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) AB 2253 (Pan) Page 2 of ? 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 AB 2253 (Pan) Page 3 of ? 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).) AB 2253 (Pan) Page 4 of ? 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 AB 2253 (Pan) Page 5 of ? 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].) AB 2253 (Pan) Page 6 of ? 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 AB 2253 (Pan) Page 7 of ? 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 AB 2253 (Pan) Page 8 of ? 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) **************