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 best practices.  The full post can be read here.

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 hereContinue 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.

While the address was scant on detail, the President’s Precision Medicine Initiative appears intended to foster the development and delivery of personalized treatments for illnesses such as cancer and diabetes.  In a blog post late Wednesday afternoon, the White House noted that precision medicine “takes into account individual differences in people’s genes, environments, and lifestyles, making it possible to design highly effective, targeted treatments for cancer and other diseases.”  Echoing the President’s speech, the post cited a new treatment for cystic fibrosis (CF) that may dramatically extend longevity for those CF patients carrying a rare genetic mutation.  Similarly, precision medicine may allow physicians to optimize treatments for cancer and other illnesses based on a patient’s genetic traits.  Health information technology may be key in understanding and applying factors that can be used to tailor such treatments.

The President also called on Congress to pass cybersecurity legislation to guard against cyber attacks and protect privacy.  The President began to release details of the proposal last week; the proposed legislation would increase information sharing both within the private sector and between government and the private sector; expand criminal penalties and law enforcement authority related to cyber attacks and identity theft; and impose a single, federal data breach reporting standard.  Cybersecurity has become an increasing concern for health care providers though stakeholders appear divided over the need for additional legislation.

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