Law Commons^™

The Use And Misuse Of Biomedical Data: Is Bigger Really Better?”, Sharona Hoffman, Andy Podgurski

Faculty Publications

Very large biomedical research databases, containing electronic health records (HER) 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 …

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 …

Meaningful Use And Certification Of Health Information Technology: What About Safety?, Sharona Hoffman, Andy Podgurski

Faculty Publications

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 214. 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 29 (ARRA), dedicated $27 billion to the promotion of health information technology. It provides payments of up to $44, per clinician under the Medicare incentive program and $63,75 per clinician under the …

Improving Health Care Outcomes Through Personalized Comparisons Of Treatment Effectiveness Based On Electronic Health Records, Sharona Hoffman, Andy Podgurski

Faculty Publications

Comparative effectiveness research (CER) is one of the Patient Protection and Affordable Care Act’s significant initiatives that aims to improve treatment outcomes and lower health care costs. This Article takes CER a step further and suggests a novel clinical application for it. The Article proposes the development of a national framework to enable physicians to rapidly perform, through a computerized service, medically sound personalized comparisons of the effectiveness of possible treatments for patients’ conditions. A treatment comparison for a given patient would be based on data from electronic health records of a cohort of clinically similar patients who received the …