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Full-Text Articles in Law
Regulating Black-Box Medicine, W. Nicholson Price Ii
Regulating Black-Box Medicine, W. Nicholson Price Ii
Michigan Law Review
Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process of care, and increase efficiency. Those algorithms, however, vary widely in quality. Some are accurate and powerful, while others may be riddled with errors or based on faulty science. When an opaque algorithm recommends an insulin dose to a diabetic patient, how do we know that dose is correct? Patients, providers, and insurers face substantial difficulties in identifying high-quality algorithms; they …
The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah
The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah
Michigan Telecommunications & Technology Law Review
Until the December 2016 passage of the Cures Act, the FDA had regulatory power over clinical decision support (CDS) software; however, the Act removed a large group of CDS software from the FDA’s statutory authority. Congressional intent was to increase innovation by removing regulatory blockades—such as device testing and certification—from the FDA’s purview. This note argues that the enactment of this specific provision of the Act will instead stymie innovation and overlook the unfortunate safety consequences inherent in its deregulation. CDS software is a burgeoning field ripe for innovation; however, rapid innovation can often lead to a slew of mistakes—mistakes …
Should Regulatory Compliance Be A Goal Or A Constraint For Health Care Companies? Finding Effective Methods To Assure Compliance With The Federal Anti-Kickback Statute And The False Claims Act, Roni A. Elias
Florida A & M University Law Review
The stereotypical conception of compliance is reinforced by some of the fundamental assumptions about what the primary objectives of a corporation should be and about how a corporation should accomplish those objectives. According to the prevailing theory of corporate structure, a corporation exists for the sole purpose of earning profits for its shareholders, and all of its actions are to be directed toward that end. If compliance with the law is not an inherently profit making activity, it is to be treated as a constraint on the corporation's efficient operation. According to this view, compliance will generally be considered a …
Working Well(Ness): The Impact Of The Ada Final Rule On Wellness Program Regulation And A Proposal For A Zero-Incentive Rule, Stefanie Brody
Working Well(Ness): The Impact Of The Ada Final Rule On Wellness Program Regulation And A Proposal For A Zero-Incentive Rule, Stefanie Brody
Saint Louis University Journal of Health Law & Policy
The Equal Employment Opportunity Commission (EEOC) recently amended wellness program regulation under 29 C.F.R. § 1630.14 of the Americans with Disabilities Act (ADA). Amidst criticism of the new rule, this article proposes the EEOC return to a zero-incentive policy for voluntary wellness programs that include disability-related inquiries or medical examinations. First, it reviews existing literature on wellness programs and the ADA, highlighting the legal and ethical challenges facing American workers with disabilities. Then, it explores the latest case law, illustrating the effects of the new rule compared to the proposal. By eliminating the thirty percent incentive limit and redefining “voluntary” …