Medical Jurisprudence Commons^™

German Pharmaceutical Pricing: Lessons For The United States, Marc A. Rodwin, Sara Gerke

Faculty Scholarly Works

To control pharmaceutical spending and improve access, the United States could adopt strategies similar to those introduced in Germany by the 2011 German Pharmaceutical Market Reorganization Act. In Germany, manufacturers sell new drugs immediately upon receiving marketing approval. During the first year, the German Federal Joint Committee assesses new drugs to determine their added medical benefit. It assigns them a score indicating their added benefit. New drugs comparable to drugs in a reference price group are assigned to that group and receive the same reimbursement, unless they are therapeutically superior. The National Association of Statutory Health Insurance Funds then negotiates …

Digital Home Health During The Covid-19 Pandemic Challenges To Safety, Liability, And Informed Consent, And The Way To Move Forward, Sara Gerke

Faculty Contributions to Books

In this chapter, I will first give an overview of the promise of digital home health. I will then discuss the regulation of digital home health before and during COVID-19 in the context of the US Federal Food, Drug, and Cosmetic Act (FDCA). This will be followed by a discussion of three digital home health challenges during the pandemic: 1) safety, 2) liability, and 3) informed consent. In this context, I will also make suggestions on how to move forward.

Privacy Aspects Of Direct-To-Consumer Artificial Intelligence/Machine Learning Health Apps, Sara Gerke, Delaram Rezaeikhonakdar

Faculty Scholarly Works

Direct-To-Consumer Artificial Intelligence/Machine Learning health apps (DTC AI/ML health apps) are increasingly being made available for download in app stores. However, such apps raise challenges, one of which is providing adequate protection of consumers' privacy. This article analyzes the privacy aspects of DTC AI/ML health apps and suggests how consumers' privacy could be better protected in the United States. In particular, it discusses the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Federal Trade Commission (FTC) Act, the FTC's Health Breach Notification Rule, the California Consumer Privacy Act of 2018, the California Privacy Rights Act of 2020, the …

When Is A Change Significant? The Update Problem Of Apps In Medical And Behavioral Research, Carmel Shachar, Sara Gerke, Walker Morrell, Aaron Kirby, I. Glenn Cohen, Barbara E. Bierer

Faculty Scholarly Works

Digital applications (apps) are commonly used across the research ecosystem. While apps are frequently updated in the course of clinical and behavioral research, there is limited guidance as to when an app update should trigger action related to human research participant protections and who should be responsible for monitoring and reviewing these updates. We term this the “update problem” and argue that, while it is the principal investigator's duty to track all relevant updates, the level of involvement and re-review by the institutional review board (IRB) of an approved research protocol should vary depending on whether the update may be …

Stemming The Shadow Pandemic: Integrating Sociolegal Services In Contact Tracing And Beyond, Medha D. Makhlouf

Faculty Scholarly Works

The COVID-19 pandemic has shed light on the challenges of complying with public health guidance to isolate or quarantine without access to adequate income, housing, food, and other resources. When people cannot safely isolate or quarantine during an outbreak of infectious disease, a critical public health strategy fails. This article proposes integrating sociolegal needs screening and services into contact tracing as a way to mitigate public health harms and pandemic-related health inequities.

Non-Consensual Disclosures, Nina Varsava

BYU Law Review

In the course of biomedical research on humans — for example, flu, imaging, and genomic studies — researchers often uncover information about participants that is important to their health and wellbeing. In many cases, the information is not anticipated in advance, and participants did not consent to receiving it. This Article examines the law and policy governing human subjects research, focusing on the set of regulations known as the "Common Rule." I argue that human subjects researchers will often have strong ethical reason s to disclose results even when participants did not consent to the disclosure in advance. I also …

Paging Doctor Robot: Medical Artificial Intelligence, Tort Liability, And Why Personhood May Be The Answer, Benedict See

Brooklyn Law Review

Artificial intelligence (AI) is a part of everyday life. From our phones, to social media accounts, to online shopping, AI is present and enhances our daily experiences. One area where AI has a heavy (and an increasing) presence is the medical industry. Just as humans make mistakes, so does AI. However, when a human doctor makes a mistake, they can be sued for malpractice, but when AI makes a mistake, who is to be held responsible? Because tort law was designed with humans in mind, it may be hard to apply to medical AI, who’s “black box” algorithms make their …

Contract Remedies Need Not Undercompensate Aspiring Parents When Cryopreserved Reproductive Material Is Lost Or Destroyed: Recovery Of Consequential Damages For Emotional Disturbance When Breach Of Contract Results In The Lost Opportunity To Become Pregnant With One's Own Biological Child, Joseph M. Hnylka

Journal of Law and Health

The Center for Disease Control and Prevention (CDC) has reported that the use of assisted reproductive technology (ART) has doubled over the past decade. In vitro fertilization (IVF) is the most prevalent form of ART. During IVF, a woman’s eggs are extracted, fertilized in a laboratory setting, and then implanted in the uterus. Many IVF procedures use eggs or sperm that were stored using a process called cryopreservation. A recent survey reported that cryopreservation consultations increased exponentially during the coronavirus pandemic, rising as much as 60 percent. It is estimated that more than one million embryos are stored in cryopreservation …

Copying Copyright: Adopting A Fair Use Defense In Patent Law In Times Of Public Health Crisis, Kellie C. Van Beck

Brooklyn Law Review

Epidemics have devastated humankind for centuries. Given the simultaneous rise of advanced disease prevention and treatment and the great potential for mass public uptake, it is unsurprising that the U.S. pharmaceutical industry has grown to $775 billion in annual sales revenue. It is clear that the commercialization of important public health measures is not without controversy. Of particular debate is that vaccine and other drug manufacturers monopolize their products and control them through patent laws. Yet there is a strong dichotomy between the importance of patents and the need for public access to innovations. This is not to say that …

Pain Is Enough: Chronic Pain As Disability, Katherine L. Moore

Buffalo Law Review

States have historically failed to recognize chronic pain as a disability. In medicine, chronic pain has gained increasing recognition as a disability in and of itself, even absent a current, medically determinable physical impairment. The law, however, has been slow to catch up. This Article argues that chronic pain is a disability, even without medical evidence of an underlying impairment, because of pain’s significant functional impact on the body and mind. In the 2018 case of Saunders v. Wilkie, the United States Court of Appeals for the Federal Circuit recognized that “pain is enough” for a veteran to be …

Scope Of Duty, Counterfactual Analysis And Birth Defects: The Challenging Case Of Khan V Meadows, Kee Yang Low, Jordan Ting Xuan Chia

Research Collection Yong Pung How School Of Law

The tort of negligence has evolved into a sophisticated and calibrated framework. Even then, aspects of this elaborate structure are constantly being tweaked and, sometimes, challenged. Most recently, in the UKSC decision of Khan v Meadows, the spotlight is thrown on scope of duty analysis against the challenging backdrop of medical negligence and unwanted birth defects. The judgment of the majority suggests there is more that needs to be considered at the stage of damages, and that the sequential framework of negligence may benefit from some rearrangement.

Federalized Corporate Governance: The Dream Of William O. Douglas As Sarbanes-Oxley Turns 20, Joan Macleod Heminway

Brooklyn Journal of Corporate, Financial & Commercial Law

The federalization of U.S. corporate governance has been a topic of conversation among policymakers from the very beginning of federal securities law in the New Deal era. Among the early proponents of a federalized system of corporate governance oversight was William O. Douglas—perhaps best known as the longest-serving U.S. Supreme Court justice, but who also was a former commissioner and chair of the U.S. Securities and Exchange Commission. Reflecting on Douglas’s federal corporate governance ideas, Professor Roberta Karmel wrote a law review article for the Delaware Journal of Corporate Law, published in 2005, commenting on the extent and nature of …

Letter In Reply To Bernard Prusak, Et Al., Govind C. Persad

Sturm College of Law: Faculty Scholarship

Scarce medical resource allocation should aim to prevent harm, especially to those who would be most disadvantaged if not helped. Bernard Prusak et al.’s letter reveals a narrow vision of which harms and disadvantages matter, one that overlooks opportunities to simultaneously prevent important harms and avoid exacerbating disadvantage.

Justice Delayed Is Not Justice Denied: Considerations And Concerns For Addressing The National Sexual Assault Kit Backlog, Bryan Schwartz

University of Cincinnati Law Review

Across the nation, many states have started clearing their backlogs of thousands of untested sexual assault kits. Most states have also implemented legislative and procedural safeguards to improve sexual assault investigation and prevent future backlogs. This article first posits that states seeking to address their sexual assault kit backlog should consider Nevada’s approach, which successfully eliminated the backlog and simultaneously reformed its sexual assault investigation procedures. However, this article primarily argues that, without allocating reoccurring future funding to support the recent legislative and procedural changes, states run the risk of future backlogs of sexual assault cases. State legislatures and policymakers …

Shifting Antitrust Laws And Regulations In The Wake Of Hospital Mergers: Taking The Focus Off Of Elective Markets And Centering Health Care, Maya Inka Ureño-Dembar

Brooklyn Law Review

Access to health care requires access to a care center and access to comprehensive health care services. Rampant hospital mergers are uniquely poised to reduce both the number of hospitals, requiring patients to travel further, and the services provided within a newly merged hospital, namely reproductive health services. This phenomenon is clearly seen through the merging of secular and nonsecular hospitals, which often result in patients being forced to travel much further for reproductive health care. In the United States’ current model, health care is not a right, but is treated as a commodity. As such, it is governed by …

I Just Took A Dna Test—Turns Out, I'M 100% Breaching My Donor Anonymity Contract: Direct-To-Consumer Dna Testing And Parental Medical-Decision-Making, Morgan C. York

Indiana Journal of Global Legal Studies

Part I of this note provides a brief history of assisted reproductive technology and its increased use throughout the world, illustrating the growing number of donor-conceived children and the related importance of knowing genetic information. Part I also surveys regulations concerning donor anonymity in the United States and the United Kingdom to illustrate different jurisdictions' approaches to the regulation of donor anonymity. This note uses the United Kingdom as a model of countries that have prohibited sperm donor anonymity. Part II of this note discusses direct-to-consumer DNA testing, specifically 23andMe's products. This note selects 23andMe as the direct-to-consumer company for …

Medical Error Disclosure: A Content Analysis Of State Legislation, Teresa Kathleen Sparks

Graduate Theses and Dissertations

Medical error is a public health problem in the United States (U.S.), causing approximately 250,000 hospital deaths per year. Health care leaders and policy-makers have identified medical error disclosure as one of many viable evidence-based solutions to address the problem of medical error – leading to increased transparency in health care, improved patient outcomes, potential medical malpractice cost reduction, and decreased health care provider distress and turnover. Unfortunately, health care providers are often hesitant to practice disclosure and are not required to do so in most U.S. jurisdictions. A qualitative inquiry using content analysis was conducted to understand the language …

Fighting The Ftca: Medical Malpractice, Veterans, And The Va, Taylor C. Spillers

Arkansas Law Review

Dr. Levy, who served as the Chief of Pathology at the Fayetteville Veterans Health Care System of the Ozarks (“Fayetteville VA”) from 2005 to 2018, diagnosed veterans with an error rate of 10%. The “pathology practice average is 0.7%.” Of the more than 3,000 cases Dr. Levy misdiagnosed, 589 were classified as “Level 3 (major) errors” which should always “trigger an [internal] investigation.” Unfortunately, no investigations ensued until Dr. Levy’s ultimate arrest, although the Fayetteville VA addressed Dr. Levy’s behavior repeatedly throughout his employment.

- د. خليفة بابكر الحسن تقرير عن ندوة المسؤولية الطبية في الشريعة والقانون

UAEU Law Journal

أقامت كلية الشريعة والقانون في إطار نشاطها الفصلي في الفصل الدراسي الأول ندوة عن المسؤولية الطبية في الشريعة والقانون

يوم الثلاثاء 27 ربيع الثاني 1409هـ الموافق 6/12/1988 بقاعة المسرح بالمعهد الإسلامي بالجامعة واشترك فيها لفيق من أساتذة الكلية في الشريعة والقانون بالغضافة إلى طبيب أخصائي من مستشفى الجزيرة بأبوظبي تولى تقديمها الأستاذ الدكتور رمضان السيد علي الشرنباصي رئيس قسم الشريعة الإسلامية بالكلية .

Let It All In? Expert Witness Qualification In Medical Malpractice Lawsuits, Benjamin M. Parks

Louisiana Law Review

The article discusses expert witness qualification under Louisiana Revised Statutes Section 9:2794, and proposes that state legislature should revise statute to promote clarity and consistency for medical malpractice litigants.