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Landmark 21st Century Cures Act

Jason S. Shapiro, MD, FACEP
ACEP Emergency Medicine Informatics Section Chair
Professor, Emergency Medicine
Icahn School of Medicine at Mount Sinai

Jason Shapiro_2016On Tuesday, December 13, 2016, President Barack Obama signed the $6.3 billion 21st Century Cures Act into law. The bill received overwhelming bipartisan support, and is aimed at helping “modernize and personalize health care, encourage greater innovation, support research, and streamline the system,” according to its mission statement.

The Act is organized into three parts: 1) Discovery, which provides $4.8 billion to the NIH, including $1.5 billion to expand the Precision Medicine Initiative, and $1.8 billion to fund Vice President Biden’s Cancer Moonshot and the BRAIN Initiative, and also includes an NIH Innovation fund to implement a new strategic plan and support early investigators and high-risk/high-reward research. 2) Development, which focuses on streamlining drug and device development processes at the FDA to more rapidly translate scientific discoveries into treatments, and 3) Delivery, which focuses on bringing new therapies to patients in a timely manner, and which addresses many important issues in informatics, including interoperability, usability, information blocking, patient access to information, increased exchange among HIEs, and reducing clinical documentation burdens for physicians.

Specifically, sections 4001 to 4008 of the full 996-page act: 1) encourage certification of HIT and reduce documentation burden on clinicians; 2) create a reporting system to gather information about EHR usability and interoperability; 3) create a digital provider directory and a framework for adoption of standards developed in the private sector to promote interoperability; 4) grant enforcement powers to the HHS Office of the Inspector General to assign penalties for information blocking; 5) promote exchange between registries and EHRs; 6) promote certification of patient-centered EHRs and promote patient access to their information through HIEs; 7) fund further study of methods for secure patient record matching; and 8) require a review of barriers to and methods for patient access to their electronic health information. Section 4013 also establishes a bipartisan working group to explore clinical conditions that might improve with telehealth. This is very important legislation that will have a significant impact on the practice of emergency medicine and the advancement of emergency medicine informatics priorities. There is a detailed summary of the 21st Century Cures Act on the website for those seeking more information.

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