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1 August 2009 Privacy and Security Solutions for Interoperable Health Information Exchange Report on State Law Requirements for Patient Permission to Disclose Health Information Prepared for RTI International 230 W Monroe, Suite 2100 Chicago, IL Jonathan White, MD Director of Health IT Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD Jodi Daniel, JD, MPH, Director Steven Posnack, MHS, MS, Policy Analyst Office of Policy and Research Office of the National Coordinator for Health IT 200 Independence Avenue, SW, Suite 729D Washington, DC Contract Number RTI Project Number
2 Contract Number RTI Project Number August 2009 Privacy and Security Solutions for Interoperable Health Information Exchange Report on State Law Requirements for Patient Permission to Disclose Health Information Prepared for RTI International 230 W Monroe, Suite 2100 Chicago, IL Jonathan White, MD Director of Health IT Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD Jodi Daniel, JD, MPH, Director Steven Posnack, MHS, MS, Policy Analyst Office of Policy and Research Office of the National Coordinator for Health IT 200 Independence Avenue, SW, Suite 729D Washington, DC Prepared by Joy Pritts, JD Stephanie Lewis, JD, LLM Robin Jacobson, JD Kevin Lucia, JD Kyle Kayne, JD Health Policy Institute & O Neill Institute for National and Global Health Law Georgetown University 3300 Whitehaven Street, NW, Suite 5000 Washington, DC Under subcontract with RTI International 3040 Cornwallis Road Research Triangle Park, NC 27709
3 Identifiable information in this report or presentation is protected by federal law, section 924(c) of the Public Health Service Act, 42 USC. 299c-3(c). Any confidential identifiable information in this report or presentation that is knowingly disclosed is disclosed solely for the purpose for which it was provided. Disclaimer This survey was conducted in 2008 and early The authors have attempted to assure that the information presented is accurate as of January The information in this report is intended to provide an overview of a specific subset of the state statutes and regulations governing the requirements for certain providers to obtain patient permission to disclose health information for treatment. It should not be used as a substitute for legal or other expert advice. The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the U.S. Department of Health and Human Services. This report does not contain any individually identifiable information.
4 CONTENTS Section Executive Summary Page ES-1 1. Background and Purpose Federal Law Overview HIPAA Alcohol and Drug Abuse Confidentiality Requirements, 42 C.F.R. Part Clinical Laboratory Improvement Amendments (CLIA) Project Purpose Methodology Scope Research Protocol Data Analysis Permission Classifications Findings Overview General Clinical Information Hospitals Doctors of Medicine Pharmacies and Pharmacists HIV-Related Information Scope of Laws Disclosure Limitations Permission Requirements Genetics-Related Information Scope of Laws Permission Requirements Substance Abuse Treatment-Related Information Information Originating at Substance Abuse Treatment Programs and Facilities Incidental Health Information Related to Alcohol or Substance Abuse iii
5 3.6 Mental Health Treatment-Related Information Information Maintained by Clinical Laboratories Overview by Health Care Entity Synopsis of Findings and Conclusion 4-1 Appendix 4.1 Broad Categorical Approaches Toward Health Information Exchange HIPAA-Based Standard No Patient Permission Required for Disclosure for Treatment of the Patient Who Is the Subject of the Information Patient Permission Required to Disclose Health Information for Treatment Purposes No Patient Permission Required for Disclosure for Treatment of the Patient under Certain Conditions Implications and Conclusion Proposed Federal Solutions Proposed State-Based Solutions Conclusion A: Data Collection Outline and Tables... A-1 iv
6 EXECUTIVE SUMMARY Background and Purpose This report is one of a series produced under RTI International s contract with the Agency for Healthcare Research and Quality (AHRQ). The contract, entitled Privacy and Security Solutions for Interoperable Health Information Exchange, is managed by AHRQ and the Office of the National Coordinator for Health Information Technology (ONC). In the first phase of this project, 33 states and 1 territory (collectively referred to as states or state teams) conducted an assessment of variation in business practices, policies, and laws that might be perceived as barriers to electronic health information exchange, suggested possible solutions to these barriers, and prepared plans to implement these solutions. In doing so, the states focused on a number of different scenarios, including treatment, health information exchange, payment, research, and public health. 1 As a result, the states identified a number of state laws and policies addressing the limitations on disclosure of health information between health care providers and third parties that may impede electronic health information exchange. The majority of states that participated in Phase I of this project (30/34) reported significant variation in the business practices and policies surrounding the need for and process of obtaining patient permission 2 to use and disclose personal health information for a variety of purposes, including for treatment. Information related to health conditions that are often considered sensitive, such as HIV/AIDS, alcohol and drug addiction, mental illness, and genetic makeup, are often afforded heightened legal protections. These protections, which often require patient permission to disclose health information, vary from state to state. States identified the need to obtain patient permission to disclose certain information and the variations associated with such permission as potential impediments to the electronic exchange of health information both within states and across state lines. This report is intended to further the initial work of this project by collating and analyzing state laws that govern the disclosure of identifiable health information for treatment purposes to identify commonalities and differences. 1 Dimitropoulos, L. (2007, July). Privacy and Security Solutions for Interoperable Health Information Exchange, Assessment of Variation and Analysis of Solutions. Report prepared for the Agency for Healthcare Research and Quality and the Office of the National Coordinator for Health IT. 2 States use various terms to refer to the concept of obtaining approval from a patient to share health information with an outside party, including consent, authorization, and release. The Privacy Rule issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA Privacy Rule) uses the term consent for individual permission to disclose protected health information for treatment. See 45 C.F.R We use the term patient permission to refer to this concept, unless we are directly quoting a state statute or regulation. ES-1
7 Report on State Law Requirements for Patient Permission to Disclose Health Information Methodology To obtain some consistency across the states for comparison purposes, we focused our review on whether a few specific categories of health care entities may share specific types of health information of adult patients for treatment under state law. The categories that we reviewed were consistent with those assessed in the first phase of this project. We identified and compiled statutes and regulations that govern the disclosure of the following types of health information: clinical health information (general) HIV/AIDS (tests and other information) mental health substance abuse genetics (tests and other information) by the following entities: private practice doctors of medicine hospitals pharmacists outpatient substance abuse treatment programs inpatient mental health care facilities independent clinical laboratories (i.e., not associated with hospitals or public health departments We used the assessments conducted in Phase I as well as prior publicly available state law surveys as the starting point for identifying relevant state statutes and regulations. We supplemented this information by conducting original research using online legal research tools, including Lexis/Nexis, Westlaw, and relevant websites operated by state governments. In addition to reviewing statutes and regulations, we reviewed case law and state attorney general opinions interpreting these laws as identified in case notes provided by the legal search engines. We summarized the statutes and regulations we identified on Excel charts, answering a series of standard questions designed to elicit details on whether the statute or regulation requires patient permission to disclose information. We initially classified state law provisions using the following categories: Y = Yes, provider may disclose health information for treatment without patient permission. S = Sometimes. Provider may sometimes disclose health information for treatment without patient permission. ES-2
8 Executive Summary N = No, provider may not disclose health information for treatment without patient permission. U = It is unclear whether the provider or program must obtain patient permission to disclose health information for treatment without patient permission. We answered a structured series of questions designed to address the following main issues: Whether the provider or program may disclose the pertinent type of information for treatment purposes without patient permission? Are there limits to whom information may be disclosed without patient permission? Are there limits on the amount or type of information that may be disclosed without permission (e.g., minimum necessary or only summary information)? If permission is or may be required, must the permission be in writing? Are there specific format or content requirements? If so, what are the requirements? Does the law restrict the receiving party from redisclosing the information? Does the law permit disclosure without patient permission for emergency treatment? Information from the Excel data collection templates were imported into a SQL database. (Questions from the Excel template eliciting this information are shown in Appendix A: Data Collection Outline.) We generated a series of reports based on provider type and health information category. After reviewing the information collected in aggregate, we further refined the categories for state disclosure laws, in light of recurring provisions. We added such categories as: NT = May disclose when necessary for treatment. E = May disclose for emergency treatment. SP = May disclose to specified providers (e.g., only to other mental health providers) AP = Must attempt to obtain permission first, but may disclose if unable to obtain permission. PJ = May disclose subject to professional judgment We used these broad categories to organize our data. In analyzing the data, we used standard techniques for statutory interpretation including reviewing a state s statutes and regulations together, reading official comments, pertinent case law, and attorney general opinions. We also reviewed materials submitted by states in Phase I of this project, material developed by the Interstate Disclosure and Patient Consent Requirements Collaborative, and state preemption analyses where publicly available. We note, however, that there was a dearth of explanatory material for many statutes and regulations and that we interpreted these based on the plain reading of the law. ES-3
9 Report on State Law Requirements for Patient Permission to Disclose Health Information Findings General Clinical Information Many states have laws that generally regulate the disclosure of health information or medical records and that are not specific to one type of medical condition (general clinical information). These laws govern specific types of health care entities, and often pertain to hospitals, doctors, or both. Pharmacists are often subject to distinct laws. Because the laws governing hospitals and doctors are fairly similar, their findings are summarized together. 3 Approximately a dozen states have statutory or regulatory provisions that generally permit hospitals and/or doctors to disclose general clinical information for treatment without patient permission. In a few states (less than five), such disclosures are generally permitted but patients have the right to opt out of disclosures to providers who have previously provided care. 4 One state appears to permit hospitals and doctors to disclose health information for treatment without patient permission, but only to a specified group of other health care providers (see Tables A-1a and A-1b). In many states, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule sets the standard for hospitals and doctors disclosure of health information for treatment, either expressly or implicitly. A few states expressly incorporate the HIPAA Privacy Rule standard. An additional handful of states have statutes and regulations that permit hospitals and doctors to disclose health information as authorized by law or similar standard, which implicitly incorporates HIPAA. We were unable to identify statutes or regulations governing the disclosure of health information for treatment purposes by hospitals in 22 states and by doctors in 28 states. Because of the apparent absence of controlling state law in these states, the HIPAA Privacy Rule provides the standard for disclosure. Either through express provisions or through absence of state law, the HIPAA Privacy Rule appears to be the standard for disclosure for treatment in approximately 30 states for hospitals and 35 states for doctors (see Tables A-1a and A-1b). When the two categories summarized above are combined (states that expressly permit disclosure for treatment plus states that rely on the HIPAA Privacy Rule either expressly or implicitly), it appears that in over 40 states hospitals and/or doctors may disclose general clinical health information for treatment without patient permission and not subject to express limitations (such as a limited opt out) (see Tables A-1a and A-1b). Only a handful of states usually require hospitals and/or doctors to obtain patient permission before disclosing general clinical health information to other providers for treatment purposes. 3 Numbers are approximate because there are slight variances in state laws governing hospitals and doctors. 4 The opt-out provisions appear to be intended to give patients some control in obtaining second opinions or consultations for treatment. ES-4
10 Executive Summary State laws establishing disclosure standards for pharmacies and pharmacists (hereinafter pharmacists) tend to be less clear-cut than laws governing doctors and hospitals. Pharmacists in at least 34 states appear to be able to generally disclose general clinical health information to health providers without patient permission, either under express statutory or regulatory provisions, by incorporating the HIPAA Privacy Rule, or because an applicable state standard is lacking. A number of other states have statutory or regulatory provisions that expressly permit pharmacists to disclose health information that they maintain subject to professional judgment, although it is unclear how this standard is interpreted. Pharmacists in two states may disclose health information without patient permission only to specific types of health care providers. Laws in six states were unclear primarily due to inconsistent statutory or regulatory provisions [see discussion in Section Only two states, New York and Minnesota, generally require pharmacists to obtain patient permission to disclose information for treatment. Both allow disclosures for emergency treatment. Due to the ambiguity in pharmacy laws, it is somewhat difficult to obtain an overall figure for states which permit all three categories of health care providers discussed (doctors, hospitals and pharmacists) to disclose health information for treatment without patient permission and not subject to other limitations. However, it is clear that in about half the states, hospitals, doctors, and pharmacists may all disclose general clinical information for treatment to a wide range of health care providers without patient permission (see Tables A-1a, A-1b, and A-1c). 5 HIV-Related Information The majority of states (41) have statutes or regulations that specifically regulate the disclosure of information related to human immunodeficiency virus (HIV) or to information related to communicable diseases, including HIV (see Table A-2). Most apply to a broad range of entities, such as any person who obtains such information in the course of providing a health service. As a practical matter, the effective scope of HIV-specific laws in many states is quite broad because the law prohibits recipients of HIV-related information from further disclosing the information except as authorized under the terms of the law. At least 19 states have HIV-specific laws that apply to a fairly wide range of HIV-related information, while 22 states take a narrower approach and afford protection to information related only to HIV tests and test results (see Table A-2). For the most part, laws regulating the disclosure of HIV-related information apply similarly across the board to hospitals, doctors of medicine, and pharmacists/pharmacies. Twelve 5 This figure excludes states that impose a professional judgment standard on disclosure, where it is somewhat ambiguous whether the provider may always disclose health information for treatment without patient permission. ES-5
11 Report on State Law Requirements for Patient Permission to Disclose Health Information states have laws that usually require hospitals and doctors to obtain patient permission before disclosing HIV-related health information to other providers. Slightly fewer states (8) impose a similar standard on pharmacists (perhaps because pharmacists do not administer or analyze HIV tests). 6 Approximately 12 states have HIV-specific statutes and regulations that permit health care providers to disclose information without patient permission to other providers when knowledge of the information is necessary to provide care or treatment, or similar standard, which some interpret as akin to the minimum necessary standard of the HIPAA Privacy Rule (see Tables A-3a, A-3b, and A-3c). Approximately 20 states permit hospitals, doctors, and pharmacists to disclose HIV-related information to other health care providers for treatment without the patient s permission, and apparently absent minimum necessary type requirements (see Tables A-3a, A-3b, and A-3c). Only one state s HIV-specific law expressly incorporates the disclosure standard set by the HIPAA Privacy Rule. Another state, Nevada, provides that more stringent state restrictions on sharing HIV information do not apply when the information is electronically transmitted in accordance with HIPAA. Patients, however, have the right to opt out of having their information electronically transmitted. States that require patient permission to disclose HIV-related information generally require that such permission be in writing. However, some states make clear that patient permission need not be obtained for every instance of disclosure. Genetics-Related Information State laws often provide heightened protection for information related to individuals genetic makeup (genetics-related information). Although most of the state restrictions on sharing genetics-related information are imposed on health insurers, 18 states have geneticsrelated information laws that are broad enough to encompass disclosure by health care providers. 7 The scope of information covered by these laws varies. Some state laws afford protection solely to genetic testing and testing-related information, while others are somewhat broader and also protect other information tied to genetic makeup such as family health history or information about inherited characteristics (see Table A-4). For the most part, state genetics-related information laws apply to any person, or any entity, categories that include any health care provider in possession of the information. 6 With respect to hospitals and doctors, four of these states do not have HIV specific laws, but have general health information laws that require patient permission to disclose health information for treatment and are broad enough to encompass HIV-related information. The same holds true in one state for pharmacists. 7 Many of these laws were promulgated in response limits on the use of genetic health information by group health insurers contained in the portability provisions of HIPAA. The Genetic Information Non-Discrimination Act of 2008, Public Law no , which prohibits discrimination on a wider basis, supersedes less stringent state laws. ES-6
12 Executive Summary Genetics-related information laws in 14 states generally require the permission of the test subject for disclosure of such information even for treatment. Laws in three states expressly permit the disclosure of genetic information without patient permission to another provider for treatment. As noted, most states do not have laws that specifically govern the disclosure of genetics-related information that is maintained by health care providers. In these states, disclosure laws that apply to general clinical health information are often broad enough to encompass genetics-related information. Many of these general clinical information laws permit the disclosure of health information for treatment without the patient s permission. In total, it appears that at least 30 states permit hospitals to disclose genetics-related information to other providers for treatment purposes without patient permission (see Table A-5a). A similar pattern is true for medical doctors and pharmacists (see Tables A-5b and A-5c). Substance Abuse Treatment-Related Information Almost every state has a statute or regulation that specifically governs the disclosure of information related to substance abuse treatment generated by substance abuse treatment programs and facilities (as opposed to information related to substance abuse that may be incidentally generated in a general clinical care context). The entities covered by these laws vary from state to state, making a cross-state comparison of substance abuse treatment facilities extremely difficult. However, some themes do emerge. Most (over 30) state laws governing substance abuse treatment programs incorporate by reference the federal requirements for protecting the confidentiality of alcohol and drug abuse treatment records, 42 U.S.C. 290dd-2, 42 C.F.R. Part 2. For the most part, state laws that govern substance abuse treatment programs and facilities, like the related Federal statute and rules, impose confidentiality requirements on patient identities including information about identified individuals (i.e., the fact that they have sought treatment for substance abuse) as well as treatment records. Laws in a few states expressly expand the federal protections to programs that are not federally funded. In other states, it is less clear whether the state statute or regulation incorporating federal law is intended to apply solely to federally assisted programs or is intended to apply to a broader range of entities. 8 In addition (or in lieu of) incorporating federal law, a few states substance abuse laws independently require patient permission to disclose information, even for treatment. More often, state laws governing substance abuse treatment records permit the disclosure of information without patient permission for treatment in some circumstances, such as when the patient transfers from one treatment program to another or to obtain advice concerning 8 One potential rationale for applying the federal confidentiality standards to substance abuse programs regardless of whether they receive federal assistance may be the inconsistent receipt of such assistance. For example, a substance abuse program may receive federal assistance (e.g., funding through a federal grant) one year but not another year. Applying the federal confidentiality standards regardless of whether the program receives federal assistance assures some degree of continuity and clarity in a state s confidentiality requirements from year to year. ES-7
13 Report on State Law Requirements for Patient Permission to Disclose Health Information a specific medical problem to assist in ongoing treatment. Although the particular circumstances vary, these laws may be seen as attempting to ensure that information may be shared for continuity of care, but only in a limited manner. Some states impose confidentiality requirements that exceed those in 42 C.F.R. Part 2, such as limiting the type of information that may be disclosed even pursuant to patient permission. Federal law imposes strict limits on disclosures of information by federally-assisted programs. While most states have statutory provisions that specifically address information originating in substance abuse treatment programs and facilities, only a few have laws that specifically regulate alcohol or substance abuse-related information that is incidentally generated in the course of treatment outside of such a program or facility. Information Generated by In-patient Mental Health Facilities States protect information related to mental health in a number of ways, including through recognition of mental health care provider-patient privileges, confidentiality requirements imposed on psychotherapists, social workers, and other mental health care providers as well as laws that apply to information generated in the mental health commitment process. Due to resource limitations we were unable to conduct a comprehensive analysis of all of these mental health laws. We, therefore, focused our study on one general category of law, those that govern information maintained by in-patient mental health treatment facilities. We selected this category based on the belief that these facilities, which include hospitals, may be more likely to have electronic medical records. 9 Almost every state has statutes or regulations that fall within this category. Although the scope of these laws varies greatly among the states, some trends are evident. First, the vast majority of state laws governing in-patient mental health treatment facilities protect a broad range of information and records generated by such a facility. The protections are not limited to just information related to the patient s mental health condition or treatment. Second, although these laws are written to protect information originating at mental health facilities, as a practical matter, they have a broader impact. Laws in at least 10 states prohibit the recipients of health information originating from these mental health facilities from further disclosing the information except as authorized under the terms of the law. In these states, the legal protection essentially follows the health information as it flows to different entities. Third, information related to mental health services often is afforded a higher degree of protection than information generated in other clinical settings. At their most stringent, 9 Our decision to limit our inquiry in this fashion was made prior to the passage of the American Recovery and Reinvestment Act of 2009, Pub. Law Public Law 111-5, which contains incentives for certain physicians to adopt electronic medical records. ES-8
14 Executive Summary state laws require an in-patient mental health facility to obtain the permission of the patient to disclose health information even for treatment except in emergent circumstances. Only a few states have provisions that fall in this category. Most states, however, permit mental health treatment facilities to disclose information for treatment purposes without patient permission subject to certain conditions including the following: upon the patient s transition into, between, or among mental health care providers; to specific types or categories of providers: only other mental health care professionals, those who are actively engaged in the patient s diagnosis and care, those who are part of a formal arrangement of organizations providing services; and subject to minimum necessary requirements or specified limited categories of information. A few states, such as Arizona, treat information generated in the context of in-patient mental health treatment the same as other health information. Information Maintained by Clinical Laboratories Clinical laboratories are subject to disclosure standards distinct from those that apply to other health care entities and, therefore, are discussed here separately. Laboratory testing in the United States is comprehensively regulated by the federal Clinical Laboratory Improvement Amendments (CLIA). Unlike HIPAA, which generally permits a covered entity to disclose health information to any other provider for treatment without patient permission, CLIA generally restricts the providers with whom a laboratory may share health information to those who are responsible for using the test, generally understood to include the provider who ordered the test, 10 and to persons authorized under state law to order tests or receive test results, or both. Thus, state law plays an important role in determining whether a clinical laboratory may disclose health information to another health care provider for treatment. Laws in only two states, the District of Columbia and New Hampshire, expressly require the patient s written permission for the release of test results to persons other than the ordering provider (see Tables A-6a, A-6b, and A-6c, ). Laws in 15 states permit clinical laboratories to disclose test results to providers in addition to the provider who requested the test. Ten restrict disclosure to providers authorized by law to use or employ the results, a matter which is generally determined by state health practitioner licensing laws. In addition, clinical laboratories are subject to laws that restrict the disclosure of specific health information including HIV- and genetics-related information (see Tables A-6c and A-6d). However, the 10 It is unclear who else, other than the provider who ordered the test, qualifies as an individual responsible for using the test results under CLIA. ES-9
15 Report on State Law Requirements for Patient Permission to Disclose Health Information general restrictions on clinical laboratories reporting test results appear to pose the most significant restriction on their ability to disclose health information to other providers for treatment. Overview by Health Care Entity To obtain a perspective of how health information may be shared by other specific entities (similar to that of clinical laboratories), we collated laws governing general clinical information, genetics-related information, and HIV-related information by entity across the states for the following categories of providers: hospitals, medical doctors, and pharmacists 11 (Tables A-7(a-c), A-8(a-c), and A-9(a-c), respectively). This view presents but a small snapshot of how information may be shared. Overall, several states permit these entities to disclose general clinical, genetics-related, and HIV-related information without patient permission for treatment. Some do so by expressly incorporating the standards of the HIPAA Privacy Rule. Others do so by having legal provisions that expressly provide that disclosures for treatment of the patient are permitted. Approximately half the states impose additional restrictions on the sharing of HIV-related information. Very few states generally require patient permission in all these instances (Guam, Minnesota, Puerto Rico, Vermont). It is important to note that this analysis is primarily based on the plain meaning of the statutes and regulations, which are often subject to various interpretations. In addition, even if a state law permits the disclosure of information without patient permission, professional ethics, judgment, or business choice often dictate other business practices. Synopsis Many of the state health information laws we reviewed may be organized into macro categories or approaches based on the need to obtain patient permission to disclose information. The most prevalent categories are: Based on HIPAA Privacy rule, either expressly or implicitly. No patient permission is required for disclosure for treatment of the patient who is the subject of the information. Patient permission is required to disclose health information for treatment purposes Only two states appear to generally require patient permission to disclose all types of health information. 11 We did not include substance abuse-related information in this analysis because federal law, 42 U.S.C. 290dd-2 and implementing regulations at 42 C.F.R. Part 2, require the patient s permission by federally-assisted substance abuse programs uniformly across the states. Moreover, information that is created by or originated in federally-assisted programs and disclosed pursuant to patient consent may not be redisclosed without patient permission. We also did not include information generated by mental health facilities, since the definition of these facilities varied greatly from state to state (whereas medical doctors, hospitals and pharmacists are defined in a fairly uniform fashion among the states)... ES-10
16 Executive Summary Most states permit disclosure of general health information for treatment without patient permission, either based on HIPAA or through independent statutory or regulatory provisions, but require patient permission to disclose information related to certain types of medical conditions, generally considered sensitive. No patient permission is required for disclosure for treatment of the patient under certain conditions. Some of the more common parameters include limitations on the amount or type of information to be disclosed (i.e., a minimum necessarytype standard); disclosure based on the occurrence of certain events (e.g., upon admission, transfer, or discharge of patient); additional time restrictions, such as only during the time the patient is being treated at the in-patient facility; the providers to whom information may be disclosed (either by type of provider or by formal relationship to each other); and subject to professional judgment. Implications and Conclusion Although state statutes and regulations governing the disclosure of health information for treatment vary widely in their details, they evince some broad common patterns or approaches toward disclosing health information to other providers for treatment purposes. These findings may be informative in assessing some of the means of harmonizing state health information privacy laws that have been proposed. A suggestion for harmonizing or simplifying state laws is one federal standard that would uniformly preempt state law. Some stakeholders have suggested that the HIPAA Privacy Rule should fill this role. Our findings indicate that adopting this approach would effectively eliminate many state laws that impose greater restrictions on the disclosure of health information for treatment purposes. The National Committee on Vital and Health Statistics has proposed that the federal government adopt a national policy to allow individuals to have limited control, uniformly, over the disclosure of certain designated categories of information. Our findings suggest that this approach aligns with some common state approaches, particularly with respect to the disclosure of sensitive health information. We note, however, that this approach would impede the ability of health care providers to disclose health information for treatment in states that permit such disclosure without patient permission. Absent a federal solution, states will need to determine a means for implementing their laws in an electronic environment. Some suggestions for state-based solutions to variable state law include developing a uniform or model act for health information disclosure, entering into interstate compacts, and developing a standardized rules structure for disclosure that could be used in an automated consent and disclosure management component of a health information exchange system. Given the wide variance in state approaches to disclosure of ES-11
17 Report on State Law Requirements for Patient Permission to Disclose Health Information health information, it seems that state approval of a uniform act is unlikely. Some of the other state-based proposals seem more viable because they account for some state variability. The broad categories of disclosure approaches we identified may serve as a starting point for developing options for a model act, the general parameters for developing interstate compacts, or the broad principles underlying standardized rule sets for automated rules engines. Regardless of the means adopted, whether it be a model act, interstate compact, or rules engine, implementation will require more objective standardized rules than current statutory or regulatory language, which is subject to varying interpretation. Detailed fixed rule sets that meet or exceed statutory or regulatory requirements for disclosure of health information will be required. Some of the parameters that we have identified may serve as a starting point for establishing such rules. ES-12
18 1. BACKGROUND AND PURPOSE In the first phase of this project, RTI International provided oversight to 33 states and 1 territory (collectively referred to as states or state teams) that conducted an assessment of variation in business practices, policies, and laws that might be perceived as barriers to electronic health information exchange, suggested possible solutions to these barriers, and prepared plans to implement these solutions. The state assessments were not intended to be a comprehensive legal analysis. Rather, the states focused on practices and laws that were implicated by a limited number of different scenarios, including treatment, regional health information exchanges, payment, research, and public health. The resulting Assessment of Variation and Analysis of Solutions report, an earlier product of this project, presented an overview of the major areas states identified as presenting challenges to the privacy and security of electronic health information exchange. State laws requiring patient permission to disclose health information, particularly with respect to disclosures for treatment, were consistently identified as potential impediments to such exchange. States expressed confusion about how to electronically implement permission requirements within their state. In addition, state teams expressed concern about the variability of permission requirements among the states. 1.1 Federal Law Overview HIPAA 12 The Privacy Rule, which was promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA Privacy Rule), establishes a floor of national standards protecting individuals identifiable health information. With the exception of psychotherapy notes, the HIPAA Privacy Rule affords all identifiable health information that is held by HIPAA covered entities the same degree of protection, and generally permits it to be used and disclosed for treatment (as well as payment and health care operations) without the patient s written permission (called consent) [see 45 C.F.R (c)]. 13 The HIPAA Privacy Rule does, however, permit covered entities to obtain consent if they choose to do so [45 C.F.R (b)]. Because the HIPAA Privacy Rule makes obtaining consent optional, it does not specify any content or format requirements for this type of permission. Rather, the procedure for obtaining consent to disclose health information for treatment, as 12 This overview of HIPAA focuses on the rules governing disclosures for treatment because this report addresses state requirements for disclosing information for this purpose. 13 The HIPAA Privacy Rule uses the term consent to refer to written permissions to use or disclose protected health information for treatment, payment, and health care operations, while the term authorization is used to refer to written permission to use or share health information for other purposes. An individual s authorization is generally required to use or disclose psychotherapy notes. See 45 C.F.R (a). 1-1
19 Report on State Law Requirements for Patient Permission to Disclose Health Information well as the content and format for such consents are wholly within the discretion of the covered entity. 14 The HIPAA Privacy Rule generally preempts provisions of state law that are contrary to its standards. A state law provision is considered contrary and, therefore, is generally preempted if either a covered entity would find it impossible to comply with both the state and federal requirements; or the provision of state law stands as an obstacle to the objectives of HIPAA [45 C.F.R ; ]. However, the HIPAA Privacy Rule does not preempt state law provisions about the privacy of individually identifiable health information that, while contrary to the HIPAA Privacy, are more stringent than it. With respect to a use or disclosure of health information, a state law is considered more stringent than the HIPAA Privacy Rule if it restricts a use or disclosure in circumstances under which the Privacy Rule would otherwise allow such disclosure (45 C.F.R ). Under this preemption framework, state laws that require the individual s permission to disclose identifiable health information for treatment remain in effect because a covered entity would not find it impossible to comply with both the HIPAA Privacy Rule and the state law and because the state law does not stand as an obstacle to the objectives of HIPAA Alcohol and Drug Abuse Confidentiality Requirements, 42 C.F.R. Part 2 In addition to the HIPAA Privacy Rule, other federal confidentiality law and implementing regulations apply to specific types of health information, In specific 42 C.F.R. Part 2 establishes detailed confidentiality requirements for patient records that are maintained in connection with application for or services provided by federally assisted programs that provide alcohol or drug abuse treatment, diagnosis, or referral for treatment (42 U.S.C. 290-dd2; 42 C.F.R. Part 2). These federal confidentiality requirements apply to alcohol and drug abuse treatment programs that receive federal assistance, a term which is broadly defined and includes, for example, not only programs that receive direct federal funding, but also those that receive tax exempt status from the Internal Revenue Service [see 42 C.F.R. 2.12(b)]. These regulations generally require the patient s permission for disclosure of information including for treatment (except in emergency circumstances) and prohibit a health care provider or plan that receives such information from redisclosing that information without patient permission. State law may not authorize or compel any disclosure prohibited by these federal regulations [42 C.F.R. 2.20]. 14 Unlike consents, authorizations must meet detailed content requirements to be valid under the HIPAA Privacy Rule. See 45 C.F.R (b)(c). 1-2
20 Section 1 Background and Purpose Clinical Laboratory Improvement Amendments (CLIA) Laboratory testing in the United States is comprehensively regulated by the federal Clinical Laboratory Improvement Amendments (CLIA). Unlike HIPAA, which generally permits a covered entity to disclose health information to any other provider for treatment without patient permission, CLIA generally restricts the providers with whom a laboratory may share health information. Specifically, with respect to disclosing the results of clinical laboratory tests CLIA provides: Test results must be released only to authorized persons and, if applicable, the individual responsible for using the test results and the laboratory that initially requested the test [42 C.F.R (f)]. The term authorized person is defined in CLIA as, [A]n individual authorized under State law to order tests or receive test results, or both (42 C.F.R ). The term individual responsible for using the test results is not defined in the CLIA regulations, and its meaning is uncertain. It is generally understood, however, to include the person who ordered the test. This regulatory scheme establishes the following general framework: Clinical laboratories may disclose test results to the health care provider who ordered the test under federal law. The extent to which another party may receive test results under federal law as an individual authorized to use the test is unclear. State law may also specify who is authorized to receive a clinical laboratory test result. 15 Thus, state law plays an important role in determining whether a clinical laboratory may disclose health information to another health care provider for treatment. 1.2 Project Purpose The purpose of this report is to build on state assessments provided in the first phase of this project and to provide a more detailed overview of state laws that govern the ability of health care providers to disclose health information to other providers for treatment purposes. The report identifies, collates, and summarizes key aspects of state laws governing the disclosure of health information for treatment purposes that apply to a defined group of health care providers. 15 The HIPAA Privacy Rule also applies to clinical laboratories. The HIPAA Privacy Rule permits, but does not require, covered entities, including health care providers such as clinical laboratories, to disclose to others protected health information for treatment, payment and health care operations without the consent of the patient. See 45 C.F.R (c). Because the HIPAA Privacy Rule does not require such disclosures, it does not conflict with more restrictive federal and state laws (i.e. a covered entity can comply with both HIPAA and the more restrictive law). As a consequence, the more restrictive provisions of CLIA and state laws regarding the disclosure of laboratory test results remain in effect. 1-3
December 20, 2007 Privacy and Security Solutions for Interoperable Health Information Exchange Impact Analysis Prepared for Jodi Daniel, JD, MPH, Director Steven Posnack, MHS, MS, Program Analyst Office
GAP ANALYSIS OF NEW YORK LAW AND RECOMMENDATIONS REGARDING IMPLEMENTATION OF ELECTRONIC HEALTH RECORDS IN HEALTH INFORMATION EXCHANGES HEALTH LAW COMMITTEE DECEMBER 2013 THE ASSOCIATION OF THE BAR OF THE