For the Record Protecting Electronic Health Information

Committee on Maintaining Privacy and Security in Health Care Applications of the National Information Infrastructure

Computer Science and Telecommunications Board

Commission on Physical Sciences, Mathematics, and Applications

National Research Council

NATIONAL ACADEMY PRESS
Washington, D.C.
1997



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--> For the Record Protecting Electronic Health Information Committee on Maintaining Privacy and Security in Health Care Applications of the National Information Infrastructure Computer Science and Telecommunications Board Commission on Physical Sciences, Mathematics, and Applications National Research Council NATIONAL ACADEMY PRESS Washington, D.C. 1997

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--> NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. Support for this project was provided by the National Library of Medicine and the Warren Grant Magnuson Clinical Center of the National Institutes of Health and by the Massachusetts Health Data Consortium. Any opinions, findings, conclusions, or recommendations expressed in this material are those of the authors and do not necessarily reflect the views of the sponsors. Library of Congress Catalog Card Number 97-65240 International Standard Book Number 0-309-05697-7 Additional copies of this report are available from: National Academy Press 2101 Constitution Avenue, NW Box 285 Washington, DC 20055 800/624-6242 202/334-3313 (in the Washington Metropolitan Area) http://www.nap.edu Copyright 1997 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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--> Committee On Maintaining Privacy And Security In Health Care Applications Of The National Information Infrastructure PAUL D. CLAYTON, Columbia-Presbyterian Medical Center, Chair W. EARL BOEBERT, Sandia National Laboratories GORDON H. DeFRIESE, University of North Carolina at Chapel Hill SUSAN P. DOWELL, Medicus Systems Corporation MARY L. FENNELL, Brown University KATHLEEN A. FRAWLEY, American Health Information Management Association JOHN GLASER, Partners Healthcare System RICHARD A. KEMMERER, University of California at Santa Barbara CARL E. LANDWEHR, U.S. Naval Research Laboratory THOMAS C. RINDFLEISCH, Stanford University SHEILA A. RYAN, University of Rochester BRUCE J. SAMS, JR., Permanente Medical Group (retired) PETER SZOLOVITS, Massachusetts Institute of Technology ROBBIE G. TRUSSELL, Presbyterian Healthcare System, Dallas ELIZABETH WARD, Washington State Department of Health Special Advisor PAUL M. SCHWARTZ, University of Arkansas Staff JERRY R. SHEEHAN, Study Director and Program Officer HERBERT S. LIN, Senior Staff Officer LESLIE M. WADE, Research Assistant MOLLA S. DONALDSON, Staff Liaison, Institute of Medicine

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--> Computer Science And Telecommunications Board DAVID D. CLARK, Massachusetts Institute of Technology, Chair FRANCES E. ALLEN, IBM T.J. Watson Research Center JEFF DOZIER, University of California at Santa Barbara SUSAN L. GRAHAM, University of California at Berkeley JAMES GRAY, Microsoft Corporation BARBARA J. GROSZ, Harvard University PATRICK HANRAHAN, Stanford University JUDITH HEMPEL, University of California at San Francisco DEBORAH A. JOSEPH, University of Wisconsin BUTLER W. LAMPSON, Microsoft Corporation EDWARD D. LAZOWSKA, University of Washington BARBARA H. LISKOV, Massachusetts Institute of Technology JOHN MAJOR, Motorola Inc. ROBERT L. MARTIN, Lucent Technologies Inc. DAVID G. MESSERSCHMITT, University of California at Berkeley CHARLES L. SEITZ, Myricom Inc. DONALD SIMBORG, Know Med Systems Inc. LESLIE L. VADASZ, Intel Corporation MARJORY S. BLUMENTHAL, Director HERBERT S. LIN, Senior Staff Officer PAUL D. SEMENZA, Program Officer JERRY R. SHEEHAN, Program Officer LESLIE M. WADE, Research Assistant JULIE C. LEE, Administrative Assistant LISA L. SHUM, Project Assistant

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--> Commission On Physical Sciences, Mathematics, And Applications ROBERT J. HERMANN, United Technologies Corporation, Cochair W. CARL LINEBERGER, University of Colorado, Cochair PETER M. BANKS, Environmental Research Institute of Michigan LAWRENCE D. BROWN, University of Pennsylvania RONALD G. DOUGLAS, Texas A&M University JOHN E. ESTES, University of California at Santa Barbara L. LOUIS HEGEDUS, Elf Atochem North America Inc. JOHN E. HOPCROFT, Cornell University RHONDA J. HUGHES, Bryn Mawr College SHIRLEY A. JACKSON, U.S. Nuclear Regulatory Commission KENNETH H. KELLER, University of Minnesota KENNETH I. KELLERMANN, National Radio Astronomy Observatory MARGARET G. KIVELSON, University of California at Los Angeles DANIEL KLEPPNER, Massachusetts Institute of Technology JOHN KREICK, Sanders, a Lockheed Martin Company MARSHA I. LESTER, University of Pennsylvania THOMAS A. PRINCE, California Institute of Technology NICHOLAS P. SAMIOS, Brookhaven National Laboratory L.E. SCRIVEN, University of Minnesota SHMUEL WINOGRAD, IBM T.J. Watson Research Center CHARLES A. ZRAKET, MITRE Corporation (retired) NORMAN METZGER, Executive Director

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--> The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce Alberts is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. William A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

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--> Preface In response to a request from the National Library of Medicine (NLM), and with support from the Warren Grant Magnuson Clinical Center of the National Institutes of Health and from the Massachusetts Health Data Consortium, the Computer Science and Telecommunications Board (CSTB) initiated a study in October 1995 on maintaining privacy and security in health care applications of the national information infrastructure (NII). As one of the lead agencies within the executive branch for facilitating the development and expansion of health care applications of the NII, NLM identified privacy and security as primary issues that need to be addressed in order to facilitate greater use of information technology within the health care sector.1 Several reports written over the last two decades note the potential vulnerabilities of health information systems and the potential risks to patient privacy that could result from the 1   The terms privacy, confidentiality, and security are used in many different ways to discuss the protection of personal health information. This report uses the term privacy to refer to an individual's desire to limit the disclosure of personal information. It uses the term confidentiality to refer to a condition in which information is shared or released in a controlled manner. Organizations develop confidentiality policies to codify their rules for controlling the release of personal information in an effort to protect patient privacy. Security consists of a number of measures that organizations implement to protect information and systems. It includes efforts not only to maintain the confidentiality of information, but also to ensure the integrity and availability of that information and the information systems used to access it.

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--> unauthorized use of health data.2 Although they outline risks and discuss possible corrective measures, these earlier reports do not attempt to evaluate the effectiveness of alternative mechanisms for protecting electronic health information. To remedy this situation, CSTB was asked to investigate the threats to electronic health information and to evaluate alternative technical and nontechnical means of protecting health information that are being used today. A natural outgrowth of this assessment is a judgment about the technical and nontechnical means that can be used to maintain privacy and security in health care information systems, about future research that is needed to develop additional mechanisms, and about the obstacles that stand in the way of future advances. The Committee And Its Charge To conduct this study, CSTB formed a committee of 15 members and a special advisor with expertise in computer and information security, medical informatics, health information management, health care privacy, law, medical sociology, and health information systems. Both developers and users of health information systems were included. NLM charged the committee to do the following: Observe and assess existing technical and nontechnical mechanisms for protecting the privacy and maintaining the security of health care information systems, identify other mechanisms worthy of testing in a health care environment, and outline promising areas for further research. In carrying out this charge, the committee was asked to address questions in the following areas: Threats to health care information: What problems have health care organizations encountered to date regarding unauthorized access to individually identified patient data? To what extent has the security of health information systems been compromised or threatened by the introduction of electronic medical records and networked information systems? What problems could be encountered in the future related to unauthorized access to individually identifiable patient data? How sig- 2   See National Institute of Standards and Technology, 1994, Putting the Information Infrastructure to Work: Report of the Information Infrastructure Task Force Committee on Applications and Technology, NIST Special Publication 857, U.S. Government Printing Office, Washington, D.C., May; Institute of Medicine, 1994, Health Data in the Information Age: Use, Disclosure and Privacy, Molla S. Donaldson and Kathleen N. Lohr (eds.), National Academy Press, Washington, D.C.; Office of Technology Assessment, 1993, Protecting Privacy in Computerized Medical Information, OTA-TCT-576, U.S. Government Printing Office, Washington, D.C., September; National Research Council, 1972, Databanks in a Free Society: Computers, Record Keeping, and Privacy, National Academy of Sciences, Washington, D.C.

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--> nificant is the threat posed by inferential identification through the linking of databases with unidentifiable information? Adequacy of existing privacy and security measures: What types of policies are in place to provide privacy, security, and confidentiality? How adequate are these policies in practice? What technical features are incorporated into health information systems to provide security? How effective are they? What has been done to educate users about the need for privacy and security and their responsibilities for protecting health information? Future mechanisms and best practices: What other approaches to information privacy and security are worthy of testing in health care organizations? What approaches should be broadly promulgated? How cost-effective are various approaches? What combination of technologies, policies, and standards would help to promote better information security for health-related data? How can highly sensitive aspects of an individual's health care records (e.g., mental health history and HIV status) be better protected? Barriers to adoption: What barriers exist to the adoption of better information security practices and technology (e.g., cost, ease of use)? What incentives are needed to encourage providers to adopt sound information privacy and security practices and to secure health information systems? Although the focus of the committee's charge was to evaluate practices that individual organizations can use to better protect electronic health information, the committee quickly learned from its research that the primary threats to patient privacy originate from the lack of controls over the legal (and generally legitimate) demands for data made by organizations not directly involved in the provision of care, such as managed care organizations, insurers, public health agencies, and self-insured employers. The committee regarded this larger threat as significant enough to warrant systematic attention. Given the committee's original charge and its composition, however, this report does not make specific recommendations in this area, although it does call for a national debate on these issues.3 Accordingly, this report undertakes the tasks of raising consciousness in the health care industry (and the nation as a whole) regarding privacy and security issues in health care; demonstrating ways in which these issues can be addressed; and providing practical guidance to practitioners in the field of medical informatics and health information management who must continually wrestle with privacy and security concerns. 3   Another study committee convened by the Institute of Medicine was charged to investigate systemic uses of health information and to offer recommendations in this area. See Institute of Medicine. 1994. Health Data in the Information Age: Use, Disclosure, and Privacy, National Academy Press, Washington, D.C.

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--> Recognizing that organizations strive to balance security against other concerns such as cost and access to information, the committee investigated both the efficacy of various privacy and security measures and the implications of such measures for the ability of users to access critical information in a timely manner. In order that its work would have lasting value to the community, the committee attempted, where possible, to project future changes in the uses of health information, the potential threats to such information, and the technologies capable of addressing these threats. Methodology The committee's primary mechanism for gathering information about technical and nontechnical approaches to protecting electronic health information consisted of a series of site visits to six organizations that collect, process, and store electronic health information. Sites were selected on the basis of their reputed leadership in the development of electronic medical records, networked clinical systems, and privacy and security policies. Committee nominations were verified against reports or rankings in several highly regarded health care publications. The selected sites included a large, urban hospital; a tightly integrated health care system; a second tightly integrated health care system affiliated with a community health information network; a more loosely affiliated provider network; a state health care system; and a large insurer. To encourage personnel at the various sites to share their experiences candidly, the committee decided to keep sites' identities confidential. Because site visits were conducted by different subsets of the committee's members, the committee as a whole developed a standard site visit protocol to ensure some degree of uniformity among the visits (see Appendix A). Prior to each visit, the site visit team gathered information from the site regarding its organizational structure, computer and data security policies, information systems, security mechanisms, confidentiality policies, procedures for releasing medical records, employee training and orientation materials, and disciplinary policies. This information proved valuable not only in orienting committee members to idiosyncrasies of each site, but also in indicating the degree to which the organizations had codified their policies and procedures. During each one-and-a-half-day visit, the site visit team met with corporate executives; staff from the information systems, health information management (i.e., medical records), human resources, and legal departments; doctors; nurses; and other system users. Where possible, it met with members of health information management committees and of privacy and confidentiality committees. The site visit team discussed a

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--> wide range of topics with its hosts on each visit: confidentiality policies, policies regarding data exchanges and uses or releases of aggregated data, means of implementing policies, perceived and experienced threats to patient privacy and system security, training and education programs, information systems, electronic medical records, security mechanisms, users' perceptions of the information systems and security practices, and future needs. In addition to its site visits, the full committee met five times during the course of the study to plan its work, listen to briefings from relevant stakeholders, and deliberate over its conclusions and recommendations. During these sessions, the committee met with health care providers, insurers, pharmaceutical benefits managers,4 vendors of health information systems, experts in computer security (from both the health care and the non-health care communities), privacy advocates and consumer representatives, federal agencies interested in health information systems, insurers, relevant industry associations, and other organizations that maintain health-related databases. The committee also met with groups attempting to develop health care applications of the NII and with researchers who study the uses of medical information, including genetic information. Additional meetings were held with the Massachusetts Health Data Consortium and with representatives of European data commissions to understand the problems they face and the solutions they are implementing (see Appendix B for a complete list of people who briefed the committee). The site visits and committee meetings provided committee members with numerous opportunities to observe and discuss the confidentiality and security policies, mechanisms, and practices used in a variety of health care organizations and firms in other industries. The visits themselves facilitated extended dialogue with key decision makers within the organizations, allowing the committee to better understand the objectives and motivations of the sites' privacy and security strategies. Many of the practices the committee observed during its site visits were described in its interim report released in September 1996.5 This final report provides additional analysis of practices observed during the site visits and describes other practices that have not yet been applied in health care set- 4   Pharmaceutical benefits managers are organizations such as Merck-Medco Managed Care Inc. and PCS Inc. that offer benefits plans that pay for prescriptions. They typically assist in designing the benefits programs, offer point-of-sale claims processing, and develop formularies of the drugs that participating pharmacies prescribe. 5   Computer Science and Telecommunications Board, National Research Council. 1996. ''Observed Practices for Improving the Security and Confidentiality of Electronic Health Information: Interim Report," National Academy Press, Washington, D.C., September.

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--> tings; describes the general exchanges of health information throughout the industry and identifies obstacles to and incentives for increased attention to privacy and security concerns; and presents the committee's conclusions and recommendations on the state of practice today, on practices that should be more widely adopted throughout the industry, and on research needs for the future. The committee recognizes that this report will serve multiple audiences: information systems and operations staffs within medical organizations who are charged with developing and implementing practices to improve privacy and security, government agencies and accrediting bodies with roles to play in overseeing health care organizations and other users of health information, and legislators and other policy makers who are interested in establishing a policy framework for protecting health information while allowing legitimate access. The committee hopes that each of these audiences will find useful guidance in this report, both in the detailed practices described in Chapters 4 and 5, and in the findings and recommendations contained in Chapter 6. Acknowledgments The committee members that came together represented a number of different backgrounds and perspectives (Appendix E). The harmony with which people with such diverse points of view worked together is testament to the character of the individual committee members and a reflection upon the importance of the issue this report addresses. Each committee member volunteered a substantial amount of time over the course of the study to meet, conduct site visits, and draft sections of this report. To the extent that this report improves the privacy and security environment by enlightening the public, policy makers who set institutional priorities, daily users of health information, and those who build the systems, the committee members will believe that their effort was worthwhile. To the CSTB staff, the committee expresses its admiration and gratitude for their faithful capture of the wide-ranging content of its deliberations and for the gentle but effective way they kept things on schedule. It is hard to find people of such talent who are willing to facilitate and support rather than impose their observations and conclusions. Thanks are also extended to those who volunteered to review and critique an early draft of this document, as well as to the numerous briefers who volunteered their time to meet with it and to help the committee better understand their concerns. The committee also owes many thanks to those who hosted the site visits. The committee received honest and open cooperation from a variety of individuals at each site. Finally, the committee wishes to express appreciation to the sponsors

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--> of this report who were willing to invest in developing solutions to societal concerns: Dr. Donald Lindberg and Ms. Betsy Humphreys of the National Library of Medicine; Dr. John Gallin of the Warren Grant Magnuson Clinical Center; and Mr. Elliot Stone of the Massachusetts Health Data Consortium. Such leadership is crucial in motivating more than a fragmented approach to the search for solutions.

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--> Contents     Executive Summary   1 1   Introduction   19     The Growing Use of Information Technology in Health Care   20     Changes in the Health Care Delivery System   21     Integrated Delivery Systems   22     Managed Care   22     New Users of Health Information   24     The Electronic Medical Record   25     Content of Electronic Medical Records   25     Advantages of Electronic Medical Records   26     Protecting the Privacy and Security of Health Information   26     Privacy and Security Concerns   27     Addressing Privacy and Security Concerns   29     Goals and Limitations of This Report   33     Objectives   33     What This Report Does Not Do   34     Organization of This Report   35 2   The Public Policy Context   37     Federal and State Protections   39     Federal Statutes and Regulations   40     Limitations of Federal Protections   42

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-->     State Statutes and Regulations   44     Limitations of State Protections   45     Nongovernmental Initiatives   47     American National Standards Institute   47     Computer-based Patient Record Institute   48     Joint Commission on Accreditation of Healthcare Organizations   48     Improving Public Policy   49     Building National Consensus   50     Legislative Initiatives   52 3   Privacy and Security Concerns Regarding Electronic Health Information   54     Concerns Regarding Health Information Held by Individual Organizations   54     Scale of the Threat to Health Information Held by Individual Organizations   55     General Taxonomy of Organizational Threats   56     Factors Accounting for Differences Among Threats   56     Levels of Threat to Information in Health Care Organizations   59     Countering Organizational Threats   61     Developing Appropriate Countermeasures   61     Observations on Countering Organizational Threats   64     Systemic Concerns About Health Information   65     Uses and Flows of Health Information   65     Alice's Medical Records   69     Government Collection of Health Data   72     Risks Created by Systemic Flows of Health Information   74     Universal Patient Identifiers   78     Conclusions Regarding Systemic Concerns   80 4   Technical Approaches to Protecting Electronic Health Information   82     Observed Technological Practices at Studied Sites   84     Authentication   86     Authentication Technologies Observed on Site Visits   88     Authentication Technologies Not Yet Deployed in Health Care Settings   89     Access Controls   93     Access Control Technologies Observed on Site Visits   94     Access Control Technologies Not Yet Deployed in Health Care Settings   96

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-->     Audit Trails   97     Audit Trail Technologies Observed on Site Visits   98     Audit Trail Technologies Not Yet Deployed in Health Care Settings   98     Physical Security of Communications, Computer, and Display Systems   99     Control of External Communication Links and Access   102     Network Control Technologies Observed on Site Visits   104     Network Control Technologies Not Yet Deployed in Health Care Settings   104     Encryption,   106     Software Discipline   108     Software Control Technologies Observed on Site Visits   110     Software Control Technologies Not Yet Deployed in Health Care Settings   110     System Backup and Disaster Recovery Procedures   111     System Backup Procedures Observed on Site Visits   111     System Backup Procedures Not Yet Deployed in Health Care Settings   112     System Self-Assessment and Attention to Technological Awareness   112     Site Visit Summary   114     Key Issues in Using Technology to Protect Health Information   117     Patient Identifiers and Techniques for Linking Records   117     Control of Secondary Users of Health Care Information   120     Obstacles to Use of Security Technology   122     Difficulty of Building Useful Electronic Medical Records   122     Lack of Market Demand for Security Technology   123     Organizational Systems Accumulate-They Are Not Designed   123     Cryptography-based Tools Are Still Out of Reach   124     Effective Public-key Management Infrastructures Are Essential but Still Nonexistent   124     Helpful Technologies Are Hard to Buy and Use   125     Education and Demystifying Issues of Distributed Computing and Security   125 5   Organizational Approaches to Protecting Electronic Health Information   127     Formal Policies   128     Policies Regarding Information Uses and Flows   129     Security Policies   129     Confidentiality Policies   130

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-->     Policies to Protect Sensitive Information   131     Policies on Research Uses of Health Information   134     Policies Guiding Release of Information   135     Patient-centered Policies   136     Patient Bill of Rights   136     Authorization Forms   136     Access to Records and Audit Logs   137     Organizational Structures   138     Policy Development Process   138     Structures for Implementing Policy   139     Structures for Granting Access Privileges   140     Education and Training   142     Training Programs   143     Nonformal Training   144     Educational Tools   145     User Confidentiality Agreements   149     Sanctions for Breaches of Confidentiality   149     Improving Organizational Management: Closing the Gap Between Theory and Practice   153     Implementing an Integrated Security and Confidentiality Management Model   154     Overcoming Obstacles to Effective Organizational Practices   155     Lack of Public or External Incentives   155     Resource Constraints   156     Competing Demands   156     Lack of Focus on Information Technology   157     Cultural Constraints   158 6   Findings and Recommendations   160     Findings and Conclusions   161     Recommendations   167     Improving Privacy and Security Practices   167     Technical Practices and Procedures for Immediate Implementation   169     Organizational Practices for Immediate Implementation   173     Security Practices for Future Implementation   175     Creating an Industry-wide Security Infrastructure   177     Addressing Systemic Issues Related to Privacy and Security   180     Developing Patient Identifiers   185     Meeting Future Technological Needs   189     Technologies Relevant to the Computer Security Community as a Whole   191     Technologies Specific to Health Care   192

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-->     Testbeds for Privacy and Security   193     Concluding Remarks   194     Bibliography   197     Appendixes         AStudy Committee's Site Visit Guide   211     BIndividuals Who Briefed the Study Committee   221     CNational Library of Medicine Awards to Develop Health Care Applications of the National Information Infrastructure   222     DSections of the Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191) Related to the Privacy and Security of Electronic Health Information   233     ECommittee Biographies   247     Index   255

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--> Whoever you are— I have always depended on the kindness of strangers. Blanche, in A Streetcar Named Desire Tennessee Williams

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