The U.S. Senate passed the 21st Century Cures Act on Dec. 6, legislation that has some important implications for health IT including providing funding to initiatives started by President Barack Obama in which health IT plays a major role, interoperability and data blocking, and FDA approval of medical devices.
The Cures Act invests $1.8 billion in Vice President Joe Biden’s project with the National Cancer Institute to transform cancer research, the Cancer Moonshot, which includes the use of health IT, according to a White House release.
The Cures Act also earmarks nearly $3 billion to continue Obama’s BRAIN initiative (The Brain Research through Advancing Innovative Neurotechnologies).
The Brain Initiative aims to further understanding of the brain through the development and application of innovative technologies, including precision medicine and research on other new ways to treat disease, such as the use of genomics. Some political observers have said that all these efforts may be in doubt when the administration of president-elect Donald Trump takes over in 2017.
Interoperability and data blocking
The Cures Act also addresses interoperability and data blocking.
The legislation states that in order to be considered interoperable, technology must satisfy the following criteria:
- Secure transfer of all electronic health information
- Complete access to health information
- Ensure the technology is not set up to block information
The law establishes requirements for interoperability and the certification of health information technologies. It also further prohibits practices from discouraging the exchange of electronic health information.
FDA approval of medical devices
The Cures Act also speeds up and de-regulates the process for the FDA to approve certain medical devices. The Act says: “The FDA must identify types of medical devices that do not require submission of a report prior to commercial marketing.”
This provision has elicited criticism from some liberal Democrats.
The White House addressed these concerns in its release, stating: “Like all comprehensive legislation, the bill is not perfect, and there are provisions the Administration would prefer were improved, but the legislation offers advances in health that far outweigh these concerns.”