21st Century Cures

The 21st Century Cures Act (P.L. 114-255) is landmark, bipartisan legislation that was signed into law on Dec. 13, 2016, and touches virtually all aspects of biomedical research, medical product development and the regulatory approval process. Read what FasterCures has said about 21st Century Cures over the years.

FasterCures worked closely with Congress, federal agencies and the advocacy community throughout the legislation’s journey to the president’s desk. In February 2017, we debuted the 21st Century Cures Tracker to track the implementation of the 100+ sections in Division A, which include the key provisions relevant to biomedical research and innovation. (Other divisions of the law pertain to mental health and Medicare; since those are not areas of focus for FasterCures, we will not be actively tracking them here.) Learn more about how to use the tracker with our FAQs page.

A few examples of the issues we will be tracking include the impact of changes to the National Institutes of Health’s administrative requirements for grantees, how the Food and Drug Administration implements new changes designed to enhance patient engagement and how the Department of Health and Human Services is using its new authorities to promote health information technology interoperability.

Many external factors will affect the progress of these initiatives, including policies related to hiring freezes and uncertain funding levels. This tracker is not meant to be a pass/fail report card, but rather a snapshot in time that can help explain impact and identify where progress is needed.

Please keep coming back, as we will be updating the information regularly. Use the button below to send us feedback on the value of the information we are presenting, and the usability of this new resource.

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FasterCures' 21st Century Cures Act Tracker (P.L. 114-255)

Status Section Tracked Deadlines and Requirements Update Date of Update Tags
fa fa-2x fa-binoculars Sec. 4004. Information blocking. HHS is directed, through rule-making, to determine activities that do not constitute information blocking, and therefore are not subject to penalties established by this section. (No date provided in law.)

8/14/2019: CMS requests information on the provider to patient exchange initiative specific to the Cures Act’s proposed rule for new proposals that focus on how certified health IT can use APIs to allow health information to be accessed, exchanged, and used without special effort through the use of APIs or successor technology or standards, as provided for under applicable law.

8/8/2019: HHS requested healthcare providers review the proposed rules, “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program” and “Interoperability and Patient Access,” and provide feedback on they might affect prospective payment rates for inpatient rehab facilities (IRFs). CMS announced the feedback here.

8/7/2019: HHS requested healthcare providers review the proposed rules, “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program” and “Interoperability and Patient Access,” and provide feedback on they might affect prospective payment systems for skilled nursing facilities (SNFs). CMS announced the feedback here.

4/25/2019: CMS proposed a rule which will further interoperability and advance health information exchange. Comments are requested for the proposed rule, and may be submitted electronically until June 18, 2019.

2/11/2019: HHS proposed a new rule to improve the interoperability, access, and exchange of electronic health information, impacting sections 4001, 4002, 4003, 4004, and 4006 of the Cures Act. Comments are requested for the proposed rule, and may be submitted electronically until 5/3/2019.

12/11/2018: The Subcommittee on Health held a hearing entitled "Implementing the 21st Century Cures Act: An Update from the Office of the National Coordinator" which included a discussion on information blocking.

7/31/2018: The Centers for Medicare and Medicaid Services posed a question pertaining to the reduction of information blocking if CMS were to propose a new CoP/CfC/RfP standard to require electronic exchange of medically necessary information.

4/8/2018: POLITICO speculated at a summer release of information blocking rule by HHS

10/31/2017: James A. Cannatti III Senior Counselor for Health Information Technology provided testimony on HHS activities before the United States Senate Committee on Health, Education, Labor, and Pensions. 

20190815 08/15/2019 Health IT, HHS, Interoperability, ONC, Regulatory Affairs
fa fa-2x fa-long-arrow-right Sec. 4006. Empowering patients and improving patient access to their electronic health information. Requires HHS issuance of guidance to health information exchanges on best practices to ensure that patient data is private, secure, accurate, and able to be shared when appropriate.

8/14/2019: CMS requests information on the provider to patient exchange initiative specific to the Cures Act’s proposed rule for new proposals that focus on how certified health IT can use APIs to allow health information to be accessed, exchanged, and used without special effort through the use of APIs or successor technology or standards, as provided for under applicable law.

8/8/2019: HHS requested healthcare providers review the proposed rules, “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program” and “Interoperability and Patient Access,” and provide feedback on they might affect prospective payment rates for inpatient rehab facilities (IRFs). CMS announced the feedback here.

8/7/2019: HHS requested healthcare providers review the proposed rules, “21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program” and “Interoperability and Patient Access,” and provide feedback on they might affect prospective payment systems for skilled nursing facilities (SNFs). CMS announced the feedback here.

2/11/2019: HHS proposed a new rule to improve the interoperability, access, and exchange of electronic health information, impacting sections 4001, 4002, 4003, 4004, and 4006 of the Cures Act. Comments are requested for the proposed rule, and may be submitted electronically until 5/3/2019.

20190815 08/15/2019 Guidances, Health IT, HHS, Interoperability, ONC

 

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