Original Content (c) MultiState Associates Inc.

 

 

Association of Health Information Outsourcing Services

07/27/2005 - 08/03/2005

 

Legislative Movement

 

 

Illinois H.B. 875

Category:

Pricing

 

Last Action:

08/02/2005 In House; Governor Approved; Public Act . . . . . . . . . 94-0409

 

Synopsis:

As Introduced: Amends the Regulatory Sunset Act. Extends the repeal of the Illinois Dental Practice Act to January 1, 2016. Amends the Illinois Dental Practice Act. Defines "titration" and "dental emergency responder". Prohibits the titration of orally administered sedative agents that exceeds the maximum recommended dose. Provides that a dentist shall not be required to maintain a general license in addition to a specialty license. Provides that restricted faculty licenses shall be valid for a period of 3 years, rather than 2 years. Provides that each license issued under the Act shall be valid for 3 years, rather than being set by rule of the Department of Financial and Professional Regulation. Changes continuing education requirements for hours of study. Provides that a surviving spouse or certain other interested parties in an estate may employ, contract with, or otherwise make arrangements for a dentist or dentists to temporarily continue to operate a dental practice under the name of a deceased or incapacitated dentist under certain specified circumstances. Provides that dentists shall be entitled to reasonable reimbursement for the costs of reproducing patient dental records. Provides that a dentist or dental hygienist who is a dental emergency responder acts within the bounds of his or her license when he or she provides care during a declared local, State, or national emergency. Makes other changes. Effective immediately. House Amendment #1 makes the following changes: Removes references to titration and provisions concerning the maintenance of a general license in addition to a specialty license. Removes a provision requiring the vote of at least 7/10 of the members of the Board of Dentistry for the Department of Financial and Professional Regulation to adopt the recommendations of the Board in any rulemaking under the Act. Makes changes in the requirements for licensure as a dentist if the applicant completed his or her dental education by graduating from a dental college or school outside the United States or Canada. Provides that each license issued under the Act shall be valid for 3 years and may be renewed or restored for additional 3-year periods, as provided by rule (rather than just renewed for additional 3-year periods). Provides that any dentist or dental hygienist whose license has expired or is on inactive status must, in addition to paying the required fee, show proof of compliance with current continuing education requirements in order to have the license restored at any time within 5 years after the expiration of the license. Removes the provision concerning the continued operation of a dental practice upon death or incapacitation of a dentist. Provides that prior to taking an in-person statement from a dentist or dental hygienist who is the subject of a complaint, the investigator shall inform the dentist or the dental hygienist in writing that failure of the dentist or dental hygienist to proceed with the interview does not prohibit the Department from conducting a visual inspection of the facility. Makes other changes. Effective immediately.

 

House Amendment #2: Deletes everything after the enacting clause. Reinserts the contents of the bill as engrossed and incorporates Senate Amendment Nos. 1 and 3. Effective December 31, 2005.

 

Additional Information:

Language as Enacted on August 2, 2005:

 

SEC. 25.1. SUBPOENA POWERS.

 

(A) THE DEPARTMENT, UPON A DETERMINATION BY THE CHAIRPERSON OF THE BOARD THAT REASONABLE CAUSE EXISTS THAT A VIOLATION OF ONE OR MORE OF THE GROUNDS FOR DISCIPLINE SET FORTH IN SECTION 23 OR SECTION 24 OF THIS ACT HAS OCCURRED OR IS OCCURRING, MAY SUBPOENA THE DENTAL RECORDS OF INDIVIDUAL PATIENTS OF DENTISTS AND DENTAL HYGIENISTS LICENSED UNDER THIS ACT.

 

(B) NOTWITHSTANDING SUBSECTION (A) OF THIS SECTION, THE BOARD AND THE DEPARTMENT MAY SUBPOENA COPIES OF HOSPITAL, MEDICAL, OR DENTAL RECORDS IN MANDATORY REPORT CASES ALLEGING DEATH OR PERMANENT BODILY INJURY WHEN CONSENT TO OBTAIN THE RECORDS HAS NOT BEEN PROVIDED BY A PATIENT OR A PATIENT'S LEGAL REPRESENTATIVE. ALL RECORDS AND OTHER INFORMATION RECEIVED PURSUANT TO A SUBPOENA SHALL BE CONFIDENTIAL AND SHALL BE AFFORDED THE SAME STATUS AS INFORMATION CONCERNING MEDICAL STUDIES UNDER PART 21 OF ARTICLE VIII OF THE CODE OF CIVIL PROCEDURE. THE USE OF THESE RECORDS SHALL BE RESTRICTED TO MEMBERS OF THE BOARD, THE DENTAL COORDINATOR, AND APPROPRIATE DEPARTMENT STAFF DESIGNATED BY THE SECRETARY FOR THE PURPOSE OF DETERMINING THE EXISTENCE OF ONE OR MORE GROUNDS FOR DISCIPLINE OF THE DENTIST OR DENTAL HYGIENIST AS PROVIDED FOR IN SECTION 23 OR SECTION 24 OF THIS ACT.

 

(C) ANY REVIEW OF AN INDIVIDUAL PATIENT'S RECORDS SHALL BE CONDUCTED BY THE DEPARTMENT IN STRICT CONFIDENTIALITY, PROVIDED THAT THE PATIENT RECORDS SHALL BE ADMISSIBLE IN A DISCIPLINARY HEARING BEFORE THE SECRETARY, THE BOARD, OR A HEARING OFFICER DESIGNATED BY THE DEPARTMENT WHEN NECESSARY TO SUBSTANTIATE THE GROUNDS FOR DISCIPLINE ALLEGED AGAINST THE DENTIST OR DENTAL HYGIENIST LICENSED UNDER THIS ACT.

 

(D) THE DEPARTMENT MAY PROVIDE REIMBURSEMENT FOR FEES AND MILEAGE ASSOCIATED WITH ITS SUBPOENA POWER IN THE SAME MANNER PRESCRIBED BY LAW FOR JUDICIAL PROCEDURE IN A CIVIL CASE.

 

(E) NOTHING IN THIS SECTION SHALL BE DEEMED TO SUPERSEDE THE PROVISIONS OF PART 21 OF ARTICLE VIII OF THE CODE OF CIVIL PROCEDURE, NOW OR HEREAFTER AMENDED, TO THE EXTENT APPLICABLE.

 

(225 ILCS 25/50)(from Ch. 111, par. 2350)

 

(Section scheduled to be repealed on January 1, 2006)

 

Sec. 50. Patient Records. Every dentist shall make a record of all dental work performed for each patient. The record shall be made in a manner and in sufficient detail that it may be used for identification purposes.

 

Dental records required by this Section shall be maintained for 10 years. Dental records required to be maintained under this Section, or copies of those dental records, shall be made available upon request to the patient or the patient's guardian . A DENTIST SHALL BE ENTITLED TO REASONABLE REIMBURSEMENT FOR THE COST OF REPRODUCING THESE RECORDS, WHICH SHALL NOT EXCEED THE COST ALLOWED UNDER SECTION 8-2003 OF THE CODE OF CIVIL PROCEDURE , provided that the reasonable cost of reproducing the records has been paid by the patient or the patient's guardian . (Source: P.A. 87-576.)

 

(225 ILCS 25/54.2 new)

 

Status:

02/02/2005 In House; Filed; First Reading; Referred to Rules Committee

02/08/2005 In House; Assigned to Registration and Regulation Committee

02/17/2005 In House; Do Pass / Short Debate Registration and Regulation Committee ; 023-001-001

02/18/2005 In House; Placed on Calendar 2nd Reading - Short Debate; Added Chief Co-Sponsor Rep. David E. Miller; Added Chief Co-Sponsor Rep. Harry Osterman; Added Chief Co-Sponsor Rep. John A. Fritchey; Added Chief Co-Sponsor Rep. William Delgado

03/03/2005 In House; Second Reading - Short Debate; Placed on Calendar Order of 3rd Reading - Short Debate

04/12/2005 In House; Recalled to Second Reading - Short Debate; Held on Calendar Order of Second Reading - Short Debate; House Amendment No. 1 Filed; House Amendment No. 1 Referred to Rules Committee

04/13/2005 In House; House Amendment No. 1 Recommends Be Adopted Rules Committee ; 004-000-000; Co-Sponsor Rep. Bill Mitchell; House Amendment No. 1 Adopted by Voice Vote; Placed on Calendar Order of 3rd Reading - Short Debate

04/14/2005 In House; Added Co-Sponsor Rep. Kurt M. Granberg; Third Reading - Short Debate - Passed 088-025-000

04/15/2005 In Senate; Arrive in Senate; Placed on Calendar Order of First Reading April 19, 2005

04/19/2005 In Senate; Chief Senate Sponsor Sen. William R. Haine

04/21/2005 In Senate; First Reading; Referred to Rules; Assigned to Licensed Activities

04/27/2005 In Senate; Senate Committee Amendment No. 1 Filed; Senate Committee Amendment No. 1 Referred to Rules

04/29/2005 In Senate; Senate Committee Amendment No. 2 Filed; Senate Committee Amendment No. 2 Referred to Rules

05/02/2005 In Senate; Senate Committee Amendment No. 3 Filed; Senate Committee Amendment No. 3 Referred to Rules

05/03/2005 In Senate; Senate Committee Amendment No. 1 Rules Refers to Licensed Activities; Senate Committee Amendment No. 2 Rules Refers to Licensed Activities; Senate Committee Amendment No. 3 Rules Refers to Licensed Activities

05/05/2005 In Senate; Senate Committee Amendment No. 1 Tabled in Licensed Activities; Senate Committee Amendment No. 2 Tabled in Licensed Activities; Senate Committee Amendment No. 3 Tabled in Licensed Activities; Do Pass Licensed Activities ; 007-000-000; Placed on Calendar Order of 2nd Reading May 10, 2005

05/09/2005 In Senate; Senate Floor Amendment No. 4 Filed; Senate Floor Amendment No. 4 Referred to Rules; Senate Floor Amendment No. 5 Filed; Senate Floor Amendment No. 5 Referred to Rules

05/11/2005 In Senate; Second Reading; Placed on Calendar Order of 3rd Reading May 12, 2005; Added as Alternate Chief Co-Sponsor Sen. Arthur J. Wilhelmi

05/16/2005 In Senate; Senate Floor Amendment No. 5 Rules Refers to Licensed Activities

05/18/2005 In Senate; Senate Floor Amendment No. 5 Recommend Do Adopt Licensed Activities ; 006-000-000; Recalled to Second Reading; Senate Floor Amendment No. 5 Adopted; Haine; Placed on Calendar Order of 3rd Reading May 19, 2005

05/19/2005 In Senate; Third Reading - Passed; 056-001-001; Senate Floor Amendment No. 4 Tabled Pursuant to Rule 5-4(a)

05/20/2005 In House; Arrived in House; Placed on Calendar Order of Concurrence Senate Amendment(s) 5

05/24/2005 In House; Senate Floor Amendment No. 5 Motion Filed; Senate Floor Amendment No. 5 Motion to Concur Referred to Rules Committee

05/25/2005 In House; Senate Floor Amendment No. 5 Motion to Concur Rules Referred to Registration and Regulation Committee; Senate Floor Amendment No. 5 Motion to Concur Recommends be Adopted Registration and Regulation Committee ; 016-003-000

05/26/2005 In House; Added Co-Sponsor Rep. Elizabeth Coulson

05/27/2005 In House; Senate Floor Amendment No. 5 House Concurs 082-033-001; Passed Both Houses

06/24/2005 In House; Sent to the Governor

08/02/2005 In House; Governor Approved; Public Act . . . . . . . . . 94-0409

 

Sponsor Information:

Angelo 'Skip' Saviano (R-Minority)

 

Sponsor:

Saviano

 

 

 

New York S.B. 4855

Category:

Medical Records Privacy

 

Last Action:

07/28/2005 DELIVERED TO GOVERNOR

 

Synopsis:

Relates to the service of a subpoena duces tecum upon a hospital or a health care professional.

 

Additional Information:

Language as Amended on June 16, 2005:

 

Section 1. Section 2306 of the civil practice law and rules, subdivision (a) as amended by chapter 4 of the laws of 1986, is amended to read as follows:

 

Section 2306. Hospital records; medical records of A HEALTH CARE PRACTITIONER; MEDICAL RECORDS OF department or bureau of a municipal corporation or of the state. (a) Transcript or reproduction. Where a subpoena duces tecum is served TOGETHER WITH A LEGALLY SUFFICIENT AUTHORIZATION AS OTHERWISE PROVIDED BY LAW, upon a hospital, AS DEFINED UNDER ARTICLE TWENTY-EIGHT OF THE PUBLIC HEALTH LAW, UPON A HEALTH CARE PRACTITIONER LICENSED UNDER THE EDUCATION LAW, or upon a department or bureau of a municipal corporation or of the state, or an officer thereof, requiring the production of records relating to the condition or treatment of a patient, a transcript or a full-sized legible reproduction, certified as correct by the superintendent or head of the hospital, department or bureau or his assistant, or the officer, may SHALL be produced unless otherwise ordered by a court. Such RECORDS SHALL BE CERTIFIED AS CORRECT, IN THE FORM REQUIRED BY RULE THIRTY-ONE HUNDRED TWENTY-TWO-A OF THIS CHAPTER, BY THE SUPERINTENDENT OR HEAD OF THE HOSPITAL, DEPARTMENT OR BUREAU, BY THE STATE OR MUNICIPAL OFFICER OR OTHER STATE OR MUNICIPAL OFFICER DELEGATED FOR THE PURPOSE, BY THE HEALTH CARE PRACTITIONER OR BY AN EMPLOYEE CHARGED WITH THE RESPONSIBILITY OF MAINTAINING THE RECORDS. EXCEPT AS OTHERWISE PROVIDED IN PARAGRAPH ONE OF THIS SUBDIVISION, THE RECORDS SO CERTIFIED SHALL BE DEEMED TO HAVE SATISFIED THE REQUIREMENTS OF SUBDIVISION (A) OF RULE FORTY-FIVE HUNDRED EIGHTEEN OF THIS CHAPTER. SUCH a subpoena shall be served at least three days before the time fixed for the production of the records unless otherwise ordered by a court. , EXCEPT IN THE CASE OF MEDICAL RECORDS OF A HEALTH CARE PRACTITIONER SUCH A SUBPOENA SHALL BE SERVED NO LATER THAN THREE DAYS BEFORE THE COMMENCEMENT OF JURY SELECTION OR THE COMMENCEMENT OF THE TRIAL, IF NO JURY IS SELECTED, UNLESS OTHERWISE ORDERED BY A COURT.

 

(1) THE MEDICAL RECORDS OF A HEALTH CARE PRACTITIONER, OTHERWISE CERTIFIED AS PROVIDED BY THIS SECTION, SHALL NOT BE ADMISSIBLE AT TRIAL WITHOUT THE APPEARANCE OF A WITNESS TO TESTIFY AS TO THEIR ADMISSIBILITY UNDER SUBDIVISION (A) OF RULE FORTY-FIVE HUNDRED EIGHTEEN OF THIS CHAPTER UNLESS SUCH SUBPOENA DUCES TECUM HAS BEEN SERVED TOGETHER WITH LEGALLY SUFFICIENT AUTHORIZATION AS OTHERWISE PROVIDED BY LAW INCLUDING THAT REQUIRED BY THE FEDERAL HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF NINETEEN HUNDRED NINETY-SIX, PUB. L. 104-191, ALSO KNOWN AS HIPAA, AND UNLESS A COPY OF SUCH SUBPOENA, THE HIPAA-COMPLIANT AUTHORIZATION AND ANY OTHER DOCUMENTS SERVED ON THE HEALTH CARE PRACTITIONER WITH THE SUBPOENA HAVE BEEN SERVED ON ALL PARTIES PURSUANT TO THE REQUIREMENTS OF SECTION TWENTY-THREE HUNDRED THREE OF THIS ARTICLE.

 

(2) NOTWITHSTANDING THE PROVISIONS OF SUBDIVISION (B) OF SECTION TWENTY-THREE HUNDRED TWO OF THIS ARTICLE, NOTHING IN THIS SECTION SHALL BE DEEMED TO REQUIRE THE ISSUANCE OF A SUBPOENA BY A COURT FOR THE PRODUCTION OF AN ORIGINAL RECORD OF A HEALTH CARE PRACTITIONER.

 

(b) Delivery to clerk. Where a court has designated a clerk to receive records described in subdivision (A) OF THIS SECTION, delivery may be made to him OR HER at or before the time fixed for their production. The clerk shall give a receipt for the records and notify the person subpoenaed when they are no longer required. The records shall be delivered in a sealed envelope indicating the title of the action, the date fixed for production and the name and address of the attorney appearing on the subpoena. They shall be available for inspection pursuant to the rules or order of the court.

 

Section 2. This act shall take effect immediately.

 

Status:

04/18/2005 REFERRED TO CODES

05/04/2005 AMEND AND RECOMMIT TO CODES; PRINT NUMBER 4855A

06/01/2005 REPORTED AND COMMITTED TO RULES

06/07/2005 ORDERED TO THIRD READING CAL.1397

06/16/2005 AMENDED ON THIRD READING 4855B

06/20/2005 PASSED SENATE; DELIVERED TO ASSEMBLY; referred to judiciary

06/24/2005 substituted for a8560a; ordered to third reading rules cal.1011; passed assembly; returned to senate

07/28/2005 DELIVERED TO GOVERNOR

 

Sponsor Information:

John A. DeFrancisco (R-Majority)

 

Sponsor:

DeFrancisco

 

 


 

Regulatory Report

 

 

UTAH

Title:

MEDICAL RECORDS STATE ID: 27891

 

Agency:

Labor Commission/Division of Industrial Accidents

 

Summary:

Rewrites existing rule governing access to injured worker's medical records for

workers' compensation purposes.

 

Summary Comments:

R612-2-22

 

Medical Records

 

NOTICE OF PROPOSED RULE

 

(Amendment)

 

DAR File No.: 27891

 

Filed: 05/13/2005, 11:46

 

RULE ANALYSIS

 

Purpose of the rule or reason for the change: In response to changes in

medical record access established by the federal government under HIPAA (

Health Insurance Portability and Accountability Act of 1996), this rule

completely rewrites the Commission's existing rule governing access to injured

workers' medical records for workers' compensation purposes. Under HIPAA, an

individual's medical information can be released in accordance with standards

established by states to administer workers' compensation systems. This rule

establishes such standards for Utah.

 

Summary of the rule or change: The rule recognizes the needs of insurers,

employers and the Labor Commission to obtain a workers' compensation applicant's

medical records. The rule identifies those circumstances where a medical

provider can release such information without the claimant's consent. The rule

also sets out other circumstances in which the claimant's permission is required

for release of medical information. The rule defines the types of records

that are considered relevant for workers' compensation purposes. It also

addresses subsequent use of such information, sets fees that may be charged

for providing information, and establishes a procedure to resolve disputes.

 

State statutory or constitutional authorization for this rule: Sections

34A-2-101 et seq., 34A-3-101 et seq., and 34A-1-104

 

Anticipated cost or savings to:

 

the state budget: The Commission does not anticipate any appreciable costs or

savings to the State in administering this rule or in its capacity as an

employer.

 

local governments: This rule only affects local government in their capacity

as employers. The Commission does not anticipate any appreciable costs or

savings to local governments.

 

other persons: This rule primarily affects insurance adjusting functions. The

Commission anticipates that the definitions and procedures established by this

rule will not require any appreciable additional expense or result in any

appreciable savings ti other persons.

 

Compliance costs for affected persons: Federal HIPAA regulations already

impose record keeping standards on medical providers. This rule will not add

any additional requirements of that nature. Insurers' adjusting functions will

be somewhat affected by new definitions and procedures, but the Labor Commission

is unaware of any information indicating that compliance with these standards

will impose any significant compliance costs.

 

Comments by the department head on the fiscal impact the rule may have on

businesses: The requirements of this rule are less onerous than would otherwise

be applied under federal HIPAA. Although the rule contains new safeguards to

limit disclosure of medical records to only those records that are relevant

to workers' compensation claims, the rule also establishes definitions and

procedures to facilitate the identification of records as relevant or

nonrelevant. On balance, the rule will have no negative impact on business. R.

Lee Ellertson, Commissioner

 

The full text of this rule may be inspected, during regular business hours,

at:

 

Labor Commission

Industrial Accidents

HEBER M WELLS BLDG

160 E 300 S

SALT LAKE CITY UT 84111-2316, or

at the Division of Administrative Rules.

 

Direct questions regarding this rule to:

 

Joyce Sewell at the above address, by phone at 801-530-6988, by FAX at

801-530-6804, or by Internet E-mail at jsewell@utah.gov

 

Interested persons may present their views on this rule by submitting written

comments to the address above no later than 5:00 PM on 07/01/2005.

 

This rule may become effective on: 07/02/2005

 

Authorized by: R Lee Ellertson, Commissioner

 

Agency Contact:

Joyce Sewell, Labor Commission, Division of Industrial

Accidents, Herber M Wells Bldg, 160 E 300 S, Salt Lake City, UT 84111-2316, 801-

530-6988, Fax 801-530-6804

 

Citation:

R612-2-22

 

Status:

05/13/2005 Proposed Rule

 

Comment Deadline:

07/01/2005

08/01/2005 Rule Adoption

 

Effective Date:

07/02/2005

 

 

 

Federal New Bills

 

 

United States S. 1503

Category:

Medical Records Privacy

 

Sponsor:

FRIST, BILL (R-TN)

 

Sponsor Comments

DEMINT, JAMES W (R-SC)- Cosponsor

ENZI, MICHAEL B (R-WY)- Cosponsor

GREGG, JUDD (R-NH)- Cosponsor

MCCONNELL, MITCH (R-KY)- Cosponsor

MURKOWSKI, LISA (R-AK)- Cosponsor

 

Date Introduced:

07/26/2005

 

Last Action:

07/26/2005 Introduced

 

Status:

07/26/2005 Introduced

 

Synopsis:

A bill to reduce healthcare costs, expand access to affordable healthcare coverage, and improve healthcare and strengthen the healthcare safety net, and for other purposes

 

Full Text:

Subtitle B-- Health Information Technology

CHAPTER 1--GENERAL PROVISIONS

SEC. 121. IMPROVING HEALTH CARE, QUALITY, SAFETY, AND EFFICIENCY.

The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by

adding at the end the following:

"TITLE XXIX-- HEALTH INFORMATION TECHNOLOGY

"SEC. 2901. DEFINITIONS.

"In this title:

"(1) Health care provider. The term 'health care provider'

means a hospital, skilled nursing facility, home health entity, health

care clinic, federally qualified health center, group practice (as

defined in section 1877(h)(4) of the Social Security Act), a

pharmacist, a pharmacy, a laboratory, a physician (as defined in

section 1861(r) of the Social Security Act), a health facility

operated by or pursuant to a contract with the Indian Health Service,

a rural health clinic, and any other category of facility or clinician

determined appropriate by the Secretary.

"(2) Health information. The term ' health information' has

the meaning given such term in section 1171(4) of the Social Security

Act.

"(3) Health insurance plan. The term 'health insurance plan' means--

"(A) a health insurance issuer (as defined in section 2791(b)(2));

"(B) a group health plan (as defined in section 2791(a)(1)); and

"(C) a health maintenance organization (as defined in section

2791(b)(3)).

"(4) Laboratory. The term 'laboratory' has the meaning given

that term in section 353.

"(5) Pharmacist. The term 'pharmacist' has the meaning given

that term in section 804 of the Federal Food, Drug, and Cosmetic Act.

"(6) State. The term 'State' means each of the several

States, the District of Columbia, Puerto Rico, the Virgin Islands,

Guam, American Samoa, and the Northern Mariana Islands.

"SEC. 2902. OFFICE OF THE NATIONAL COORDINATOR OF HEALTH INFORMATION

TECHNOLOGY.

"(a) Office of National Health Information Technology. There is

established within the Office of the Secretary an Office of the National

Coordinator of Health Information Technology (referred to in this section as

the 'Office'). The Office shall be headed by a National Coordinator who

shall be appointed by the Secretary, in consultation with the President, and

shall report directly to the Secretary.

"(b) Purpose. It shall be the purpose of the Office to coordinate with

relevant Federal agencies and oversee programs and activities to develop a

nationwide interoperable health information technology infrastructure that--

"(1) ensures that patients' individually identifiable health

information is secure and protected;

"(2) improves health care quality, reduces medical errors,

and advances the delivery of patient-centered medical care;

"(3) reduces health care costs resulting from inefficiency,

medical errors, inappropriate care, and incomplete information;

"(4) ensures that appropriate information to help guide

medical decisions is available at the time and place of care;

"(5) promotes a more effective marketplace, greater

competition, and increased choice through the wider availability of

accurate information on health care costs, quality, and outcomes; and

"(6) improves the coordination of care and information among

hospitals, laboratories, physician offices, and other entities through

an effective infrastructure for the secure and authorized exchange of

health care information.

"(c) Duties of the National Coordinator. The National

Coordinator shall--

"(1) provide support to the public-private American Health

Information Collaborative established under section 2903;

"(2) serve as the principal advisor to the Secretary

concerning the development, application, and use of health information

technology, and coordinate and oversee the health information

technology programs of the Department;

"(3) facilitate the adoption of a nationwide, interoperable

system for the electronic exchange of health information;

"(4) ensure the adoption and implementation of standards for

the electronic exchange of health information to reduce cost and

improve health care quality;

"(5) ensure that health information technology policy and

programs of the Department are coordinated with those of relevant

executive branch agencies (including Federal commissions) with a goal

of avoiding duplication of efforts and of helping to ensure that each

agency undertakes health information technology activities primarily

within the areas of its greatest expertise and technical capability;

"(6) to the extent permitted by law, coordinate outreach and

consultation by the relevant executive branch agencies (including

Federal commissions) with public and private parties of interest,

including consumers, payers, employers, hospitals and other health

care providers, physicians, community health centers, laboratories,

vendors and other stakeholders;

"(7) advise the President regarding specific Federal health

information technology programs; and

"(8) submit the reports described under section 2903(i)

(excluding paragraph (4) of such section).

"(d) Rule of Construction. Nothing in this section shall be construed to

require the duplication of Federal efforts with respect to the establishment

of the Office, regardless of whether such efforts were carried out prior to

or after the enactment of this title.

"SEC. 2903. AMERICAN HEALTH INFORMATION COLLABORATIVE.

"(a) Purpose. The Secretary shall establish the public-private American

Health Information Collaborative (referred to in this section as the

'Collaborative') to--

"(1) advise the Secretary and recommend specific actions to

achieve a nationwide interoperable health information technology

infrastructure;

"(2) serve as a forum for the participation of a broad range

of stakeholders to provide input on achieving the interoperability of

health information technology; and

"(3) recommend standards (including content, communication,

and security standards) for the electronic exchange of health

information for adoption by the Federal Government and voluntary

adoption by private entities.

"(b) Composition.

"(1) In general. The Collaborative shall be composed of--

"(A) the Secretary, who shall serve as the chairperson of the

Collaborative;

"(B) the Secretary of Defense, or his or her designee;

"(C) the Secretary of Veterans Affairs, or his or her designee;

"(D) the Secretary of Commerce, or his or her designee;

"(E) representatives of other relevant Federal agencies, as determined

appropriate by the Secretary; and

"(F) representatives from among the following categories to be appointed

by the Secretary from nominations submitted by the public--

"(i) consumer and patient organizations;

"(ii) experts in health information privacy and security;

"(iii) health care providers;

"(iv) health insurance plans or other third party payors;

"(v) standards development organizations;

"(vi) information technology vendors;

"(vii) purchasers or employers; and

"(viii) State or local government agencies or Indian tribe or tribal

organizations.

"(2) Considerations. In appointing members under paragraph (1)(F), the

Secretary shall select individuals with expertise in--

"(A) health information privacy;

"(B) health information security;

"(C) health care quality and patient safety, including those individuals

with experience in utilizing health information technology to improve health

 

care quality and patient safety;

"(D) data exchange; and

"(E) developing health information technology standards and new health

information technology.

"(3) Terms. Members appointed under paragraph (1)(G) shall

serve for 2 year terms, except that any member appointed to fill a

vacancy for an unexpired term shall be appointed for the remainder of

such term. A member may serve for not to exceed 180 days after the

expiration of such member's term or until a successor has been

appointed.

"(c) Recommendations and Policies. The Collaborative shall make

recommendations to identify uniform national policies for adoption by the

Federal Government and voluntary adoption by private entities to support the

widespread adoption of health information technology, including--

"(1) protection of individually identifiable health

information through privacy and security practices;

"(2) measures to prevent unauthorized access to health information;

"(3) methods to facilitate secure patient access to health

information;

"(4) the ongoing harmonization of industry-wide health

information technology standards;

"(5) recommendations for a nationwide interoperable health

information technology infrastructure;

"(6) the identification and prioritization of specific use

cases for which health information technology is valuable, beneficial,

and feasible;

"(7) recommendations for the establishment of an entity to

ensure the continuation of the functions of the Collaborative; and

"(8) other policies determined to be necessary by the Collaborative.

"(d) Standards.

"(1) Existing standards. The standards adopted by the

Consolidated Health Informatics Initiative shall be deemed to have

been recommended by the Collaborative under this section.

"(2) First year review. Not later than 1 year after the date

of enactment of this title, the Collaborative shall--

"(A) review existing standards (including content, communication, and

security standards) for the electronic exchange of health information,

including such standards adopted by the Secretary under paragraph (2)(A);

"(B) identify deficiencies and omissions in such existing standards; and

"(C) identify duplication and overlap in such existing standards;

and recommend modifications to such standards as necessary.

"(3) Ongoing review. Beginning 1 year after the date of

enactment of this title, and annually thereafter, the Collaborative

shall--

"(A) review existing standards (including content, communication, and

security standards) for the electronic exchange of health information,

including such standards adopted by the Secretary under paragraph (2)(A);

"(B) identify deficiencies and omissions in such existing standards; and

"(C) identify duplication and overlap in such existing standards;

and recommend modifications to such standards as necessary.

"(4) Limitation. The standards described in this section

shall be consistent with any standards developed pursuant to the

Health Insurance Portability and Accountability Act of 1996.

"(e) Federal Action. Not later than 60 days after the issuance of a

recommendation from the Collaborative under subsection (d)(2), the Secretary

of Health and Human Services, in consultation with the Secretary of Veterans

Affairs, the Secretary of Defense, and representatives of other relevant

Federal agencies, as determined appropriate by the Secretary, shall review

such recommendations. The Secretary shall provide for the adoption by the

Federal Government of any standard or standards contained in such

recommendation.

"(f) Coordination of Federal Spending. Not later than 1 year after the

adoption by the Federal Government of a recommendation as provided for in

subsection (e), and in compliance with chapter 113 of title 40, United

States Code, no Federal agency shall expend Federal funds for the purchase

of any form of health information technology or health information

technology system for clinical care or for the electronic retrieval,

storage, or exchange of health information that is not consistent with

applicable standards adopted by the Federal Government under subsection (e).

"(g) Coordination of Federal Data Collection. Not later than 3 years

after the adoption by the Federal Government of a recommendation as provided

for in subsection (e), all Federal agencies collecting health data for the

purposes of surveillance, epidemiology, adverse event reporting, research,

or for other purposes determined appropriate by the Secretary shall comply

with standards adopted under subsection (e).

"(h) Voluntary Adoption.

"(1) In general. Any standards adopted by the Federal

Government under subsection (e) shall be voluntary with respect to

private entities.

"(2) Rule of construction. Nothing in this section shall be

construed to require that a private entity that enters into a contract

with the Federal Government adopt the standards adopted by the Federal

Government under section 2903 with respect to activities not related

to the contract.

"(3) Limitation. Private entities that enter into a contract

with the Federal Government shall adopt the standards adopted under

section 2903 for the purpose of activities under such Federal

contract.

"(i) Effect on Other Provisions. Nothing in this title shall be

construed to effect the scope or substance of--

"(1) section 264 of the Health Insurance Portability and

Accountability Act of 1996;

"(2) sections 1171 through 1179 of the Social Security Act; and

"(3) any regulation issued pursuant to any such section;

and such sections shall remain in effect and shall apply to the

implementation of standards, programs and activities under this title.

"(j) Reports. The Secretary shall submit to the Committee on Health,

Education, Labor, and Pensions and the Committee on Finance of the Senate

and the Committee on Energy and Commerce and the Committee on Ways and Means

of the House of Representatives, on an annual basis, a report that--

"(1) describes the specific actions that have been taken by

the Federal Government and private entities to facilitate the adoption

of an interoperable nationwide system for the electronic exchange of

health information;

"(2) describes barriers to the adoption of such a nationwide system;

"(3) contains recommendations to achieve full implementation

of such a nationwide system; and

"(4) contains a plan and progress toward the establishment of

an entity to ensure the continuation of the functions of the

Collaborative.

"(k) Application of FACA. The Federal Advisory Committee Act

(5 U.S.C. App.) shall apply to the Collaborative, except that the term

provided for under section 14(a)(2) shall be 5 years.

"(l) Rule of Construction. Nothing in this section shall be construed to

require the duplication of Federal efforts with respect to the establishment

of the Collaborative, regardless of whether such efforts were carried out

prior to or after the enactment of this title.

"SEC. 2904. IMPLEMENTATION AND CERTIFICATION OF HEALTH INFORMATION

STANDARDS.

"(a) Implementation.

"(1) In general. The Secretary, based upon the

recommendations of the Collaborative, shall develop criteria to ensure

uniform and consistent implementation of any standards for the

electronic exchange of health information voluntarily adopted by

private entities in technical conformance with such standards adopted

under this title.

"(2) Implementation assistance. The Secretary may recognize a

private entity or entities to assist private entities in the

implementation of the standards adopted under this title using the

criteria developed by the Secretary under this section.

"(b) Certification.

"(1) In general. The Secretary, based upon the

recommendations of the Collaborative, shall develop criteria to ensure

and certify that hardware, software, and support services that claim

to be in compliance with any standard for the electronic exchange of

health information adopted under this title have established and

maintained such compliance in technical conformance with such

standards.

"(2) Certification assistance. The Secretary may recognize a

private entity or entities to assist in the certification described

under paragraph (1) using the criteria developed by the Secretary

under this section.

"(c) Delegation Authority. The Secretary, through consultation with the

Collaborative, may delegate the development of the criteria under

subsections (a) and (b) to a private entity.

"SEC. 2905. STUDY OF STATE HEALTH INFORMATION LAWS AND PRACTICES.

"(a) In General. The Secretary shall carry out, or contract with a

private entity to carry out, a study that examines--

"(1) the variation among State laws and practices that relate

to the privacy, confidentiality, and security of health information;

"(2) how such variation among State laws and practices may

impact the electronic exchange of health information --

"(A) among the States;

"(B) between the States and the Federal Government; and

"(C) among private entities; and

"(3) how such laws and practices may be harmonized to permit

the secure electronic exchange of health information.

"(b) Report and Recommendations. Not later than 1 year after the date of

enactment of this title, the Secretary shall submit to Congress a report

that--

"(1) describes the results of the study carried out under

subsection (a); and

"(2) makes recommendations based on the results of such study.

"SEC. 2906. SECURE EXCHANGE OF HEALTH INFORMATION; INCENTIVE GRANTS.

"(a) In General. The Secretary may make grants to States to carry out

programs under which such States cooperate with other States to develop and

implement State policies that will facilitate the secure electronic exchange

of health information utilizing the standards adopted under section 2903--

"(1) among the States;

"(2) between the States and the Federal Government; and

"(3) among private entities.

"(b) Priority. In awarding grants under subsection (a), the Secretary

shall give priority to States that provide assurance that any funding

awarded under such a grant shall be used to harmonize privacy laws and

practices between the States, the States and the Federal Government, and

among private entities related to the privacy, confidentiality, and security

of health information.

"(c) Dissemination of Information. The Secretary shall disseminate

information regarding the efficacy of efforts of a recipient of a grant

under this section.

"(d) Technical Assistance. The Secretary may provide technical

assistance to recipients of a grant under this section.

"(e) Authorization of Appropriations. For the purpose of carrying out

subsection (a), there are authorized to be appropriated such sums as may be

necessary for each of the fiscal years 2006 through 2010.

"SEC. 2907. LICENSURE AND THE ELECTRONIC EXCHANGE OF HEALTH INFORMATION.

"(a) In General. The Secretary shall carry out, or contract with a

private entity to carry out, a study that examines--

"(1) the variation among State laws that relate to the

licensure, registration, and certification of medical professionals;

and

"(2) how such variation among State laws impacts the secure

electronic exchange of health information --

"(A) among the States; and

"(B) between the States and the Federal Government.

"(b) Report and Recommendations. Not later than 1 year after the date of

enactment of this title, the Secretary shall publish a report that--

"(1) describes the results of the study carried out under

subsection (a); and

"(2) makes recommendations to States regarding the

harmonization of State laws based on the results of such study.

"SEC. 2908. AUTHORIZATION OF APPROPRIATIONS.

"(a) In General. For the purpose of carrying out this title, there is

authorized to be appropriated $125,000,000 for fiscal year 2006, and such

sums as may be necessary for each of fiscal years 2007 through 2010.

"(b) Availability. Amounts appropriated under subsection (a) shall

remain available through fiscal year 2010.".

SEC. 122. HIPAA REPORT.

(a) Study. Not later than 2 years after the date of enactment of this

Act, the Secretary of Health and Human Services shall carry out, or contract

with a private entity to carry out, a study that examines the integration of

the standards adopted under the amendments made by this subtitle with the

standards adopted under the Health Insurance Portability and Accountability

Act of 1996 (Public Law 104-191).

(b) Plan; Report.

(1) Plan. Not later than 3 years after the date of enactment

of this Act, the Secretary of Health and Human Services shall, based

on the results of the study carried out under subsection (a), develop

a plan for the integration of the standards described under such

subsection and submit a report to Congress describing such plan.

(2) Periodic reports. The Secretary shall submit periodic

reports to Congress that describe the progress of the integration

described under paragraph (1).

SEC. 123. STUDY OF REIMBURSEMENT INCENTIVES.

The Secretary of Health and Human Services shall carry out, or contract

with a private entity to carry out, a study that examines methods to create

efficient reimbursement incentives for improving health care quality in

Federally qualified health centers, rural health clinics, and free clinics.

SEC. 124. REAUTHORIZATION OF INCENTIVE GRANTS REGARDING TELEMEDICINE.

Section 330L(b) of the Public Health Service Act (42 U.S.C. 254c-18(b))

is amended by striking "2002 through 2006" and inserting "2006 through

2010".

SEC. 125. SENSE OF THE SENATE ON PHYSICIAN PAYMENT.

It is the sense of the Senate that modifications to the medicare fee

schedule for physicians' services under section 1848 of the Social Security

Act (42 U.S.C. 1394w-4) should include provisions based on the reporting of

quality measures pursuant to those adopted in section 2909 of the Public

Health Service Act (as added by section 121) and the overall improvement of

healthcare quality through the use of the electronic exchange of health

information pursuant to the standards adopted under section 2903 of such Act

(as added by section 121).

 

 


 

Federal Bill Movement

 

 

United States S.B. 544

Category:

Medical Records Privacy

 

Sponsor:

JEFFORDS, JAMES M (I-VT)

 

Sponsor Comments

JEFFORDS, JAMES M (I-VT) - Sponsor

BINGAMAN, JEFF (D-NM)- Cosponsor

ENZI, MICHAEL B (R-WY)- Cosponsor

FRIST, BILL (R-TN)- Cosponsor

GREGG, JUDD (R-NH)- Cosponsor

MURRAY, PATTY (D-WA)- Cosponsor

SESSIONS, JEFF (R-AL)- Cosponsor

 

Date Introduced:

03/08/2005

 

Last Action:

07/27/05 Passed in the House

 

Status:

03/08/2005 Introduced in the Senate

07/21/05 Considered in the Senate

07/21/05 Senate agreed to Enzi Amendment No. 1411

07/21/05 Passed in the Senate, as amended

07/27/05 Considered in the House

07/27/05 Passed in the House

 

Synopsis:

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 affect patient safety

 

Synopsis Comments:

Patient Safety and Quality Improvement Act of 2005 - Amends the Public Health Service Act to designate patient safety data as privileged and confidential. Permits certain disclosures of patient safety data by a provider or patient safety organization (PSO), including: (1) voluntary disclosures of non-identifiable data; (2) disclosures of data containing evidence of a wanton and criminal act to directly harm the patient; (3) disclosures necessary to carry out PSO or research activities; and (4) voluntary disclosures for public health surveillance. Defines a "patient safety organization" as an organization certified by the Secretary of Health and Human Services that conducts efforts to improve patient safety and the quality of health care delivery through the collection and analysis of patient safety data. Prohibits an accrediting body from: (1) taking any accrediting action against a provider based on the provider's good faith participation in collecting, developing, reporting, or maintaining patient safety data; or (2) requiring a provider to reveal its communications with any PSO. Prevents a provider from taking an adverse employment action against an individual based upon the good faith reporting of information. Requires the Secretary to: (1) maintain a patient safety network of databases that has the capacity to accept, aggregate, and analyze non-identifiable patient safety data voluntarily reported and that provides an interactive resource for providers and PSOs; (2) develop or adopt voluntary national standards to promote the electronic exchange of health care information; and (3) contract with a research organization to study the impact of medical technologies and therapies on health care.

 

Full Text:

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

"(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).