THE MEDICAL INFORMATION PROTECTION AND RESEARCH ENHANCEMENT ACT OF 1999 HEARING BEFORE THE SUBCOMMITTEE ON HEALTH AND ENVIRONMENT OF THE COMMITTEE ON COMMERCE HOUSE OF REPRESENTATIVES ONE HUNDRED SKTH CONGRESS FIRST SESSION JULY 15, 1999 Serial No. 106-53 Printed for the use of the Committee on Commerce U.S. GOVERNMENT PRINTING OFFICE 58-501CC WASHINGTON 1999 : ForsalebytheU.S.GovernmentPrintingOrUce SuperintendentofDocuments,CongressionalSalesOffice.Washington.DC 2(U()2 ISBN 0-16-059576-2 COMMITTEE ON COMMERCE TOM BLILEY, Virginia, Chairman W.J. "BILLY" TAUZIN, Louisiana JOHN D. DINGELL, Michigan MICHAEL G. OXLEY, Ohio HENRYA. WAXMAN, CaUfomia MICHAEL BILIRAKIS, Florida EDWARD J. MARKEY, Massachusetts JOE BARTON, Texas RALPH M. HALL, Texas FRED UPTON, Michigan RICK BOUCHER, Virginia CLIFF STEARNS, Florida EDOLPHUS TOWNS, New York PAUL E. GILLMOR, Ohio FRANK PALLONE, Jr., New Jersey Vice Chairman SHERROD BROWN, Ohio JAMES C. GREENWOOD, Pennsylvania BART GORDON, Tennessee CHRISTOPHER COX, CaUfomia PETER DEUTSCH, Florida NATHAN DEAL, Georgia BOBBY L. RUSH, lUinois STEVE LARGENT, Oklahoma ANNA G. ESHOO, CaUfomia RICHARD BURR, North CaroUna RON KLINK, Pennsylvania BRIAN P. BILBRAY, CaUfomia BART STUPAK, Michigan ED WHITFIELD, Kentucky ELIOT L. ENGEL, New York GREG GANSKE, Iowa THOMAS C. SAWYER, Ohio CHARLIE NORWOOD, Georgia ALBERT R. WYNN, l^laryland TOM A. COBURN, Oklahoma GENE GREEN, Texas RICK LAZIO, New York KAREN MCCARTHY, Missouri BARBARA CUBIN, Wyoming TED STRICKLAND, Ohio JAMES E. ROGAN, California DLySTA DeGETTE, Colorado JOHN SHIMKUS, Illinois THOMAS M. BARRETT, Wisconsin HEATHER WILSON, New Mexico BILL LUTHER, Minnesota JOHN B. SHADEGG, Arizona LOIS CAPPS, CaUfomia CHARLES W. "CHIF' PICKERING, Mississippi VITO FOSSELLA, New York ROY BLUNT, Missouri ED BRYANT, Tennessee ROBERT L. EHRLICH, Jr., Maryland James E. Derderian, ChiefofStaff James D. Barnette, General Counsel Reid P.F. Stuntz, Minority StaffDirector and ChiefCounsel Subcommittee on Health and Environment MICHAEL BILIRAKIS, Florida, Chairman FRED UPTON, Michigan SHERROD BROWN, Ohio CLIFF STEARNS, Florida HENRY A. WAXMAN, CaUfomia JAMES C. GREENWOOD, Pennsylvania FRANK PALLONE, Jr., New Jersey NATHAN DEAL, Georgia PETER DEUTSCH, Florida RICHARD BURR, North CaroUna BART STUPAK, Michigan BRIAN P. BILBRAY, CaUfomia GENE GREEN, Texas ED WHITFIELD, Kentucky TED STRICKLAND, Ohio GREG GANSKE, Iowa DIANA DeGETTE, Colorado CHARLIE NORWOOD, Georgia THOMAS M. BARRETT, Wisconsin TOM A. COBURN, Oklahoma LOIS CAPPS, CaUfomia Vice Chairman RALPH M. HALL, Texas RICK LAZIO, New York EDOLPHUS TOWNS, New York BARBARA CL^IN, Wyoming ANNA G. ESHOO, CaUfomia JOHN B. SHADEGG, Arizona JOHN D. DINGELL, Michigan, CHARLES W. "CHIF' PICKERING, (Ex Officio) Mississippi ED BRYANT, Tennessee TOM BLILEY, Virginia, (Ex Officio) (II) CHS Library C2-07-13 7500 Security B3v<J. Briltimore, Marytend 21244 _| CONTENTS Page Testimonyof: Andrews, Elizabeth B., Director of Worldwide Epidemiology, Glaxo Wellcome Inc 138 Appelbaum, Paul, Professor and Chair, Department of Psychiatry, Uni- versity of Massachusetts Medical School, on behalf of the American PsychiatricAssociation 32 Carty, Cristin,VicePresident, California Health Institute 127 Feldblum, Chai, Professor ofLaw and Director, Federal Legislation Clin- ic, Georgetown UniversityLaw Center 38 Frey, Carolin M., Chairman, Institutional Research Review Board, Penn- sylvania State GeisingerHealth System 148 Johnson, Randel K, Vice President, Labor and Employee Benefits, U.S. ChamberofCommerce 131 Koski, Greg, Director, Human Research Affairs, Partner Health Care System, Massachusetts General Hospital 143 Nielsen, John T., Senior Counsel and Director ofGovernment Relations, IntermountainHealth Care 19 Pawlak, Linda, parent 31 Tang, Paul C, Medical Director, Chnical Informatics, Palo Alto Medical Clinic 27 Material submittedforthe recordby: Shays, Hon. Christopher, a Representative in Congress from; the State ofConnecticut, prepared statementof 164 (III) THE MEDICAL EVFORMATION PROTECTION AND RESEARCH ENHANCEMENT ACT OF 1999 THURSDAY, JULY 15, 1999 House of Representatives, Committee on Commerce, Subcommittee on Health and Environment, Washington, DC. The subcommittee met, pursuant to notice, at 10 a.m., in room 2322, Rayburn House Office Building, Hon. Michael Bilirakis (chairman) presiding. Members present: Representatives Bilirakis, Upton, Greenwood, Burr, Bilbray, Ganske, Norwood, Coburn, Cubin, Bryant, Brown, Waxman, Stupak, Green, DeGette, Barrett, Capps, Hall, and Eshoo. Also present: Representative Markey. Staff present: John Manthei, majority counsel; Marc Wheat, ma- jority counsel; Cliff Riccio, legislative clerk; and John Ford, minor- ity counsel. Mr. Bilirakis. The hearing will come to order. Good morning. I would like to first thank all of our witnesses for joining us today, and particularly Justin Pawlak and his mother Linda. The purpose ofthis hearing is to explore the issues ofmedical confiden- tiality. Today we will have an opportunity to examine H.R. 2470, which is the Medical Information Protection and Research Enhancement Act of 1999. I would like to start by commending our colleague Jim Green- wood for drafting this legislation and also to recognize the efforts of Congressmen Upton, Shays, Norwood and Burr in working with him to address this very complicated issue. As you know, the Health Insurance Portability and Accountabil- ity Act of 1996 set a deadline for Congress to pass legislation ad- dressing the confidentiality of individual identifiable health infor- mation. Unless Congress acts by August 21, the Secretary of Health and Human Services is directed to issue regulations within 6 months to address the confidentiality of administrative data stored or transmitted electronically. Significantly, the Secretary's regulatory authority is limited to establishing standards for infor- mation that is transmitted and stored electronically, a more narrow focus than the comprehensive approach taken in the bill before us. While the modern health care delivery system is increasingly electronic, as we well know, most patient health information re- mains paper based. We all know that medical records contain very personal and sensitive information. Certainly this information (1) 2 must be safeguarded and any abuse of it cannot be tolerated. How- ever, we must also ensure that increased protections do not inad- vertently jeopardize the quality of health care in this country. Any legislation must take into account the highly integrated and com- plex nature ofour health care system. In our previous hearing, I emphasized the need to develop re- sponsible legislation to safeguard confidential medical information and to impose tough penalties for abuse. We must ensure strict ac- countability for the use of this information while preserving the ability to conduct important medical research. I believe that H.R. 2470 is a significant step forward in accom- plishing these goals and I hope that it serves as a starting point for legislative action on a truly bipartisan basis. Again, I would like to thank all of our witnesses for taking time to be here. I would now recognize the ranking member, Mr. Brown from Ohio. Mr. Brown. Thank you, Mr. Chairman, for holding this hearing and I would like to thank the witnesses also for joining us today. I am glad that we are taking up the issue ofmedical records pri- vacy. The statutory deadline is about 5 weeks away, which means we have no time to spare. I am disappointed the majority chose to focus on only one of the privacy bills. It is my experience that it is unusual to limit a legislative hearing to one bill when other ini- tiatives have also been introduced: H.R. 1941, the bill sponsored by Mr. Condit ofCalifornia, which had 57 cosponsors, and Mr. Markey ofMassachusetts has a bill, H.R. 1057, that has 41. These are other privacy bills that deserve the same consideration that we are giving to H.R. 2470. The best way to make progress is to compare H.R. 2470 to the bill of Mr. Condit. The key dif- ference between those two bills are the core issues in the privacy debate: Should individuals have a private right ofaction when their med- ical records have been exploited? H.R. 2470 does not establish this right. Mr. Condit's bill does. Rights that can be denied without remedy are not rights, they are only hopes. Should privately funded research be treated differently from pub- licly funded research when it comes to protecting the confidential- ity of medical information? H.R. 2470 says yes; Mr. Condit's bill says no. What would a participant in privately funded research say? I am guessing that participant would assume and expect the same level of protection regardless of who funds the research. The goal is not to establish basic privacy protections for some individuals, it is to establish them for all individuals. Should Federal privacy laws preempt stronger State laws? H.R. 2470 says yes; our bill says no. States are typically the first to identify consumer issues, and they are the innovators when it comes to addressing them. Federal protection should function as the floor, not the ceiling, for medical privacy protections. I look forward to hearing our witnesses with respect to these issues and what I hope will be a productive and balanced hearing. Mr. BiLiRAKis. Mr. Greenwood for an opening statement. 3 Mr. Greenwood. Thank you, Mr. Chairman. The title ofthe leg- islation that we are considering today is the Medical Information Protection and Research Enhancement Act and it is important to understand that those two goals are what we mean to accomplish here. Obviously the personal security and the well-being of every American will be profoundly improved if we succeed in accomplish- ing these dual purposes. First on the privacy issue, our medical records contain personal, sensitive, potentially humiliating information, which if misused could cause discrimination in the workplace and adversely affect one's ability to purchase insurance. For that reason we create in this legislation the definition ofthe term "protected health care in- formation" to make sure that it is kept private and to make sure that there are remedies and penalties for its misuse. Second, the second goal, every one of us and every American in America, every one of our family members, will benefit from, con- tinue to benefit from the ability of researchers, assurers of quality and others to use the awesome power of information processing to study health outcomes and thereby discover new and better treat- ment modalities and ways to deliver health care as effectively and efficiently as possible. With the wrong public policy, these two admirable and critical goals are competing adversaries. With the right public policy, they are complementary colleagues. As has been mentioned, we do con- front on August 21 a deadline, the 1996 Kennedy-Kassebaum. Health Insurance Portability and Accountability Act sets that date, and if we do not accomplish a legislative remedy, the Department will issue regulations. Of course, that will be insufficient because it only applies to electronic records, and most medical records are not electronic but in fact still on paper. The policy incorporated in H.R. 2470 does the following: It estab- lishes the individual's right, which does not currently exist at the Federal level, to inspect, copy and amend his or her patient records. That is brand new. It enacts strong uniform Federal stand- ards which replace conflicting State laws and impose strong civil and criminal penalties for the misuse ofthese records, the remedies to which Mr. Brown refers; requires law enforcement officials to demonstrate legitim.ate need in order to obtain protected health in- formation; and protects patients involved in medical research trials when ensuring information can be used to continue research break- throughs. The question has been raised and will be raised throughout this hearing: Why State preemption? Why is it important for the Fed- eral Government and Congress to establish a unified standard: The founders of our Constitution recognized the need to protect inter- state commerce. The logic of the commerce clause is plain sense. It made sense to ensure that buggy whips and butter churns could be transported across State lines without being subjected to the micro manage- ment of 13 colonies. It certainly is plain that medical data trans- mitted at the speed oflight across 50 States and the District of Co- lumbia requires a uniform standard that ensures both privacy and utility. I believe every member of this committee shares the twin goals ofprotecting privacy and enhancing research. 4 H.R. 2470 is not the first bill drafted toward these ends and it will not be the last, but I have every confidence that if we reach across the aisle toward one another in good faith and with a posi- tive, constructive approach, we can produce a final product that is worthy of us all, and I pledge to work with all of my colleagues on both sides ofthis committee toward that end. Two footnotes: I would like to draw attention to a drafting over- sight in the last draft the inadvertent elimination of workplace in- formation protections, and I would like, Mr. Chairman, to submit a letter indicating my desire to correct that in the next draft. Mr. BiLlRAKlS. Without objection, so ordered. [The information referred to follows:] Congress of the United States House of representatives July 14, 1999 Deborah V. Dibenedetto, MBA, RN, COHN-S, ABDA President AmericanAssociation ofOccupationalHealthNurses, Inc. 2920BrandywineRoad Atlanta, Georgia 30341-4146 Dear Ms. Dibenedetto: When drafting H.R. 2470, the Medical Information Pro- tection and Research Enhancement Act, an oversight was made that excluded pro- tections for medical information used in the workplace. Clearly this type ofinforma- tion is extremely sensitive and can be used to discriminate not only against employ- ees, but for occupational health nurses and other providers who sometimes must weigh the threat of losing theirjob against protecting the information oftheir co- workers. As originally drafted, the bill ensured that the disclosure of the protected em- ployee health information within the entityis compatible with the purpose forwhich the information was obtained and limited to information necessary to accomplish the purpose ofthe disclosure. In addition, the draft legislation also required the em- ployer to prohibit the release, transfer or communication ofthe protected health in- formation to officers, employees, or agents responsible for hiring, promotion, and making work assignment decisions with respect to the subject of the information. Itwas unfortunate these protections were inadvertentlyremoved in thefinalversion of the bill. It is my intention to do all in my ability to add these protections back in toH.R. 2470. I lookforward to workingwithyou in the future on this critical patientprotection. Please do not hesitate to contact me should you have additional questions or con- cerns. Sincerely, James C. Greenwood Mr. Greenwood. And I would like to take the opportunity to in- troduce to our panel Justin Pawlak. He is the young man in the center of the table there. I have learned that Justin wants to run for Congress someday. And, Justin, I will let you know when it is your turn. Thank you, Mr. Chairman. Mr. BiLlRAKlS. Thank you. Mr. Waxman for an opening state- ment? Mr. Waxman. I will yield to Ms. Eshoo. Ms. Eshoo. Thank you, Mr. Waxman, and thank you, Mr. Chair- man, for holding this important hearing today. As I was walking into the Rayburn building this morning, I thought that the last several hearings and/or markups that I have been to have dealt with the issue ofprivacy, and here we are again on the issue ofprivacy as it relates to medical records. I would like to begin by recognizing my constituent, Dr. Paul Tang of Palo Alto, California. Welcome. It is a pleasure to see you 5 here. I also want to welcome Cristin Carty who does superb work with the California Health Care Institute. They have taken their place in a prominent way in working with members and providing a great deal ofthe research and information that members need in order to make informed decisions. With the advent of managed care increasing, numbers of people are involved in health care treatment, pa3niient and oversight, giv- ing them direct access to often very sensitive medical information. Today we have to place our trust in entire networks of insurers and health care providers. And I don't think that we can any longer expect that information supplied to our doctors will indeed remain confidential. The American people expect, and I think they are entitled to confidential, fair and respectful treatment of their private health information. It is incumbent upon Congress to enact a strong uniform Federal standard ofprotection for medical records privacy. Currently, of course, there is no Federal standard, and the exist- ing patchwork ofState laws provide erratic protection at best. Unfortunately, I don't think that my colleague Mr. Greenwood's bill is the total answer. Rather than providing privacy protections for medical records, the bill in fact, I think, steps back from the issue of medical privacy. The bill would allow insurers to use our private health information without consent for anything that can be called, "health care operations." It is a very, very broad term that is not defined in the bill. The bill is written in such broad terms that virtually anjdihing the health plan writes into its con- tracts could be considered a health care operation. For example, a health plan could include a contract clause that says health information will be used for marketing purposes. Or in- formation can be used for insurance underwriting, allowing one to be rated as a bad risk and harming their ability to get insurance in the future. It is a very, very sensitive area for the American peo- ple. Another major problem, as I see it, with the bill is the lack of enforcement. Providing for a right ofaction would give every Amer- ican the basic right to seek redress for violations of their private medical records and yet the bill is silent. It is often said that si- lence is deafening. The bill is silent on this issue. I would ask what good is a right if it can't be enforced? I think we should all think about that instead of scurrying to ideological corners. Just apply it to oneself. What good is it to have a right unless there is an ability to enforce it? I too want to ensure that research is not hampered. I see first- hand, day in and day out in my very distinguished congressional district, the enormous good and the impact of that good the re- search does day in and day out. But I think we need to be sure that any legislation enacted doesn't erect any unnecessary barriers that would slow and impede medical research, and I think we can do both. I don't think that we have to do one at the cost of the other. But I don't think that we can risk the privacy ofevery Amer- ican to keep their most personal medical records private. Again, I think we need to establish a strong Federal standard to protect against unauthorized uses ofour private health information 6 while remaining mindful ofthe effect our laws will have on medical research and the lives it can and does save every day. Thank you, Mr. Chairman, for your leadership in this sub- committee. I think we have a ways to go in terms of hammering out something if in fact we are going to do that before the laws on the book would allow the Secretary to do so. I look forward to working with you and other members of our committee to produce something not only for the full committee, but the full Congress that we can really be proud of. Thank you very much. Mr. BiLlRAKlS. I thank the gentlelady. And we will, if we are willing to work together. Mr. Upton for an opening statement. Mr. Upton. I have a statement for the record. I would just like to add that I have very strong support for this, and allowing Jim Greenwood to lead this charge in a bipartisan way was terrific. He has been a good leader. [The prepared statement ofHon. Fred Upton follows:] Prepared StatementofHon. Fred Upton,aRepresentative inCongressfrom THE State ofMichigan Mr. Chairman, thank you for holding today's hearing on the Medical Information Protection and Research Enhancement Act. I also want to commend our colleague, Jim Greenwood, has shown in developing the comprehensive, thoughtful bill we will bediscussingthis morning. I am pleasedtobea cosponsorofthislegislation. I am sure thatdevelopingthislegislation was no easyundertaking. Itmustreflect a dehcate balance between the need to ensure the privacy of individuals' medical information and the need that arises to use personally identifiable health informa- tion in biomedical research, to evaluate the safety and effectiveness oftreatments and coordinate the deliveryofhealth care, andforotherlegitimatepurposes. I am looking to hearing from our witnesses today about their perspective on achievingthisbalance. Mr. BILIRAKIS. Mr. Waxman. Mr. Waxman. Thank you. I am pleased that we are meeting today to discuss medical records legislation. Ensuring medical pri- vacy in our multifaceted health care system is a vital patient pro- tection. That is why I join together with Representative Gary Condit, Ed Markey, John Dingell, Sherrod Brown and others who have introduced consensus legislation that addresses the complex issues related to medical privacy in a commonsense manner. Strong Federal privacy protections for medical records are critical to ensuring that our health care system operates effectively. Cur- rently, only a patchwork of State laws address medical privacy matters and many of these provide minimal protections. As a re- sult, individuals are withholding information from their health care providers, even avoiding care for fear ofprivacy violations. Unfortunately, the majority's proposal, H.R. 2470, would only ex- acerbate individual's concerns. Among other provisions, H.R. 2470 would allow health insurers to use an individual's information for insurance underwriting and marketing without an individual's con- sent, and for health research without an individual's consent or any review ofthe research. It would override carefully crafted State laws which protect the privacy of sensitive information such as dental health records, genetic information and HIV test results and it would block States' ability to address such issues in the future.