shall not apply if the 

25 defendant would otherwise be subject to a penalty 
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1 under the regulations promulgated under section 

2 264(c) of the Health Insurance Portability and Ac3 countability Act of 1996 (42 U.S.C. 1320d–2 note) 

4 or under section 1176 of the Social Security Act (42 

5 U.S.C. 1320d–5) for the same disclosure. 

6 ‘‘(3) EQUITABLE RELIEF.—

7 ‘‘(A) IN GENERAL.—Without limiting rem8 edies available to other parties, a civil action 

9 may be brought by any aggrieved individual to 

10 enjoin any act or practice that violates sub11 section (g) and to obtain other appropriate eq12 uitable relief (including reinstatement, back 

13 pay, and restoration of benefits) to redress such 

14 violation. 

15 ‘‘(B) AGAINST STATE EMPLOYEES.—An 

16 entity that is a State or an agency of a State 

17 government may not assert the privilege de18 scribed in subsection (a) unless before the time 

19 of the assertion, the entity or, in the case of 

20 and with respect to an agency, the State has 

21 consented to be subject to an action as de22 scribed by this paragraph, and that consent has 

23 remained in effect. 

24 ‘‘(i) RULE OF CONSTRUCTION.—Nothing in this sec25 tion shall be construed to—
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1 ‘‘(1) limit other privileges that are available 

2 under Federal, State, or local laws that provide 

3 greater confidentiality protections or privileges than 

4 the privilege and confidentiality protections provided 

5 for in this section; 

6 ‘‘(2) limit, alter, or affect the requirements of 

7 Federal, State, or local law pertaining to informa8 tion that is not privileged or confidential under this 

9 section; 

10 ‘‘(3) alter or affect the implementation of any 

11 provision of section 264(c) of the Health Insurance 

12 Portability and Accountability Act of 1996 (Public 

13 Law 104–191; 110 Stat. 2033), section 1176 of the 

14 Social Security Act (42 U.S.C. 1320d–5), or any 

15 regulation promulgated under such sections; 

16 ‘‘(4) limit the authority of any provider, patient 

17 safety organization, or other person to enter into a 

18 contract requiring greater confidentiality or dele19 gating authority to make a disclosure or use in ac20 cordance with subsection (c) or (d); and 

21 ‘‘(5) prohibit a provider from reporting a crime 

22 to law enforcement authorities, regardless of whether 

23 knowledge of the existence of, or the description of, 

24 the crime is based on patient safety data, so long as 
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1 the provider does not disclose patient safety data in 

2 making such report. 

3 ‘‘SEC. 923. PATIENT SAFETY NETWORK OF DATABASES. 

4 ‘‘(a) IN GENERAL.—The Secretary shall maintain a 

5 patient safety network of databases that provides an inter6 active evidence-based management resource for providers, 

7 patient safety organizations, and other persons. The net8 work of databases shall have the capacity to accept, aggre9 gate, and analyze nonidentifiable patient safety data vol10 untarily reported by patient safety organizations, pro11 viders, or other persons. 

12 ‘‘(b) NETWORK OF DATABASE STANDARDS.—The 

13 Secretary may determine common formats for the report14 ing to the patient safety network of databases maintained 

15 under subsection (a) of nonidentifiable patient safety data, 

16 including necessary data elements, common and consistent 

17 definitions, and a standardized computer interface for the 

18 processing of such data. To the extent practicable, such 

19 standards shall be consistent with the administrative sim20 plification provisions of Part C of title XI of the Social 

21 Security Act. 

22 ‘‘SEC. 924. PATIENT SAFETY ORGANIZATION CERTIFI23 CATION AND LISTING. 

24 ‘‘(a) CERTIFICATION.—
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1 ‘‘(1) INITIAL CERTIFICATION.—Except as pro2 vided in paragraph (2), an entity that seeks to be a 

3 patient safety organization shall submit an initial 

4 certification to the Secretary that the entity intends 

5 to perform the patient safety organization activities. 

6 ‘‘(2) DELAYED CERTIFICATION OF COLLECTION

7 FROM MORE THAN ONE PROVIDER.—An entity that 

8 seeks to be a patient safety organization may—

9 ‘‘(A) submit an initial certification that it 

10 intends to perform patient safety organization 

11 activities other than the activities described in 

12 subparagraph (B) of section 921(4); and 

13 ‘‘(B) within 2 years of submitting the ini14 tial certification under subparagraph (A), sub15 mit a supplemental certification that it per16 forms the patient safety organization activities 

17 described in subparagraphs (A) through (F) of 

18 section 921(4). 

19 ‘‘(3) EXPIRATION AND RENEWAL.—

20 ‘‘(A) EXPIRATION.—An initial certification 

21 under paragraph (1) or (2)(A) shall expire on 

22 the date that is 3 years after it is submitted. 

23 ‘‘(B) RENEWAL.—

24 ‘‘(i) IN GENERAL.—An entity that 

25 seeks to remain a patient safety organiza-
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1 tion after the expiration of an initial cer2 tification under paragraph (1) or (2)(A) 

3 shall, within the 3-year period described in 

4 subparagraph (A), submit a renewal cer5 tification to the Secretary that the entity 

6 performs the patient safety organization 

7 activities described in section 921(4). 

8 ‘‘(ii) TERM OF RENEWAL.—A renewal 

9 certification under clause (i) shall expire 

10 on the date that is 3 years after the date 

11 on which it is submitted, and may be re12 newed in the same manner as an initial 

13 certification. 

14 ‘‘(b) ACCEPTANCE OF CERTIFICATION.—Upon the 

15 submission by an organization of an initial certification 

16 pursuant to subsection (a)(1) or (a)(2)(A), a supplemental 

17 certification pursuant to subsection (a)(2)(B), or a re18 newal certification pursuant to subsection (a)(3)(B), the 

19 Secretary shall review such certification and—

20 ‘‘(1) if such certification meets the require21 ments of subsection (a)(1), (a)(2)(A), (a)(2)(B), or 

22 (a)(3)(B), as applicable, the Secretary shall notify 

23 the organization that such certification is accepted; 

24 or 
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1 ‘‘(2) if such certification does not meet such re2 quirements, as applicable, the Secretary shall notify 

3 the organization that such certification is not accept4 ed and the reasons therefor. 

5 ‘‘(c) LISTING.—

6 ‘‘(1) IN GENERAL.—Except as otherwise pro7 vided in this subsection, the Secretary shall compile 

8 and maintain a current listing of patient safety or9 ganizations with respect to which the Secretary has 

10 accepted a certification pursuant to subsection (b). 

11 ‘‘(2) REMOVAL FROM LISTING.—The Secretary 

12 shall remove from the listing under paragraph (1)—

13 ‘‘(A) an entity with respect to which the 

14 Secretary has accepted an initial certification 

15 pursuant to subsection (a)(2)(A) and which 

16 does not submit a supplemental certification 

17 pursuant to subsection (a)(2)(B) that is accept18 ed by the Secretary; 

19 ‘‘(B) an entity whose certification expires 

20 and which does not submit a renewal applica21 tion that is accepted by the Secretary; and 

22 ‘‘(C) an entity with respect to which the 

23 Secretary revokes the Secretary’s acceptance of 

24 the entity’s certification, pursuant to subsection 

25 (d). 
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1 ‘‘(d) REVOCATION OF ACCEPTANCE.—

2 ‘‘(1) IN GENERAL.—Except as provided in para3 graph (2), if the Secretary determines (through a re4 view of patient safety organization activities) that a 

5 patient safety organization does not perform one of 

6 the patient safety organization activities described in 

7 subparagraph (A) through (F) of section 921(4), the 

8 Secretary may, after notice and an opportunity for 

9 a hearing, revoke the Secretary’s acceptance of the 

10 certification of such organization. 

11 ‘‘(2) DELAYED CERTIFICATION OF COLLECTION

12 FROM MORE THAN ONE PROVIDER.—A revocation 

13 under paragraph (1) may not be based on a deter14 mination that the organization does not perform the 

15 activity described in section 921(4)(B) if—

16 ‘‘(A) the listing of the organization is 

17 based on its submittal of an initial certification 

18 under subsection (a)(2)(A); 

19 ‘‘(B) the organization has not submitted a 

20 supplemental certification under subsection 

21 (a)(2)(B); and 

22 ‘‘(C) the 2-year period described in sub23 section (a)(2)(B) has not expired. 

24 ‘‘(e) NOTIFICATION OF REVOCATION OR REMOVAL

25 FROM LISTING.—
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1 ‘‘(1) SUPPLYING CONFIRMATION OF NOTIFICA2 TION TO PROVIDERS.—Within 15 days of a revoca3 tion under subsection (d)(1), a patient safety organi4 zation shall submit to the Secretary a confirmation 

5 that the organization has taken all reasonable ac6 tions to notify each provider whose patient safety 

7 data is collected or analyzed by the organization of 

8 such revocation. 

9 ‘‘(2) PUBLICATION.—Upon the revocation of an 

10 acceptance of an organization’s certification under 

11 subsection (d)(1), or upon the removal of an organi12 zation from the listing under subsection (c)(2), the 

13 Secretary shall publish notice of the revocation or 

14 removal in the Federal Register. 

15 ‘‘(f) STATUS OF DATA AFTER REMOVAL FROM LIST16 ING.—

17 ‘‘(1) NEW DATA.—With respect to the privilege 

18 and confidentiality protections described in section 

19 922, data submitted to an organization within 30 

20 days after the organization is removed from the list21 ing under subsection (c)(2) shall have the same sta22 tus as data submitted while the organization was 

23 still listed. 

24 ‘‘(2) PROTECTION TO CONTINUE TO APPLY.—If 

25 the privilege and confidentiality protections de-
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1 scribed in section 922 applied to data while an orga2 nization was listed, or during the 30-day period de3 scribed in paragraph (1), such protections shall con4 tinue to apply to such data after the organization is 

5 removed from the listing under subsection (c)(2). 

6 ‘‘(g) DISPOSITION OF DATA.—If the Secretary re7 moves an organization from the listing as provided for in 

8 subsection (c)(2), with respect to the patient safety data 

9 that the organization received from providers, the organi10 zation shall—

11 ‘‘(1) with the approval of the provider and an12 other patient safety organization, transfer such data 

13 to such other organization; 

14 ‘‘(2) return such data to the person that sub15 mitted the data; or 

16 ‘‘(3) if returning such data to such person is 

17 not practicable, destroy such data. 

18 ‘‘SEC. 925. TECHNICAL ASSISTANCE. 

19 ‘‘The Secretary, acting through the Director, may 

20 provide technical assistance to patient safety organiza21 tions, including convening annual meetings for patient 

22 safety organizations to discuss methodology, communica23 tion, data collection, or privacy concerns. 
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1 ‘‘SEC. 926. PROMOTING THE INTEROPERABILITY OF 

2 HEALTH CARE INFORMATION TECHNOLOGY 

3 SYSTEMS. 

4 ‘‘(a) DEVELOPMENT.—Not later than 36 months 

5 after the date of enactment of the Patient Safety and 

6 Quality Improvement Act of 2005, the Secretary shall de7 velop or adopt voluntary standards that promote the elec8 tronic exchange of health care information. 

9 ‘‘(b) UPDATES.—The Secretary shall provide for the 

10 ongoing review and periodic updating of the standards de11 veloped under subsection (a). 

12 ‘‘(c) DISSEMINATION.—The Secretary shall provide 

13 for the dissemination of the standards developed and up14 dated under this section. 

15 ‘‘SEC. 927. AUTHORIZATION OF APPROPRIATIONS. 

16 ‘‘There is authorized to be appropriated such sums 

17 as may be necessary to carry out this part.’’. 

18 SEC. 4. STUDIES AND REPORTS. 

19 (a) IN GENERAL.—The Secretary of Health and 

20 Human Services shall enter into a contract (based upon 

21 a competitive contracting process) with an appropriate re22 search organization for the conduct of a study to assess 

23 the impact of medical technologies and therapies on pa24 tient safety, patient benefit, health care quality, and the 

25 costs of care as well as productivity growth. Such study 

26 shall examine—
28

•S 544 IS 

1 (1) the extent to which factors, such as the use 

2 of labor and technological advances, have contrib3 uted to increases in the share of the gross domestic 

4 product that is devoted to health care and the im5 pact of medical technologies and therapies on such 

6 increases; 

7 (2) the extent to which early and appropriate 

8 introduction and integration of innovative medical 

9 technologies and therapies may affect the overall 

10 productivity and quality of the health care delivery 

11 systems of the United States; and 

12 (3) the relationship of such medical technologies 

13 and therapies to patient safety, patient benefit, 

14 health care quality, and cost of care. 

15 (b) REPORT.—Not later than 18 months after the 

16 date of enactment of this Act, the Secretary of Health and 

17 Human Services shall prepare and submit to the appro18 priate committees of Congress a report containing the re19 sults of the study conducted under subsection (a).

Æ