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Full-Text Articles in Law
The Patient's Voice: Legal Implications Of Patient-Reported Outcome Measures, Sharona Hoffman, Andy Podgurski
The Patient's Voice: Legal Implications Of Patient-Reported Outcome Measures, Sharona Hoffman, Andy Podgurski
Faculty Publications
In recent years, the medical community has paid increasing attention to patients' own assessments of their health status. Even regulatory agencies, such as the Food and Drug Administration and the Centers for Medicare and Medicaid Services, are now interested in patient self-reports. The legal implications of this shift, however, have received little attention. This Article begins to fill that gap. It introduces to the legal literature a discussion that has been ongoing in the health care field.
Patient-reported outcome measures (PROMs) are reports of patients’ symptoms, treatment outcomes, and health status that are documented directly by patients, typically through electronic …
Specialty Drugs And The Health Care Cost Crisis, Sharona Hoffman, Isaac D. Buck
Specialty Drugs And The Health Care Cost Crisis, Sharona Hoffman, Isaac D. Buck
Faculty Publications
Specialty drugs, often dispensed by specialty pharmacies, are among the most expensive drugs on the market. They are significant contributors to the American health care cost problem, but in many ways they escape public and regulatory scrutiny. Surprisingly, medications are designated as specialty drugs by pharmacy benefit managers (PBMs), entities that are part of the insurance industry, rather than by the Food and Drug Administration or medical authorities.
Specialty drugs have thus far received little attention in the legal literature. Yet, they raise important legal and regulatory questions. For example, there are no federal government rules (and only a handful …
The Drugs Stop Here: A Public Health Framework To Address The Drug Shortage Crisis, Sharona Hoffman
The Drugs Stop Here: A Public Health Framework To Address The Drug Shortage Crisis, Sharona Hoffman
Faculty Publications
Drug shortages are emerging as a major public health threat. Grave concern has been expressed by the medical community and government officials, and the crisis has been highlighted in recent media stories. Nevertheless, little has been written to date in the legal literature about the drug shortage crisis, and this timely article begins to fill this gap. It provides a thorough analysis of the origins and implications of the drug shortage problem and formulates a multi-layered approach to addressing it. The article argues that drug shortages result from a combination of market failures and regulatory constraints. It proposes a blend …
Improving Health Care Outcomes Through Personalized Comparisons Of Treatment Effectiveness Based On Electronic Health Records, Sharona Hoffman, Andy Podgurski
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 …