Law Commons^™

Healthy Data Protection, Lothar Determann

Michigan Technology Law Review

Modern medicine is evolving at a tremendous speed. On a daily basis, we learn about new treatments, drugs, medical devices, and diagnoses. Both established technology companies and start-ups focus on health-related products and services in competition with traditional healthcare businesses. Telemedicine and electronic health records have the potential to improve the effectiveness of treatments significantly. Progress in the medical field depends above all on data, specifically health information. Physicians, researchers, and developers need health information to help patients by improving diagnoses, customizing treatments and finding new cures.

Yet law and policymakers are currently more focused on the fact that health …

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 …

A Comment On Privacy And Accountability In Black-Box Medicine, Carl E. Schneider

Michigan Telecommunications & Technology Law Review

Human institutions and activities cannot avoid failures. Anxiety about them often provokes governments to try to prevent those failures. When that anxiety is vivid and urgent, government may do so without carefully asking whether regulation’s costs justify their benefits. Privacy and Accountability in Black Box Medicine admirably labors to bring discipline and rationality to thinking about an important development — the rise of “black-box medicine” — before it causes injuries regulation should have prevented and before it is impaired by improvident regulation. That is, Privacy and Accountability weighs the costs against the benefits of various forms of regulation across the …

Privacy And Accountability In Black-Box Medicine, Roger Allan Ford, W. Nicholson Price Ii

Michigan Telecommunications & Technology Law Review

Black-box medicine—the use of big data and sophisticated machine-learning techniques for health-care applications—could be the future of personalized medicine. Black-box medicine promises to make it easier to diagnose rare diseases and conditions, identify the most promising treatments, and allocate scarce resources among different patients. But to succeed, it must overcome two separate, but related, problems: patient privacy and algorithmic accountability. Privacy is a problem because researchers need access to huge amounts of patient health information to generate useful medical predictions. And accountability is a problem because black-box algorithms must be verified by outsiders to ensure they are accurate and unbiased, …

Satmed: Legal Aspects Of The Physical Layer Of Satellite Telemedicine, Stephen Rooke

Michigan Journal of International Law

In 2003, Paul Hunt, the U.N. Commission on Human Rights' Special Rapporteur on the Right to Health, presented a report on the global availability of health care. Special Rapporteur Hunt argued that states are obligated to implement a right to health. Included in this right is the obligation "to ensure that no international agreement or policy adversely impacts upon the right to health, and that .. . international organizations take due account of the right to health, as well as the obligation of international assistance and cooperation, in all policy-making matters." One area Hunt left unexplored in his report was …

Property As Control: The Case Of Information, Jane B. Baron

Michigan Telecommunications & Technology Law Review

If heath policy makers' wishes come true, by the end of the current decade the paper charts in which most of our medical information is currently recorded will be replaced by networked electronic health records ("EHRs").[...] Like all computerized records, networked EHRs are difficult to secure, and the information in EHRs is both particularly sensitive and particularly valuable for commercial purposes. Sadly, the existing federal statute meant to address this problem, the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), is probably inadequate to the task.[...] Health law, privacy, and intellectual property scholars have all suggested that the river …

Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang

University of Michigan Journal of Law Reform

Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …

There Is A Time To Keep Silent And A Time To Speak, The Hard Part Is Knowing Which Is Which: Striking The Balance Between Privacy Protection And The Flow Of Health Care Information, Daniel J. Gilman, James C. Cooper

Michigan Telecommunications & Technology Law Review

Health information technology (HIT) has become a signal element of federal health policy, especially as the recently enacted American Recovery and Reinvestment Act of 2009 (Recovery Act or ARRA) comprises numerous provisions related to HIT and commits tens of billions of dollars to its development and adoption. These provisions charge various agencies of the federal government with both general and specific HIT-related implementation tasks including, inter alia, providing funding for HIT in various contexts: the implementation of interoperable HIT, HIT-related infrastructure, and HIT-related training and research. The Recovery Act also contains various regulatory provisions pertaining to HIT. Provisions of the …