[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 544 Introduced in Senate (IS)]







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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Patient Safety and Quality 
Improvement Act of 2005''.

SEC. 2. FINDINGS AND PURPOSES.

    (a) Findings.--Congress makes the following findings:
            (1) In 1999, the Institute of Medicine released a report 
        entitled To Err is Human that described medical errors as the 
        eighth leading cause of death in the United States, with as 
        many as 98,000 people dying as a result of medical errors each 
        year.
            (2) To address these deaths and injuries due to medical 
        errors, the health care system must identify and learn from 
        such errors so that systems of care can be improved.
            (3) In their report, the Institute of Medicine called on 
        Congress to provide legal protections with respect to 
        information reported for the purposes of quality improvement 
        and patient safety.
            (4) The Health, Education, Labor, and Pensions Committee of 
        the Senate held 4 hearings in the 106th Congress and 1 hearing 
        in the 107th Congress on patient safety where experts in the 
        field supported the recommendation of the Institute of Medicine 
        for congressional action.
            (5) Myriad public and private patient safety initiatives 
        have begun. The Quality Interagency Coordination Taskforce has 
        recommended steps to improve patient safety that may be taken 
        by each Federal agency involved in health care and activities 
        relating to these steps are ongoing.
            (6) The research on patient safety unequivocally calls for 
        a learning environment, rather than a punitive environment, in 
        order to improve patient safety.
            (7) Voluntary data gathering systems are more supportive 
        than mandatory systems in creating the learning environment 
        referred to in paragraph (6) as stated in the Institute of 
        Medicine's report.
            (8) Promising patient safety reporting systems have been 
        established throughout the United States and the best ways to 
        structure and use these systems are currently being determined, 
        largely through projects funded by the Agency for Healthcare 
        Research and Quality.
            (9) Many organizations currently collecting patient safety 
        data have expressed a need for legal protections that will 
        allow them to review protected information and collaborate in 
        the development and implementation of patient safety 
        improvement strategies. Currently, the State peer review 
        protections are inadequate to allow the sharing of information 
        to promote patient safety.
    (b) Purposes.--It is the purpose of this Act to--
            (1) encourage a culture of safety and quality in the United 
        States health care system by providing for legal protection of 
        information reported voluntarily for the purposes of quality 
        improvement and patient safety; and
            (2) ensure accountability by raising standards and 
        expectations for continuous quality improvements in patient 
        safety.

SEC. 3. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT.

    Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.) 
is amended--
            (1) in section 912(c), by inserting ``, in accordance with 
        part C,'' after ``The Director shall'';
            (2) by redesignating part C as part D;
            (3) by redesignating sections 921 through 928, as sections 
        931 through 938, respectively;
            (4) in 934(d) (as so redesignated), by striking the second 
        sentence and inserting the following: ``Penalties provided for 
        under this section shall be imposed and collected by the 
        Secretary using the administrative and procedural processes 
        used to impose and collect civil money penalties under section 
        1128A of the Social Security Act (other than subsections (a) 
        and (b), the second sentence of subsection (f), and subsections 
        (i), (m), and (n)), unless the Secretary determines that a 
        modification of procedures would be more suitable or reasonable 
        to carry out this subsection and provides for such modification 
        by regulation.'';
            (5) in section 938(1) (as so redesignated), by striking 
        ``921'' and inserting ``931''; and
            (6) by inserting after part B the following:

                  ``PART C--PATIENT SAFETY IMPROVEMENT

``SEC. 921. DEFINITIONS.

    ``In this part:
            ``(1) Non-identifiable information.--
                    ``(A) In general.--The term `non-identifiable 
                information' means, with respect to information, that 
                the information is presented in a form and manner that 
                prevents the identification of a provider, a patient, 
                or a reporter of patient safety data.
                    ``(B) Identifiability of patient.--For purposes of 
                subparagraph (A), the term `presented in a form and 
                manner that prevents the identification of a patient' 
                means, with respect to information that has been 
                subject to rules promulgated pursuant to section 264(c) 
                of the Health Insurance Portability and Accountability 
                Act of 1996 (42 U.S.C. 1320d-2 note), that the 
                information has been de-identified so that it is no 
                longer individually identifiable health information as 
                defined in such rules.
            ``(2) Patient safety data.--
                    ``(A) In general.--The term `patient safety data' 
                means--
                            ``(i) any data, reports, records, 
                        memoranda, analyses (such as root cause 
                        analyses), or written or oral statements that 
                        are--
                                    ``(I) collected or developed by a 
                                provider for reporting to a patient 
                                safety organization, provided that they 
                                are reported to the patient safety 
                                organization within 60 days;
                                    ``(II) requested by a patient 
                                safety organization (including the 
                                contents of such request), if they are 
                                reported to the patient safety 
                                organization within 60 days;
                                    ``(III) reported to a provider by a 
                                patient safety organization; or
                                    ``(IV) collected by a patient 
                                safety organization from another 
                                patient safety organization, or 
                                developed by a patient safety 
                                organization;
                        that could result in improved patient safety, 
                        health care quality, or health care outcomes; 
                        or
                            ``(ii) any deliberative work or process 
                        with respect to any patient safety data 
                        described in clause (i).
                    ``(B) Limitation.--
                            ``(i) Collection.--If the original material 
                        from which any data, reports, records, 
                        memoranda, analyses (such as root case 
                        analyses), or written or oral statements 
                        referred to in subclause (I) or (IV) of 
                        subparagraph (A)(i) are collected and is not 
                        patient safety data, the act of such collection 
                        shall not make such original material patient 
                        safety data for purposes of this part.
                            ``(ii) Separate data.--The term `patient 
                        safety data' shall not include information 
                        (including a patient's medical record, billing 
                        and discharge information or any other patient 
                        or provider record) that is collected or 
                        developed separately from and that exists 
                        separately from patient safety data. Such 
                        separate information or a copy thereof 
                        submitted to a patient safety organization 
                        shall not itself be considered as patient 
                        safety data. Nothing in this part, except for 
                        section 922(f)(1), shall be construed to 
                        limit--
                                    ``(I) the discovery of or 
                                admissibility of information described 
                                in this subparagraph in a criminal, 
                                civil, or administrative proceeding;
                                    ``(II) the reporting of information 
                                described in this subparagraph to a 
                                Federal, State, or local governmental 
                                agency for public health surveillance, 
                                investigation, or other public health 
                                purposes or health oversight purposes; 
                                or
                                    ``(III) a provider's recordkeeping 
                                obligation with respect to information 
                                described in this subparagraph under 
                                Federal, State, or local law.
            ``(3) Patient safety organization.--The term `patient 
        safety organization' means a private or public entity or 
        component thereof that is currently listed by the Secretary 
        pursuant to section 924(c).
            ``(4) Patient safety organization activities.--The term 
        `patient safety organization activities' means the following 
        activities, which are deemed to be necessary for the proper 
        management and administration of a patient safety organization:
                    ``(A) The conduct, as its primary activity, of 
                efforts to improve patient safety and the quality of 
                health care delivery.
                    ``(B) The collection and analysis of patient safety 
                data that are submitted by more than one provider.
                    ``(C) The development and dissemination of 
                information to providers with respect to improving 
                patient safety, such as recommendations, protocols, or 
                information regarding best practices.
                    ``(D) The utilization of patient safety data for 
                the purposes of encouraging a culture of safety and of 
                providing direct feedback and assistance to providers 
                to effectively minimize patient risk.
                    ``(E) The maintenance of procedures to preserve 
                confidentiality with respect to patient safety data.
                    ``(F) The provision of appropriate security 
                measures with respect to patient safety data.
                    ``(G) The utilization of qualified staff.
            ``(5) Person.--The term `person' includes Federal, State, 
        and local government agencies.
            ``(6) Provider.--The term `provider' means--
                    ``(A) a person licensed or otherwise authorized 
                under State law to provide health care services, 
                including--
                            ``(i) a hospital, nursing facility, 
                        comprehensive outpatient rehabilitation 
                        facility, home health agency, hospice program, 
                        renal dialysis facility, ambulatory surgical 
                        center, pharmacy, physician or health care 
                        practitioner's office, long term care facility, 
                        behavior health residential treatment facility, 
                        clinical laboratory, or health center; or
                            ``(ii) a physician, physician assistant, 
                        nurse practitioner, clinical nurse specialist, 
                        certified registered nurse anesthetist, 
                        certified nurse midwife, psychologist, 
                        certified social worker, registered dietitian 
                        or nutrition professional, physical or 
                        occupational therapist, pharmacist, or other 
                        individual health care practitioner; or
                    ``(B) any other person specified in regulations 
                promulgated by the Secretary.

``SEC. 922. PRIVILEGE AND CONFIDENTIALITY PROTECTIONS.

    ``(a) Privilege.--Notwithstanding any other provision of Federal, 
State, or local law, patient safety data shall be privileged and, 
subject to the provisions of subsection (c)(1), shall not be--
            ``(1) subject to a Federal, State, or local civil, 
        criminal, or administrative subpoena;
            ``(2) subject to discovery in connection with a Federal, 
        State, or local civil, criminal, or administrative proceeding;
            ``(3) disclosed pursuant to section 552 of title 5, United 
        States Code (commonly known as the Freedom of Information Act) 
        or any other similar Federal, State, or local law;
            ``(4) admitted as evidence or otherwise disclosed in any 
        Federal, State, or local civil, criminal, or administrative 
        proceeding; or
            ``(5) utilized in a disciplinary proceeding against a 
        provider.
    ``(b) Confidentiality.--Notwithstanding any other provision of 
Federal, State, or local law, and subject to the provisions of 
subsections (c) and (d), patient safety data shall be confidential and 
shall not be disclosed.
    ``(c) Exceptions to Privilege and Confidentiality.--Nothing in this 
section shall be construed to prohibit one or more of the following 
uses or disclosures:
            ``(1) Disclosure by a provider or patient safety 
        organization of relevant patient safety data for use in a 
        criminal proceeding only after a court makes an in camera 
        determination that such patient safety data contains evidence 
        of a wanton and criminal act to directly harm the patient.
            ``(2) Voluntary disclosure of non-identifiable patient 
        safety data by a provider or a patient safety organization.
    ``(d) Protected Disclosure and Use of Information.--Nothing in this 
section shall be construed to prohibit one or more of the following 
uses or disclosures:
            ``(1) Disclosure of patient safety data by a person that is 
        a provider, a patient safety organization, or a contractor of a 
        provider or patient safety organization, to another such 
        person, to carry out patient safety organization activities.
            ``(2) Disclosure of patient safety data by a provider or 
        patient safety organization to grantees or contractors carrying 
        out patient safety research, evaluation, or demonstration 
        projects authorized by the Director.
            ``(3) Disclosure of patient safety data by a provider to an 
        accrediting body that accredits that provider.
            ``(4) Voluntary disclosure of patient safety data by a 
        patient safety organization to the Secretary for public health 
        surveillance if the consent of each provider identified in, or 
        providing, such data is obtained prior to such disclosure. 
        Nothing in the preceding sentence shall be construed to prevent 
        the release of patient safety data that is provided by, or that 
        relates solely to, a provider from which the consent described 
        in such sentence is obtained because one or more other 
        providers do not provide such consent with respect to the 
        disclosure of patient safety data that relates to such 
        nonconsenting providers. Consent for the future release of 
        patient safety data for such purposes may be requested by the 
        patient safety organization at the time the data is submitted.
            ``(5) Voluntary disclosure of patient safety data by a 
        patient safety organization to State of local government 
        agencies for public health surveillance if the consent of each 
        provider identified in, or providing, such data is obtained 
        prior to such disclosure. Nothing in the preceding sentence 
        shall be construed to prevent the release of patient safety 
        data that is provided by, or that relates solely to, a provider 
        from which the consent described in such sentence is obtained 
        because one or more other providers do not provide such consent 
        with respect to the disclosure of patient safety data that 
        relates to such nonconsenting providers. Consent for the future 
        release of patient safety data for such purposes may be 
        requested by the patient safety organization at the time the 
        data is submitted.
    ``(e) Continued Protection of Information After Disclosure.--
            ``(1) In general.--Except as provided in paragraph (2), 
        patient safety data that is used or disclosed shall continue to 
        be privileged and confidential as provided for in subsections 
        (a) and (b), and the provisions of such subsections shall apply 
        to such data in the possession or control of--
                    ``(A) a provider or patient safety organization 
                that possessed such data before the use or disclosure; 
                or
                    ``(B) a person to whom such data was disclosed.
            ``(2) Exception.--Notwithstanding paragraph (1), and 
        subject to paragraph (3)--
                    ``(A) if patient safety data is used or disclosed 
                as provided for in subsection (c)(1), and such use or 
                disclosure is in open court, the confidentiality 
                protections provided for in subsection (b) shall no 
                longer apply to such data; and
                    ``(B) if patient safety data is used or disclosed 
                as provided for in subsection (c)(2), the privilege and 
                confidentiality protections provided for in subsections 
                (a) and (b) shall no longer apply to such data.
            ``(3) Construction.--Paragraph (2) shall not be construed 
        as terminating or limiting the privilege or confidentiality 
        protections provided for in subsection (a) or (b) with respect 
        to data other than the specific data used or disclosed as 
        provided for in subsection (c).
    ``(f) Limitation on Actions.--
            ``(1) Patient safety organizations.--Except to enforce 
        disclosures pursuant to subsection (c)(1), no action may be 
        brought or process served against a patient safety organization 
        to compel disclosure of information collected or developed 
        under this part whether or not such information is patient 
        safety data unless such information is specifically identified, 
        is not patient safety data, and cannot otherwise be obtained.
            ``(2) Providers.--An accrediting body shall not take an 
        accrediting action against a provider based on the good faith 
        participation of the provider in the collection, development, 
        reporting, or maintenance of patient safety data in accordance 
        with this part. An accrediting body may not require a provider 
        to reveal its communications with any patient safety 
        organization established in accordance with this part.
    ``(g) Reporter Protection.--
            ``(1) In general.--A provider may not take an adverse 
        employment action, as described in paragraph (2), against an 
        individual based upon the fact that the individual in good 
        faith reported information--
                    ``(A) to the provider with the intention of having 
                the information reported to a patient safety 
                organization; or
                    ``(B) directly to a patient safety organization.
            ``(2) Adverse employment action.--For purposes of this 
        subsection, an `adverse employment action' includes--
                    ``(A) loss of employment, the failure to promote an 
                individual, or the failure to provide any other 
                employment-related benefit for which the individual 
                would otherwise be eligible; or
                    ``(B) an adverse evaluation or decision made in 
                relation to accreditation, certification, 
                credentialing, or licensing of the individual.
    ``(h) Enforcement.--
            ``(1) Prohibition.--Except as provided in subsections (c) 
        and (d) and as otherwise provided for in this section, it shall 
        be unlawful for any person to negligently or intentionally 
        disclose any patient safety data, and any such person shall, 
        upon adjudication, be assessed in accordance with section 
        934(d).
            ``(2) Relation to hipaa.--The penalty provided for under 
        paragraph (1) shall not apply if the defendant would otherwise 
        be subject to a penalty under the regulations promulgated under 
        section 264(c) of the Health Insurance Portability and 
        Accountability Act of 1996 (42 U.S.C. 1320d-2 note) or under 
        section 1176 of the Social Security Act (42 U.S.C. 1320d-5) for 
        the same disclosure.
            ``(3) Equitable relief.--
                    ``(A) In general.--Without limiting remedies 
                available to other parties, a civil action may be 
                brought by any aggrieved individual to enjoin any act 
                or practice that violates subsection (g) and to obtain 
                other appropriate equitable relief (including 
                reinstatement, back pay, and restoration of benefits) 
                to redress such violation.
                    ``(B) Against state employees.--An entity that is a 
                State or an agency of a State government may not assert 
                the privilege described in subsection (a) unless before 
                the time of the assertion, the entity or, in the case 
                of and with respect to an agency, the State has 
                consented to be subject to an action as described by 
                this paragraph, and that consent has remained in 
                effect.
    ``(i) Rule of Construction.--Nothing in this section shall be 
construed to--
            ``(1) limit other privileges that are available under 
        Federal, State, or local laws that provide greater 
        confidentiality protections or privileges than the privilege 
        and confidentiality protections provided for in this section;
            ``(2) limit, alter, or affect the requirements of Federal, 
        State, or local law pertaining to information that is not 
        privileged or confidential under this section;
            ``(3) alter or affect the implementation of any provision 
        of section 264(c) of the Health Insurance Portability and 
        Accountability Act of 1996 (Public Law 104-191; 110 Stat. 
        2033), section 1176 of the Social Security Act (42 U.S.C. 
        1320d-5), or any regulation promulgated under such sections;
            ``(4) limit the authority of any provider, patient safety 
        organization, or other person to enter into a contract 
        requiring greater confidentiality or delegating authority to 
        make a disclosure or use in accordance with subsection (c) or 
        (d); and
            ``(5) prohibit a provider from reporting a crime to law 
        enforcement authorities, regardless of whether knowledge of the 
        existence of, or the description of, the crime is based on 
        patient safety data, so long as the provider does not disclose 
        patient safety data in making such report.

``SEC. 923. PATIENT SAFETY NETWORK OF DATABASES.

    ``(a) In General.--The Secretary shall maintain a patient safety 
network of databases that provides an interactive evidence-based 
management resource for providers, patient safety organizations, and 
other persons. The network of databases shall have the capacity to 
accept, aggregate, and analyze nonidentifiable patient safety data 
voluntarily reported by patient safety organizations, providers, or 
other persons.
    ``(b) Network of Database Standards.--The Secretary may determine 
common formats for the reporting to the patient safety network of 
databases maintained under subsection (a) of nonidentifiable patient 
safety data, including necessary data elements, common and consistent 
definitions, and a standardized computer interface for the processing 
of such data. To the extent practicable, such standards shall be 
consistent with the administrative simplification provisions of Part C 
of title XI of the Social Security Act.

``SEC. 924. PATIENT SAFETY ORGANIZATION CERTIFICATION AND LISTING.

    ``(a) Certification.--
            ``(1) Initial certification.--Except as provided in 
        paragraph (2), an entity that seeks to be a patient safety 
        organization shall submit an initial certification to the 
        Secretary that the entity intends to perform the patient safety 
        organization activities.
            ``(2) Delayed certification of collection from more than 
        one provider.--An entity that seeks to be a patient safety 
        organization may--
                    ``(A) submit an initial certification that it 
                intends to perform patient safety organization 
                activities other than the activities described in 
                subparagraph (B) of section 921(4); and
                    ``(B) within 2 years of submitting the initial 
                certification under subparagraph (A), submit a 
                supplemental certification that it performs the patient 
                safety organization activities described in 
                subparagraphs (A) through (F) of section 921(4).
            ``(3) Expiration and renewal.--
                    ``(A) Expiration.--An initial certification under 
                paragraph (1) or (2)(A) shall expire on the date that 
                is 3 years after it is submitted.
                    ``(B) Renewal.--
                            ``(i) In general.--An entity that seeks to 
                        remain a patient safety organization after the 
                        expiration of an initial certification under 
                        paragraph (1) or (2)(A) shall, within the 3-
                        year period described in subparagraph (A), 
                        submit a renewal certification to the Secretary 
                        that the entity performs the patient safety 
                        organization activities described in section 
                        921(4).
                            ``(ii) Term of renewal.--A renewal 
                        certification under clause (i) shall expire on 
                        the date that is 3 years after the date on 
                        which it is submitted, and may be renewed in 
                        the same manner as an initial certification.
    ``(b) Acceptance of Certification.--Upon the submission by an 
organization of an initial certification pursuant to subsection (a)(1) 
or (a)(2)(A), a supplemental certification pursuant to subsection 
(a)(2)(B), or a renewal certification pursuant to subsection (a)(3)(B), 
the Secretary shall review such certification and--
            ``(1) if such certification meets the requirements of 
        subsection (a)(1), (a)(2)(A), (a)(2)(B), or (a)(3)(B), as 
        applicable, the Secretary shall notify the organization that 
        such certification is accepted; or
            ``(2) if such certification does not meet such 
        requirements, as applicable, the Secretary shall notify the 
        organization that such certification is not accepted and the 
        reasons therefor.
    ``(c) Listing.--
            ``(1) In general.--Except as otherwise provided in this 
        subsection, the Secretary shall compile and maintain a current 
        listing of patient safety organizations with respect to which 
        the Secretary has accepted a certification pursuant to 
        subsection (b).
            ``(2) Removal from listing.--The Secretary shall remove 
        from the listing under paragraph (1)--
                    ``(A) an entity with respect to which the Secretary 
                has accepted an initial certification pursuant to 
                subsection (a)(2)(A) and which does not submit a 
                supplemental certification pursuant to subsection 
                (a)(2)(B) that is accepted by the Secretary;
                    ``(B) an entity whose certification expires and 
                which does not submit a renewal application that is 
                accepted by the Secretary; and
                    ``(C) an entity with respect to which the Secretary 
                revokes the Secretary's acceptance of the entity's 
                certification, pursuant to subsection (d).
    ``(d) Revocation of Acceptance.--
            ``(1) In general.--Except as provided in paragraph (2), if 
        the Secretary determines (through a review of patient safety 
        organization activities) that a patient safety organization 
        does not perform one of the patient safety organization 
        activities described in subparagraph (A) through (F) of section 
        921(4), the Secretary may, after notice and an opportunity for 
        a hearing, revoke the Secretary's acceptance of the 
        certification of such organization.
            ``(2) Delayed certification of collection from more than 
        one provider.--A revocation under paragraph (1) may not be 
        based on a determination that the organization does not perform 
        the activity described in section 921(4)(B) if--
                    ``(A) the listing of the organization is based on 
                its submittal of an initial certification under 
                subsection (a)(2)(A);
                    ``(B) the organization has not submitted a 
                supplemental certification under subsection (a)(2)(B); 
                and
                    ``(C) the 2-year period described in subsection 
                (a)(2)(B) has not expired.
    ``(e) Notification of Revocation or Removal From Listing.--
            ``(1) Supplying confirmation of notification to 
        providers.--Within 15 days of a revocation under subsection 
        (d)(1), a patient safety organization shall submit to the 
        Secretary a confirmation that the organization has taken all 
        reasonable actions to notify each provider whose patient safety 
        data is collected or analyzed by the organization of such 
        revocation.
            ``(2) Publication.--Upon the revocation of an acceptance of 
        an organization's certification under subsection (d)(1), or 
        upon the removal of an organization from the listing under 
        subsection (c)(2), the Secretary shall publish notice of the 
        revocation or removal in the Federal Register.
    ``(f) Status of Data After Removal From Listing.--
            ``(1) New data.--With respect to the privilege and 
        confidentiality protections described in section 922, data 
        submitted to an organization within 30 days after the 
        organization is removed from the listing under subsection 
        (c)(2) shall have the same status as data submitted while the 
        organization was still listed.
            ``(2) Protection to continue to apply.--If the privilege 
        and confidentiality protections described in section 922 
        applied to data while an organization was listed, or during the 
        30-day period described in paragraph (1), such protections 
        shall continue to apply to such data after the organization is 
        removed from the listing under subsection (c)(2).
    ``(g) Disposition of Data.--If the Secretary removes an 
organization from the listing as provided for in subsection (c)(2), 
with respect to the patient safety data that the organization received 
from providers, the organization shall--
            ``(1) with the approval of the provider and another patient 
        safety organization, transfer such data to such other 
        organization;
            ``(2) return such data to the person that submitted the 
        data; or
            ``(3) if returning such data to such person is not 
        practicable, destroy such data.

``SEC. 925. TECHNICAL ASSISTANCE.

    ``The Secretary, acting through the Director, may provide technical 
assistance to patient safety organizations, including convening annual 
meetings for patient safety organizations to discuss methodology, 
communication, data collection, or privacy concerns.

``SEC. 926. PROMOTING THE INTEROPERABILITY OF HEALTH CARE INFORMATION 
              TECHNOLOGY SYSTEMS.

    ``(a) Development.--Not later than 36 months after the date of 
enactment of the Patient Safety and Quality Improvement Act of 2005, 
the Secretary shall develop or adopt voluntary standards that promote 
the electronic exchange of health care information.
    ``(b) Updates.--The Secretary shall provide for the ongoing review 
and periodic updating of the standards developed under subsection (a).
    ``(c) Dissemination.--The Secretary shall provide for the 
dissemination of the standards developed and updated under this 
section.

``SEC. 927. AUTHORIZATION OF APPROPRIATIONS.

    ``There is authorized to be appropriated such sums as may be 
necessary to carry out this part.''.

SEC. 4. STUDIES AND REPORTS.

    (a) In General.--The Secretary of Health and Human Services shall 
enter into a contract (based upon a competitive contracting process) 
with an appropriate research organization for the conduct of a study to 
assess the impact of medical technologies and therapies on patient 
safety, patient benefit, health care quality, and the costs of care as 
well as productivity growth. Such study shall examine--
            (1) the extent to which factors, such as the use of labor 
        and technological advances, have contributed to increases in 
        the share of the gross domestic product that is devoted to 
        health care and the impact of medical technologies and 
        therapies on such increases;
            (2) the extent to which early and appropriate introduction 
        and integration of innovative medical technologies and 
        therapies may affect the overall productivity and quality of 
        the health care delivery systems of the United States; and
            (3) the relationship of such medical technologies and 
        therapies to patient safety, patient benefit, health care 
        quality, and cost of care.
    (b) Report.--Not later than 18 months after the date of enactment 
of this Act, the Secretary of Health and Human Services shall prepare 
and submit to the appropriate committees of Congress a report 
containing the results of the study conducted under subsection (a).
                                 <all>