Policy/Regulation Fact Sheet
The 21st Cures Act
The development and implementation of a nationwide electronic health record system holds
great assurance for nursing practice and nursing informatics (McGonigle & Mastrian, 2018).
Even though the federal regulation provides patients the right to access their EHR and
encourages increased use of HIT, patient’s access to EHR remains limited. I selected, The
21st Century Cures Act as my nursing informatics policy for system implementation. The 21st
Century Cures Act is enacted into a law and has got important features that could
significantly improve access and health data availability. These features will call for
collaboration among health information exchange networks, educational and research
initiatives, and HIT certification requirements that encourage interoperability (Lye et al.,
2018).
Explanation of the policy
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The 21st Cures Act is commonly known for its features relevant to the drug and device
approval process, but an important portion of the Act builds upon the use of EHR and
electronic health data across the continuum of care, with HIT features in the Cures
Act pivoting on data availability, usability, and patient access (Milstein & Longhurst,
2019).
The main intension of this Act is to provide the opportunity for innovative patientfacing tools that can pull information from an EHR for a patient’s use in accordance
with the patient’s right of access. The objective of this Act is to improve nationwide
health information exchange and patient access to their health information.
The Cures Act motivate partnerships between health information exchange
organizations, networks, and healthcare organizations to encourage patient access to
their EHR in a single, longitudinal format which is easy to understand, safe, and
updated automatically (Lye et al., 2018).
The Cures Act seeks to focus on the promotion of patient access as a pilot for
research. The patients can easily acquire electronic access to their health information
in a way that facilitates communication with researchers which helps them to access
the patient’s clinical data from EHRs (Lye et al., 2018).
The Cures Act creates a new shape to motivate interoperability, limiting the practice
of information blocking by developers, networks, healthcare providers, network, and
exchanges (Lye et al., 2018).
The Office of the National Coordinator for Health Information Technology (ONC)
works to make sure that all individuals, their families and their health care providers
have proper access to electronic health information to help improve the overall
wellbeing of the country’s population.
Besides, helping medical research, motivating interoperability, verifying HIPAA
privacy rules, and by assisting substance abuse and mental health services, the Cures
Act defines interoperability as the exchange ability and use electronic health
information without special effort on the part of the user and as not constituting
information blocking.
ONC concentrates on the following services to implement the Cures Act:
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Section 4001: Health IT Usability
Section 4002(a): Conditions of Certification
Section 4003(b): Trusted Exchange Framework and Common Agreement
Section 4003(c): Health Information Technology Advisory Committee
Section 4004: Identifying reasonable and necessary activities that do not constitute
information blocking
ONC is also encouraging and collaborating with the federal partners, such as the Centres for
Medicare and Medicaid Services, the HHS Office of Civil Rights, the HHS Inspector
General, the Agency for Healthcare Research and Quality, and the National Institute for
Standards and Technology (Lye et al., 2018).
The impact of the policy on system implementation
This Act helps the Americans to promote innovation in the health care technology
ecosystem to render better information, more appropriately, to patients and healthcare
team. It also facilitates transparency, using modern computers, smartphones, and
software to provide opportunities for the people to recover visibility in the services,
quality, and costs of health care.
The impact of the policy on clinical care, patient/provider interactions, and
workflow
The ONC Cures Act Final Rule implements interoperability requirements outlined in the
Cures Act. Patients need more power in their health care, and access to information is key to
making that happen (Milstein & Longhurst, 2019).
By placing the patient first in health technology facilitates the health care system to
deliver:
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Transparency into the cost and outcomes of their care
Competitive options in getting medical care
Modern smartphone apps to provide them convenient access to their
records
An app economy that provides patients, physicians, hospitals, payers, and
employers with innovation and choice
The 21st Century Cures Act was signed to reduce the bureaucracy for drug approval, provides
billions of dollars to the NIH for research, and provides funding to state governments to deal
with the opioid epidemic. But along with these touted benefits, this law includes significant
impacts for healthcare IT.
Patients in the U.S. need better access to information about their care – information ranging
from their medical records to data about the costs and quality of the care they receive. The
Cures Act aims to empower Americans with their health data, delivered conveniently to
computers, cell phones, and mobile applications. Under HIPAA, patients already have a
legal right to their data electronically. The ONC Cures Act Final Rule is one step in this
process by enhancing access to clinical data.
Ease of Access to Their Records
ONC's Cures Act Final Rule supports a patient's control of their health care and their
medical record through smartphones and modern software apps. These choices are made
by the patient, not taken away by a doctor, hospital, or health IT developer under the narrative
of protecting patient privacy.
Protecting Patient Privacy and Security
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The rule supports secure patient access to their electronic medical record data.
Patients will be able to use applications they authorize to receive data from their
medical records. OAuth 2 is used to authorize applications – the same highly
secure protocol used on travel and banking apps.
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Privacy and security are real concerns throughout modern computing
environments. When implemented with appropriate security standards,
application programming interfaces (APIs) are rarely the source of security
issues.
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The final rule outlines that a patient should be able to select an application to use
for accessing their health data, and using a highly secure protocol called OAuth 2
(the same protocol used on your travel and banking apps), the application is
helpful to access information securely from the patient’s medical records.
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ONC's Cures Act Final Rule allows certified health IT developers to require apps
to clearly state their consent and use of data policies.
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As the consumers select reputable banks, the patients also use a similar level of
judgment with their medical records and choose respected brand name
providers or apps that have garnered a level of trust before sharing sensitive
data.
Promoting the Ability to Shop for Care and Manage
Costs
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ONC's Cures Act looks to expand patient and payer choice in health care by
increasing the availability of data that can support insights about care quality
and costs.
The current health care system offers little transparency for patients regarding medical
care, its quality, and its cost. Mobile applications have helped transparency in many
industries such as online shopping, travel, and banking. While it will take time to be
built, it is critical to support patient-centric innovation and not hide behind privacy
protections to limit transparency. It is possible to improve information sharing while
also protecting patient health information.
Information access will provide patients with the ability to shop around for the best
possible health care by giving them insight into the real costs of that care.
Making Patient Data Requests Easy and Inexpensive
Modern technology allows clinicians and hospitals to easily provide patients with access
to their information in a fully automated, low-cost manner. Patients will be able to
access their health information from an app of their choice. Secure, standardized
application programming interfaces (APIs) allow for this access without special effort
on the part of the clinician.
Allowing Choice of Apps
Clinicians, hospitals, and health systems can benefit from a competitive, vibrant app
marketplace. The ONC Cures Act calls for open APIs, which encourages secure access to
data for applications. The final rule will help ensure these certified APIs are made
available in a way that is safe, secure, and affordable. These APIs support innovation in
the marketplace for health IT and app developers.
Implementation
The Cures Act prohibits information blocking and defines the practices that are
considered reasonable and necessary activities that would not constitute information
blocking. ONC's Cures Act Final Rule establishes exceptions to allow clinicians and
hospitals common sense operational flexibility, including protecting patient privacy and
security as well as handling situations where moving data is technically infeasible.
Improving Patient Safety
The final rule aims for a thoughtful balance between patient and clinician needs. For
example, it encourages transparency around patient safety issues within health IT,
while also attempting to protect the intellectual property rights of health IT developers
who have made large investments in building user interfaces and workflows.
The organizational policies and procedures that will be in place to address the
policy
The first step to making the Cure Act a success is implementing a data normalization strategy
to improve the efficiency and accuracy of your EMR. To enable this, health systems first the
organization should deploy a set of technical and security standards that offer patients access to
their electronic health information. Patients must then activate the connection between their health
system’s records and their smartphones. Patients who activate this connection go beyond viewing
their data on a patient portal by transmitting data elements, such as current medications, test
results, and immunization history, to a smartphone, where they can control them (Milstein &
Longhurst, 2019).
Conclusion
The Cures Act is certainly quite broad but overall, it continues the march forward on several
key initiatives for clinical research, precision medicine, the productive use of HIT, and the
engagement of patients. The Cures Act attempts to move the country towards a fully interoperable
nationwide health information exchange system. This legislation has the potential to bring many
benefits to patients (Milstein & Longhurst, 2019).
References
Carolyn T Lye, Howard P Forman, Jodi G Daniel, & Harlan M Krumholz, (2018). The 21st Century
Cures Act and electronic health records one year later: will patients see the benefits. Journal of the
American Medical Informatics Association, 25(9), 1218–1220. doi: 10.1093/jamia/ocy065
HealthIT.gov. (2018). Health IT legislation. Retrieved from
https://www.healthit.gov/topic/laws-regulation-and-policy/health-it-legislation
HealthIT.gov. (2018). Meaningful use and MACRA. Retrieved from
https://www.healthit.gov/topic/meaningful-use-and-macra/meaningful-use-and-macra
Julia Adler-Milstein, & Christopher Longhurst, (2019). Assessment of Patient Use of a New
Approach to Access Health Record Data Among 12 US Health Systems. JAMA Network
Open, 2(8). doi:10.1001/jamanetworkopen.2019.9544
McGonigle, D., & Mastrian, K. G. (2018). Nursing informatics and the foundation of
knowledge (4th ed.). Burlington, MA: Jones & Bartlett Learning.
Brian, L. (2017). The Impacts of the 21st Century Cures Act. Wolters Kluwer Health.
Retrieved from https://blog.healthlanguage.com/the-impacts-of-the-21st-century-cures-act