21st Century Cures Act

Division A, titled "21st Century Cures," contains provisions related to National Institutes of Health funding and administration, reducing opioid abuse, medical research, and drug development.{{USBill|114|H.R.|34}} [https://www.congress.gov/bill/114th-congress/house-bill/34/text#toc-HF4DFF8B9C70B4DC8984506C3257564BF Division A—21st Century Cures]

{{See also|Opioid crisis|Federal drug policy of the United States}}

The Comprehensive Addiction and Recovery Act (CARA) was passed a few months earlier. This act authorized many harm-reduction strategies, including increased access to the overdose reversal drug naloxone{{cite web|title=The Comprehensive Addiction and Recovery Act (CARA)|publisher=Community Anti-Drug Coalitions of America|url=https://www.cadca.org/comprehensive-addiction-and-recovery-act-cara|access-date=14 October 2020}} for the opioid crisis, but didn't provide any federal funding for implementation. The 21st Century Cures Act designated $1 billion in grants for states over two years to fight the opioid epidemic.{{cite journal |last=Levin |first=Aaron |date=December 30, 2016 |title=Obama Signs Landmark Legislation With Major Mental Health Provisions |journal=Psychiatric News |volume=52 |pages=1 |issue=1| doi=10.1176/appi.pn.2017.1a10 }} The money may be used to improve prescription drug monitoring programs, to make treatment programs more accessible, to train healthcare professionals in best practices of addiction treatment, and to research the most effective approaches to prevent dependency.{{cite news|last1=Jacoby|first1=Sarah|title=What The Controversial 21st Century Cures Act Means For You|url=http://www.refinery29.com/2016/12/133255/21st-century-cures-act-health-funding|access-date=31 December 2016|work=Refinery29|date=December 16, 2016}}

The 21st Century Cures Act modified the FDA Drug Approval process. It was intended to expedite the process by which new drugs and devices are approved by easing the requirements put on drug companies looking for FDA approval on new products or new indications on existing drugs. For instance, under certain conditions, the act allows companies to provide "data summaries" and "real world evidence" such as observational studies, insurance claims data, patient input, and anecdotal data rather than full clinical trial results.

The 21st Century Cures Act facilitates the development and approval of genetically targeted and variant protein targeted drugs for treatment of rare diseases.{{cite web |title=PUBLIC LAW 114–255—DEC. 13, 2016 |url=https://www.govinfo.gov/content/pkg/PLAW-114publ255/pdf/PLAW-114publ255.pdf |website=www.govinfo.gov |publisher=U.S. Government Publishing Office |access-date=2 October 2021}}

In section 3024, the 21st Century Cures Act allows researchers to waive the requirement for "informed consent" in cases where clinical testing of drugs or devices "poses no more than minimal risk" and "includes appropriate safeguards to protect the rights, safety, and welfare of the human subject."

One example is a high-tech bandage that monitors blood flow. Standard procedure requires researchers to obtain the patient's permission before testing any new device on them. However, in this example, researchers might want to test the bandage on unconscious patients. In such circumstances, researchers may waive an informed consent requirement since the patient is still getting the standard, medically accepted care of blood pressure and heart rate monitoring. Researchers would still need to obey standard research protocols including institutional review boards to approve their research design and ethics.

The 21st Century Cures Act calls on the Secretary of Health and Human Services to harmonize differences between the HHS Human Subject Regulations and FDA Human Subject Regulations. In so doing, the Secretary may change rules applying to vulnerable populations in order "to reduce regulatory duplication and unnecessary delays" and "modernize such provisions in the context of multisite and cooperative research projects."

Section 3023 provides for joint or shared review of research, review by institutional review boards other than that of the sponsor of research, and use of other means "to avoid duplication of effort."

The act allocates $4.8 billion to the National Institutes of Health for precision medicine and biomedical research.{{cite news|last1=Kaplan|first1=Sheila|title=Winners and losers of the 21st Century Cures Act|url=https://www.statnews.com/2016/12/05/21st-century-cures-act-winners-losers/|access-date=31 December 2016|work=STAT News|date=5 December 2016}} Of this, $1.5 billion is earmarked for research on brain disease. In October 2016, the Cohort Program{{What|reason=This is not described in the text?|date=July 2024}} was renamed as the All of Us Research Program.{{Cite web |date=2018 |title=All of Us (project web page) |url=https://allofus.nih.gov/ |access-date=20 January 2018 |publisher=U.S. Department of Health & Human Services – National Institutes of Health |language=en}}{{Cite news |last=Muoio |first=Dave |date=7 November 2017 |title=Fitbit wearables will help power NIH's All of Us Research Program |url=http://www.mobihealthnews.com/content/fitbit-wearables-will-help-power-nihs-all-us-research-program |access-date=20 January 2018 |work=MobiHealthNews |language=en}}{{Cite news |date=17 November 2017 |title=NIH Partners With 14 Community Groups, Healthcare Associations on Outreach for All of Us Program |url=https://www.genomeweb.com/research-funding/nih-partners-14-community-groups-healthcare-associations-outreach-all-us-program |access-date=20 January 2018 |work=GenomeWeb |language=en}}

Another $1.8 billion is dedicated to cancer research in what is called the "Beau Biden Cancer Moonshot" initiative, named in honor of Vice President Joe Biden's son Beau Biden, who died of brain cancer in 2015.{{cite news|title=Learn from Cures Act bipartisanship|url=http://www.app.com/story/opinion/editorials/2016/12/17/st-century-cures-act-obama/95567222/|access-date=31 December 2016 |newspaper=Asbury Park Press |department=Editorial |location=Asbury Park, NJ |publisher=Gannett |date=17 December 2016 }}{{cite press release |last1=Biden|first1=Joe|author1-link=Joe Biden |last2=Obama|first2=Barack |author2-link=Barack Obama |title=Remarks by the President and the Vice President at the 21st Century Cures Act Bill Signing |url=https://obamawhitehouse.archives.gov/the-press-office/2016/12/13/remarks-president-and-vice-president-21st-century-cures-act-bill-signing |publisher=The White House, Office of the Press Secretary |location=Washington, DC |access-date=31 December 2016|date=13 December 2016}}{{Cite press release|publisher=American Association for Cancer Research|location=Philadelphia, PA|url=http://www.aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=986|title=AACR Commends President Obama for Signing the 21st Century Cures Act|date=13 December 2016|access-date=2016-12-31}} The initiative aimed to reduce cancer death rates by half.{{Cite news |last=Schumaker |first=Erin |date=29 April 2024 |title=Beating cancer used to be bipartisan. What happened? |url=https://www.politico.com/news/2024/04/29/congress-is-killing-bidens-cancer-moonshot-00154718 |work=Politico}}

When Joe Biden became president, his administration revamped the cancer initiative. On the 60th anniversary of the John F. Kennedy moonshot speech, President Biden gave a speech at the JFK library, promoting the revival of the Beau Biden Cancer Moonshot, including the new Advanced Research Projects Agency for Health.{{cite news |url=https://www.bostonglobe.com/2022/09/12/metro/channeling-jfk-boston-visit-biden-breathes-new-life-into-cancer-moonshot/ |title=Channeling JFK in Boston visit, Biden breathes new life into cancer 'moonshot' |author=Jessica Bartlett |newspaper=The Boston Globe |date=September 12, 2022}}

In May 2024, Congress voted against renewing funding to the program.{{Cite web |last=Lew |first=Dr Thomas K. |title=Congress voted against funding a cure for cancer just to block a win for Biden |url=https://www.usatoday.com/story/opinion/voices/2024/05/05/biden-cancer-moonshot-initiative-congress-funding/73525016007/ |access-date=2024-07-25 |website=USA TODAY |language=en-US}} The 2024 budget passed by Congress was tight, due to Republican control of the house, deficit concerns, and Republican desire to deny Biden a win soon before the election. The White House said it was "well prepared to take forward the cancer moonshot in a tough funding cycle;" mandatory moonshot funding was included in Biden's fiscal year 2025 budget request.

The Act defined interoperability and prohibited21st Century Cures Act, 42 USC § 300jj-52(a)(1)(A) (2016). information blocking.{{Cite journal|last1=Black|first1=Jennifer R.|last2=Hulkower|first2=Rachel L.|last3=Ramanathan|first3=Tara|date=2018-08-22|title=Health Information Blocking: Responses Under the 21st Century Cures Act|journal=Public Health Reports|language=en|volume=133|issue=5|pages=610–613|doi=10.1177/0033354918791544|issn=0033-3549|pmc=6134556|pmid=30134128}} Information blocking is defined as a practice that interferes with or prevents access to electronic health information, that is, information about a patient's medical history or treatment.{{cite web |title=What is an electronic health record (EHR)? {{!}} HealthIT.gov |url=https://www.healthit.gov/faq/what-electronic-health-record-ehr |website=www.healthit.gov |access-date=2 October 2021}}

Under section 4004, information blocking can expose entities to fines of up to $1 million per violation.

Medical software is regulated as a medical device by the FDA in the Federal Food, Drug, and Cosmetic Act.{{Cite journal|last=Health|first=Center for Devices and Radiological|date=2020-09-09|title=What are examples of Software as a Medical Device?|url=https://www.fda.gov/medical-devices/software-medical-device-samd/what-are-examples-software-medical-device|archive-url=https://web.archive.org/web/20190612193643/https://www.fda.gov/medical-devices/software-medical-device-samd/what-are-examples-software-medical-device|url-status=dead|archive-date=June 12, 2019|journal=FDA|language=en}} Section 3060 of the 21st Century Cures Act was created as an amendment to section 520 of the FD&C Act, which addressed how medical devices are defined.{{Cite web|last=Guidance for Industry and Food and Drug Administration Staff|date=|title=Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act|url=https://www.fda.gov/media/109622/download|access-date=|website=Food and Drug Administration}}{{Cite web|last=Health|first=Center for Devices and Radiological|date=2019-09-30|title=Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act|url=https://www.fda.gov/regulatory-information/search-fda-guidance-documents/changes-existing-medical-software-policies-resulting-section-3060-21st-century-cures-act|archive-url=https://web.archive.org/web/20190522235616/https://www.fda.gov/regulatory-information/search-fda-guidance-documents/changes-existing-medical-software-policies-resulting-section-3060-21st-century-cures-act|url-status=dead|archive-date=May 22, 2019|access-date=2020-12-05|website=U.S. Food and Drug Administration|language=en}} It outlined software functions that would be exempt from FDA regulation, such as those used for administrative purposes, encouraging a healthy lifestyle, electronic health records, clinical laboratory test results and related information, and clinical decision tools.{{Cite journal|last1=Evans|first1=Barbara|last2=Ossorio|first2=Pilar|date=2018-08-14|title=The Challenge of Regulating Clinical Decision Support Software After 21st Century Cures|url=https://journals.sagepub.com/doi/10.1177/0098858818789418|journal=American Journal of Law & Medicine|volume=44|issue=2–3|pages=237–251|language=en|doi=10.1177/0098858818789418|pmid=30106648|s2cid=52006753|url-access=subscription}}

{{Expand section|date=January 2017}}

Division C, titled "Increasing Choice, Access, and Quality in Health Care for Americans," concerns Medicare programs and federal tax laws related to health plans for small employers.{{USBill|114|H.R.|34}} [https://www.congress.gov/bill/114th-congress/house-bill/34/text#toc-H3DD73ABD39A0402DAD47C1982E4209C4 Division C—Increasing Choice, Access, and Quality in Health Care for Americans]

The 21st Century Cures Act also included provisions that created a QSEHRA (Qualified Small Employer Health Reimbursement Arrangement), a more efficient way for small businesses and non-profits to offer health insurance to their employees.{{Citation needed|date=July 2024}}

Division B, titled "Helping Families in Mental Health Crisis," addresses the prevention and treatment of mental illnesses and substance abuse, treatment coverage, communication permitted by HIPAA, and interactions with law enforcement and the criminal justice system.{{USBill|114|H.R.|34}} [https://www.congress.gov/bill/114th-congress/house-bill/34/text#toc-H810AAB881DFD45FDBC0C1CAC7FE24E5E Division B—Helping Families in Mental Health Crisis]

The law strengthens mental health parity regulation, which require insurance companies to cover mental health treatments to the same extent and in the same way as medical treatments. It also includes grants to provide community mental health resources, suicide prevention and intervention programs, and de-escalation training for law enforcement. It also provides five-year grants for a demonstration program in which psychiatry residents and other mental health clinicians will practice in underserved areas. Provisions for reform of HIPAA, elevating the standing of families in commitment decisions, and reforms of procedures for challenging release decisions, were not included in the final bill.

Some of these provisions were originally proposed in earlier bills, including

the Mental Health Reform Act of 2016 ({{USBill|114|S.|2680}});

the Mental Health and Safe Communities Act of 2015 ({{USBill|114|H.R.|3722}}, {{USBill|114|S.|2002}});

the Helping Families in Mental Health Crisis Act of 2016 ({{USBill|114|H.R.|2646}});

the Comprehensive Justice and Mental Health Act of 2015 ({{USBill|114|H.R.|1854}}, {{USBill|114|S.|993}});

the Mental Health Awareness and Improvement Act of 2015 ({{USBill|114|H.R.|5327}}, {{USBill|114|S.|1893}});

the Justice and Mental Health Collaboration Act of 2015 ({{USBill|114|H.R.|731}}); and

the Behavioral Health Care Integration Act of 2016 ({{USBill|114|H.R.|4388}}).{{cite web |title=H.R. 34 (114th): 21st Century Cures Act |website=GovTrack |publisher=Civic Impulse, LLC |url=https://www.govtrack.us/congress/bills/114/hr34 |access-date=January 10, 2017 }}

The act requires sale of 25 million barrels of crude oil (10,000,000 in 2017, 9,000,000 in 2018, and 6,000,000 in 2019) from the Strategic Petroleum Reserve.{{cite web |date=21 December 2016 |title=This Week in Petroleum |url=http://www.eia.gov/petroleum/weekly/archive/2016/161221/includes/analysis_print.cfm |access-date=21 December 2016 |publisher=US Department of Energy}}{{USBill|114|H.R.|34}}, [https://www.congress.gov/bill/114th-congress/house-bill/34/text#toc-H5EFDEA271E2D4385A43D08964613EFC5 Sec. 5010. Strategic Petroleum Reserve Drawdown]. Revenue from these sales will provide part of the NIH funding provided in the law.{{cite web |last=Lupkin |first=Sydney |date=25 November 2016 |title=Legislation That Would Shape FDA And NIH Triggers Lobbying Frenzy |url=https://www.npr.org/sections/health-shots/2016/11/25/503176370/legislation-that-would-shape-fda-and-nih-triggers-lobbying-frenzy |website=Shots: Health News from NPR |publisher=National Public Radio}}

The 21st Century Cures Act was originally introduced as {{USbill|114|H.R.|6}} by Fred Upton (R–MI) on May 19, 2015. It passed the House on July 10, 2015, but did not pass in the Senate.{{cite web |title=Actions – H.R.6 – 114th Congress (2015–2016): 21st Century Cures Act |website=Congress.gov |publisher=Library of Congress |date=July 13, 2015 |url=https://www.congress.gov/bill/114th-congress/house-bill/6/actions |access-date=2017-01-10 }}{{Cite web|date=2016-12-14|title=21st Century Cures Act (Public Law 114-255)|url=https://scipol.duke.edu/track/21st-century-cures-act-public-law-114-255|access-date=2020-12-05|website=SciPol.org|language=en}}

More than 1,400 registered lobbyists worked on this bill, representing more than 400 different organizations,{{cite news|last1=Franz|first1=Julia|title=America's new 21st Century Cures Act will speed up drug approvals. Is that a good thing?|url=http://www.pri.org/stories/2016-12-25/americas-new-21st-century-cures-act-will-speed-drug-approvals-good-thing|access-date=2016-12-31|work=PRI|date=December 25, 2016}} mostly pharmaceutical companies.

Of 455 organizations registered to lobby on the bill, the top five by number of reports and specific issues according to OpenSecrets were:

• Roche Holdings (61)
• Blue Cross Blue Shield (49)
• Pharmaceutical Research and Manufacturers of America PhRMA (49)
• Amgen (41)
• American Hospital Association (36).{{Cite web | url=https://www.opensecrets.org/lobby/billsum.php?id=hr6-114 | title=Lobbying Spending Database H.R.6 , 2014 | OpenSecrets}}

The bill passed the House first by a wide margin.{{cite web |first=Sheila |last=Kaplan |date=30 November 2016 |title=House approves the 21st Century Cures Act, sending landmark bill to Senate |website=Stat |url=https://www.statnews.com/2016/11/30/21st-century-cures-act-house/ }} Only five senators voted against it: Elizabeth Warren of Massachusetts; Bernie Sanders of Vermont; Ron Wyden and Jeff Merkley, both of Oregon, all Democrats; and Mike Lee, a Republican of Utah.{{USSRollCall|114|2|157}} Warren, Sanders, and Merkley, in particular, objected to the pharmaceutical industry's influence on the bill. In early December 2016, the act had support from both houses of congress.{{cite news|last1=Pear|first1=Robert|title=Cures Act Gains Bipartisan Support That Eluded Obama Health Law|url=https://www.nytimes.com/2016/12/08/us/politics/cures-act-health-care-congress.html|access-date=14 December 2016|work=The New York Times|date=8 December 2016}}{{cite web|last1=Ornstein|first1=Norm|title=Congress Achieves a Rare Bipartisan Victory for Science|url=https://www.theatlantic.com/politics/archive/2015/07/21st-century-cures-act-bipartisan/398369/|website=The Atlantic|access-date=2016-12-14|date=2015-07-13}}

President Obama signed the act on December 13, 2016.{{cite web|last1=Somanader|first1=Tanya|title=3 Letters That Explain Why President Obama Is Signing the Cures Act|url=https://obamawhitehouse.archives.gov/blog/2016/12/12/3-letters-explain-why-president-obama-signing-cures-act|access-date=2016-12-14|via=National Archives|work=whitehouse.gov|date=13 December 2016}} The reasons stated for his support included combatting opioid abuse, advancing cancer research, advancing the BRAIN Initiative, advancing the Precision Medicine Initiative, and addressing bipartisan health issues.

Stakeholders who praised the passing of the act include drug companies; medical device manufacturers; the National Institutes of Health; people advocating for lowered barriers to collecting human subject research data; Representatives Fred Upton (R-MI), Diana DeGette (D-CO), Timothy F. Murphy (R-PA); Senator Lamar Alexander (R-TN); and Vice President Joe Biden. Hospitals and universities, as well as the American Cancer Society Action Network, Research!America, and FasterCures supported the bill for its commitment toward funding research. The American Psychological Association supported the bill due to its mental health provisions.{{cite press release |first=Jim |last=Sliwa |title=APA Hails House Passage Of Mental Health Provisions In 21st Century Cures Act |url=http://www.apa.org/news/press/releases/2016/12/mental-health-provisions.aspx |publisher=American Psychological Association |location=Washington, DC |access-date=31 December 2016 |date=1 December 2016}} The Advanced Medical Technology Association supported the bill for easing the process of introducing new medical technologies. The American Society of Human Genetics (ASHG) commended the passage of the bill for strengthened genetic privacy for research participants.{{cite press release |first=Nalini |last=Padmanabhan |title=ASHG Supports Genetic Privacy Provisions in 21st Century Cures Act |date=7 December 2016 |url=http://www.ashg.org/press/201612-21CC.html |publisher=American Society of Human Genetics |location=Bethesda, MD |access-date=2 January 2017}}{{cite web|first=Dennis |last=Thompson |date=8 December 2016 |title=Congress passes 21st Century Cures Act with billions for new research, treatments|url=http://www.cbsnews.com/news/21st-century-cures-act-congress-health-care-passed/|website=CBS News |publisher=CBS Interactive Inc. |access-date=2 January 2017}}{{cite news |first=Mike |last=Enzi |author-link=Mike Enzi |date=15 December 2016 |title=Congress acts to protect the most personal data – genetic information |url=http://www.pinebluffspost.com/story/2016/12/15/opinion/congress-acts-to-protect-the-most-personal-data-genetic-information/5208.html |newspaper=Pine Bluffs Post |department=Opinion |location=Pine Bluffs, WY |volume=108 |issue=50 |access-date=2 January 2017}} Prison Fellowship supported the bill due to its inclusion of the Comprehensive Justice and Mental Health Act, a portion designed to encourage collaboration among criminal justice, juvenile justice, mental health treatment, and substance abuse systems.{{cite web|last=DeRoche|first=Craig|title=Urgent need for support for 21st Century Cures Act|date=29 November 2016|website=PrisonTalk.com|url=http://www.prisontalk.com/forums/showpost.php?s=8075199040143178a5ebd8df10abb3d0&p=7585991&postcount=1|archive-url=https://web.archive.org/web/20170223130040/http://www.prisontalk.com/forums/showpost.php?s=8075199040143178a5ebd8df10abb3d0&p=7585991&postcount=1|url-status=usurped|archive-date=February 23, 2017|access-date=22 February 2017}}{{cite web|last=DeRoche|first=Craig|title=Dear Scotty|date=14 December 2016|website=New Abolitionists Radio|url=https://www.facebook.com/newabolitionistsradio/posts/1024553841024552|access-date=22 February 2017}}

Stakeholders who criticized the passing of the act include the FDA, advocates for strong protections in clinical research, consumer organizations, and advocates of regenerative medicine. The expedited drug approval process has been one topic of concern and debate. The Public Citizen's Health Research Group and the National Center for Health Research campaigned against the Cures Act in fear that it will endanger public health by weakening FDA standards. Senator Elizabeth Warren said that the bill had been "hijacked" by the pharmaceutical industry. She said the legislation watered down safety requirements for new drugs and devices and then, as a trade-off, called for research funding — at levels that must be appropriated on an annual basis. John LaMattina, former head of Pfizer research and development and current commentator on the pharmaceutical industry, said that full clinical trials are necessary to prove effectiveness, and suggests some drugs may now be approved based on early data and only later proved ineffective. The Public Citizen's Health Research Group says the designation of "breakthrough" devices is too broad, and could lead to clearance of devices that aren't ready for the market.

Lupkin points out that the NIH's funding will need to be appropriated each year through the normal budget process, and therefore may be reduced from what this bill promised. The NIH funding was actually less than many advocates hoped for, and earlier versions of the bill had promised.{{citation needed|date=December 2016}}

One of the goals of the bill was streamlining approval, but Jerry Avorn and Aaron Kesselheim pointed out that a third of medicines are approved from a single clinical trial averaging fewer than 700 patients;{{Cite journal|last1=Avorn|first1=Jerry|last2=Kesselheim|first2=Aaron S.|date=2015-06-25|title=The 21st Century Cures Act — Will It Take Us Back in Time?|journal=New England Journal of Medicine|language=EN|volume=372|issue=26|pages=2473–2475|doi=10.1056/nejmp1506964|pmid=26039522|issn=0028-4793}} ultimately, however, the law did not allow real-world evidence for approving drugs, but rather for label expansions.{{Cite news|url=https://www.science.org/content/blog-post/politics-21st-century-cures-act|title=The Politics of the 21st Century Cures Act|date=2016-12-09|work=In the Pipeline|access-date=2018-11-25|language=en-US}}

• BRAIN Initiative
• Cancer Moonshot 2020
• Precision Medicine Initiative

{{reflist}}

{{refbegin}}

• {{cite web |date=14 December 2016 |url=https://energycommerce.house.gov/cures |website=United States House of Representatives: Energy and Commerce Committee |title=21st Century Cures |access-date=22 December 2016 |archive-url=https://web.archive.org/web/20161224190803/https://energycommerce.house.gov/cures |archive-date=24 December 2016 |url-status=dead }}
• {{cite web |date=1 May 2014 |url=http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/analysis/21stCenturyCures/20140501WhitePaper.pdf |website=United States House of Representatives: Energy and Commerce Committee |title=21st Century Cures: A Call to Action }}
• {{cite web |date=26 January 2015 |title=Discussion Document 114th Congress, 1st Session: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes |website=United States House of Representatives: Energy and Commerce Committee |url=http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/114/Analysis/Cures/20150127-Cures-Discussion-Document.pdf }}
• {{cite web |date=27 January 2015 |title=The 21st Century Cures Discussion Document |website=United States House of Representatives: Energy and Commerce Committee |url=http://energycommerce.house.gov/sites/republicans.energycommerce.house.gov/files/files/114/FINAL%20Cures%20Discussion%20Document%20White%20Paper.pdf }}
• {{cite journal|last1=Hudson|first1=Kathy L.|last2=Collins|first2=Francis S.|author2-link=Francis Collins|title=The 21st Century Cures Act — A View from the NIH|journal=New England Journal of Medicine |volume=376 |issue=2 |pages=111–113 |date=12 January 2017 |issn=0028-4793 |doi=10.1056/NEJMp1615745 |doi-access=free |pmid=27959585 |pmc=6688288}}
• {{cite journal|last1=Avorn|first1=Jerry|last2=Kesselheim|first2=Aaron S.|title=The 21st Century Cures Act — Will It Take Us Back in Time?|journal=New England Journal of Medicine|volume=372|issue=26|date=25 June 2015|pages=2473–2475|issn=0028-4793|doi=10.1056/NEJMp1506964 |doi-access= |pmid=26039522 }}
• {{cite web |last=Stone |first=Judy |date=22 September 2016 |url=https://www.forbes.com/sites/judystone/2016/09/22/21st-century-cures-act-pork-or-promise/ |website=Forbes |title=21st Century Cures Act: Pork or Promise? }}
• {{cite web |date=25 June 2015 |title=We Support the 21st Century Cures Act |url=http://www.nationalhealthcouncil.org/21-century-cures-support |website=National Health Council }}
• {{cite press release |first=Barack |last=Obama |author-link=Barack Obama |date=3 December 2016 |title=Weekly Address: Pass the 21st Century Cures Act |publisher=The White House, Office of the Press Secretary |location=Washington, DC |url=https://obamawhitehouse.archives.gov/the-press-office/2016/12/03/weekly-address-pass-21st-century-cures-act }}
• {{cite web |author=Alden |date=19 February 2015 |title= 21st Century Cures: Improving the cycle from discovery to treatment |url=http://curealliance.org/21st-century-cures/ |website=Cure Alliance for Mental Illness }}
• {{cite web |first=Paul |last=Gionfriddo |date=15 December 2016 |title=Why the New Mental Health Reform Law Passed, and What It Means to Me |url=http://www.mentalhealthamerica.net/blog/why-new-mental-health-reform-law-passed-and-what-it-means-me |website=Mental Health America }}
• {{cite web |first=Sydney |last=Lupkin |date=28 November 2016 |title=A Frenzy Of Lobbying On 21st Century Cures |website=Kaiser Health News |publisher=Kaiser Family Foundation |url=http://khn.org/news/a-frenzy-of-lobbying-on-21st-century-cures/ }}

{{refend}}

• [https://www.govinfo.gov/content/pkg/COMPS-13005/uslm/COMPS-13005.xml 21st Century Cures Act] as amended ([https://www.govinfo.gov/content/pkg/COMPS-13005/pdf/COMPS-13005.pdf PDF]/[https://www.govinfo.gov/app/details/COMPS-13005 details]) in the GPO [https://www.govinfo.gov/help/comps Statute Compilations collection]
• [https://www.govinfo.gov/link/plaw/114/public/255?link-type=uslm 21st Century Cures Act] as enacted ([https://www.govinfo.gov/link/plaw/114/public/255?link-type=pdf&.pdf PDF]/[https://www.govinfo.gov/link/plaw/114/public/255?link-type=details details]) in the US Statutes at Large
• {{USBill|114|hr|34}} on Congress.gov
• Health and Human Services Department's final rule on [https://www.federalregister.gov/d/2020-07419 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program] in the Federal Register
• 45 CFR [https://www.law.cornell.edu/cfr/text/45/part-170 Part 170] and [https://www.law.cornell.edu/cfr/text/45/part-171 Part 171] on LII
• 45 CFR [https://www.ecfr.gov/current/title-45/part-170?toc=1 Part 170] and [https://www.ecfr.gov/current/title-45/part-171?toc=1 Part 171] on the e-CFR
• [https://www.healthit.gov/curesrule/ Cures Act Final Rule] website from the ONC

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Category:Acts of the 114th United States Congress

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