criminal or civil penalty for a transaction 
described 
in 
section 
1128A(b)(4), 
1128B(b)(3)(J), or 1877(e)(9) of the Social 
Security Act, as added by this section, if 
the conditions described in the respective 
section of such Act, with respect to such 
transaction, are met. 
(e) STUDY AND REPORT TO ASSESS EFFECT OF 
SAFE HARBORS AND EXCEPTION ON HEALTH SYS-
TEM.— 
(1) IN
GENERAL.—The Secretary of 
Health and Human Services shall conduct 
a study to determine the impact of each 
of the safe harbors and the exception de-
scribed in paragraph (3). In particular, 
the study shall examine the following: 
(A) The effectiveness of each safe 
harbor and exception in increasing 
the adoption of health information 
technology. 
(B) The types of health informa-
tion technology provided under each 
safe harbor and exception. 
(C) The extent to which the finan-
cial or other business relationships 
VerDate Aug 31 2005 
05:05 Jul 27, 2006
Jkt 049200
PO 00000
Frm 00064
Fmt 6652
Sfmt 6202
E:\BILLS\H4157.RH
H4157
bajohnson on PROD1PC77 with BILLS
between providers under each safe 
harbor or exception have changed as 
a result of the safe harbor or excep-
tion in a way that affects the health 
care system, affects choices available 
to consumers, or affects health care 
expenditures. 
(2) REPORT.—Not later than three 
years after the HIT effective date, the 
Secretary of Health and Human Services 
shall submit to Congress a report on the 
study under paragraph (1) and shall in-
clude such recommendations for changes 
in the safe harbors and exception as the 
Secretary determines may be appro-
priate. 
(3) SAFE HARBORS AND EXCEPTION DE-
SCRIBED.—For 
purposes 
of 
this 
sub-
section, the safe harbors and exception 
described in this paragraph are— 
(A) the safe harbor under section 
1128A(b)(4) of the Social Security Act 
(42 U.S.C. 1320a–7a(b)(4)), as added by 
subsection (a); 
VerDate Aug 31 2005 
05:05 Jul 27, 2006
Jkt 049200
PO 00000
Frm 00065
Fmt 6652
Sfmt 6202
E:\BILLS\H4157.RH
H4157
bajohnson on PROD1PC77 with BILLS
(B) the safe harbor under section 
1128B(b)(3)(J) of such Act (42 U.S.C. 
1320a–7b(b)(3)(J)), as added by sub-
section (b); and 
(C) the exception under section 
1877(e)(9) of such Act (42 U.S.C. 
1395nn(e)(9)), as added by subsection 
(c). 
SEC. 4. COMMONALITY AND VARIATION IN HEALTH INFOR-
MATION LAWS AND REGULATIONS. 
(a) STUDY TO DETERMINE IMPACT OF VARI-
ATION AND COMMONALITY IN STATE HEALTH IN-
FORMATION LAWS AND REGULATIONS.— 
(1) IN GENERAL.—For purposes of pro-
moting the development of a nationwide 
interoperable health information tech-
nology infrastructure consistent with sec-
tion 271(b) of the Public Health Service 
Act (as added by section 2(a)), the Sec-
retary of Health and Human Services 
shall conduct a study of the impact of 
variation in State security and confiden-
tiality laws and current Federal security 
and confidentiality standards on the 
timely exchanges of health information in 
VerDate Aug 31 2005 
05:05 Jul 27, 2006
Jkt 049200
PO 00000
Frm 00066
Fmt 6652
Sfmt 6202
E:\BILLS\H4157.RH
H4157
bajohnson on PROD1PC77 with BILLS
order to ensure the availability of health 
information necessary to make medical 
decisions at the location in which the 
medical care involved is provided. Such 
study shall examine— 
(A)(i) the degree of variation and 
commonality among the requirements 
of such laws for States; and 
(ii) the degree of variation and 
commonality between the require-
ments of such laws and the current 
Federal standards; 
(B) insofar as there is variation 
among and between such require-
ments, the strengths and weaknesses 
of such requirements; and 
(C) the extent to which such vari-
ation may adversely impact the se-
cure, confidential, and timely ex-
change of health information among 
States, the Federal government, and 
public and private entities, or may 
otherwise impact the reliability of 
such information. 
VerDate Aug 31 2005 
05:05 Jul 27, 2006
Jkt 049200
PO 00000
Frm 00067
Fmt 6652
Sfmt 6202
E:\BILLS\H4157.RH
H4157
bajohnson on PROD1PC77 with BILLS
(2) REPORT.—Not later than 18 months 
after the date of the enactment of this 
Act, the Secretary of Health and Human 
Services shall submit to Congress a re-
port on the study under paragraph (1) 
and shall include in such report the fol-
lowing: 
(A) ANALYSIS OF NEED FOR GREATER 
COMMONALITY.—A 
determination 
by 
the Secretary on the extent to which 
there is a need for greater com-
monality of the requirements of State 
security and confidentiality laws and 
current Federal security and con-
fidentiality standards to better pro-
tect or strengthen the security and 
confidentiality of health information 
in the timely exchange of health in-
formation among States, the Federal 
government, and public and private 
entities. 
(B) RECOMMENDATIONS FOR GREAT-
ER COMMONALITY.—Insofar as the Sec-
retary determines under subpara-
graph (A) that there is a need for 
VerDate Aug 31 2005 
05:05 Jul 27, 2006
Jkt 049200
PO 00000
Frm 00068
Fmt 6652
Sfmt 6202
E:\BILLS\H4157.RH
H4157
bajohnson on PROD1PC77 with BILLS
greater commonality of such require-
ments, the extent to which (and how) 
the current Federal standards should 
be changed, and the extent to which 
(and how) the State laws should be 
conformed, in order to provide the 
commonality needed to better protect 
or strengthen the security and con-
fidentiality of health information in 
the timely exchange of health infor-
mation. 
(b) IMPLEMENTATION OF RECOMMENDATIONS 
IF CONGRESS FAILS TO ACT.— 
(1) IN
GENERAL.—If the conditions 
under paragraph (2) are met, the Sec-
retary shall, by regulation, modify the 
current Federal security and confiden-
tiality standards to the extent that the 
Secretary determines it necessary in 
order to achieve the needed degree of 
commonality 
to 
better 
protect 
or 
strengthen the security and confiden-
tiality of health information in the timely 
exchange of health information. Such a 
modification shall be based upon the rec-
VerDate Aug 31 2005 
05:05 Jul 27, 2006
Jkt 049200
PO 00000
Frm 00069
Fmt 6652
Sfmt 6202
E:\BILLS\H4157.RH
H4157
bajohnson on PROD1PC77 with BILLS