Four important law for Patient Safety

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Patient Safety and Quality Improvement Act of 2005

[Page 119 STAT. 424]

Public Law 109-41 109th Congress
An Act

To amend title IX of the Public Health Service Act to provide for the improvement of patient safety and to reduce the incidence of events that adversely effect patient safety. <<NOTE: July 29, 2005 - [S. 544]>>
Be it enacted by the Senate and House of Representatives of the United States of America in Congress <<NOTE: Patient Safety and Quality Improvement Act of 2005.>> assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title.--This Act may be cited as the ''Patient Safety and Quality Improvement Act of 2005''.
(b) Table of Contents.--The table of contents for this Act is as follows:

Sec. 1. Short title; table of contents. Sec. 2. Amendments to Public Health Service Act.

''Part C--Patient Safety Improvement

''Sec. 921. Definitions.
''Sec. 922. Privilege and confidentiality protections.
''Sec. 923. Network of patient safety databases.
''Sec. 924. Patient safety organization certification and listing.
''Sec. 925. Technical assistance.
''Sec. 926. Severability.

SEC. 2. AMENDMENTS TO PUBLIC HEALTH SERVICE ACT.

...

Source: Patient Safety and Quality Improvement Act of 2005 | AHRQ Patient Safety Organization Program

(more coming soon...)

[Janis.Y.Chen]

S.1784

National MEDiC Act (Introduced in Senate - IS)

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S 1784 IS
109th CONGRESS1st SessionS. 1784To amend the Public Health Service Act to promote a culture of safety within the health care system through the establishment of a National Medical Error Disclosure and Compensation Program.
IN THE SENATE OF THE UNITED STATESSeptember 28, 2005

Mrs. CLINTON (for herself and Mr. OBAMA) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

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A BILLTo amend the Public Health Service Act to promote a culture of safety within the health care system through the establishment of a National Medical Error Disclosure and Compensation Program.

• 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 `National Medical Error Disclosure and Compensation Act' or the `National MEDiC Act'.

SEC. 2. FINDINGS.

• Congress makes the following findings:

• 
  
  • (1) In 1999, the Institute of Medicine released a report entitled `To Err is Human' that found medical errors to be the eighth leading cause of death in the United States, with as many as 98,000 people dying each year as a result of medical errors.

• 
  
  • (2) To reduce deaths and injuries due to medical errors, the health care system must identify and learn how to prevent such errors so that health care quality can be improved.

• 
  
  • (3) The goals of the liability system are to identify causes of medical error, remediate those causes to prevent reoccurrence, and to compensate those injured by medical negligence. Studies have shown, however, that only one medical malpractice claim is filed for every 8 medical injuries, and the average duration of malpractice claim resolution is between 4 and 8 years. Thus, the current health care liability system has been found to be an inefficient and sometimes ineffective mechanism for initiating or resolving claims of medical error, medical negligence, or malpractice.

• 
  
  • (4) The current liability system has also been shown to be a deterrent to the timely sharing of information among health care professionals, as well as between health care professionals and patients, which impedes efforts to improve patient safety and quality of care.

• 
  
  • (5) Solutions to the patient safety, litigation, and medical liability insurance problems have been elusive. A middle ground solution that meets the basic needs of all stakeholders including patients, health care providers, insurers, purchasers, and attorneys is desperately needed.

• 
  
  • (6) Some hospital systems and private medical liability insurance companies have adopted a policy of robust disclosure of medical errors, apologies for such errors, and early compensation for patient injury. For example, a Department of Veterans Affairs hospital in Lexington, Kentucky, the University of Michigan Health System, and the private insurer Copic Insurance Company in Colorado have adopted such policies and have reported significantly decreased legal expenses and smaller claim payouts. Overall, these policies have resulted in fewer numbers of malpractice suits being filed, more patients being compensated for injuries, greater patient trust and satisfaction, and significantly reduced administrative and legal defense costs for providers, insurers, and hospitals where such policies are in place.

SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

• (a) In General- Title IX of the Public Health Service Act (42 U.S.C. 299 et seq.), as amended by the Patient Safety and Quality Improvement Act of 2005 (Public Law 109-41), is amended--

• 
  
  • (1) by redesignating part D as part E;

• 
  
  • (2) by redesignating sections 931 through 938 as sections 941 through 948, respectively;

• 
  
  • (3) in section 948(1) (as so redesignated), by striking `931' and inserting `941'; and

• 
  
  • (4) by inserting after part C the following:

`PART D--MEDICAL ERROR DISCLOSURE AND COMPENSATION

`SEC. 931. DEFINITIONS.


Source: AHRQ Patient Safety Network

[Janis.Y.Chen]

120 STAT. 4 PUBLIC LAW 109–171—FEB. 8, 2006


Public Law 109–171
109th Congress


An Act

To provide for reconciliation pursuant to section 202(a) of the concurrent resolution on the budget for fiscal year 2006 (H. Con. Res. 95).

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 ‘‘Deficit Reduction Act of 2005’’.

SEC. 2. TABLE OF TITLES.

The table of titles is as follows:

TITLE I—AGRICULTURE PROVISIONS
TITLE II—HOUSING AND DEPOSIT INSURANCE PROVISIONS
TITLE III—DIGITAL TELEVISION TRANSITION AND PUBLIC SAFETY
TITLE IV—TRANSPORTATION PROVISIONS
TITLE V—MEDICARE
TITLE VI—MEDICAID AND SCHIP
TITLE VII—HUMAN RESOURCES AND OTHER PROVISIONS
TITLE VIII—EDUCATION AND PENSION BENEFIT PROVISIONS
TITLE IX—LIHEAP PROVISIONS
TITLE X—JUDICIARY RELATED PROVISIONS
TITLE I—AGRICULTURE PROVISIONS

SECTION 1001. SHORT TITLE.

This title may be cited as the ‘‘Agricultural Reconciliation Act of 2005’’.

Subtitle A—Commodity Programs

SEC. 1101. NATIONAL DAIRY MARKET LOSS PAYMENTS.

(a) AMOUNT.—Section 1502(c) of the Farm Security and Rural Investment Act of 2002 (7 U.S.C. 7982(c)) is amended by striking paragraph (3) and inserting the following new paragraph:

‘‘(3)(A) during the period beginning on the first day of the month the producers on a dairy farm enter into a contract under this section and ending on September 30, 2005, 45 percent;‘‘

(B) during the period beginning on October 1, 2005, and ending on August 31, 2007, 34 percent; and Effective dates.


Agricultural Reconciliation Act of 2005. 7 USC 7901 note.


Deficit Reduction Act of 2005. 42 USC 1305 note.


Feb. 8, 2006
[S. 1932]


VerDate 14-DEC-2004 08:29 Mar 15, 2006 Jkt 049139 PO 00171 Frm 00002 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL171.109 APPS06 PsN: PUBL171

Source: http://www.gpo.gov/fdsys/pkg/PLAW-10...109publ171.pdf

[Janis.Y.Chen]

[United States Statutes at Large, Volume 121, 110th Congress, 1st Session]
[From the U.S. Government Printing Office, www.gpo.gov]

121 STAT. 823

Public Law 110-85
110th Congress

An Act



To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user-fee programs for prescription drugs and for medical devices, to
enhance the postmarket authorities of the Food and Drug Administration
with respect to the safety of drugs, and for other
purposes. [NOTE: Sept. 27, 2007 - [H.R. 3580]

Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, [NOTE: Food and Drug
Administration Amendments Act of 2007.]
SECTION 1. [NOTE: 21 USC 301 note.] SHORT TITLE.

This Act may be cited as the ``Food and Drug Administration
Amendments Act of 2007''.
SEC. 2. TABLE OF CONTENTS.

The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.

TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

Sec. 101. Short title; references in title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Fees relating to advisory review of prescription-drug
television advertising.
Sec. 105. Reauthorization; reporting requirements.
Sec. 106. Sunset dates.
Sec. 107. Effective date.
Sec. 108. Savings clause.
Sec. 109. Technical amendment; conforming amendment.

TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2007

Sec. 201. Short title; references in title; finding.

Subtitle A--Fees Related to Medical Devices

Sec. 211. Definitions.
Sec. 212. Authority to assess and use device fees.
Sec. 213. Reauthorization; reporting requirements.
Sec. 214. Savings clause.
Sec. 215. Additional authorization of appropriations for postmarket
safety information.
Sec. 216. Effective date.
Sec. 217. Sunset clause.

Subtitle B--Amendments Regarding Regulation of Medical Devices

Sec. 221. Extension of authority for third party review of premarket
notification.
Sec. 222. Registration.
Sec. 223. Filing of lists of drugs and devices manufactured, prepared,
propagated, and compounded by registrants; statements;
accompanying disclosures.
Sec. 224. Electronic registration and listing.
Sec. 225. Report by Government Accountability Office.
Sec. 226. Unique device identification system.
Sec. 227. Frequency of reporting for certain devices.


[[Page 824]]
121 STAT. 824


Sec. 228. Inspections by accredited persons.


Sec. 229. Study of nosocomial infections relating to medical devices.
Sec. 230. Report by the Food and Drug Administration regarding labeling
information on the relationship between the use of indoor
tanning devices and development of skin cancer or other skin
damage.

TITLE III--PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007

Sec. 301. Short title.
Sec. 302. Tracking pediatric device approvals.
Sec. 303. Modification to humanitarian device exemption.
Sec. 304. Encouraging pediatric medical device research.
Sec. 305. Demonstration grants for improving pediatric device
availability.
Sec. 306. Amendments to office of pediatric therapeutics and pediatric
advisory committee.
Sec. 307. Postmarket surveillance.

TITLE IV--PEDIATRIC RESEARCH EQUITY ACT OF 2007

Sec. 401. Short title.
Sec. 402. Reauthorization of Pediatric Research Equity Act.
Sec. 403. Establishment of internal committee.
Sec. 404. Government Accountability Office report.

TITLE V--BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007

Sec. 501. Short title.
Sec. 502. Reauthorization of Best Pharmaceuticals for Children Act.
Sec. 503. Training of pediatric pharmacologists.

TITLE VI--REAGAN-UDALL FOUNDATION

Sec. 601. The Reagan-Udall Foundation for the Food and Drug
Administration.
Sec. 602. Office of the Chief Scientist.
Sec. 603. Critical path public-private partnerships.

TITLE VII--CONFLICTS OF INTEREST

Sec. 701. Conflicts of interest.

TITLE VIII--CLINICAL TRIAL DATABASES

Sec. 801. Expanded clinical trial registry data bank.

TITLE IX--ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS

Subtitle A--Postmarket Studies and Surveillance

Sec. 901. Postmarket studies and clinical trials regarding human drugs;
risk evaluation and mitigation strategies.
Sec. 902. Enforcement.
Sec. 903. No effect on withdrawal or suspension of approval.
Sec. 904. Benefit-risk assessments.
Sec. 905. Active postmarket risk identification and analysis.
Sec. 906. Statement for inclusion in direct-to-consumer advertisements
of drugs.
Sec. 907. No effect on veterinary medicine.
Sec. 908. Authorization of appropriations.
Sec. 909. Effective date and applicability.

Subtitle B--Other Provisions to Ensure Drug Safety and Surveillance

Sec. 911. Clinical trial guidance for antibiotic drugs.
Sec. 912. Prohibition against food to which drugs or biological products
have been added.
Sec. 913. Assuring pharmaceutical safety.
Sec. 914. Citizen petitions and petitions for stay of agency action.
Sec. 915. Postmarket drug safety information for patients and providers.
Sec. 916. Action package for approval.
Sec. 917. Risk communication.
Sec. 918. Referral to advisory committee.
Sec. 919. Response to the institute of medicine.
Sec. 920. Database for authorized generic drugs.
Sec. 921. Adverse drug reaction reports and postmarket safety.

TITLE X--FOOD SAFETY
Source: 121 Stat. 823 - Food and Drug Administration Amendments Act of 2007