Search results for: precision medicine

Last week I published an article on the Inside Medical Devices Blog, discussing eight data security principles that companies participating in the Precision Medicine Initiative should aim to meet.  The Administration’s guidance document additionally recommends a basic framework that organizations collecting, storing, and sharing patient information should adopt as current…
Continue Reading Obama Administration Releases Final Data Security Policy Principles and Framework for Its Precision Medicine Initiative

Yesterday, the Senate Health, Education, Labor and Pensions (HELP) Committee held a final mark-up of legislation comprising the Committee’s counterpart to the House-passed 21st Century Cures Act.  The HELP Committee approved five bills including S. 2713 to advance the development of “precision medicine” through research and data sharing.  We have reported on the President’s precision medicine initiative in other posts available here. 
Continue Reading Senate HELP Committee Marks Up Precision Medicine, Other “Cures” Bills

In a 107-page report, released last week, the White House set forth its plan to create and manage a database containing 1 million or more Americans’ medical records in furtherance of the Precision Medicine Initiative. As announced by President Obama during his 2015 State of the Union Address, the Precision Medicine Initiative was launched “to bring us closer to curing diseases like cancer and diabetes, and give all of us access to the personalized information we need to keep ourselves and our families healthier.”

To achieve this goal, the Precision Medicine Initiative Cohort Program (“PMI-CP”) will build a “research cohort” of at least 1 million volunteers, which will provide the “platform” for improved understanding and knowledge of precision medicine approaches. As explained in the report, “[p]recision medicine is an approach to disease treatment and prevention that seeks to maximize effectiveness by taking into account individual variability in genes, environment, and lifestyle.”
Continue Reading Report Outlines Plan for Precision Medicine Database

As we described in an a post last month, in the State of the Union the President announced a new “Precision Medicine Initiative” to foster the development and delivery of personalized treatments for illnesses such as cancer and diabetes.  The FY 2016 budget released by the President yesterday includes $215 million in funding to launch the Precision Medicine initiative.
Continue Reading President’s Budget Includes Funding for Precision Medicine Initiative

This year’s State of the Union address included little explicit discussion of health IT, but did highlight two areas that could have significant implications for health IT: the President announced a new “Precision Medicine Initiative” and also urged Congress to pass legislation to combat cyber attacks and prevent identity theft.
Continue Reading President Obama Announces Precision Medicine Initiative, Presses for Cybersecurity Legislation

Hot on the heels of recent announcements from the U.S. Food and Drug Administration (see our prior blogs here), the European Medicines Agency (“EMA”) has joined the conversation on the use of Artificial Intelligence (“AI”) and Machine Learning (“ML”) technologies in the medicinal product lifecycle.

AI and ML have…

Continue Reading EMA Releases Reflection Paper on AI/ML in the Medicinal Product Lifecycle

Bloomberg BNA reports (subscription required) that FDA will recognize a regulatory category called “complementary diagnostics” for tests that provide additional information about how a drug might be used, but that are distinct from “companion diagnostics,” which are essential for the safe and effective use of a drug.
Continue Reading FDA to Focus on “Complementary” Diagnostics in Addition to Companion Diagnostics