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⭐THE QUEST FOR INTEROPERABLE ELECTRONIC HEALTH RECORDS: A Guide to Legal Issues in Establishing Health Information Networks
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1 July 2005 MEMBER BRIEFING INTEROPERABLE ELECTRONIC HEALTH RECORDS TASK FORCE THE QUEST FOR INTEROPERABLE ELECTRONIC HEALTH RECORDS: A Guide to Legal Issues in Establishing Health Information Networks Editors:* Kristen Rosati, Esquire Coppersmith Gordon Schermer Owens & Nelson PLC Marilyn Lamar,Esquire McDermott Will & Emery LLP I. INTRODUCTION The purpose of this Briefing is to provide an overview of the myriad legal issues that may arise in planning, implementing, and operating interoperable electronic health records (EHRs) in Health Information Networks (HINs). 1 The editors hope that by identifying these legal issues, healthcare attorneys, industry leaders and the government can formulate solutions to reduce the legal risks that would otherwise present significant barriers to further adoption of EHRs and HINs. A. Background The increased use of information technology (IT) has been expected to reduce healthcare costs and improve the quality of patient care for more than a decade. For example, anticipated cost savings from information technology was a factor in federal efforts to impose uniformity in electronic transactions through the administrative simplification provisions of the Health Insurance Portability and Accountability Act of * The editors would like to thank the many AHLA members that contributed to this Briefing. The contributors and their roles are listed in the Introduction. 1 Health Information Networks (HINs) may be called by a variety of other terms, such as Regional Health Information Organizations (RHIOs) or Community Health Information Networks (CHINs). In this Briefing, we use the broader and more inclusive term HIN.2 1996 (HIPAA). Similarly, many people expect that the use of IT in patient care particularly by making electronic health records easily available to all healthcare providers also will reduce healthcare costs and improve the quality of care. Indeed, a few community-based HINs now serve as positive examples of how IT can be used to realize these benefits. Unfortunately, many segments of the healthcare industry directly involved with patient care lag far behind other industries in the use of IT. Some healthcare providers still use paper-based medical record storage and retrieval, communicate with labs and pharmacies by telephone or fax rather than , and do not use electronic systems to assist in clinical decision making. The lower level of IT being utilized in patient care adversely affects costs and the quality of care. Limited adoption of IT by providers may be due to aspects of healthcare that present unique challenges to the use of IT, including: the large number of physicians in solo or small group practices with very limited administrative support for IT and related practice changes; the lack of uniformity and interoperability of IT systems from different vendors; regulatory limitations on hospital funding of IT for physicians; antitrust and other legal concerns with respect to joint IT solutions; and privacy and security concerns. However, momentum appears to be building now for increased use of IT in healthcare with renewed focus from the federal government on the potential benefits and a growing number of community-based initiatives. B. Recent Federal Government Initiatives In April 2004, President Bush called for the widespread adoption of electronic medical records for most Americans within the next ten years Dr. David Brailer, MD, PhD, was then appointed to serve as the National Coordinator for Health Information Technology, a new position within the Department of Health and Human Services (DHHS). Dr. Brailer s office issued its Framework for Strategic Action in July 2004 (the Framework), which outlined four major goals: (1) to inform clinical practice with the use of EHRs; 23 (2) to interconnect clinicians so that they can exchange health information using advanced and secure electronic communications; (3) to personalize care with consumer-based health records and better information for consumers; and (4) to improve public health through advanced biosurveillance methods and streamlined collection of data for quality measurement and research. As a next step in this process, the Office of the National Coordinator for Health Information Technology (ONC or ONCHIT) issued a Request for Information (RFI) in November 2004 seeking information regarding the definition and structure of a National Health Information Network (NHIN), a proposed organization and business framework, the management and operation, standards and policies for interoperability, and financial, regulatory, and legal considerations. ONC reportedly received over 500 responses to the RFI, some of which have been published by the respondents. A summary published in June 2005 noted that the following concepts emerged from the majority of RFI respondents: A NHIN should be a decentralized architecture built using the Internet linked by uniform communications and a software framework of open standards and policies. A NHIN should reflect the interests of all stakeholders and be a joint public/private effort. A governance entity composed of public and private stakeholders should oversee the determination of standards and policies. A NHIN should be patient-centric with sufficient safeguards to protect the privacy of personal health information. Incentives will be needed to accelerate deployment and adoption of a NHIN. Existing technologies, federal leadership, prototype regional exchange efforts, and certification of EHRs will be the critical enablers of NHIN. Key challenges will be the need for additional and better-refined standards; addressing privacy concerns; paying for the development and operation of, and access to the NHIN; accurately matching patients; and addressing discordant state laws regarding health information exchange. 34 The Framework also called for a Health Information Technology Leadership Panel to be convened to examine the importance of investing in health information technology (HIT) and the roles of government and the private sector in its widespread implementation. The report issued by the HIT Leadership Panel on May 11, 2005 identified three key imperatives for HIT: (1) Widespread adoption of interoperable HIT as a top priority; (2) The federal government using its leverage as the nation s largest healthcare provider and payer to drive adoption of HIT; and (3) Collaboration by private sector purchasers and healthcare organizations with the federal government to drive adoption of HIT. Additional conclusions of the HIT Leadership Panel focused on a positive cost-benefit expectation regarding adoption, the need for a broad vision with a practical adoption strategy, and alignment of stakeholder incentives. Unlike some studies that have focused on physician adoption as a critical element, the HIT Leadership Panel concluded that consumers will be the key to adoption. It also noted that the federal government should provide leadership and that industry would follow. Fostering the wider adoption of HIT continues to attract a bipartisan following in Congress, with Representative Patrick Kennedy (D-R.I.) and Representative Tim Murphy (R-Pa.) sponsoring H.R. 2234, the 21st Century Health Information Act. Senator Hillary Rodham Clinton (D-N.Y.) and Senate majority leader Dr. Bill Frist (R- Tenn.) have also introduced HIT legislation in the Senate known as the Health Technology to Enhance Quality Act of 2005 (or the Health TEQ Act, S. 1262). C. Alternative Structures for Health Information Networks HINs have been identified by ONC as a favored approach to the initial goal of EHRs that would operate across a community or region. For purposes of this briefing, we will focus on three current approaches for a HIN: Pointer System in which the HIN identifies where a patient s information is located and makes it available to an authorized user. All participants in a HIN (hereinafter referred to as Participants) interact with each other to exchange information, although an intermediary may do some of the processing. 45 Data Warehouse-Silo System in which the HIN holds each participant s information in separate silos, but pulls information from applicable silos when information about a particular patient is requested. This is also referred to as a hub and spokes arrangement. Community Health Record System where the HIN combines information from different providers in a single record. These three approaches are represented graphically as follows: Pointer System Diagram courtesy of Jeffrey Short, Hall, Render, Killian, Heath & Lyman, P.S.C Retrieve Data Provider 1 Provider 2 Get Pointer HIN Retrieve Data Retrieve Data Provider 3 Provider 4 56 Data Warehouse-Silo System Diagram courtesy of Jeffrey Short, Hall, Render, Killian, Heath & Lyman, P.S.C Request Data Provider 1 HIN Dump Data Provider 3 Dump Data #1 #2 #3 #4 Provider 2 Dump Data Dump Data Provider 4 Community Health Record System Diagram courtesy of Jeffrey Short, Hall, Render, Killian, Heath & Lyman, P.S.C Request Data Provider 1 Provider 2 Dump Data HIN Dump Data Dump Data Dump Data Provider 3 Provider 4 In evaluating and structuring a HIN it may be helpful to analyze a client s needs in terms of these three forms of HINs, but variations on these models and entirely new approaches are likely to evolve over time. An ultimate goal of this process will be to link 67 the HINs on a nationwide basis, but this effort appears likely to occur only at a later stage of the overall initiative. Another significant aspect of structuring a HIN is the decision of whether to form a new legal entity to serve as the HIN or whether one or more of the entities that participate in a HIN would serve those functions. For example, each of the HIN arrangements described above could be comprised of local hospitals, physicians, and clinical laboratories that assign the HIN functions to one of the hospital participants pursuant to a contract. Alternatively, the parties could form a new legal entity (Newco) that would conduct the HIN functions pursuant to a contract between the Newco and the participants. Use of a Newco obviously will present additional issues regarding ownership, tax status, and regulatory compliance for the HIN and its participants but should not present insurmountable barriers if the participants select this approach. D. Overview of Legal Issues Numerous legal issues will need to be considered and addressed in structuring, implementing, and operating a HIN or other systems of interoperable EHRs. Issues arising in each of the following areas are discussed in more detail in the separate Chapters that follow: Privacy (Chapter 1) Security (Chapter 2) Stark and Anti-Kickback (Chapter 3) Non-Profit Tax (Chapter 4) Antitrust (Chapter 5) Intellectual Property (Chapter 6) Medical Malpractice and Other Potential Liability (Chapter 7) State Law Issues (Chapter 8) Although HINs and EHR arrangements will entail numerous agreements to delineate the scope of activities and satisfy HIPAA and other legal requirements, this Briefing does not propose model forms of these agreements because the overall arrangements are rapidly evolving and must meet the unique needs of the various communities they serve. This Briefing is not intended as a substitute for legal advice in 78 light of specific circumstances and after a review of the latest developments in each of these areas. E. Acknowledgments The editors would like to thank the numerous American Health Lawyers Association members who contributed to this Briefing. It is only with the assistance of dozens of members that AHLA is able to provide this Briefing to assist in analyzing and implementing new technologies that should be of great benefit to the healthcare system and to each of us as potential patients. Contributors to this Briefing include: Chapter 1: Privacy Alice J. Becker, PeaceHealth (Co-chair); Rebecca L. Williams, JD, RN, Davis Wright Tremaine LLP (Co-chair); Jana H. Aagaard, Law Office of Jana H. Aagaard; Sheryl Tater Dacso, JD, DrPH, Law Officers of Sheryl Tatar Dacso PLLC; William P. Dillon, McMorrow & Dillon PA; Alexander D. Eremia, MedStar Health; Cecelia A. Gassner, dba Lifetech Law Group; Kimberly S. Gray, Highmark Inc.; Kate Hickner-Cruz, Raymond & Prokop PC; Michael W. Hubbard, Smith Anderson Blout Dorsett Mitchell & Jernigan LLP; Keith A. Kelly, Ray Quinney & Nebeker PC; Sallie Hunt, West Virginia Health Care Authority; Kimiko L. Orosz, Bass Berry & Sims PLC; Abbie P. Maliniak, Fulbright & Jaworski LLP; Gail Ruffin-Cruz Jones, CIGNA HealthCare; Jim C. Pyles, Powers Pyles Sutter & Verville PC; Kristen B. Rosati, Coppersmith Gordon Schermer Owens & Nelson PLC; Cynthia Marcotte Stamer, Epstein Becker & Green PC; Beth L. Rubin, Dechert LLP; Claire Turcotte, Rosenn Jenkins & Greenwald LLP; Robert H. Schwartz, Raymond & Prokop PC; and Brian M. Wyatt, Hospital for Special Surgery. Chapter 2: Security Margaret Marchak, Raymond & Prokop PC (Chair); Jana Harder Aagaard, Law Office of Jana H. Aagaard; William P. Dillon, McMorrow & Dillon PA; Claudia Egan, von Briesen & Roper SC; Alexander D. Eremia, MedStar Health; Randy Gainer, Davis Wright Tremaine LLP; Cecelia A. Gassner, Lifetech Law Group; Pat King, Law Practice of Patricia D. King; Marilyn Lamar, McDermott, Will & Emery LLP; Beth L. Rubin, Dechert LLP; Claire Turcotte, Rosenn, Jenkins & Greenwald LLP; Cindy Wisner, Trinity Health; and Brian M. Wyatt, Hospital for Special Surgery. Chapter 3: Stark and Anti-Kickback Robert G. Homchick, Davis Wright Tremaine LLP (Chair), Laird A. Pisto, MultiCare Health System; Dan Brown, Greenberg Traurig LLP; Claudia Egan, von Briesen & Roper SC; Rob Falk, Powell Goldstein LLP; Beth Schermer, Coppersmith Gordon Schermer Owens & Nelson PLC; Jordana G. Schwartz, Sonnenschein Nath & Rosenthal LLP; and Claire Turcotte, Rosenn, Jenkins & Greenwald, LLP. 89 Chapter 4: Non-Profit Taxation Bernadette Broccolo, McDermott Will & Emery LLP (Chair); Gordon Apple, Law Offices of Gordon J. Apple PC; Charles M. Key, The Bogatin Law Firm PLC; Robert Q. Wilson, The Bogatin Law Firm PLC. Chapter 5: Antitrust Christine White, McDermott Will & Emery LLP (Chair). Chapter 6: Intellectual Property Virginia Holden, McDermott Will & Emery LLP (Chair); Jason A. Bernstein, Powell Goldstein LLP; Benjamin T. Butler, Crowell & Moring LLP; Heidi Echols, McDermott Will & Emery LLP; Donna Z. Eden; Cecelia A. Gassner, Lifetech Law Group; Marilyn Lamar, McDermott Will & Emery LLP; Patrick Richards, McDermott Will & Emery LLP; and Cynthia Wisner, Trinity Health. Chapter 7: Medical Malpractice and Other Potential Liability Edward Shay, Post & Schell PC (Chair); Jana Harder Aagaard, Law Office of Jana H. Aagaard; Kenneth C. Bartholomew, Rath Young & Pignatelli PA; Sarah E. Coyne, Quarles & Brady LLP; Sheryl Tater Dacso, Law Offices of Sheryl Tatar Dacso PLLC; John Humber, Radiology Clinic LLC; Charles Key, The Bogatin Law Firm PLC; Libby Lincoln, The MMIC Group; and Robert Q. Wilson, The Bogatin Law Firm PLC. Chapter 8: State Law Brian D. Gradle, Hogan & Hartson LLP (Chair); Nancy P. Gillette, Ohio State Medical Association; Rachel Glitz, Davis Wright Tremaine LLP; Barry S. Herrin, Smith Moore LLP; Pat King, Law Practice of Patricia D. King; and Kristen B. Rosati, Coppersmith Gordon Schermer Owens & Nelson PLC. 910 CHAPTER 1: PRIVACY Because an EHR system likely will not be successful if patients do not trust that their information will be held confidentially, adequate protection for the privacy of health information included in the system is an essential step in the development of HINs. As the Department of Health and Human Service (DHHS) concluded, the entire health delivery system is built upon the willingness of individuals to share the most intimate details of their lives with their health providers. 2 In enacting the Health Insurance Portability and Accountability Act (HIPAA), 3 Congress recognized that adequate protection of the privacy and security of health information is a sine qua non of the increased efficiency... brought about by the electronic revolution. 4 The protection of medical privacy is essential for access to effective, high quality healthcare. 5 The public perceives the increasing use of interconnected electronic information systems as one of the greatest threats to medical privacy. 6 Thus, rigorous privacy protection for the health information stored in an EHR system is essential to the long term success of this mission. In this Chapter, we describe legal issues relating to privacy, which we define as the right of patients to not have their information disclosed to unauthorized parties. These legal issues arise from a myriad of legal sources, including the HIPAA Privacy Rule, other federal privacy laws such as the federal Privacy Act 7 and the federal substance abuse treatment confidentiality regulations, 8 state laws for special classes of information (such as AIDS, mental health, substance abuse, genetic information, and developmental disabilities), 9 federal and state constitutional rights to privacy, 10 federal 2 65 Fed. Reg. 82,467 (Dec. 28, 2000). 3 Health Insurance Portability and Accountability Act of 1996, Pub. L. No (Aug. 21, 1996), 42 U.S.C. 201, et seq.; see also HIPAA Privacy Rule, 45 C.F.R. Part 160 and Part 164, Subpart E Fed. Reg. 82, Fed. Reg. 82,467; see also Jaffee v. Redmond, 116 S. Ct. 1923, 1928 (1996) Fed. Reg. 82, Privacy Act of 1974, Pub. L. No (1974), 5 U.S.C. 552a C.F.R. Part 2. 9 See, e.g., Arizona Revised Statutes et seq. (protecting mental health information). 10 See, e.g., Lawrence v. Texas, 539 U.S. 558, 123 S. Ct. 2472, 2478 (2003) (holding that, while the Constitution only protects citizens against violations of their rights by the government, encroachments by 1011 Medicare Conditions of Participation, 11 state provider licensure requirements, 12 and Joint Commission on Accreditation of Healthcare Organizations accreditation standards. 13 Counsel involved in establishing HINs should be familiar with this wide variety of privacy laws and how they affect health information, but due to space constraints this Chapter discusses only the application of the HIPAA Privacy Rule because all health plans and most healthcare providers in the United States must comply with this regulation. The particular legal issues relating to privacy protection will of course vary depending on how the interoperable EHR is organized. As explored in the Introduction, the legal structure for HINs can take a number of forms the Pointer/Locator System, Data Warehouse/Silo System, or Community Health Record System. Moreover, whether the HIN is formed by a web of contracts between the HIN Participants, or whether a separate legal entity is created to own and operate the HIN, will affect greatly how the HIPAA issues are addressed. Counsel thus must closely examine the HIN s structure and operations, its purposes, and the identity of the participants in the HIN (such as providers, plans, payors, government agencies, and patients) HIPAA Organizational Issues 1-1(a). HIN as a Covered Entity HIPAA applies only to covered entities, which are defined as: (i) health plans; (ii) healthcare providers that electronically conduct certain financial and administrative transactions for which standards have been adopted by the Secretary of DHHS under HIPAA; and (iii) healthcare clearinghouses. 14 Therefore, one of the key questions with private entities exercising governmentally-granted authority can be determined a violation of constitutional rights if that is the practical effect, purpose, or intent of a law); Ferguson v. City of Charleston, 532 U.S. 67, 78, 121 S. Ct. 1281, 1288 (2001) (holding that disclosures of patient health information for law enforcement purposes without a warrant or patient notice and consent violates the Fourth Amendment); Whalen v. Roe, 429 U.S. 589, 599, 97 S. Ct. 869, 876 (1977); Santa Fe Indep. School Dist., 530 U.S. 290, 309, 120 S. Ct. 2266, 2278 (2000); Gilmore v. City of Montgomery, 417 U.S. 556, 565, 94 S. Ct. 2416, 2422 (1974); Reitman v. Mulkey, 387 U.S. 369, 371, 87 S. Ct. 1627, 1629 (1967). 11 See, e.g., 42 C.F.R (medical records requirements for hospitals). 12 See, e.g., Pa. Stat (8). 13 See, e.g., Management of Information (IM) Standards, 2005 Hospital Accreditation Standards C.F.R12 respect to HIPAA compliance is whether the HIN itself is a covered entity, assuming it is a separate legal entity. We first note that under all three models discussed in this Briefing, a HIN could function entirely pursuant to contractual provisions among the participating organizations. Under this scenario, an additional legal entity would not exist that could be characterized as a covered entity for purposes of HIPAA. Instead, the analysis would focus on the obligations of the participating entities (the HIN Participants) to enter into agreements with the party that performs the HIN services as a business associate of the participating covered entities. Alternatively, if a separate legal entity performs the HIN functions under any of the approaches described in the Introduction, HIPAA compliance will require a review of whether the functions that the HIN entity performs would make it a covered entity for purposes of HIPAA. 15 In most cases the HIN functions would not, standing alone, satisfy two of the three HIPAA definitions of a covered entity. Specifically, such functions would not make the HIN entity a health plan (defined as an individual or group health plan that pays the cost of medical care) or a healthcare provider (defined as furnishing, billing, or being paid for health or medical services in the normal course of business). 16 However, an entity performing the HIN functions would be a covered entity with respect to those functions if it satisfied the following definition of a healthcare clearinghouse: a public or private entity, including a billing service, repricing company, community health management information system or community health information system, and value-added networks and switches, that does either of the following functions: (1) Processes or facilitates the processing of health information received from another entity in a nonstandard 15 CMS has provided a decision tool to assist in the analysis as to whether an entity is a covered entity for HIPAA purposes at C.F.R13 format or containing nonstandard data content into standard data elements or a standard transaction. (2) Receives a standard transaction from another entity and processes or facilitates the processing of health information [in the standard transaction] into nonstandard format or nonstandard data content for the receiving entity. 17 (Emphasis supplied.) For example, an entity providing HIN services in the Community Health Record System model might be taking information from providers and other sources and reformatting it in a manner that would involve the processing of nonstandard data into a standard format (or vice versa). Further, DHHS s inclusion of community health management information system and community health information system as examples in the definition could lend weight to the conclusion that a person or entity performing HIN functions in the Community Health Record System model might be considered a healthcare clearinghouse if the functions described above were performed or facilitated (b). HIN as a Business Associate As discussed above, an entity performing HIN services is unlikely to be a covered entity under HIPAA unless it functions as a healthcare clearinghouse. However, the HIN may be a business associate (BA) of the HIN Participants that are covered entities. 19 If the HIN is an independent legal entity that operates the EHR system, the HIN itself will be a HIPAA business associate of the HIN Participants who are covered entities. If the HIN is a contractual web, on the other hand, the HIN Participants should evaluate whether any of the Participants are providing a service to the others (such as housing the EHR or performing administrative services for the HIN 17 Id. 18 Although these terms were part of the original definition of healthcare clearinghouse in the November 3, 1999 Notice of Proposed Rulemaking for the Privacy Rule, DHHS has not explained their meaning in depth. See 64 Fed. Reg. at 59,227 and 59,930 (Nov. 3, 1999); 65 Fed. Reg. at 82,477 and 82,572 (Dec. 28, 2000) C.F.R (b)(1). Note the exceptions included in (b)(2) for transmissions of EPHI by a covered entity to a provider concerning treatment of an individual and by certain health plans and insurers to a plan sponsor if certain requirements are met. 1314 in which the entity has access to the other Participant s patient or member health information), and thus will meet the definition of a business associate of the other HIN Participants. Of course, the HIPAA Privacy Rule requires the covered entities each to have a contract in place with the business associate. 20 The HIPAA-required provisions for a business associate contract likely would best belong in the contract governing how the HIN will be operated, or that outlines the services to be provided by the HIN Participant/business associate. Because we assume the reader is familiar with the HIPAA-required provisions in a BA contract, we do not discuss them here. As a practical matter, one common contract should be used between the HIN and the HIN Participants, so that inconsistent obligations are not created between Participants. The contracts should address how the system will deal with BA violations of the HIPAA rules. If a covered entity knows of a pattern of activity or practice of the BA that constituted a material breach of the BA s contractual obligations, the covered entity must take steps to cure the breach or end the violation. If such steps are unsuccessful, the covered entity must terminate the contract or report the problem to the Secretary of DHHS. This possibility should be anticipated in advance to protect the HIN Participants from liability under HIPAA (c). Organized Healthcare Arrangements The HIN Participants should consider whether the HIN meets the requirements of an Organized Healthcare Arrangement (OHCA) under the HIPAA Privacy Rule. The Privacy Rule defines five different types of OHCAs. The OHCA definitions most likely to apply to a HIN include: (a) a clinically integrated care setting in which individuals typically receive care from more than one healthcare provider, or (b) an organized system of healthcare... in which the participating covered entities... hold themselves C.F.R (e); (E) C.F.R (a covered entity is liable under the federal common law of agency for the acts of a business associate, unless the covered entity complies with (b), (a)(1)(ii), (e), and (e)(1)(ii). 1415 out to the public as participating in a joint arrangement and participate in joint activities involving utilization review, quality assessment, or payment activities. 22 Unfortunately, there is little guidance regarding whether a HIN could qualify as an OHCA, such as whether the HIN Participants could be considered a clinically integrated care setting, or how much joint activity is needed to qualify as a jointarrangement OHCA. This may depend on the degree to which OHCA participants share a common patient population or provide services along a continuum of care to the community at large. It is noteworthy that DHHS has indicated that OHCAs may take different legal structures. 23 This suggests at least the possibility of some flexibility in legal structure for OHCAs. Nevertheless, this uncertainty and lack of clear guidance may present an obstacle to pursuing an OHCA-model HIN and cause HINs to pursue other models for compliance, such as having business associate agreements in place between the HIN and HIN Participants. If OHCA status is pursued, it will permit all OHCA/HIN Participants to use and disclose health information for the joint management and operations of the HIN, as well as for the already permissible joint treatment of patients and payment, all without patient authorization and without business associate agreements in place (subject to applicable state and other federal privacy laws). 24 Without OHCA status, covered entities may not use and disclose health information for the full range of healthcare operations of the HIN Participants without patient authorization. 25 OHCA status also may minimize the HIPAA compliance burden otherwise generally applicable to OHCA participants, such as allowing for a joint notice of privacy practices and avoiding the need for business associate agreements among the HIN Participants. Before establishing an OHCA, a HIN Participant should consider whether it may have potential liability for actions of other OHCA members, especially where the HIN C.F.R Fed. Reg. 82, C.F.R (c). 25 See 45 C.F.R (c) (limiting disclosures for other covered entities healthcare operations to where the recipient covered entity has or had a relationship with the patient, and where the healthcare operations are for fraud and abuse compliance, or fall within the first two paragraphs of the definition of healthcare operations); 45 C.F.R (defining healthcare operations). 1516 Participants holding themselves out as participating in a joint arrangement, and especially if the HIN does not already possess some degree of joint integration other than that envisioned by the HIN Uses and Disclosures of Health Information by the HIN 1-2(a). Use and Disclosure for Treatment, Payment, and Healthcare Operations The Privacy Rule permits uses and disclosures of protected health information (PHI) for treatment, payment, and healthcare operations (TPO) without patient authorization by the entity that cared for the patient. 26 It also permits disclosure to other entities for the treatment or payment activities. 27 However, a covered entity may disclose PHI for the healthcare operations of another entity only if that entity is a covered entity under HIPAA, the entity has or had a relationship with the patient, and the healthcare operations are for the purposes of fraud and abuse detection and compliance or those listed in the first two paragraphs of the definition of healthcare operations (including such activities as quality assurance, care coordination, peer review, training, accreditation, and licensure). 28 Alternatively, the Privacy Rule also permits the disclosure of PHI to participants in an organized healthcare arrangement, for any healthcare operations of the [OHCA]. 29 A HIN that limits uses and disclosures of health information by HIN Participants to treatment, payment, and the permitted healthcare operations reduces the risks of a privacy violation. Such limitations, however, may not be practical or preferable for certain HINs. The following sections discuss uses and disclosures beyond TPO that likely will be proposed for HINs. 1-2(b). Public Health Disclosures The federal government is looking to HINs as repositories of information to be mined for public health surveillance and research. How a HIN will respond to these government requests for information will be a challenge. Disclosure of health C.F.R ; 45 C.F.R (a); (c)(1) C.F.R (c)(2)-(3) C.F.R (c)(4); (defining healthcare operations) C.F.R (c)(5). 1617 information for public health purposes may be required or permissive under state or federal law. For example, with regard to public health reporting, certain HIN Participants may be required to report cancer cases to a state registry. On the other hand, reporting certain diagnoses for public health initiatives may be voluntary. Under HIPAA, HIN Participants may disclose health information to public health authorities as long as the disclosures are authorized or mandated by state or federal law. 30 The disclosure by or through a HIN of health information for public health purposes will depend on the structure and purposes of the HIN. HIN Participants will need to address which entity is required or authorized to make the disclosure. Questions to consider include: Should the HIN or the HIN Participants be permitted to disclose health information for public health purposes and, if so, in which circumstances? Does the HIN Participant that receives reportable information from or about an individual make the report, or will the HIN handle that reporting? If it is to be reported by the HIN, through what mechanism? Who is responsible to log the disclosure to include on an accounting to the individual? Who is responsible for any required follow-up contact with public health authorities? Should reportable information (such as information about communicable diseases) be available to all HIN Participants, or would this violate state confidentiality laws? Will the HIN permit a public health authority to have access to the HIN Participants records for public health activities? 1-2(c). Research Disclosures The federal government and other research proponents are calling for access to health information to accelerate the pace of clinical research toward cures for disease C.F.R (b). 31 For example, see Moving Medical Innovations Forward New Initiatives from HHS, available at see also the goals of the Office of the National Coordinator for Health Information Technology s Health Information Technology Strategic Framework, 1718 HINs have the potential to help meet this goal, because they will have control over a large number of medical records. Of course, in order to allow access to those records for research, the HIN Participants (or HIN on behalf of the Participants), must comply with the HIPAA Privacy Rule provisions on research, 32 the DHHS Common Rule, 33 and Food and Drug Administration (FDA) regulations on human subject research and using electronic records in submitting data to the FDA. 34 State laws may pose additional barriers to accessing EHR for research purposes. Questions to consider include: Who is responsible for confirming that an Institutional Review Board (IRB) has approved the research project and the appropriate HIPAA rule has been met before use or disclosure of any health information within or outside of the HIN for research purposes? Who may determine whether a research sponsor may have access to identifiable patient health information? Can mechanisms be created to limit use and disclosure to only the health information pertinent to the clinical trial or other research project? Who is responsible for accounting for disclosures if authorizations are waived for use or disclosure of the health information for the research? Who will be responsible for determining what other privacy laws may apply to the research (such as state genetic testing laws), which may prevent the access for research? If the FDA, a pharmaceutical company, or medical device manufacturer is investigating an adverse event linked to a clinical trial, how will HIN Participants determine the appropriate disclosure of health information that is held by the HIN? available at In addition, FasterCures.org, an organization devoted to accelerating medical research, advocates the creation of new medical records and biospecimens databases. See C.F.R (i) C.F.R. Part C.F.R. Parts 11, 50 and 56. For a recent discussion of the FDA regulations on electronic records submission to the FDA, see Neil F. O Flaherty and Pamela J. Furman, FDA Considerations Related to Maintaining Clinical Trial Records in Electronic Form, Health Lawyers News (December 2004). 1819 1-2(d). Law Enforcement Disclosures HIN Participants should define the process by which a HIN may disclose health information to law enforcement agencies, or by which the HIN Participants may disclose health information that originates in a different HIN Participant. For example: If one participant is served with a compulsory disclosure request, such as a grand jury subpoena or a search warrant, may a HIN Participant or the HIN disclose health information to law enforcement beyond health information that originated with that HIN Participant? If so, what type of notice, if any, must the HIN Participant provide to the other HIN Participants before the disclosure? How will the HIN Participants apportion liability if a HIN Participant improperly releases health information to law enforcement agencies? If the HIN has HIN Participants in multiple states, who will be responsible for determining compliance with the different state laws regarding disclosures to law enforcement, which vary widely? Who will be responsible for any accountings of disclosures? 1-2(e). Fundraising Disclosures The HIPAA Privacy Rule strictly limits the elements of health information that may be used or disclosed for fundraising purposes, and state laws also may apply to these disclosures. The Privacy Rule permits a covered entity to disclose only patient names and other demographics and dates of healthcare to an institutionally-related foundation or a business associate, but that information may be used only for the fundraising of the disclosing covered entity. 35 Therefore, the HIN must limit HIN Participants access to other Participants health information in accordance with these rules, and must establish rules for which entity will monitor which patients have opted-out of receiving fundraising requests. 1-2(f). Marketing Disclosures The Privacy Rule s provisions on marketing are even more restrictive, 36 and some state laws prohibit marketing with patient health information entirely. 37 Indeed, C.F.R (f) C.F.R (a)(3). 1920 there is real potential for liability for violating the marketing rules, as privacy advocacy groups have argued that misuse of health information for marketing purposes are egregious violations of patient privacy, in part because misuse is alleged to be motivated by financial gain. 38 As a result, a HIN will need to consider carefully at the time of its formation whether it will allow disclosures for marketing purposes, and if so, to what extent. Allowing marketing disclosures may be particularly difficult in HINs that include a large number and wide variety of HIN Participants (particularly where the HIN Participants hail from different states), or where patient authorization is logistically difficult to obtain (such as in a Community Health Record type of HIN). 1-2(g). Compliance with State Laws There are many state laws that limit the ability to use and disclose health information. In particular, laws that protect highly sensitive information, such as those regarding HIV/AIDS, mental health, substance abuse treatment, developmental disability, and genetic testing, operate on the fundamental premise that the use and disclosure of this sensitive health information is prohibited unless specifically permitted by the law. Violations of such laws may subject the offender to criminal or civil sanctions or to disciplinary action by state licensing authorities. A HIN should consider carefully how this sensitive health information will be included in the system: Will this sensitive information be integrated in the EHR and fully available to all HIN Participants? If so, how will the HIN Participants be protected against others misuse of this information? Will this sensitive information be segregated into an electronic lock-box that requires special access rights? Does segregating this health information and thus making it less accessible to care providers, pose a risk to patients by depriving potential care givers of complete information? If the HIN includes providers or plans from more than one state, how will the HIN structure accommodate differing state laws on the protection of this sensitive information? 37 Confidentiality of Medical Information Act, Civil Code (restrictions on marketing). 38 See, e.g., the medical information used for marketing stories collected by the Health Privacy Project, available at: 20 View more
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