SB 217-GENETIC PRIVACY  SENATOR DONNY OLSON, sponsor of SB 217, gave the following sponsor statement: SB 217 has to do with the genetic privacy laws here in Alaska. I introduced this bill because I think the reason for introducing such legislation is to get a handle on this very complicated issue that is related to genetic privacy. Genetic privacy goes back to the make-up of every one of us as individuals that goes back farther than we can remember historically. We're all familiar with the useful DNA identification that's been used for law enforcement and paternity disputes. But there's another side to this new technology that I feel has a special need for some type of privacy here in the state of Alaska. Up until the year 2000, much of this information had been essentially hidden within our genetic code. However, with a public consortium and a private company, they announced that they had cracked the code and were able to spell out the 3 billion letters of each genetic genome, the biochemical messages that's encoded within everyone's DNA. This is the stepping-stone in deciphering the blueprint that makes us human. In fact, every human cell, including hair, blood, fingernails, body tissues, with the exception of gametocytes [ph], the sperm and the ovaries in particular, are made up of the same complete set of our genetic make-up. Consequently these genetic profiles yield information that could be used against us. We certainly have state laws to restrict access to medical records, however the State of Alaska has yet to specify any protection of our genetic information. Medical information is presumed confidential, but with the increasing capability to store and rapidly transfer data, this escalates the challenge for protecting privacy. At the present time there are no national statutes regarding the genetic privacy laws, however 15 states have required informed consent for a third party to perform or acquire genetic tests to obtain genetic information. Twenty-three other states require informed consent to disclose genetic information. Let me just re-emphasize that this bill is not to interfere with law enforcement, paternity determination, or any kind of medical necessity. Therefore, I've introduced SB 217 to give special consideration to the advancing biotechnology and to protect our privacy rights before it gets so complicated that we can't handle it. Thank you very much, Mr. Chairman. CHAIR SEEKINS noted that Senator Ogan had joined the committee and took questions from committee members. SENATOR SCOTT OGAN asked who is opposed to SB 217 and whether any insurance companies want access to genetic information to determine eligibility for insurance coverage. SENATOR OLSON said he was not sure that insurance companies are necessarily opposed to SB 217; however, they would like to amend it. He said insurance companies realize that technological advances will require some action and their concerns are valid and need to be addressed. SENATOR OGAN told members he believes SB 217 is a good idea because insurance is based on a pooled risk. He is concerned that without such legislation, if genetic information became more readily available, it could be used to discriminate against people based on predetermined genetic conditions. He pointed out everyone's family has some predisposition to disease. SENATOR OLSON said the bottom line of SB 217 is that a person, and only that person, should have the right to his or her genetic information, and that person should have to provide informed consent before that information is disseminated. CHAIR SEEKINS asked about using genetic information for the purpose of criminal identification. SENATOR OLSON said this bill contains exemptions for law enforcement, paternity determination, and medical necessity. Therefore, it should have no effect on law enforcement. CHAIR SEEKINS asked Senator Olson if law enforcement were to keep a database of genetic information, whether that information would be shared only within the State of Alaska or whether it would be shared on a nationwide basis for criminal identification purposes. SENATOR OLSON said, as in the case of fingerprint identification, which is shared nationwide, he anticipates that genetic information will also eventually be shared. CHAIR SEEKINS asked Senator Olson if he is suggesting that genetic information used for law enforcement purposes should be sequestered within the State of Alaska and not shared on a national basis. SENATOR OLSON said the intent of the bill is not to interfere with law enforcement at all, therefore that issue is beyond the scope of this legislation. SENATOR HOLLIS FRENCH said he reviewed the bill with a careful eye on the law enforcement aspects. He pointed out that the FBI maintains a nationwide genetic database named CODIS [Combined DNA Index System] that states have access to when seeking out crime suspects. He explained: If a rape is committed in Alaska and we gather evidence of who the rapist is here and enter that information into the database and ... if he's arrested in New York, we can link him up to that through use of the database but it's carefully maintained for just that purpose. And somewhere in the materials I noted the penalties for disclosing that information outside that database are felony penalties. They're much more severe than the penalties proposed by this bill. And I, like Senator Ogan, have concerns about how the insurance industry can use genetic information about you in setting rates and so forth. But I think the one aspect that I was looking at most closely was whether this would interfere with the collection of information for sex offenders.... It does not interfere with it and so I think it's carefully crafted to allow for the collection for information in the law enforcement arena but mainly it just sort of recognizes that Alaska has a constitutional right to privacy and that before you disclose someone's genetic information that you get in a routine medical test to some insurance company or another health agency or somebody else, that you get that patient's point blank disclosure. It may be that the patient wants to disclose it and is interested in disclosing and he can do that.... But I just think it's one of those intensely personal pieces of information that you should have an opportunity to disclose knowingly, instead of just disclosing at someone else's desire. I think this bill goes a long way to getting us on the right track as far as this information goes. CHAIR SEEKINS noted his point was to put the fact that the committee is concerned about the law enforcement aspect on the record. He then indicated an applicant for an insurance policy must provide information about his or her family medical history so that the insurance company can determine the risk factor. He asked if SB 217 is enacted, whether his insurance company could ask him to undergo a genetic screening if the company made it available and, if he signed a waiver, the insurance company could use that information to determine his insurability. SENATOR OLSON said it could. CHAIR SEEKINS asked if anything in SB 217 protects the potential insured from being forced to provide genetic information to be considered for a policy. He said he understands Senator Ogan's concern, yet a family medical history already provides a vague picture of one's genetic predisposition. He asked Senator Olson whether he has considered how that scenario should be addressed. SENATOR OLSON said that question has and needs to be considered. He maintained that some type of informed consent is required in Alaska and nationwide to protect one's family medical history and medical record information. SB 217 is an attempt to provide the same protection for one's genetic code so that it fits under [medical record] information. He repeated that one can voluntarily disclose the information; however his goal is to make sure the information cannot be used against a person who is unaware. He explained: Going on to the next step, where it's going to be a hammer that's used against you by, as you pointed out, specifically the insurance company, I think that is another level of legislation that needs - that could address it at that time. At this point, all I want to do is make sure that we have some type of protection for our genetic code, which is establishing a privacy or property right so that we have some control as to who gets that information and that's it. CHAIR SEEKINS said his concern is that an insurance company could refuse to consider an applicant without a DNA analysis. SENATOR FRENCH agreed with Senator Olson that the issue raised by Chair Seekins should be the subject of a separate bill. SENATOR OLSON said his legal education told him to [limit the scope of the bill] at that point. 8:27 a.m. SENATOR GENE THERRIAULT referred to Section 1 of SB 217, the findings and purpose section, and noted that when he was the chair of the House Finance Committee, he routinely took the findings sections out of bills to keep the statutes streamlined. He asked Senator Olson if the legal drafter suggested including a findings section and whether there is any compelling reason to include it in the bill rather than in a letter of intent. SENATOR OLSON said because of the complexity of the genetic information available, the bill needs specific language to create parameters, "so that we don't have anything that just kind of blankets over anything because all of a sudden you get this interpretation that this means this and that means that so that's the reason I think the drafters put it in." SENATOR THERRIAULT asked if he requested a findings section. SENATOR OLSON deferred to his chief of staff. MR. DAVE GRAY, Chief of Staff to Senator Olson, said he believes SB 217 is a composite of legislation from other state laws on this subject. SENATOR THERRIAULT pointed out his own bill, SB 203, before the committee today has a shorter findings section, which he plans to review to see if it is necessary. He repeated that when a findings section is unnecessary, he believes the legislature should write a letter of intent to avoid adding pages to the statutes. CHAIR SEEKINS noted that he does not intend to pass SB 217 from committee today so members will have an opportunity to look at that question. SENATOR OLSON explained: The information that's within not just the nucleus of the cell but within the mitochondria and all those other things...when you start to go and deal with things like ribonucleic acid and deoxyribonucleic acid and all those complexities, you have to have more than just what the intent is because otherwise the bill...misses, I think, how deep this really goes because certainly there are issues - and even within the definitions, when you're starting to talk chromosomes and the protein that make up the chromosomes and the genetic code that's there, that's why...I thought that we should have the, instead of just the intent, which is far more efficient - I understand, but when you start looking deeper and more and more technology goes forward...this defines in a tighter way what we're trying to do. SENATOR THERRIAULT noted the statute should address what is to be enforced. The findings and intent go into the uncodified section of the state law for the purpose of clarification. SENATOR OGAN said the Alaskan Civil Liberties Union (ACLU) is calling DNA a property right and believes if human genes are property, poor people could be pressured into selling their organs or genetic material. He said that raises ethical questions about whether human material should be devalued to the point of being marketable commodities. He happens to agree with the ACLU on that matter. He said the bill refers to genetic information as a property right and the intent language would codify it that way in statute. He asked Senator Olson his feeling on that issue. SENATOR OLSON said he discussed that question with ACLU representatives and opted not to change the language in the bill because he feels comfortable with the property right. SENATOR OGAN asked Senator Olson, as a medical doctor, whether he is aware of a split in opinion among the medical community about classifying genetic information as a property or privacy right. SENATOR OLSON replied: That is a very good question, Senator Ogan....It is appalling to sometimes see what goes on throughout the world having, as you pointed out, studied in England, and studied law in England at Cambridge, the stuff that you saw out there has some type of negative visceral reaction to it.... On the other end of the spectrum...most students in college have had the opportunity at one time or another to go down to the local Red Cross and have your blood drawn and get 10 bucks or so, so that's for giving blood, which I don't have a problem with. So you have that on the other end of the spectrum. So between the two, ...we all fall as to what our thoughts are on this ethical issue but I would say that the intent of this bill, and in the inclusion of the property right, that it's not for certainly the sale of organs, tissues.... CHAIR SEEKINS acknowledged that the purpose of SB 217 is to protect genetic information based on an individual right, not to determine the ethics of selling body parts. SENATOR OLSON agreed. CHAIR SEEKINS took public testimony. 8:45 a.m. MS. JENNIFER RUDINGER, Executive Director of the Alaska Civil Liberties Union, said that the right to privacy is among the strongest guarantees in the Alaska Constitution. The ACLU appreciates Senator Olson's and the committee's interest in this important issue. The ACLU made several suggestions in a letter sent to Senator Olson and feels most strongly about two of those suggestions. First, the ACLU would like the bill to define "informed consent" and second, the ACLU would like to see protections from discrimination included in the bill. She noted that she respectfully disagrees with Senator French that including such protections would be outside the scope of the bill. She pointed out if the state is going to acknowledge this important privacy right, the bill should contain some "teeth" to protect that right. She said 46 states have some type of anti- discrimination measure, mainly related to health insurance policies. Alaska has two statutes that deal with that discrimination based on genetic information; however, "genetic information" is not defined in Alaska statute. Those statutes say that a health care provider cannot discriminate in terms of eligibility for health insurance based on genetic information, among other things. She suggested, "It would be important, I think, to beef that up a little bit and define genetic information and then beyond eligibility, protecting people in terms of their coverage." MS. RUDINGER noted the other statute prohibits discrimination based on genetic information in regard to pre-existing conditions. She said it is important to protect people in both the health insurance and employment context. It is a common scenario for an employer to get consent for a genetic test from an applicant and then to misuse the information when the employee's disclosure of a genetic condition leads to employment discrimination. The ACLU wants to see SB 217 protect people in the two areas of employment and insurance. CHAIR SEEKINS referred to page 3 of the ACLU letter, which clarifies that in Alaska statute, a person includes corporations and all different entities. He then asked Mr. George to testify. MR. JOHN GEORGE, representing the American Council of Life Insurers (ACLI), told members the ACLI has been working with Senator Olson on its concerns with SB 217. The ACLI believes the basis of the bill is well founded. Because insurers need to require some medical tests, the ACLI feels the definition of genetic testing in the bill is overly broad because that definition would include the test results from, for example, a cholesterol test and a serum iron test. Insurance companies use tests that are widely accepted, cheap, and reliable. The type of genetic testing that Senator Olson intends to protect does not fit that description. MR. GEORGE informed members that he provided a proposed amendment to Senator Olson that contains a new definition. He said he would prefer to work with Senator Olson to see if they can agree on a new definition. He then told members that ACLI's second concern regards adverse selection. He explained that if an insured knows he or she has a medical condition and does not disclose that to the insurance company, there is the possibility of adverse selection. If a person knows that he or she is likely to die in a year from now, that person is likely to buy more life insurance. Insurance companies believe that if the insured knows something about a medical condition beforehand, that information should be disclosed to the insurance company for underwriting purposes. He informed members that applicants sign a disclosure form for medical information when applying for insurance. He also noted a good portion of the Division of Insurance's privacy regulations have to do with disclosure of health information and what insurance companies can do with that information. Insurance companies are also subject to the Health Insurance Portability and Accountability Act (HIPAA) regulations, which address authorization by an applicant for disclosure of medical information. SB 217 would require a separate authorization for disclosure of genetic information. He noted if an insurance company does business in 50 states and each state has a different requirement, it would have to provide a different form in each state and deal with insureds that move from state to state. The ACLI believes the authorization forms it uses now comply with HIPAA and are adequate for people who voluntarily apply for insurance. He said once an insurance company has information, it is obligated to maintain those records. SB 217 originally allowed a person to withdraw his or her information, however the insurance company would be required to maintain the file. Insurance companies are subject to audit by the Division of Insurance and disclose client files when selling the company or applying for reinsurance. 8:56 a.m. CHAIR SEEKINS asked if he were to voluntarily get a DNA test to learn how to live a better life, whether he would be obligated to share the information with an insurance company. MR. GEORGE said if an insurance company asked health related questions, he would be obligated to answer them. He asked Chair Seekins if he knew he had a disease that was diagnosed using a non-genetic type test, he would feel obligated to disclose it. CHAIR SEEKINS said he would feel obligated to disclose a pre- existing condition but he was referring to a predisposition. MR. GEORGE said the definition he plans to address with Senator Olson addresses a predisposition and a pre-existing condition. CHAIR SEEKINS asked if once the insurance company has that information, it becomes the insurance company's property and can be sold and shared. MR. GEORGE said he was not sure how to answer that question. He pointed out an insurance company would be prohibited from selling the information. However, if he bought a life insurance policy from Company A and that company decided to get out of the life insurance business and sell to Company B, Company B would want to review the underwriting files to determine the risk. CHAIR SEEKINS indicated the information appears to be a saleable commodity. MR. GEORGE said ownership of the policy is with the policyholder but the insurance company offering that policy can sell the book of business. In addition, if a company wants to reinsure a policy, the reinsurance company will want to look at that file. He noted the privacy regulations that the Division of Insurance is in the process of adopting contain specific guidelines about what is permissible and what is not. Medical information is not public information and is not available on the Internet. CHAIR SEEKINS asked if that information is put into a database that is available to other members of the insurance industry, either on a membership or fee basis. MR. GEORGE said it is not. CHAIR SEEKINS asked, in that case, if he gave the information to Company A, it would not be put into a database that is accessible by Company B. MR. GEORGE replied: Senator, my understanding is that if we're talking about a national database that someone can subscribe to and just access, the answer is absolutely not. I gave the example of Company A and B and, in that case, it would be because there is a business relationship and a reason for doing that. Again, what are they doing with the information? Are they using it for a business purpose to decide whether or not to accept the business as opposed to selling it to your credit card company or to your bank or to a prescription drug company? CHAIR SEEKINS said it seems that the intent of SB 217 is to establish a level of privacy on an individual relationship basis. He asked if when he shares information with Company A, whether, without his knowledge or consent, it is a shareable commodity with another entity. He thought that is what Senator Olson was trying to protect. He said he wants to know what actually happens to the data once it is shared with Company A and asked Mr. George to get back to him with a definitive answer. MR. GEORGE said he feels absolutely safe in saying the information is not saleable or shareable other than for the specific permissive uses listed in the Division of Insurance's regulations for claims adjusting and other purposes. It is not available for any purpose not related to that insurance policy. CHAIR SEEKINS noted with no further testimony, he would hold the bill in committee and announced a 5-minute recess.