Health Law and Policy Commons^™

The Hipaa Privacy Rule And The Eu Gdpr: Illustrative Comparisons, Stacey A. Tovino

Scholarly Works

In this Article, Professor Tovino compares and contrasts three illustrative concepts and rights in the Privacy Rule and/or the GDPR, including the concepts of authorization and consent, the rights of amendment and rectification, and the right to erasure. Identified similarities reflect the core values of HHS and the EU with respect to maintaining the confidentiality and privacy of personal data and protected health information, respectively. Identified differences reflect the Privacy Rule's original, narrow focus on health industry participants and individually identifiable health information compared to the GDPR's broad focus on data controllers and personal data. Other differences reflect, perhaps, the …

Health Information Equity, Craig Konnoth

Publications

In the last few years, numerous Americans’ health information has been collected and used for follow-on, secondary research. This research studies correlations between medical conditions, genetic or behavioral profiles, and treatments, to customize medical care to specific individuals. Recent federal legislation and regulations make it easier to collect and use the data of the low-income, unwell, and elderly for this purpose. This would impose disproportionate security and autonomy burdens on these individuals. Those who are well-off and pay out of pocket could effectively exempt their data from the publicly available information pot. This presents a problem which modern research ethics …

Teaching The Hipaa Privacy Rule: Illustrative Comparisons, Stacey A. Tovino

Faculty Articles

Twenty years ago, President Clinton signed the Health Insurance Portability and Accountability Act of 1996 (HIPAA) into law. Over the past two decades, the federal Department of Health and Human Services (HHS) has published several sets of rules implementing the Administrative Simplification provisions within HIPAA as well as the Health Information Technology for Economic and Clinical (HITECH) Act within the American Recovery and Reinvestment Act (ARRA). These rules include, but certainly are not limited to, a final rule published on January 25, 2013, governing the use and disclosure of protected health information by covered entities and their business associates (the …

Wearable Fitness Devices: Personal Health Data Privacy In Washington State, Steven Spann

Seattle University Law Review

Private entities are increasingly targeting individuals in the United States and around the world to gather personal data for such purposes as product development, market identification, and insurance risk assessment. While credit card records and online browsing histories have long been the medium through which this data is gathered, in more recent years, wearable fitness devices have added a new dimension to data production and collection. These devices are capable of gathering a significant amount of data regarding a person’s physical and physiological characteristics, thereby exposing these data producers to personal privacy infringement. Washington State lawmakers and citizens must be …

Classification Standards For Health Information: Ethical And Practical Approaches, Craig Konnoth

Washington and Lee Law Review Online

Secondary health information research requires vast quantities of data in order to make clinical and health delivery breakthroughs. Restrictive policies that limit the use of such information threaten to stymie this research. While the Notice of Proposed Rulemaking (NPRM) for the new Common Rule permits patients to provide broad consent for the use of their information for research, that policy offers insufficient flexibility. This Article suggests a flexible consenting system that allows patients to consent to a range of privacy risks. The details of the system will be fleshed out in future work.

Selected Issues Concerning The Ethical Use Of Big Data Health Analytics, Lieke Jetten, Stephen Sharon

Washington and Lee Law Review Online

No abstract provided.

Reconsidering Constitutional Protection For Health Information Privacy, Wendy K. Mariner

Faculty Scholarship

What kinds of health information should be reported to government for civil purposes? Several competing trends encourage efforts to reassess the scope of constitutional protection for health information: the social and commercial value of health information; the amount of data held by third parties, from health care providers to internet servers; critiques of the third party doctrine exception to Fourth Amendment protection; and concerns about the loss of privacy. This article describes a variety of civil purposes for which health information is collected today. A close analysis of cases applying the third party doctrine, administrative search principles, and the special …

Use Of Facial Recognition Technology For Medical Purposes: Balancing Privacy With Innovation, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Electronic Health Records And Medical Big Data: Law And Policy, Sharona Hoffman

Faculty Publications

This book helps readers gain an in-depth understanding of electronic health record (EHR) systems, medical big data, and the regulations that govern them. It is useful both as a primer for students and as a resource for knowledgeable professionals. The book analyzes the shortcomings and benefits of EHR systems, explores the law's response to the technology’s adoption, highlights gaps in the current legal framework, and develops detailed recommendations for regulatory, policy, and technological improvements. Electronic Health Records and Medical Big Data addresses not only privacy and security concerns, but also other important challenges, such as those related to data quality …

Classification Standards For Health Information: Ethical And Practical Approaches, Craig Konnoth

Publications

Secondary health information research requires vast quantities of data in order to make clinical and health delivery breakthroughs. Restrictive policies that limit the use of such information threaten to stymie this research. While the Notice of Proposed Rulemaking (NPRM) for the new Common Rule permits patients to provide broad consent for the use of their information for research, that policy offers insufficient flexibility. This Article suggests a flexible consenting system that allows patients to consent to a range of privacy risks. The details of the system will be fleshed out in future work.

Silence Is Golden...Except In Health Care Philanthropy, Stacey A. Tovino

University of Richmond Law Review

No abstract provided.

Beyond Title Vii: Rethinking Race, Ex-Offender Status, And Employment Discrimination In The Information Age, Kimani Paul-Emile

Faculty Scholarship

More than sixty-five million people in the United States—more than one in four adults—have had some involvement with the criminal justice system that will appear on a criminal history report. A rapidly expanding, for-profit industry has developed to collect these records and compile them into electronic databases, offering employers an inexpensive and readily accessible means of screening prospective employees. Nine out of ten employers now inquire into the criminal history of job candidates, systematically denying individuals with a criminal record any opportunity to gain work experience or build their job qualifications. This is so despite the fact that many individuals …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Akron Law Faculty Publications

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Aids, Employment And The Law, American Bar Association; Aids Coordinating Committee

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Legal Implications Of Substance Abuse Testing In The Workplace, Michael S. Cecere, Phillip B. Rosen

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, James Ming Chen, Jay Dratler Jr., Thomas Folsom, Timothy S. Hall, Yaniv Heled, Frank A. Pasquale Iii, Elizabeth A. Reilly, Jeffrey Samuels, Katherine J. Strandburg, Kara W. Swanson, Andrew W. Torrance, Katharine A. Van Tassel

Law Faculty Scholarship

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions. Led by the moderator, participants at the Forum focused generally on three broad …

Hipaa As An Evidentiary Rule: An Analysis Of Miguel M. And Its Impact , Jennifer Clark

Journal of Law and Health

In New York suppression of evidence is only appropriate where constitutional, statutory, or decisional authority mandates it, even if obtained by unethical or unlawful means. The courts have been split on how to apply this standard to evidence obtained in violation of HIPAA. In the case In re Miguel M., the New York Court of Appeals addressed this question for the first time, finding that such evidence should be suppressed. Because it is the first authoritative case in New York addressing the evidentiary impact of a HIPAA violation, it is tempting to read Miguel M. as creating a new evidentiary …

Gone Too Far: Federal Regulation Of Health Care Attorneys, Stacey A. Tovino

Faculty Articles

Outside health care counsel frequently obtain medical records, billing records, health insurance claims records, and other records containing individually identifiable health information in the course of representing health industry clients in medical malpractice, licensure, certification, accreditation, fraud and abuse, peer review, and other civil, criminal, and administrative health law matters. This Article is the first to argue that state rules of professional conduct, not federal health information confidentiality regulations, should govern outside health care counsel’s use and disclosure of confidential client information, and that outside counsel should be excepted from direct federal regulation under the HIPAA Privacy Rule.

'No Body Left Behind': Re-Orienting School-Based Childhood Obesity Interventions, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

Although there are now laws on the books in virtually every jurisdiction aimed at addressing childhood obesity in K-12 schools, these efforts are inadequate and may even be misguided in important ways. Efforts aimed at health promotion - through healthier eating and increased physical activity - remain woefully underfunded even as they proliferate at every level of government. It is one thing to enact a requirement that all schools offer a minimum number of minutes of physical education each week or that school lunches include more fruits and vegetables. But it is quite another to make the budgetary commitment to …

Medical Evidence In Cases Of Intrauterine Drug And Alcohol Exposure , Judith Larsen, Robert M. Horowitz, Ira J. Chasnoff

Pepperdine Law Review

No abstract provided.

The Policy Against Federal Funding For Abortions Extends Into The Realm Of Free Speech After Rust V. Sullivan, Loye M. Barton

Pepperdine Law Review

No abstract provided.

Property As Control: The Case Of Information, Jane B. Baron

Michigan Telecommunications & Technology Law Review

If heath policy makers' wishes come true, by the end of the current decade the paper charts in which most of our medical information is currently recorded will be replaced by networked electronic health records ("EHRs").[...] Like all computerized records, networked EHRs are difficult to secure, and the information in EHRs is both particularly sensitive and particularly valuable for commercial purposes. Sadly, the existing federal statute meant to address this problem, the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), is probably inadequate to the task.[...] Health law, privacy, and intellectual property scholars have all suggested that the river …

Balancing Privacy, Autonomy, And Scientific Needs In Electronic Health Records Research, Sharona Hoffman, Andy Podgurski

Faculty Publications

The ongoing transition from paper medical files to electronic health records will provide unprecedented amounts of data for biomedical research, with the potential to catalyze significant advances in medical knowledge. But this potential can be fully realized only if the data available to researchers is representative of the patient population as a whole. Thus, allowing individual patients to exclude their health information, in keeping with traditional notions of informed consent, may compromise the research enterprise and the medical benefits it produces.

This Article analyzes the tension between realizing societal benefits from medical research and granting individual preferences for privacy. It …

Sex, Privacy And Public Health In A Casual Encounters Culture, Mary D. Fan

Articles

The regulation of sex and disease is a cultural and political flashpoint and recurring challenge that law's antiquated arsenal has been hard- pressed to effectively address. Compelling data demonstrate the need for attention—for example, one in four women aged fourteen to nineteen is infected with at least one sexually transmitted disease ("STD"); managing STDs costs an estimated $15.9 billion annually; and syphilis, once near eradication, is on the rise again, as are the rates of HIV diagnosis among people aged fifteen to twenty-four. Public health officials on the front lines have called for paradigm changes to tackle the enormous challenge. …

William H. Sorrell, Attorney General Of Vermont, Et Al. V. Ims Health Inc., Et Al. - Amicus Brief In Support Of Petitioners, Kevin Outterson, David Orentlicher, Christopher T. Robertson, Frank A. Pasquale

Faculty Scholarship

On April 26, 2011, the US Supreme Court will hear oral arguments in the Vermont data mining case, Sorrell v. IMS Health Inc. Respondents claim this is the most important commercial speech case in a decade. Petitioner (the State of Vermont) argues this is the most important medical privacy case since Whalen v. Roe.

The is an amicus brief supporting Vermont, written by law professors and submitted on behalf of the New England Journal of Medicine

Privacy Rights And Public Families, Khiara Bridges

Faculty Scholarship

This Article is based on eighteen months of anthropological fieldwork conducted among poor, pregnant women receiving prenatal care provided by the Prenatal Care Assistance Program (“PCAP”) at a large public hospital in New York City. The Prenatal Care Assistance Program (“PCAP”) is a special program within the New York State Medicaid program that provides comprehensive prenatal care services to otherwise uninsured or underinsured women. This Article attempts to accomplish two goals. The first goal is to argue that PCAP’s compelled consultations – with social workers, health educators, nutritionists, and financial officers – function as a gross and substantial intrusion by …

There Is A Time To Keep Silent And A Time To Speak, The Hard Part Is Knowing Which Is Which: Striking The Balance Between Privacy Protection And The Flow Of Health Care Information, Daniel J. Gilman, James C. Cooper

Michigan Telecommunications & Technology Law Review

Health information technology (HIT) has become a signal element of federal health policy, especially as the recently enacted American Recovery and Reinvestment Act of 2009 (Recovery Act or ARRA) comprises numerous provisions related to HIT and commits tens of billions of dollars to its development and adoption. These provisions charge various agencies of the federal government with both general and specific HIT-related implementation tasks including, inter alia, providing funding for HIT in various contexts: the implementation of interoperable HIT, HIT-related infrastructure, and HIT-related training and research. The Recovery Act also contains various regulatory provisions pertaining to HIT. Provisions of the …

Employing E-Health: The Impact Of Electronic Health Records On The Workplace, Sharona Hoffman

Faculty Publications

Electronic Health Record (HER) systems may soon become a fixture in most medical settings. President Obama’s 29 stimulus legislation includes $19 billion to promote their implementation. The sophisticated features and efficiencies of HER systems have the potential to improve health outcomes and enhance patient welfare considerably. However, this emerging technology also poses significant challenges and risks, not the least of which are its workplace impacts. This article provides a first of its kind analysis of the ramifications of HER systems for workers and employers.

The potential effects of health information computerization on the workplace are numerous. Employers may obtain and …

Protecting Privacy In Health Research: The Limits Of Individual Choice, Fred H. Cate

Articles by Maurer Faculty

No abstract provided.

Race, Sex And Genes At Work: Uncovering The Lessons Of Norman-Bloodsaw, Elizabeth Pendo

All Faculty Scholarship

The Genetic Information Nondiscrimination Act of 2008 (“GINA”) is the first federal, uniform protection against the use of genetic information in both the workplace and health insurance. Signed into law on May 21, 2008, GINA prohibits an employer or health insurer from acquiring or using an individual’s genetic information, with some exceptions. One of the goals of GINA is to eradicate actual, or perceived, discrimination based on genetic information in the workplace and in health insurance. Although the threat of genetic discrimination is often discussed in universal terms - as something that could happen to any of us - the …