Precision Medicine’s Future in Government

This blog is an excerpt from GovLoop’s recent guide, Cybersecurity, Analytics & More: The 8 Government Health IT Trends You Need to Know. Download the full guide here

Trend: Precision Medicine

The National Institutes of Health defines precision medicine as “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.” This information can give researchers and clinicians greater insight into a disease and how it can be treated.

Why This Trend Matters in Government Right Now

In his 2015 State of the Union address, President Barack Obama announced the creation of the Precision Medicine Initiative (PMI). This initiative capitalizes on the convergence of several factors: broader adoption of EHRs, greater patient engagement in health research, more mobile health technologies, more sophisticated data analytics and less expensive genomic analysis.

These factors mean that health care can shift from the traditional one- size-fits-all model in which doctors treat patients as if they were genetically identical, without any regard for differences in the disease makeup or individual responses. This can result in less effective and costlier treatments.

Precision medicine has already had some success, especially in oncology. Patients with certain types of cancer, such as breast cancer, melanoma and leukemia, can have their genomes profiled in order to provide physicians with a better understanding of their genetic makeup as well as the tumor’s.

PMI aims to expand on these advances and spread its success to other common diseases, such as diabetes, heart disease, Alzheimer’s disease, obesity and mental illnesses. In addition to helping target diseases, precision medicine will help provide insights into how we can increase overall population health and lower health care costs.

The initiative includes a $215 million budget to develop a national research cohort of 1 million volunteers, increase efforts to identify genomic drivers in cancer, build high-quality databases to make the data accessible and create interoperability standards to securely share data across systems.

Precision Medicine in Government Today

While transformative, Obama’s initiative isn’t the first major effort in the field.

The Veterans Health Administration established the Million Veteran Project in 2012. The project aims to collect health information and DNA analysis from 1 million veterans and active-duty personnel. A Military Times article highlights the vast scale of the project, which currently has blood samples and medical histories from more than 455,000 veterans. VA officials expect to have more than 500,000 volunteers by June 2016 and reach the mil- lion-member mark by 2020.

The project reaches nationwide, with more than 50 volunteer sites, but also has centralized hubs for data sharing and sample storage. In addition to collecting information and blood samples, it has specialized ongoing research on the genetic makeup of individuals with schizophrenia, bipolar disorder, heart disease, kidney disease and substance abuse. Scientific American notes, “Now, as other research groups try to scale up their own efforts for the president’s initiative, the VA effort is one of the lone guideposts in a field with few landmarks.”

What’s Next? 

Included in PMI’s budget is $130 million dedicated to the development of a volunteer research cohort through NIH. The agency funded a pilot program for a PMI Cohort Program informational website and participant interface, and enrollment is expected to begin later this year.

Armed with new genetic information and funding, the National Cancer Institute will develop new clinical trials on targeted cancer treatments and drug resistance, new laboratory research models, and a national cancer knowledge system to share new insights.

Precision medicine also changes the way patients interact with their health care. Although there is an emphasis on genetic make-up, precision medicine also looks more broadly at an individual’s environment and lifestyle to provide the best possible care. This will require massive amounts of patient-generated data, leading to the increased use of mobile health applications. In turn, EHRs will need to be able to incorporate that data, requiring interoperability between the applications and the health records.

With so much personal data, security, analytics and interoperability are key issues that need to be addressed. NIH is working to develop effective methods for data sharing and analytics as part of the cohort program.

What You Need To Know 

#1: Security and privacy are major concerns.

As precision medicine initiatives gather the personal health data of hundreds of thousands of individuals, security needs to be balanced with effective data sharing. Researchers, clinicians and patients need to be able to produce, access and share data while protecting individual privacy and security.

#2: Data must be available and accessible.

Precision medicine needs to address problems of scale, incompatible technologies across hospitals and research centers, and data silos due to competition.

#3: Patient engagement is key.

PMI’s success requires the participation and continuous engagement of a million or more Americans. For the cohort to be representative, the initiative must attract volunteers from a variety of age groups, health statuses, and geographic, social, and economic backgrounds.

Download the full guide here

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