BILL ANALYSIS Ó
SENATE JUDICIARY COMMITTEE
Senator Noreen Evans, Chair
2011-2012 Regular Session
AB 2253 (Pan)
As Introduced
Hearing Date: July 3, 2012
Fiscal: No
Urgency: No
NR
SUBJECT
Clinical Laboratory Test Results: Electronic Conveyance
DESCRIPTION
Existing law authorizes the results of clinical laboratory tests
performed at the request of a health care provider to be
conveyed to the patient in electronic form if requested by the
patient and if deemed most appropriate method of disclosure by
the health care professional. However, laboratories may not
electronically release to patients their test results related to
HIV antibodies, hepatitis, drug abuse, and specified test
results that reveal malignancy.
This bill would authorize the electronic conveyance of clinical
laboratory test results related to HIV antibodies, hepatitis,
drug abuse, and specified test results that reveal a malignancy,
if requested by the patient, and the health care professional
deems electronic conveyance the most appropriate method of
disclosure, and the professional has already discussed the
results with the patient.
BACKGROUND
Both state and federal law govern the release of patient medical
records, including clinical lab results. California law allows
patients to inspect their records upon a written request to the
health care provider, and also requires health care
professionals, at whose request a clinical laboratory test is
performed, to provide or arrange for the results to be delivered
to the patient. These results may be delivered in electronic
form if the patient so requests, and the health care
(more)
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professional deems electronic conveyance the most appropriate
means of disclosure, given the circumstances. In the event that
test results are delivered electronically, they must first be
reviewed by the health care professional, and then be provided
to the patient in a reasonable amount of time. However, there
is an exception to the general rule that prohibits the
electronic transmission of clinical laboratory test results for
HIV, hepatitis, drug abuse, or test results related to routinely
processed tissues including if they reveal a malignancy. This
exception was apparently created to protect the confidentiality
of the sensitive information contained in these tests, and
ensure that a health care professional would be able to
interpret and discuss the results with the patient.
New technologies and financial incentives have resulted in
health care providers increasingly and actively using electronic
health records. In 2009, the President signed the American
Recovery and Reinvestment Act (ARRA) which included the
establishment of the Office of the National Coordinator for
Health Information Technology (ONC) to facilitate and expand the
use of health information technology pursuant to national
standards. The ARRA incorporated the health Information
Technology for Economic and Clinical Health Act (HITECH) which
included a number of funding opportunities for states that
advance health information technology and support the adoption
of electronic health records (EHR). The ARRA also included
provisions relating to the privacy and security of EHR, and
established that an individual has a right to access certain
information about him or herself in an electronic format.
This bill would authorize electronic conveyance of clinical
laboratory test results related to HIV, hepatitis, drug abuse,
or test results related to routinely processed tissues if they
reveal a malignancy, if requested by the patient, the health
care provider deems electronic conveyance the most appropriate
method of conveyance, and the health care provider has already
discussed the results with the patient.
CHANGES TO EXISTING LAW
Existing law requires that a health care provider, health care
service plan, or contractor must disclose a patient's medical
information to him or her. (Civ. Code Sec. 56.10(b)(7).)
Existing law provides that an adult patient of a health care
provider, any minor patient authorized by law to consent to
medical treatment, and any patient representative shall be
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entitled to inspect the patient's records upon presenting to the
health care provider a written request for those records and
upon payment of reasonable clerical costs incurred in locating
and making the records available. (Health & Saf. Code Sec.
123110.)
Existing law requires a health care professional at whose
request a clinical laboratory test is performed to provide or
arrange for the results to be delivered to the patient. At the
patient's request, and if deemed most appropriate by the health
care professional, the results may be conveyed in electronic
form. (Health & Saf. Code Sec. 123148(a).)
Existing law requires the electronic provision of test results
to be delivered to a patient in a reasonable time period, after
the results have been reviewed by the health care professional,
and recorded in the patient's medical record. (Health & Saf.
Code Sec. 123148(b) and (e).)
Existing law establishes use limitations and protections for
clinical lab test results conveyed by electronic means,
including:
the information shall not be used for any commercial purpose
without the consent of the patient; and
any third party to whom the results or information are
disclosed to are deemed a provider and subject to limitations
under the civil code. (Health & Saf. Code Sec. 123148(g) and
(h).)
Existing law provides that a patient or his or her physician may
revoke any consent to receive test results electronically at any
time and without penalty, except to the extent that action has
been taken in reliance on that consent. (Health & Saf. Code
Sec. 123148(j).)
Existing law prohibits the results of the following clinical
laboratory tests from being conveyed electronically to patients:
HIV antibody test;
presence of antigens indicating a hepatitis infection;
abusing the use of drugs; and
test results related to routinely processed tissues, including
skin biopsies, Pap smear tests, products of conception, and
bone marrow aspirations for morphological evaluation, if they
reveal a malignancy. (Health & Saf. Code Sec. 123148(f).)
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This bill would authorize clinical laboratory test results for
HIV antibodies, hepatitis, drug abuse, and test results related
to routinely processed tissues, as specified, if:
the patient requests the electronic conveyance;
the health care professional deems this conveyance as the most
appropriate means; and
a health care professional has first discussed the results
with the patient.
COMMENT
1.Stated need for the bill
According to the author:
This bill promotes the expansion of health information
exchange and electronic health records, as well as,
furthering the participation of patients in their own medical
decision making. As the federal government has moved to
implement health information exchange and technology with the
goal of expanding electronic health records, California has
been identified as one of a number of states with state laws
that present barriers to the expansion of health information
exchange. Particularly, existing state law prohibits the
conveyance of HIV, hepatitis, abuse of drugs, and pathology
test results electronically. The explicit prohibition
against conveyance of test results to patients on the
specified test creates a special class of information that
exceeds the Health Insurance Portability and Accountability
Act (HIPAA) privacy standards regulating all other types of
personal health information. This bill would assist eligible
professionals and hospitals to qualify for these incentive
payments while allowing patients to take an active role in
their health care.
2.Confidentiality and security of clinical laboratory results
This bill would allow, upon the request of the patient and
approval of the health care provider, clinical laboratory
results related to HIV, hepatitis, drug abuse, and test results
related to routinely processed tissues if the test reveals a
malignancy, to be electronically released to the patient, as
specified.
AB 1490 (Thompson, Chapter 529, Statutes of 2001) provided that
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test results may be delivered in electronic form if requested by
the patient and if deemed appropriate by the health care
professional who requested the test. That bill incorporated a
number of safeguards to protect the confidentiality of the
information, and also to ensure that the health care
professionals had the ability to first review the results and
contact the patient if necessary. However, uneasiness remained
concerning the posting of highly sensitive and confidential
information to the Internet. As a result, an exception was
created for the tests at issue under this bill, presumably to
protect the patient from the social consequences which may arise
if the confidentiality of the information was breached. SB 850
(Leno, Chapter 714, Statutes of 2011) was enacted a decade later
to further ensure the accuracy, integrity, and efficiency of
electronic health information and also clarified that medical
information held in both the electronic and physical forms is
protected under the law. SB 850 also required electronic
medical record systems to automatically record any change or
deletion of any electronically stored medical information,
including the identity of the person who accessed and changed
the medical information, the date and time the information was
accessed, and the change that was made.
Increasingly, health care professionals have been using
electronic records. Proponents of this trend argue that
patients' right to electronic health records allows individuals
to take a more active role in their health care. A recent
article published by Kaiser Health News noted that "patient
follow-up could make a difference in many instances. The
ÝJournal of American College of Radiology] study examined
medical malpractice claims from 425 hospitals and 52,000
providers. ? Of the 306 cases in which test results were
specifically cited as a factor in a malpractice case, the most
common problem - it occurred almost half the time - was that the
patient didn't receive the test results, cited in 143 cases. The
second-most-common problem was that the clinician didn't receive
the results, cited in 110 cases. Other problems included delays
and slow turnaround in reporting findings and test results that
were filed before the clinician reviewed them." (Andrews, Both
Patients And Physicians Can Suffer When Test Results Aren't
Reported, Nov. 29, 2011, Physician News, <
http://www.physiciansnews.com/2011/11/29/both-patients-and-physic
ians-can-suffer-when-test-results-aren%e2%80%99t-reported/> Ýas
of June 28, 2012].)
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Arguably, the confidentiality and security concerns that existed
during the enactment of AB 1490 have been assuaged by new
technologies, legislation, and a general level of comfort with
the posting of information online. Furthermore, access to one's
medical information encourages greater patient involvement in
the managing of their health care and may reduce the risk that
health care providers will inadvertently fail to provide
requested results to a patient.
3.Patient request for specified test results
This bill would authorize laboratories to electronically release
specified test results directly to the patient if requested by
the patient, the health care provider deems electronic
conveyance the most appropriate method of conveyance, and the
health care provider has already discussed the potential results
with the patient.
The American Civil Liberties Union (ACLU) opposes this bill
unless it is amended to require the patient to make the request
for an electronic conveyance of test results in writing. The
ACLU argues that a written request will "ensure that the patient
understands and in fact agrees to receive the results
electronically." In response, the author writes that:
existing state law sufficiently ensures that a patient must
have already given written consent to conduct the specified
test, to share with third parties, including themselves; and
for the information to be conveyed electronically if the
ordering physician deems it appropriate. In order to protect
patient privacy, AB 2253 only releases clinical lab results
to the patient who is the subject of the test and only if so
requested by the patient.
Staff notes that the aim of this suggested amendment, that the
patient understands he or she has made a request for an
electronic conveyance, is arguably accomplished under the
existing provisions of the bill. First, the patient must
specifically request an electronic conveyance of the test
results before a health care professional may authorize the
release of the results from the lab to the patient. Second, if
the health care professional believes that an electronic
conveyance is not the most appropriate way to communicate the
results of the test at issue, he or she may not authorize the
results to be released to the patient electronically. Thus, if
a patient cannot clearly communicate that he or she wishes to
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receive test results electronically, under this bill, the
physician should choose a more traditional method of conveyance.
This bill would also require a health care provider to first
discuss the results of the test with the patient. Because this
discussion must occur prior to the test results being delivered
to the patient, practically speaking, the health care
professional will probably need to discuss the potential range
of results with the patient when the request for an electronic
conveyance is made. Thus, it should be clear to the patient that
the health care professional will not be present to interpret or
explain the results when the patient receives them.
Furthermore, the provisions of this bill are subject to a
requirement under existing law, which provides that the health
care professional who ordered the tests must first review the
tests before the results may be released to the patient. This
allows the health care professional to contact the patient if
the range of test results were not previously discussed with the
patient, or the test produced unanticipated or difficult to
interpret results. Finally, existing law provides that a
patient may always request to receive medical information
through traditional methods, and allows a patient or health care
professional to revoke his or her request or authorization to
receive results electronically at any time with no penalty.
Arguably, adequate protections and safeguards exist to permit
patient the convenience and privacy of reviewing test results
electronically, if so requested.
Staff notes that there is pending federal legislation that would
require all lab results be made available directly to patients.
If passed, these proposed amendment to the Health Insurance
Portability and Accountability Act (HIPAA) and the Clinical
Laboratory Improvement Amendments (CLIA) would appear to preempt
California law, and this bill if enacted.
Support : Center for Democracy and Technology; California
Society of Pathologists; Quest Diagnostics Incorporated
Opposition : American Civil Liberties Union (unless amended)
HISTORY
Source : Author
Related Pending Legislation : None Known
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Prior Legislation :
AB 1490 (Thompson, Chapter 529, Statutes of 2001) See Comment 2.
SB 850 (Leno, Chapter 714, Statutes of 2011) See Comment 2.
Prior Vote :
Assembly Floor (Ayes 73, Noes 1)
Assembly Committee on Health (Ayes 18, Noes 1)
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