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Mark A Rothstein - One of the best experts on this subject based on the ideXlab platform.
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the end of the hipaa Privacy Rule currents in contemporary bioethics
Journal of Law Medicine & Ethics, 2016Co-Authors: Mark A RothsteinAbstract:The HIPAA Privacy Rule is notoriously weak because of its incomplete coverage, numerous exclusions and exemptions, and limited rights for individuals. The three areas in which it provides the most protection are fundraising, marketing, and research. Provisions of the 21st Century Cures Act, pending in Congress, and the Notice of Proposed Rulemaking to amend the federal research regulations (Common Rule), awaiting final regulatory action, would weaken the Privacy protections for research. If these measures are adopted, the HIPAA Privacy Rule would have so little value that it might not be worth the aggravation and burden.
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hipaa Privacy Rule 2 0
Journal of Law Medicine & Ethics, 2013Co-Authors: Mark A RothsteinAbstract:Mark A. Rothstein On January 25, 2013, the Federal Register published the Department of Health and Human Services (HHS) omnibus amendments to the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, Enforcement, and Breach Notification Rules.1 These modifications also include the final versions of the HIPAA regulation amendments mandated by the Health Information Technology for Economic and Clinical Health Act (HITECH Act)2 and the Genetic Information Nondiscrimination Act (GINA).3 Although the amended Rules were effective on March 26, 2013, covered entities and their business associates (which now have direct liability for violations of the regulations) have a compliance date of September 23, 2013.4 It has been 10 years since the April 14, 2003 compliance date for the original HIPAA Privacy Rule.5 Despite HHS’ clarification of some issues by posting answers to frequently asked questions (FAQs),6 there have been no significant amendments to the Privacy Rule since 2003. It has been the view of many covered entities, regulators, and analysts that several provisions of the original Privacy Rule were unworkable or caused unintended consequences. Therefore, the recent Rulemaking provided an opportunity to correct some longidentified problems and to integrate congressional directives under the HITECH Act and GINA into the Privacy, Security, Enforcement, and Breach Notification Rules. The amendments and the regulatory explanations are long, technical, and arcane. This article focuses on two important areas of the Privacy Rule with significant changes: research and genetic information. It indicates how a number of the revisions have failed to resolve or have exacerbated problems under the Privacy Rule. Research Sale of Protected Health Information (PHI) Based on language in the HITECH Act, the revised Privacy Rule prohibits the sale of protected health information (PHI) without an authorization.7 One important exception permits payment for research disclosures where the payment is “a reasonable cost-based fee to cover the cost to prepare and transmit the protected health information.”8 This means that the covered entity may be compensated by a sponsor for performing research; only the disclosure of PHI associated with the research is subject to this limitation.
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hipaa Privacy Rule 2 0
Social Science Research Network, 2013Co-Authors: Mark A RothsteinAbstract:On January 25, 2013, the Federal Register published the Department of Health and Human Services (HHS) omnibus amendments to the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, Enforcement, and Breach Notification Rules. These modifications also include the final versions of the HIPAA regulation amendments mandated by the Health Information Technology for Economic and Clinical Health Act (HITECH Act) and the Genetic Information Nondiscrimination Act (GINA). Although the amended Rules are effective on March 26, 2013, covered entities and their business associates (which now have direct liability for violations of the regulations) have a compliance date of September 23, 2013.
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disclosing decedents research results to relatives violates the hipaa Privacy Rule
Social Science Research Network, 2012Co-Authors: Mark A RothsteinAbstract:The target article (Chan et al. 2012) contains an interesting proposal that researchers disclose a select range of genetic test results to the relatives of deceased research participants. The proposal raises numerous ethical issues, but they are not generally dispositive. In the absence of a prior authorization by the research participant or the participant's legally authorized representative, disclosing the results of research to the family members of a deceased participant is unlawful under the HIPAA Privacy Rule.
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disclosing decedents research results to relatives violates the hipaa Privacy Rule
American Journal of Bioethics, 2012Co-Authors: Mark A RothsteinAbstract:The target article (Chan et al. 2012) contains an interesting proposal that researchers disclose a select range of genetic test results to the relatives of deceased research participants. The propo...
David Korn - One of the best experts on this subject based on the ideXlab platform.
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the new hipaa health insurance portability and accountability act of 1996 medical Privacy Rule help or hindrance for clinical research
Circulation, 2003Co-Authors: Jennifer Kulynych, David KornAbstract:This article was prepared and accepted in 2002. The Federal Policy for Protection of Human Research Subjects, adopted by 17 federal agencies as a common regulatory framework (the “Common Rule”) for most federally sponsored human subjects research, acknowledges the centrality of Privacy and confidentiality to the ethical conduct of research by mandating, both implicitly and explicitly, that institutional review boards (IRBs) address these concerns.1 Regulations adopted by the US Food and Drug Administration (FDA) require IRBs to assess protections for Privacy and confidentiality in a similar manner.2 Implicit in the requirement (of both the Common Rule and FDA regulations) that IRBs weigh the risks and benefits of proposed research is the expectation that risks to Privacy and confidentiality will be among those the IRB considers. Moreover, both the Common Rule and FDA regulations require IRBs to make an explicit finding that a researcher has proposed adequate protections to minimize the possibility of a breach of Privacy or confidentiality and the attendant risk that subjects could suffer embarrassment, stigmatization, or discrimination.3 Despite these regulatory mandates, critics state that the existing system of IRB oversight does not ensure that subjects’ Privacy rights are respected fully and their confidentiality protected adequately. It is argued that heavily burdened IRBs, particularly those in academic settings, may devote insufficient attention to, and may lack the expertise to evaluate, risks to Privacy and confidentiality in an electronic age in which barriers to data transmission are low and in which data stripped of names and other facial identifiers may yet be re-identified for questionable purposes through the use of computer algorithms and diverse databases publicly available from private and governmental sources.4 Claims that some commercially sponsored research may be little more than thinly disguised marketing have further heightened anxiety about an erosion of health …
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The new federal medical-Privacy Rule.
The New England journal of medicine, 2002Co-Authors: Jennifer Kulynych, David KornAbstract:On August 9, 2002, the Department of Health and Human Services released the final version of the federal medical-Privacy Rule (Federal Register 67: 53182–53273, 2002). The release ended a tortuous ...
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The effect of the new federal medical-Privacy Rule on research.
The New England journal of medicine, 2002Co-Authors: Jennifer Kulynych, David KornAbstract:The American people generally support and encourage medical research, but they also place a high priority on the Privacy of personal medical information. The Health Insurance Portability and Accoun...
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use and disclosure of health information in genetic research weighing the impact of the new federal medical Privacy Rule
American Journal of Law & Medicine, 2002Co-Authors: Jennifer Kulynych, David KornAbstract:I. INTRODUCTION Perceived threats to medical Privacy arouse intense emotion, even among those who might otherwise approach complex health policy issues with academic dispassion. The author of an August 2001 editorial in the New England Journal of Medicine describes medical records as "sacred secrets," and decries the use of medical information for purposes unrelated to patient care as "an abridgement of individual rights" and "an unfolding American tragedy."1 A like-minded commentator in the Journal of the American Medical Association strikes a more apocalyptic note, warning that with respect to medical Privacy, "[t]here is, increasingly, no place to hide."2 Not surprisingly, Privacy advocates also depict a full-blown crisis in medical Privacy, one that Janlori Goldman of the Georgetown Health Privacy Project asserts has led consumers "to withdraw from full participation in their own healthcare" for fear of "discrimination, loss of benefits, stigma and unwanted exposure."3 The distraught tenor of such rhetoric only amplifies consumer fears about the potential misuse of personal health information and has engendered strong support for increased government oversight of medical Privacy. Potential threats to the Privacy of genetic test results have been a particular source of public anxiety. Public IMAGE FORMULA95 reaction has stimulated legislative initiatives at both the state and federal levels targeted toward the amorphous category of "genetic information."4 It is inarguable that basic safeguards for the Privacy and confidentiality of genetic information and, for that matter, all other types of medical information are essential. Consumers perceive themselves to be at significant risk when third parties such as employers or commercial entities enjoy unfettered access to medical records and other confidential health data. The anticipated risks may be psychological, including annoyance at becoming the target of an intrusive marketing scheme for a medical product and embarrassment if a stigmatizing condition is revealed, or they may extend to the loss of health insurance or employment upon disclosure of a genetic predisposition to serious diseases.5 Whatever the actual magnitude of these Privacy risks,6 a thoughtful, measured response on the part of policymakers is necessary and appropriate. Yet, problems arise when the response overreaches, attempting a utopian ideal of medical Privacy that may ultimately do more harm than good. This is especially so when new limits on the use or disclosure of health information are adopted in haste (or fear). Such measures may prove costly and difficult to implement and threaten to constrict the flow of essential health data to researchers who develop insights into the determinants of health and disease, as well as new medical products, therapies and disease prevention strategies. Amidst the strident demands of Privacy advocates for near absolute individual control over medical information, the challenge for policymakers has been to keep the broader, more "communitarian" goals in sight-namely, the advancement of medical knowledge and improvement of public health through research that cannot be accomplished without ready, albeit controlled, access to medical information.7 Across the nation, the stored clinical records and archived tissues of generations of patients-a veritable library of human encounters with illness and responses to therapies-has proved over decades to be a unique, irreplaceable source of new knowledge about diseases and their treatment. Researchers recount this new IMAGE FORMULA97 knowledge in medical literature; healthcare providers turn to the literature to inform decisions about diagnosis and treatment. Consequently, every patient has a direct and personal stake in preserving researchers' ready access to medical information accumulated in archived clinical records and tissue samples. …
Jennifer Kulynych - One of the best experts on this subject based on the ideXlab platform.
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clinical genomics big data and electronic medical records reconciling patient rights with research when Privacy and science collide
Journal of Leukocyte Biology, 2017Co-Authors: Jennifer Kulynych, Henry T GreelyAbstract:Widespread use of medical records for research, without consent, attracts little scrutiny compared to biospecimen research, where concerns about genomic Privacy prompted recent federal proposals to mandate consent. This paper explores an important consequence of the proliferation of electronic health records (EHRs) in this permissive atmosphere: with the advent of clinical gene sequencing, EHR-based secondary research poses genetic Privacy risks akin to those of biospecimen research, yet regulators still permit researchers to call gene sequence data 'de-identified', removing such data from the protection of the federal Privacy Rule and federal human subjects regulations. Medical centers and other providers seeking to offer genomic 'personalized medicine' now confront the problem of governing the secondary use of clinical genomic data as Privacy risks escalate. We argue that regulators should no longer permit HIPAA-covered entities to treat dense genomic data as de-identified health information. Even with this step, the Privacy Rule would still permit disclosure of clinical genomic data for research, without consent, under a data use agreement, so we also urge that providers give patients specific notice before disclosing clinical genomic data for research, permitting (where possible) some degree of choice and control. To aid providers who offer clinical gene sequencing, we suggest both general approaches and specific actions to reconcile patients' rights and interests with genomic research.
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the new hipaa health insurance portability and accountability act of 1996 medical Privacy Rule help or hindrance for clinical research
Circulation, 2003Co-Authors: Jennifer Kulynych, David KornAbstract:This article was prepared and accepted in 2002. The Federal Policy for Protection of Human Research Subjects, adopted by 17 federal agencies as a common regulatory framework (the “Common Rule”) for most federally sponsored human subjects research, acknowledges the centrality of Privacy and confidentiality to the ethical conduct of research by mandating, both implicitly and explicitly, that institutional review boards (IRBs) address these concerns.1 Regulations adopted by the US Food and Drug Administration (FDA) require IRBs to assess protections for Privacy and confidentiality in a similar manner.2 Implicit in the requirement (of both the Common Rule and FDA regulations) that IRBs weigh the risks and benefits of proposed research is the expectation that risks to Privacy and confidentiality will be among those the IRB considers. Moreover, both the Common Rule and FDA regulations require IRBs to make an explicit finding that a researcher has proposed adequate protections to minimize the possibility of a breach of Privacy or confidentiality and the attendant risk that subjects could suffer embarrassment, stigmatization, or discrimination.3 Despite these regulatory mandates, critics state that the existing system of IRB oversight does not ensure that subjects’ Privacy rights are respected fully and their confidentiality protected adequately. It is argued that heavily burdened IRBs, particularly those in academic settings, may devote insufficient attention to, and may lack the expertise to evaluate, risks to Privacy and confidentiality in an electronic age in which barriers to data transmission are low and in which data stripped of names and other facial identifiers may yet be re-identified for questionable purposes through the use of computer algorithms and diverse databases publicly available from private and governmental sources.4 Claims that some commercially sponsored research may be little more than thinly disguised marketing have further heightened anxiety about an erosion of health …
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The new federal medical-Privacy Rule.
The New England journal of medicine, 2002Co-Authors: Jennifer Kulynych, David KornAbstract:On August 9, 2002, the Department of Health and Human Services released the final version of the federal medical-Privacy Rule (Federal Register 67: 53182–53273, 2002). The release ended a tortuous ...
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The effect of the new federal medical-Privacy Rule on research.
The New England journal of medicine, 2002Co-Authors: Jennifer Kulynych, David KornAbstract:The American people generally support and encourage medical research, but they also place a high priority on the Privacy of personal medical information. The Health Insurance Portability and Accoun...
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use and disclosure of health information in genetic research weighing the impact of the new federal medical Privacy Rule
American Journal of Law & Medicine, 2002Co-Authors: Jennifer Kulynych, David KornAbstract:I. INTRODUCTION Perceived threats to medical Privacy arouse intense emotion, even among those who might otherwise approach complex health policy issues with academic dispassion. The author of an August 2001 editorial in the New England Journal of Medicine describes medical records as "sacred secrets," and decries the use of medical information for purposes unrelated to patient care as "an abridgement of individual rights" and "an unfolding American tragedy."1 A like-minded commentator in the Journal of the American Medical Association strikes a more apocalyptic note, warning that with respect to medical Privacy, "[t]here is, increasingly, no place to hide."2 Not surprisingly, Privacy advocates also depict a full-blown crisis in medical Privacy, one that Janlori Goldman of the Georgetown Health Privacy Project asserts has led consumers "to withdraw from full participation in their own healthcare" for fear of "discrimination, loss of benefits, stigma and unwanted exposure."3 The distraught tenor of such rhetoric only amplifies consumer fears about the potential misuse of personal health information and has engendered strong support for increased government oversight of medical Privacy. Potential threats to the Privacy of genetic test results have been a particular source of public anxiety. Public IMAGE FORMULA95 reaction has stimulated legislative initiatives at both the state and federal levels targeted toward the amorphous category of "genetic information."4 It is inarguable that basic safeguards for the Privacy and confidentiality of genetic information and, for that matter, all other types of medical information are essential. Consumers perceive themselves to be at significant risk when third parties such as employers or commercial entities enjoy unfettered access to medical records and other confidential health data. The anticipated risks may be psychological, including annoyance at becoming the target of an intrusive marketing scheme for a medical product and embarrassment if a stigmatizing condition is revealed, or they may extend to the loss of health insurance or employment upon disclosure of a genetic predisposition to serious diseases.5 Whatever the actual magnitude of these Privacy risks,6 a thoughtful, measured response on the part of policymakers is necessary and appropriate. Yet, problems arise when the response overreaches, attempting a utopian ideal of medical Privacy that may ultimately do more harm than good. This is especially so when new limits on the use or disclosure of health information are adopted in haste (or fear). Such measures may prove costly and difficult to implement and threaten to constrict the flow of essential health data to researchers who develop insights into the determinants of health and disease, as well as new medical products, therapies and disease prevention strategies. Amidst the strident demands of Privacy advocates for near absolute individual control over medical information, the challenge for policymakers has been to keep the broader, more "communitarian" goals in sight-namely, the advancement of medical knowledge and improvement of public health through research that cannot be accomplished without ready, albeit controlled, access to medical information.7 Across the nation, the stored clinical records and archived tissues of generations of patients-a veritable library of human encounters with illness and responses to therapies-has proved over decades to be a unique, irreplaceable source of new knowledge about diseases and their treatment. Researchers recount this new IMAGE FORMULA97 knowledge in medical literature; healthcare providers turn to the literature to inform decisions about diagnosis and treatment. Consequently, every patient has a direct and personal stake in preserving researchers' ready access to medical information accumulated in archived clinical records and tissue samples. …
Rodney A Hayward - One of the best experts on this subject based on the ideXlab platform.
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patients Privacy and trust patients willingness to allow researchers to access their medical records
Social Science & Medicine, 2007Co-Authors: Laura J Damschroder, Joy Pritts, Michael A Neblo, Rosemarie J Kalarickal, John W Creswell, Rodney A HaywardAbstract:The federal Privacy Rule, implemented in the United States in 2003, as part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), created new restrictions on the release of medical information for research. Many believe that its restrictions have fallen disproportionately on researchers prompting some to call for changes to the Rule. Here we ask what patients think about researchers' access to medical records, and what influences these opinions. A sample of 217 patients from 4 Veteran Affairs (VA) facilities deliberated in small groups at each location with the opportunity to question experts and inform themselves about Privacy issues related to medical records research. After extensive deliberation, these patients were united in their inclination to share their medical records for research. Yet they were also united in their recommendations to institute procedures that would give them more control over whether and how their medical records are used for research. We integrated qualitative and quantitative results to derive a better understanding of this apparent paradox. Our findings can best be presented as answers to questions related to five dimensions of trust: Patients' trust in VA researchers was the most powerful determinant of the kind of control they want over their medical records. More specifically, those who had lower trust in VA researchers were more likely to recommend a more stringent process for obtaining individual consent. Insights on the critical role of trust suggest actions that researchers and others can take to more fully engage patients in research.
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patients Privacy and trust patients willingness to allow researchers to access their medical records
Social Science & Medicine, 2007Co-Authors: Laura J Damschroder, Joy Pritts, Michael A Neblo, Rosemarie J Kalarickal, John W Creswell, Rodney A HaywardAbstract:The federal Privacy Rule, implemented in the United States in 2003, as part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), created new restrictions on the release of medical information for research. Many believe that its restrictions have fallen disproportionately on researchers prompting some to call for changes to the Rule. Here we ask what patients think about researchers' access to medical records, and what influences these opinions. A sample of 217 patients from 4 Veteran Affairs (VA) facilities deliberated in small groups at each location with the opportunity to question experts and inform themselves about Privacy issues related to medical records research. After extensive deliberation, these patients were united in their inclination to share their medical records for research. Yet they were also united in their recommendations to institute procedures that would give them more control over whether and how their medical records are used for research. We integrated qualitative and quantitative results to derive a better understanding of this apparent paradox. Our findings can best be presented as answers to questions related to five dimensions of trust: (1) Are medical records kept confidential? (2) Does the research being conducted demonstrate high priority on patient welfare? (3) Are researchers held accountable and responsible for protecting Privacy? (4) Are systems to protect medical records sufficiently secure? (5) Do researchers fully disclose the research being conducted and how medical records are used to conduct that research? Patients' trust in VA researchers was the most powerful determinant of the kind of control they want over their medical records. More specifically, those who had lower trust in VA researchers were more likely to recommend a more stringent process for obtaining individual consent. Insights on the critical role of trust suggest actions that researchers and others can take to more fully engage patients in research.
Tora K Bikson - One of the best experts on this subject based on the ideXlab platform.
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the health insurance portability and accountability act Privacy Rule a practical guide for researchers
Medical Care, 2004Co-Authors: Patrick P Gunn, Allen Fremont, Melissa Bottrell, Lisa R Shugarman, Jolene Galegher, Tora K BiksonAbstract:Background:The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, intended to address potential threats to patient Privacy posed by the computerization and standardization of medical records, provides a new floor level of federal protection for health information in all 50 sta