The House Committee for Energy & Commerce recently published a discussion document following the release of the 21st Century Cures initiative. The document includes five titles that touch on everything from regulation centered on patient care and support for research conducted for medical advancement to clinical data sharing.
Congress' decision to continue its plans to use personalized medicine initiatives to encourage and support modernizing medicine comes at a time of significant political activity within the executive branch of the federal government.
New legislation set to enhance health IT
The proposed regulations are likely to have a major impact on health IT. For example, the government's regulation for clinical sharing suggests the need for uniform standards and new clinical data registries that would work to enhance and support real-time data transfer between electronic health records. EHR systems are essential to improving patient care quality and enhancing practice documentation, so it is crucial that the migration of data between systems is as efficient as possible for providers and end-users.
In addition, the legislation included standards for adjudicating and reporting unfavorable events, as well as clinical data security and integrity. The Secretary of the Department of Health & Human Services would be given a full year to asses clinical data registries to enhance patient care and provide recommendations involving standards that support interoperable health IT, such as EHR systems and the bidirectional flow between registries.
"These ideas represent an important milestone – a critical first step in a legislative process. Our solutions to boost cures and jobs are starting to take shape as we move from broad principles to legislative language," Chairman Fred Upton noted in the document.
Precision and personalized medicine: One in the same
President Obama's Precision Medicine plan released last week highlights the need for investment in medical innovation. However, it has left many experts concerned as to how the new legislation proposed by the House Committee for Energy & Commerce will mesh with the president's new plan.
However, the president has assured the health care industry that precision medicine and personalized medicine are closely related, implying that the plans will mesh nicely. The fact that both the executive and legislative branches agree on the concept of data sharing and personalized medication suggests smooth sailing as Obama's plan and the legislation are implemented.
"Because we shouldn't just celebrate innovation," Obama stated in a public address. "We have to invest in innovation. We have to nurture innovation. We have to encourage it and make sure that we're channeling it in ways that are most productive. And that's especially true when it comes to medicine."
The president recently sent the Precision Medicine Initiative to Congress. The plan currently consists of four primary focuses. The first is centered around working with the National Cancer Institute to identify genetic causes of cancer and treatment methods.
The second focus is on identifying the most effective methods to assess next-generation genetic tests by working closely with the Food & Drug Administration, while the third consists of collaborating with the National Institutes of Health to construct a genetic library after forming a group of volunteer researchers to take on the project. Patient privacy is the final goal of the plan.