American Association for Clinical Chemistry
Better health through laboratory medicine
April 2010 Clinical Laboratory News: Regulatory Profiles

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April 2010: Volume 36, Number 4

NIH and FDA to Collaborate on Regulatory Science

FDA and NIH announced a first-of-its-kind collaboration designed to speed new drugs, tests, and devices through the regulatory process. The initiative aims to incorporate both translational science—the shaping of basic scientific discoveries into clinical use—and regulatory science, defined as the tools and standards to efficiently evaluate a product’s safety, efficacy, and quality.

One subject FDA wants help on from NIH is personalized medicine, said FDA Commissioner Margaret Hamburg at a recent event hosted by the Personalized Medicine Coalition. “New approaches to the drug development paradigm are needed such that new drugs are developed along with the tests that inform their use,” she said. “New designs for clinical trials are needed so that genetics or other markers can be used to assist in patient selection, and both clinicians and patients need to be educated so that we can actually see personalized medicine move from concept to practice. As a foundation to this all, we must ensure that FDA has the scientific knowledge, tools, and standards needed to regulate these novel products—often combination products. This is an important component of our new initiative in regulatory science.”

As part of the effort, the two agencies will establish a Joint NIH-FDA Leadership Council to spearhead collaborative work on important public health issues. The Joint Leadership Council will work to help ensure that regulatory considerations are integrated in biomedical research planning, and vice a versa.

In addition, NIH and FDA will jointly issue a Request for Applications, making $6.75 million dollars available over 3 years for work in regulatory science. The research supported through this initiative should add to the scientific knowledge base by providing new methods, models, or technologies that will inform the scientific and regulatory community about better approaches to evaluating safety and efficacy in medical product development.

A public meeting will be held in the spring to solicit input on how the agencies can work better together. More information about the new collaboration is available on FDA’s website.

Report: Electronic Personal Health Information Exchanges Working

After studying four health information exchanges (HIE), the Government Accountability Office (GAO) reported that these entities are generally following practices that protect patient privacy, including limiting disclosure of information, securing electronic information that they store and transmit, and helping ensure accountability for safeguarding electronic personal health information. GAO also found that sharing electronic personal health information about patients has had a positive effect on the quality of care delivered to patients.

HIEs are electronic networks that allow sharing of electronic health records among providers in a geographic area, such as an entire state or a metropolitan area. The HIEs that GAO studied reported that they implement disclosure practices that reflect widely accepted standards for safeguarding personal information–called the Fair Information Practices–to help ensure the appropriate use and disclosure of electronic personal health information for treatment purposes. For example, some providers in the study require direct interaction with patients, such as informing patients of the use and disclosure of personal health information and providing patients access to their own records. Some providers also inform patients that their electronic personal health information may be shared through HIEs.

The HIEs reported that although they have not conducted formal studies or evaluations of the overall effect of electronically sharing personal health information, both the exchanges and providers provided examples of ways that quality of care was improved, such as more quickly reporting abnormal laboratory results and directly linking hospitals to their state’s department of health for real-time reporting.

The report is available from GAO’s website.

Large Recovery Act Awards Aim to Speed Health IT

Health and Human Services (HHS) Secretary Kathleen Sebelius and Labor Secretary Hilda Solis announced a total of nearly $1 billion in awards from the American Recovery and Reinvestment Act of 2009 (ARRA), aimed at helping healthcare providers adopt the so-called “meaningful use” of health IT and train workers for healthcare jobs.

According to HHS, the awards will help make health IT available to more than 100,000 hospitals and primary care physicians by 2014. The funds are targeted at growing the emerging health IT industry, which is expected to support tens of thousands of jobs ranging from nurses and pharmacy techs to IT technicians and trainers. Hospitals and physicians in the U.S. have until 2014 to deploy comprehensive electronic health records (EHR) to meet federal guidelines. If they get started sooner, extra reimbursement is available to those who are up and running in 2011.

Of the more than $750 million investment, $386 million will go to 40 states and qualified State Designated Entities to facilitate health information exchanges (HIE) at the state level, while $375 million will go to an initial 32 non-profit organizations to support the development of regional extension centers (RECs) that will aid health professionals implement and use health IT. Additional HIE and REC awards are to be announced in the near future. RECs will provide outreach and support services to at least 100,000 primary care providers and hospitals within 2 years, according to HHS.

In addition, more than $225 million in Department of Labor grant awards will be used to train 15,000 people in job skills needed to access careers in healthcare and IT through existing partnerships with local employers. The recipients of these grants have already identified roughly 10,000 job openings for skilled workers that likely will become available in the next 2 years. Employment services will be available via the Department of Labor's local One Stop Career Centers, and training will be offered at community colleges and other local education providers.

Additional information about the state HIE and RECs may be found at the HHS website. Information about other health IT programs funded through ARRA can be found online.

Information about Healthcare/High Growth Grants, and other DOL training programs is available online.