Law Commons^™

Direct To Consumer Or Direct To All: Home Dna Tests And Lack Of Privacy Regulations In The United States, Karen J. Kukla

IP Theory

Although the U.S. has some measures of privacy protection for genetic data, the lack of a comprehensive approach to protecting direct-to-consumer genetic testing results in privacy violations for both consumers and their relatives. This essay explores the critical need for the U.S. government to address these privacy violations and argues that the U.S. should approach the problem and strategize a solution similar to the European Union’s (EU) General Data Protection Regulation (GDPR). Part I identifies current United States law, both federal and state regulations that address DTC-GT and genetic privacy. Part II examines the lack of regulation surrounding current DTC-GT …

Encouraging Public Access To Pharmaceuticals Through Modified Protection Of Clinical Trial Data, Scott M. Nolan Ii

IP Theory

Part I of this Article investigates the development of pharmaceuticals and clinical trial data with a focus on patent and data protection. Part II evaluates the effects of protection and the challenges it poses to widespread public pharmaceutical access. Part III discusses two scholarly approaches to the public access issue that focus on clinical data protection and their associated challenges. In light of these scholarly works, Part IV suggests a new approach to clinical trial data protection that aims to improve public pharmaceutical access while maintaining the incentives to invent for drug developers.

Privacy Vs. Transparency: Handling Protected Materials In Agency Rulemaking, Christopher S. Yoo, Kellen Mccoy

Indiana Law Journal

Agencies conducting informal rulemaking proceedings increasingly confront conflicting duties with respect to protected materials included in information submitted in public rulemaking dockets. They must reconcile the broad commitment to openness and transparency reflected in federal law with the duty to protect confidential business information (CBI) and personally identifiable information (PII) against improper disclosure.

This Article presents an analysis of how agencies can best balance these often countervailing considerations. Part I explores the statutory duties to disclose and withhold information submitted in public rulemaking dockets placed on agencies. It also examines judicial decisions and other legal interpretations regarding the proper way …

Panel One: Information Issues: Intellectual Property, Privacy, Integrity, Interoperability, And The Economics Of Information, Anne W. Branscomb, Brian Kahin, Ellen M. Kirsh, P. Michael Nugent, Fred H. Cate

Federal Communications Law Journal

The first panel of From Conduit to Content: The Emergence of Information Policy and Law examines the wide range of legal and regulatory issues presented by information, including intellectual property, privacy, free expression, liability for false or damaging expression, interoperability, international trade, antitrust, and government investment in and provision of information. Participants include Anne W. Branscomb, Fred H. Cate, Brian Kahin, Ellen M. Kirsh, and P. Michael Nugent.

From Conduit to Content: The Emergence of Information Policy and Law. The Annenberg Washington Program. Friday, March 3 1995, Washington, D.C.