Sharona Hoffman

E-Health Hazards: Provider Liability and Electronic Health Record Systems

In the foreseeable future, electronic health record (EHR) systems are likely to become a fixture in medical settings. The potential benefits of computerization could be substantial, but EHR systems also give rise to new liability risks for health care providers that have received little attention in the legal literature. This Article features a first of its kind, comprehensive analysis of the liability risks associated with use of this complex and important technology. In addition, it develops recommendations to address these liability concerns. Appropriate measures include federal regulations designed to ensure the quality and safety of EHR systems along with agency guidance and well crafted clinical practice guidelines for EHR system users. In formulating its recommendations, the Article proposes a novel, uniform process for developing authoritative clinical practice guidelines and explores how EHR technology itself can enable experts to gather evidence of best practices. The authors argue that without thoughtful interventions and sound guidance from government and medical organizations, this promising technology may encumber rather than support clinicians and may hinder rather than promote health outcome improvements.

The Use and Misuse of Biomedical Data: Is Bigger Really Better?

Very large biomedical research databases, containing electronic health records (EHR) and genomic data from millions of patients, have been heralded recently for their potential to accelerate scientific discovery and produce dramatic improvements in medical treatments. Research enabled by these databases may also lead to profound changes in law, regulation, social policy, and even litigation strategies. Yet, is “big data” necessarily better data? This paper makes an original contribution to the legal literature by focusing on what can go wrong in the process of biomedical database research and what precautions are necessary to avoid critical mistakes. We address three main reasons for approaching such research with care and being cautious in relying on its outcomes for purposes of public policy or litigation. First, the data contained in biomedical databases is surprisingly likely to be incorrect or incomplete. Second, systematic biases, arising from both the nature of the data and the preconceptions of investigators, are serious threats to the validity of research results, especially in answering causal questions. Third, data mining of biomedical databases makes it easier for individuals with political, social, or economic agendas to generate ostensibly scientific but misleading research findings for the purpose of manipulating public opinion and swaying policymakers. In short, this paper sheds much-needed light on the problems of credulous and uninformed acceptance of research results derived from biomedical databases. An understanding of the pitfalls of big data analysis is of critical importance to anyone who will rely on or dispute its outcomes, including lawyers, policymakers, and the public at large. The Article also recommends technical, methodological, and educational interventions to combat the dangers of database errors and abuses.

Meaningful Use and Certification of Health Information Technology: What About Safety?

Health information technology (HIT) is becoming increasingly prevalent in medical offices and facilities. Like President George W. Bush before him, President Obama announced a plan to computerize all Americans’ medical records by 2014. Computerization is certain to transform American health care, but to ensure that its benefits outweigh its risks, the federal government must provide appropriate oversight. President Obama’s stimulus legislation, the American Recovery and Reinvestment Act of 2009 (ARRA), dedicated

Beneficial and Unusual Punishment: An Argument in Support of Prisoner Participation in Clinical Trials

27 billion to the promotion of health information technology. It provides payments of up to

Electronic Health Records and Research: Privacy Versus Scientific Priorities

44,000 per clinician under the Medicare incentive program and

Citizen Science: The Law and Ethics of Public Access to Medical Big Data

63,750 per clinician under the Medicaid program. In the summer of 2010, the Department of Health and Human Services (HHS) published three sets of regulations to implement ARRA. This article briefly describes and critiques the regulations, arguing that (1) they fail to appropriately address HIT safety and (2) further steps must be taken to protect patients and serve public health needs in the new digital era.

Mandatory Arbitration: Alternative Dispute Resolution or Coercive Dispute Suppression?

Currently, approximately 1.8 million people are incarcerated in the United States at any given time. A disproportionately large percentage of the prisoner population has serious illnesses, such as AIDS and tuberculosis. Prisoners most often, however, are barred from participation in clinical trials, even when conventional therapy has failed, and experimental treatment might provide them with their only hope of survival. Much of the reluctance to include prisoners in biomedical research is based on history. In the past, prisoners have been severely abused and even tortured in medical studies conducted in the Nazi death camps, Japanese prisoner camps, and correctional facilities in the United States. By 1969, eighty-five percent of new drugs were tested on incarcerated persons in forty-two American prisons. In the 1970s regulations regarding the use of biomedical experimentation on prisoners were issued by the federal government, designed to provide rigorous review of research protocols involving prisoners and to protect inmates from abuse in the research context. Abuse of prisoner subjects in clinical studies can lead to violations of their constitutional rights. The author argues, however, that prohibiting seriously ill prisoners from participating voluntarily in clinical research may constitute an equivalent contravention of their constitutional rights under the Eighth Amendment and the Due Process and Equal Protection clauses. The article reviews the history of prisoner participation in biomedical research, analyzes the relevant constitutional issues, and encourages the inclusion of prisoners in clinical studies involving potentially beneficial experimental treatment for life-threatening diseases.

Finding a Cure: The Case for Regulation and Oversight of Electronic Health Record Systems

In his insightful article, “Is Deidentification Sufficient to Protect Health Privacy in Research?” Mark Rothstein (2010) correctly highlights the shortcomings of deidentification and makes a compelling argument that further safeguards must be implemented to protect patient privacy and autonomy. His concerns are counterbalanced, however, by the invaluable contribution to medical knowledge that databases of deidentified electronic health records (EHRs) can make. While the privacy and autonomy of patients are extremely important, the integrity and completeness of EHR research databases deserve more attention than they receive in the article. In this commentary, I do not address biological specimens, but rather focus on EHRs, about which I have written extensively in prior pieces (Hoffman and Podgurski 2008; 2009). EHRs can allow for the creation of large databases consisting of deidentified patient records from one or more health networks. Such databases could enable researchers to conduct comprehensive observational studies based on the actual clinical experience of millions of patients with diverse demographics. Although randomized controlled trials (RCTs) are considered to be the “gold standard” for determining treatment effectiveness, observational data can help fill evidence gaps when RCTs are not possible or are inadequate (Institute of Medicine 2009). Thus, retrospective analysis of EHR data can help bridge the “inferential gap” between “the paucity of what is proved to be effective for selected groups of patients versus the infinitely complex clinical decisions required for individual patients” (Stewart et al., 2007). The U.S. government has recognized the significant contribution to human health that EHR databases can make. Kaiser Permanente recently received a grant of more than

Big Bad Data: Law, Public Health, and Biomedical Databases

3 million in stimulus funds to create a national electronic research database of deidentified health information from 30,000,000 current and past patients from eight regions in the country (Merrill 2009). The Food and Drug Administration Amendments Act of 2007 authorized the creation of the Sentinel health data network consisting of records from 100 million individuals (Evans 2010). Private entities are also independently creating databases. For example, Geisinger Health Systems established a company called MedMining to deidentify and license data to researchers (PricewaterhouseCoopers 2009).

Preparing for Disaster: Protecting the Most Vulnerable in Emergencies

Patient-related medical information is becoming increasingly available on the Internet, spurred by government open data policies and private sector data sharing initiatives. Websites such as HealthData.gov, GenBank, and PatientsLikeMe allow members of the public to access a wealth of health information. As the medical information terrain quickly changes, the legal system must not lag behind. This Article provides a base on which to build a coherent data policy. It canvasses emergent data troves and wrestles with their legal and ethical ramifications.Publicly accessible medical data have the potential to yield numerous benefits, including scientific discoveries, cost savings, the development of patient support tools, healthcare quality improvement, greater government transparency, public education, and positive changes in healthcare policy. At the same time, the availability of electronic personal health information that can be mined by any Internet user raises concerns related to privacy, discrimination, erroneous research findings, and litigation. This Article analyzes the benefits and risks of health data sharing and proposes balanced legislative, regulatory, and policy modifications to guide data disclosure and use.