In the Senate of the United States,

July 22, 2004.

Resolved, That the bill from the House of Representatives (H.R. 663) entitled ‘‘An Act 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 affect patient safety, and for other purposes.’’, do

pass with the following

AMENDMENT:

Strike out all after the enacting clause and insert:

1 SECTION 1. SHORT TITLE.

2 This Act may be cited as the ‘‘Patient Safety and

3 Quality Improvement Act of 2004’’.
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1 SEC. 2. FINDINGS AND PURPOSES.

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

3 (1) In 1999, the Institute of Medicine released a

4 report entitled To Err is Human that described med5 ical errors as the eighth leading cause of death in the

6 United States, with as many as 98,000 people dying

7 as a result of medical errors each year.

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

9 medical errors, the health care system must identify

10 and learn from such errors so that systems of care can

11 be improved.

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

13 called on Congress to provide legal protections with

14 respect to information reported for the purposes of

15 quality improvement and patient safety.

16 (4) The Health, Education, Labor, and Pensions

17 Committee of the Senate held 4 hearings in the 106th

18 Congress and 1 hearing in the 107th Congress on pa19 tient safety where experts in the field supported the

20 recommendation of the Institute of Medicine for con21 gressional action.

22 (5) Myriad public and private patient safety

23 initiatives have begun. The Quality Interagency Co24 ordination Taskforce has recommended steps to im25 prove patient safety that may be taken by each Fed-
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1 eral agency involved in health care and activities re2 lating to these steps are ongoing.

3 (6) The research on patient safety unequivocally

4 calls for a learning environment, rather than a puni5 tive environment, in order to improve patient safety.

6 (7) Voluntary data gathering systems are more

7 supportive than mandatory systems in creating the

8 learning environment referred to in paragraph (6) as

9 stated in the Institute of Medicine’s report.

10 (8) Promising patient safety reporting systems

11 have been established throughout the United States

12 and the best ways to structure and use these systems

13 are currently being determined, largely through

14 projects funded by the Agency for Healthcare Research

15 and Quality.

16 (9) Many organizations currently collecting pa17 tient safety data have expressed a need for legal pro18 tections that will allow them to review protected in19 formation and collaborate in the development and im20 plementation of patient safety improvement strate21 gies. Currently, the State peer review protections are

22 inadequate to allow the sharing of information to pro23 mote patient safety.

24 (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 for

3 legal protection of information reported voluntarily

4 for the purposes of quality improvement and patient

5 safety; and

6 (2) ensure accountability by raising standards

7 and expectations for continuous quality improvements

8 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, as

16 sections 931 through 938, respectively;

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

18 the second sentence and inserting the following: ‘‘Pen19 alties provided for under this section shall be imposed

20 and collected by the Secretary using the administra21 tive and procedural processes used to impose and col22 lect civil money penalties under section 1128A of the

23 Social Security Act (other than subsections (a) and

24 (b), the second sentence of subsection (f), and sub25 sections (i), (m), and (n)), unless the Secretary deter-
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1 mines that a modification of procedures would be

2 more suitable or reasonable to carry out this sub3 section and provides for such modification by regula4 tion.’’;

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-identifi13 able 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 pa17 tient 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 pro23 mulgated 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 safe6 ty 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 orga15 nization within 60 days;

16 ‘‘(II) requested by a patient safety

17 organization (including the contents of

18 such request), if they are reported to

19 the patient safety organization within

20 60 days;

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

22 patient safety organization; or

23 ‘‘(IV) collected by a patient safety

24 organization from another patient safe-
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1 ty organization, or developed by a pa2 tient safety organization;

3 that could result in improved patient safety,

4 health care quality, or health care outcomes;

5 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 ma11 terial from which any data, reports, records,

12 memoranda, analyses (such as root case

13 analyses), or written or oral statements re14 ferred to in subclause (I) or (IV) of sub15 paragraph (A)(i) are collected and is not

16 patient safety data, the act of such collec17 tion shall not make such original material

18 patient safety data for purposes of this

19 part.

20 ‘‘(ii) SEPARATE DATA.—The term ‘pa21 tient safety data’ shall not include informa22 tion (including a patient’s medical record,

23 billing and discharge information or any

24 other patient or provider record) that is col25 lected or developed separately from and that
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1 exists separately from patient safety data.

2 Such separate information or a copy thereof

3 submitted to a patient safety organization

4 shall not itself be considered as patient safe5 ty data. Nothing in this part, except for sec6 tion 922(f)(1), shall be construed to limit—

7 ‘‘(I) the discovery of or admissi8 bility of information described in this

9 subparagraph in a criminal, civil, or

10 administrative proceeding;

11 ‘‘(II) the reporting of information

12 described in this subparagraph to a

13 Federal, State, or local governmental

14 agency for public health surveillance,

15 investigation, or other public health

16 purposes or health oversight purposes;

17 or

18 ‘‘(III) a provider’s recordkeeping

19 obligation with respect to information

20 described in this subparagraph under

21 Federal, State, or local law.

22 ‘‘(3) PATIENT SAFETY ORGANIZATION.—The term

23 ‘patient safety organization’ means a private or pub24 lic entity or component thereof that is currently listed

25 by the Secretary pursuant to section 924(c).
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1 ‘‘(4) PATIENT SAFETY ORGANIZATION ACTIVI2 TIES.—The term ‘patient safety organization activi3 ties’ means the following activities, which are deemed

4 to be necessary for the proper management and ad5 ministration of a patient safety organization:

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

7 of efforts to improve patient safety and the qual8 ity of health care delivery.

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

10 safety data that are submitted by more than one

11 provider.

12 ‘‘(C) The development and dissemination of

13 information to providers with respect to improv14 ing patient safety, such as recommendations,

15 protocols, or information regarding best prac16 tices.

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

18 for the purposes of encouraging a culture of safe19 ty and of providing direct feedback and assist20 ance to providers to effectively minimize patient

21 risk.

22 ‘‘(E) The maintenance of procedures to pre23 serve confidentiality with respect to patient safe24 ty data.
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1 ‘‘(F) The provision of appropriate security

2 measures with respect to patient safety data.

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

4 ‘‘(5) PERSON.—The term ‘person’ includes Fed5 eral, State, and local government agencies.

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

7 ‘‘(A) a person licensed or otherwise author8 ized under State law to provide health care serv9 ices, including—

10 ‘‘(i) a hospital, nursing facility, com11 prehensive outpatient rehabilitation facility,

12 home health agency, hospice program, renal

13 dialysis facility, ambulatory surgical center,

14 pharmacy, physician or health care practi15 tioner’s office, long term care facility, be16 havior health residential treatment facility,

17 clinical laboratory, or health center; or

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

19 nurse practitioner, clinical nurse specialist,

20 certified registered nurse anesthetist, cer21 tified nurse midwife, psychologist, certified

22 social worker, registered dietitian or nutri23 tion professional, physical or occupational

24 therapist, pharmacist, or other individual

25 health care practitioner; or
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1 ‘‘(B) any other person specified in regula2 tions promulgated by the Secretary.

3 ‘‘SEC. 922. PRIVILEGE AND CONFIDENTIALITY PROTEC4 TIONS.

5 ‘‘(a) PRIVILEGE.—Notwithstanding any other provi6 sion of Federal, State, or local law, patient safety data shall

7 be privileged and, subject to the provisions of subsection

8 (c)(1), shall not be—

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

10 criminal, or administrative subpoena;

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

12 Federal, State, or local civil, criminal, or administra13 tive proceeding;

14 ‘‘(3) disclosed pursuant to section 552 of title 5,

15 United States Code (commonly known as the Freedom

16 of Information Act) or any other similar Federal,

17 State, or local law;

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

19 in any Federal, State, or local civil, criminal, or ad20 ministrative proceeding; or

21 ‘‘(5) utilized in a disciplinary proceeding

22 against a provider.

23 ‘‘(b) CONFIDENTIALITY.—Notwithstanding any other

24 provision of Federal, State, or local law, and subject to the
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1 provisions of subsections (c) and (d), patient safety data

2 shall be confidential and shall not be disclosed.

3 ‘‘(c) EXCEPTIONS TO PRIVILEGE AND CONFIDEN4 TIALITY.—Nothing in this section shall be construed to pro5 hibit one or more of the following uses or disclosures:

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

7 organization of relevant patient safety data for use in

8 a criminal proceeding only after a court makes an in

9 camera determination that such patient safety data

10 contains evidence of a wanton and criminal act to di11 rectly harm the patient.

12 ‘‘(2) Voluntary disclosure of non-identifiable pa13 tient safety data by a provider or a patient safety or14 ganization.

15 ‘‘(d) PROTECTED DISCLOSURE AND USE OF INFORMA16 TION.—Nothing in this section shall be construed to prohibit

17 one or more of the following uses or disclosures:

18 ‘‘(1) Disclosure of patient safety data by a per19 son that is a provider, a patient safety organization,

20 or a contractor of a provider or patient safety organi21 zation, to another such person, to carry out patient

22 safety organization activities.

23 ‘‘(2) Disclosure of patient safety data by a pro24 vider or patient safety organization to grantees or

25 contractors carrying out patient safety research, eval-
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1 uation, or demonstration projects authorized by the

2 Director.

3 ‘‘(3) Disclosure of patient safety data by a pro4 vider to an accrediting body that accredits that pro5 vider.

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

7 by a patient safety organization to the Secretary for

8 public health surveillance if the consent of each pro9 vider identified in, or providing, such data is ob10 tained prior to such disclosure. Nothing in the pre11 ceding sentence shall be construed to prevent the re12 lease of patient safety data that is provided by, or

13 that relates solely to, a provider from which the con14 sent described in such sentence is obtained because one

15 or more other providers do not provide such consent

16 with respect to the disclosure of patient safety date

17 that relates to such nonconsenting providers. Consent

18 for the future release of patient safety data for such

19 purposes may be requested by the patient safety orga20 nization at the time the data is submitted.

21 ‘‘(5) Voluntary disclosure of patient safety data

22 by a patient safety organization to State of local gov23 ernment agencies for public health surveillance if the

24 consent of each provider identified in, or providing,

25 such data is obtained prior to such disclosure. Noth-
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1 ing in the preceding sentence shall be construed to

2 prevent the release of patient safety data that is pro3 vided by, or that relates solely to, a provider from

4 which the consent described in such sentence is ob5 tained because one or more other providers do not

6 provide such consent with respect to the disclosure of

7 patient safety date that relates to such nonconsenting

8 providers. Consent for the future release of patient

9 safety data for such purposes may be requested by the

10 patient safety organization at the time the data is

11 submitted.

12 ‘‘(e) CONTINUED PROTECTION OF INFORMATION AFTER

13 DISCLOSURE.—

14 ‘‘(1) IN GENERAL.—Except as provided in para15 graph (2), patient safety data that is used or dis16 closed shall continue to be privileged and confidential

17 as provided for in subsections (a) and (b), and the

18 provisions of such subsections shall apply to such

19 data in the possession or control of—

20 ‘‘(A) a provider or patient safety organiza21 tion that possessed such data before the use or

22 disclosure; or

23 ‘‘(B) a person to whom such data was dis24 closed.
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1 ‘‘(2) EXCEPTION.—Notwithstanding paragraph

2 (1), and subject to paragraph (3)—

3 ‘‘(A) if patient safety data is used or dis4 closed as provided for in subsection (c)(1), and

5 such use or disclosure is in open court, the con6 fidentiality protections provided for in sub7 section (b) shall no longer apply to such data;

8 and

9 ‘‘(B) if patient safety data is used or dis10 closed as provided for in subsection (c)(2), the

11 privilege and confidentiality protections pro12 vided for in subsections (a) and (b) shall no

13 longer apply to such data.

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

15 be construed as terminating or limiting the privilege

16 or confidentiality protections provided for in sub17 section (a) or (b) with respect to data other than the

18 specific data used or disclosed as provided for in sub19 section (c).

20 ‘‘(f) LIMITATION ON ACTIONS.—

21 ‘‘(1) PATIENT SAFETY ORGANIZATIONS.—Except

22 to enforce disclosures pursuant to subsection (c)(1), no

23 action may be brought or process served against a pa24 tient safety organization to compel disclosure of infor25 mation collected or developed under this part whether
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1 or not such information is patient safety data unless

2 such information is specifically identified, is not pa3 tient safety data, and cannot otherwise be obtained.

4 ‘‘(2) PROVIDERS.—An accrediting body shall not

5 take an accrediting action against a provider based

6 on the good faith participation of the provider in the

7 collection, development, reporting, or maintenance of

8 patient safety data in accordance with this part. An

9 accrediting body may not require a provider to reveal

10 its communications with any patient safety organiza11 tion established in accordance with this part.

12 ‘‘(g) REPORTER PROTECTION.—

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

14 adverse employment action, as described in para15 graph (2), against an individual based upon the fact

16 that the individual in good faith reported

17 information—

18 ‘‘(A) to the provider with the intention of

19 having the information reported to a patient

20 safety organization; or

21 ‘‘(B) directly to a patient safety organiza22 tion.

23 ‘‘(2) ADVERSE EMPLOYMENT ACTION.—For pur24 poses of this subsection, an ‘adverse employment ac25 tion’ includes—
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1 ‘‘(A) loss of employment, the failure to pro2 mote an individual, or the failure to provide any

3 other employment-related benefit for which the

4 individual would otherwise be eligible; or

5 ‘‘(B) an adverse evaluation or decision

6 made in relation to accreditation, certification,

7 credentialing, or licensing of the individual.

8 ‘‘(h) ENFORCEMENT.—

9 ‘‘(1) PROHIBITION.—Except as provided in sub10 sections (c) and (d) and as otherwise provided for in

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

12 negligently or intentionally disclose any patient safe13 ty data, and any such person shall, upon adjudica14 tion, be assessed in accordance with section 934(d).

15 ‘‘(2) RELATION TO HIPAA.—The penalty pro16 vided for under paragraph (1) shall not apply if the

17 defendant would otherwise be subject to a penalty

18 under the regulations promulgated under section

19 264(c) of the Health Insurance Portability and Ac20 countability Act of 1996 (42 U.S.C. 1320d–2 note) or

21 under section 1176 of the Social Security Act (42

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

23 ‘‘(3) EQUITABLE RELIEF.—

24 ‘‘(A) IN GENERAL.—Without limiting rem25 edies available to other parties, a civil action
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1 may be brought by any aggrieved individual to

2 enjoin any act or practice that violates sub3 section (g) and to obtain other appropriate equi4 table relief (including reinstatement, back pay,

5 and restoration of benefits) to redress such viola6 tion.

7 ‘‘(B) AGAINST STATE EMPLOYEES.—An en8 tity that is a State or an agency of a State gov9 ernment may not assert the privilege described

10 in subsection (a) unless before the time of the as11 sertion, the entity or, in the case of and with re12 spect to an agency, the State has consented to be

13 subject to an action as described by this para14 graph, and that consent has remained in effect.

15 ‘‘(i) RULE OF CONSTRUCTION.—Nothing in this sec16 tion shall be construed to—

17 ‘‘(1) limit other privileges that are available

18 under Federal, State, or local laws that provide great19 er confidentiality protections or privileges than the

20 privilege and confidentiality protections provided for

21 in this section;

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

23 Federal, State, or local law pertaining to information

24 that is not privileged or confidential under this sec25 tion;
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1 ‘‘(3) alter or affect the implementation of any

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

3 Portability and Accountability Act of 1996 (Public

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

5 Social Security Act (42 U.S.C. 1320d–5), or any reg6 ulation promulgated under such sections;

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

8 safety organization, or other person to enter into a

9 contract requiring greater confidentiality or dele10 gating authority to make a disclosure or use in ac11 cordance with subsection (c) or (d); and

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

13 to law enforcement authorities, regardless of whether

14 knowledge of the existence of, or the description of, the

15 crime is based on patient safety data, so long as the

16 provider does not disclose patient safety data in mak17 ing such report.

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

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

20 patient safety network of databases that provides an inter21 active evidence-based management resource for providers,

22 patient safety organizations, and other persons. The net23 work of databases shall have the capacity to accept, aggre24 gate, and analyze nonidentifiable patient safety data volun-
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1 tarily reported by patient safety organizations, providers,

2 or other persons.

3 ‘‘(b) NETWORK OF DATABASE STANDARDS.—The Sec4 retary may determine common formats for the reporting to

5 the patient safety network of databases maintained under

6 subsection (a) of nonidentifiable patient safety data, includ7 ing necessary data elements, common and consistent defini8 tions, and a standardized computer interface for the proc9 essing of such data. To the extent practicable, such stand10 ards shall be consistent with the administrative simplifica11 tion provisions of Part C of title XI of the Social Security

12 Act.

13 ‘‘SEC. 924. PATIENT SAFETY ORGANIZATION CERTIFI14 CATION AND LISTING.

15 ‘‘(a) CERTIFICATION.—

16 ‘‘(1) INITIAL CERTIFICATION.—Except as pro17 vided in paragraph (2), an entity that seeks to be a

18 patient safety organization shall submit an initial

19 certification to the Secretary that the entity intends

20 to perform the patient safety organization activities.

21 ‘‘(2) DELAYED CERTIFICATION OF COLLECTION

22 FROM MORE THAN ONE PROVIDER.—An entity that

23 seeks to be a patient safety organization may—

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

25 intends to perform patient safety organization
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1 activities other than the activities described in

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

3 ‘‘(B) within 2 years of submitting the ini4 tial certification under subparagraph (A), sub5 mit a supplemental certification that it performs

6 the patient safety organization activities de7 scribed in subparagraphs (A) through (F) of sec8 tion 921(4).

9 ‘‘(3) EXPIRATION AND RENEWAL.—

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

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

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

13 ‘‘(B) RENEWAL.—

14 ‘‘(i) IN GENERAL.—An entity that

15 seeks to remain a patient safety organiza16 tion after the expiration of an initial cer17 tification under paragraph (1) or (2)(A)

18 shall, within the 3-year period described in

19 subparagraph (A), submit a renewal certifi20 cation to the Secretary that the entity per21 forms the patient safety organization activi22 ties described in section 921(4).

23 ‘‘(ii) TERM OF RENEWAL.—A renewal

24 certification under clause (i) shall expire on

25 the date that is 3 years after the date on
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1 which it is submitted, and may be renewed

2 in the same manner as an initial certifi3 cation.

4 ‘‘(b) ACCEPTANCE OF CERTIFICATION.—Upon the sub5 mission by an organization of an initial certification pur6 suant to subsection (a)(1) or (a)(2)(A), a supplemental cer7 tification pursuant to subsection (a)(2)(B), or a renewal

8 certification pursuant to subsection (a)(3)(B), the Secretary

9 shall review such certification and—

10 ‘‘(1) if such certification meets the requirements

11 of subsection (a)(1), (a)(2)(A), (a)(2)(B), or (a)(3)(B),

12 as applicable, the Secretary shall notify the organiza13 tion that such certification is accepted; or

14 ‘‘(2) if such certification does not meet such re15 quirements, as applicable, the Secretary shall notify

16 the organization that such certification is not accept17 ed and the reasons therefor.

18 ‘‘(c) LISTING.—

19 ‘‘(1) IN GENERAL.—Except as otherwise provided

20 in this subsection, the Secretary shall compile and

21 maintain a current listing of patient safety organiza22 tions with respect to which the Secretary has accepted

23 a certification pursuant to subsection (b).

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

25 shall remove from the listing under paragraph (1)—
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1 ‘‘(A) an entity with respect to which the

2 Secretary has accepted an initial certification

3 pursuant to subsection (a)(2)(A) and which does

4 not submit a supplemental certification pursu5 ant to subsection (a)(2)(B) that is accepted by

6 the Secretary;

7 ‘‘(B) an entity whose certification expires

8 and which does not submit a renewal applica9 tion that is accepted by the Secretary; and

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

11 Secretary revokes the Secretary’s acceptance of

12 the entity’s certification, pursuant to subsection

13 (d).

14 ‘‘(d) REVOCATION OF ACCEPTANCE.—

15 ‘‘(1) IN GENERAL.—Except as provided in para16 graph (2), if the Secretary determines (through a re17 view of patient safety organization activities) that a

18 patient safety organization does not perform one of

19 the patient safety organization activities described in

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

21 Secretary may, after notice and an opportunity for a

22 hearing, revoke the Secretary’s acceptance of the cer23 tification of such organization.

24 ‘‘(2) DELAYED CERTIFICATION OF COLLECTION

25 FROM MORE THAN ONE PROVIDER.—A revocation
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1 under paragraph (1) may not be based on a deter2 mination that the organization does not perform the

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

4 ‘‘(A) the listing of the organization is based

5 on its submittal of an initial certification under

6 subsection (a)(2)(A);

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

8 supplemental certification under subsection

9 (a)(2)(B); and

10 ‘‘(C) the 2-year period described in sub11 section (a)(2)(B) has not expired.

12 ‘‘(e) NOTIFICATION OF REVOCATION OR REMOVAL

13 FROM LISTING.—

14 ‘‘(1) SUPPLYING CONFIRMATION OF NOTIFICA15 TION TO PROVIDERS.—Within 15 days of a revocation

16 under subsection (d)(1), a patient safety organization

17 shall submit to the Secretary a confirmation that the

18 organization has taken all reasonable actions to no19 tify each provider whose patient safety data is col20 lected or analyzed by the organization of such revoca21 tion.

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

23 acceptance of an organization’s certification under

24 subsection (d)(1), or upon the removal of an organiza25 tion from the listing under subsection (c)(2), the Sec-
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1 retary shall publish notice of the revocation or re2 moval in the Federal Register.

3 ‘‘(f) STATUS OF DATA AFTER REMOVAL FROM LIST4 ING.—

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

6 and confidentiality protections described in section

7 922, data submitted to an organization within 30

8 days after the organization is removed from the list9 ing under subsection (c)(2) shall have the same status

10 as data submitted while the organization was still

11 listed.

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

13 the privilege and confidentiality protections described

14 in section 922 applied to data while an organization

15 was listed, or during the 30-day period described in

16 paragraph (1), such protections shall continue to

17 apply to such data after the organization is removed

18 from the listing under subsection (c)(2).

19 ‘‘(g) DISPOSITION OF DATA.—If the Secretary removes

20 an organization from the listing as provided for in sub21 section (c)(2), with respect to the patient safety data that

22 the organization received from providers, the organization

23 shall—
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1 ‘‘(1) with the approval of the provider and an2 other patient safety organization, transfer such data

3 to such other organization;

4 ‘‘(2) return such data to the person that sub5 mitted the data; or

6 ‘‘(3) if returning such data to such person is not

7 practicable, destroy such data.

8 ‘‘SEC. 925. TECHNICAL ASSISTANCE.

9 ‘‘The Secretary, acting through the Director, may pro10 vide technical assistance to patient safety organizations, in11 cluding convening annual meetings for patient safety orga12 nizations to discuss methodology, communication, data col13 lection, or privacy concerns.

14 ‘‘SEC. 926. PROMOTING THE INTEROPERABILITY OF

15 HEALTH CARE INFORMATION TECHNOLOGY

16 SYSTEMS.

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

18 the date of enactment of the Patient Safety and Quality

19 Improvement Act of 2004, the Secretary shall develop or

20 adopt voluntary standards that promote the electronic ex21 change of health care information.

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

23 ongoing review and periodic updating of the standards de24 veloped under subsection (a).
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1 ‘‘(c) DISSEMINATION.—The Secretary shall provide for

2 the dissemination of the standards developed and updated

3 under this section.

4 ‘‘SEC. 927. AUTHORIZATION OF APPROPRIATIONS.

5 ‘‘There is authorized to be appropriated such sums as

6 may be necessary to carry out this part.’’.

7 SEC. 4. STUDIES AND REPORTS.

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

9 Human Services shall enter into a contract (based upon

10 a competitive contracting process) with an appropriate re11 search organization for the conduct of a study to assess the

12 impact of medical technologies and therapies on patient

13 safety, patient benefit, health care quality, and the costs of

14 care as well as productivity growth. Such study shall

15 examine—

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

17 of labor and technological advances, have contributed

18 to increases in the share of the gross domestic product

19 that is devoted to health care and the impact of med20 ical technologies and therapies on such increases;

21 (2) the extent to which early and appropriate in22 troduction and integration of innovative medical

23 technologies and therapies may affect the overall pro24 ductivity and quality of the health care delivery sys25 tems of the United States; and
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HR 663 EAS

1 (3) the relationship of such medical technologies

2 and therapies to patient safety, patient benefit, health

3 care quality, and cost of care.

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

5 of enactment of this Act, the Secretary of Health and

6 Human Services shall prepare and submit to the appro7 priate committees of Congress a report containing the re8 sults of the study conducted under subsection (a).

Attest:

Secretary.
108TH CONGRESS

2D SESSION H. R. 663

AMENDMENT