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On March 2, 2016, the FDA is hosting a public workshop on “Patient and Medical Professional Perspectives on the Return of Genetic Test Results.”  FDA is convening the workshop to discuss the specific information patients and providers prefer to receive, how those results should be returned, and the information needed to understand such …

Earlier this year, President Obama launched a high-profile “Precision Medicine Initiative” (PMI) to develop treatments, diagnostics, and prevention strategies tailored to the individual genetic characteristics of each patient.  On July 8, 2015 the White House released for public comment a draft document entitled “Precision Medicine Initiative: Proposed Privacy and Trust Principles,” which provides broad guidance…

On February 20, 2015, the FDA is hosting a public workshop on “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests.” The purpose of the workshop is to receive feedback from the community on FDA’s regulatory approach to diagnostic tests for human genetics or genomics using Next Generation Sequencing (NGS) technology. As pointed out…

The Presidential Commission for the Study of Bioethical Issues is requesting public comment on the ethical, legal, and social issues raised by “incidental findings” (e.g., information obtained from testing that was not its intended or expected object) that arise from genetic and genomic testing, imaging, and testing of biological specimens conducted in the clinical, research,…

CMS has announced a July 18, 2011 public meeting to receive comments and recommendations from the public on the appropriate basis for establishing 2012 Medicare payment amounts for a specified list of new CPT codes for clinical laboratory tests.  Registration is required.  Background information will be posted on the CMS website prior to the…

This post was written by Paul Sheives. 

FDA will hold a public workshop on November 2, 2010 to seek input on best practices related to cell and gene therapy clinical trials in pediatric populations. A panel will discuss topics including: (1) evaluating cell and gene therapy products prior to initiating pediatric clinical studies;…

A House Ways and Means Health Subcommittee hearing examined efforts to promote the adoption of health information technology through Medicare incentives designed to encourage the meaningful use of electronic health records. Likewise, the House Energy and Commerce Health Subcommittee held a hearing on implementation of the Health Information Technology for Economic and Clinical Health (HITECH)…

On October 7, 2009, CMS published an interim final rule with comment period implementing sections certain provisions of the Genetic Information Nondiscrimination Act of 2008 (GINA) that prohibit discrimination based on genetic information in health insurance coverage and group health plans.  These interim final regulations are effective on December 7, 2009; comments will be accepted …

The HHS Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) is meeting on October 8 and 9, 2009 to review three SACGHS draft reports: a final draft report and recommendations on gene patents and licensing practices; a public consultation draft report on genetics education and training; and a revised draft paper on direct-to-consumer genetic…

The HHS Secretary’s Advisory Committee on Genetics, Health, and Society has published a notice soliciting comments on a draft report on “Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests.” Comments will be accepted until May 15, 2009; comment submission information is available here.