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Establishing Nursing Informatics in Public Policy

Rebecca Freeman / Allison Viola

ABSTRACT

The U.S. healthcare industry is undergoing a profound transformation, particularly within healthcare information technology (IT), that will challenge policy makers, industry professionals, and other stakeholders to rethink the way clinical and business solutions are provided. The Precision Medicine Initiative (PMI) is just the beginning in seeking cures for patient diseases, interoperability of technology and information, research, pharmacogenomics, privacy and security challenges, mobile health, and others. The success of this program requires cross-collaboration and engagement with a variety of federal agencies and other stakeholders to push this initiative forward and allow for the unprecedented collection and use of genomic data to improve health and healthcare. However, the data-enabled success of these complex initiatives depends on core concepts that are not fully mature—particularly interoperability. The failure to achieve interoperability of technology and health information continues to present challenges, and much work is still needed in this area to support the PMI, new payment models, and other initiatives that require the collection, aggregation, and use of data. The implementation of federal and state requirements, as well as initiatives by industry leaders and professional organizations, is making headway but at a pace deemed quite slow by most engaged organizations. Legislators, innovators, clinicians, and technology leaders must continue to work together to solve issues of standardization and interoperability in order to truly create the framework necessary for the unbound movement of patient data in a way that is ultimately clinically meaningful.

THE LINKAGE BETWEEN HEALTH POLICY AND HEALTH IT: WHY IT’S IMPORTANT

With increasing pressure to reduce healthcare costs and to improve patient health and their care experience, the U.S. healthcare system has used, and continues to use, technological advances to help achieve those goals. But with the opportunities technology can offer, there is also the need to develop a supporting framework of nationwide policies and in some cases, for individual disciplines to determine consistent guidance on the use of health information technology in practice. Jumpstarting these efforts was the passage of the American Recovery and Reinvestment Act (ARRA) of 2009 that established the Centers for Medicare & Medicaid Services (CMS) Electronic Health Record (EHR) Incentive Program and codified the Office of the National Coordinator for Health Information Technology (ONC) to implement standards and certification requirements to support the meaningful use of EHRs. Ensuing regulations helped to build the policy foundation from which thousands of eligible hospitals and eligible providers have adopted, implemented, and meaningfully used EHRs. Pushing the healthcare industry forward through federal, state, and local policies has accelerated the movement toward digitized records. None of these initiatives can be successful without health information being easily transmitted from one provider to another that supports patient care and research. Interoperable health IT and health information policies have been implemented to enable the movement of data through privacy protections, as well as standards, governance, and certification requirements. Without these guardrails, the U.S. healthcare system cannot truly be a system, especially not a data-empowered learning health system.

Reducing Regulatory Burden

Public Law No: 114-255, also known as H.R.34–21st Century Cures Act, was signed into law during the Obama administration on December 2016. More specifically, SEC. 4001 Assisting Doctors and Hospitals in Improving Quality of Care for Patients, amended the Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted as part of the American Recovery and Reinvestment Act of 2009, required Health and Human Services (HHS) to establish a goal, develop a strategy, and make recommendations to reduce regulatory or administrative burdens relating to the use of EHRs. ONC, in partnership with CMS, published a draft report in November 2018 to fulfill the statutory requirements for §4001.

Over the past several decades, the increased use of health information technology (IT) has changed the way providers practice medicine and has also changed the patient/provider relationship in a way that enables patients to become more of a partner in their care and decision-making. Despite increased benefits yielded by health IT, there are also challenges that continue to plague productivity, increase costs, physician burnout, and patient safety issues.

Through extensive stakeholder outreach and engagement from the healthcare community, ONC was able to capture and outline three primary goals:

1.   Reduce the effort and time required to record information in EHRs for healthcare providers during care delivery.

2.   Reduce the effort and time required to meet regulatory reporting requirements for clinician, hospitals, and healthcare organizations.

3.   Improve the functionality and intuitiveness (ease of use) of EHRs (Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs, 2018).

Based upon feedback received from the community, ONC formed four workgroups that included representation from several agencies within HHS as well as other agencies. The workgroups included Clinical documentation, Health IT and the User Experience, EHR Reporting, and Public Health Reporting. The findings in the report address issues and challenges, as well as strategies with corresponding recommendations to achieve burden reduction goals outlined in the report within a short window of 3 to 5 years and should leverage existing or easily expanded authority to administer the strategies.

Interoperability

The U.S. healthcare system continues to be a technologically complex system that requires the ability for patients, providers, hospitals, and other stakeholders within the health ecosystem to exchange health information and be able to use that information for informed decision-making about care delivery. Successful interoperability allows for healthcare IT systems to work together within and across organizational boundaries to advance effective healthcare delivery to individuals and communities. It also moves the nation closer to the promise of a learning health system, where data is integrated with evidence, knowledge is put into practice, and data is refined to impact the cycle of evidence and practice (Learning Health Systems, 2019). Three levels of interoperability exist to achieve this goal:

1.   Foundational interoperability allows for data exchange from one healthcare IT system to another and does not require interpretation of the data.

2.   Structural interoperability defines the format of data exchanged where there is uniform movement of healthcare data from one system to another. The clinical or operational purpose remains the same as it moves throughout the system and has the ability to be interpreted at the data field level.

3.   Semantic interoperability at the highest level allows for two or more systems or elements to exchange information and use the information that has been exchanged. This level of interoperability leverages the structuring of the data exchange and the classification of the data so that the receiver has the ability to interpret the data.

As a result of the CMS EHR Incentive Program implementation that encouraged the adoption, implementation, and use of healthcare IT, Congress enacted the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015. Through this law, Congress declared it a national objective to achieve widespread exchange of health information through interoperable certified EHR technology nationwide by December 31st. MACRA 2018.4 defines interoperability as “the ability of two or more health information systems or components to exchange clinical and other information and to use the information that has been exchanged using common standards as to provide access to longitudinal information for health care providers in order to facilitate coordinated care and improved patient outcomes.” As a result of this legislation, CMS has issued proposed regulations to implement the requirements outlined in the law provisions.

TEFCA

An important component toward the progress of interoperability is development of the Trusted Exchange Framework and Common Agreement (TEFCA) as identified within the 21st Century Cures Act. Congress acknowledged the value and importance of continuing its support for interoperable networks and the ability to securely exchange health information. Provisions within the law specified that ONC in collaboration with the National Institute of Standards and Technology (NIST) and other relevant agencies within HHS “convene public-private and public-public partnerships to build consensus and develop or support a trusted exchange framework, including a common agreement among health information networks nationally” (21st Century Cures Act, 2016).

ONC released its Draft Trusted Exchange and Common Agreement in January 2018 which outlined a common set of principles and set of terms and conditions for trusted exchange. Principles for trusted exchange outlined within Part A served as guardrails by which ONC defined six principles for trusted exchange to bring about trust between Health Information Networks (HINs). The six categories are as follows:

1.   Principle 1: Standardization: Adhere to industry and federally recognized standards, policies, best practices, and procedures.

2.   Principle 2: Transparency: Conduct all exchange openly and transparently.

3.   Principle 3: Cooperation and nondiscrimination: Collaborate with stakeholders across the continuum of care to exchange electronic health information, even when a stakeholder may be a business competitor.

4.   Principle 4: Security and patient safety: Exchange electronic health information securely and in a manner that promotes patient safety and ensures data integrity.

5.   Principle 5: Access: Ensure that patients and their caregivers have easy access to their electronic health information.

6.   Principle 6: Data-driven accountability: Exchange multiple records at one time to enable identification and trending of data to lower the cost of care and improve the health of the population (A User’s Guide to Understanding the Draft Trusted Exchange Framework, 2018).

Part B, Minimum Required Terms and Conditions for Trusted Exchange outline specific terms and conditions that will be incorporated into a single Common Agreement by a Recognized Coordinating Entity (RCE) (Trusted Exchange Framework and Common Agreement, 2018). An RCE is an entity that will be selected by ONC and will enter into agreements with HINs and act as a governance body to operationalize and monitor compliance with the TEFCA. ONC will need to work collaboratively across the industry to ensure its successful implementation and cooperation.

Information Blocking

Passage of the 21st Century Cures Act also addressed one of the more challenging components of exchanging health information which is information blocking. Whether real or perceived by healthcare stakeholders, blocking the exchange of health information for patient care and preventing the free flow of data has real consequences that may impact patient safety, quality of care, and increase costs. As required by Congress, in 2015 ONC issued its Report to Congress on Health Information Blocking which highlighted the extent of information blocking and a comprehensive strategy to address this issue. In this report ONC defined information blocking as “when persons or entities knowingly and unreasonably interfere with the exchange or use of electronic health information” (Report to Congress: Report on Health Information Blocking, 2015). In addition, three conditions must be met to meet the definition:

1.   Interference: Information blocking requires some act or course of conduct that interferes with the ability of authorized persons or entities to access, exchange, or use electronic health information. This interference can take many forms, from express policies that prohibit sharing information to more subtle business, technical, or organizational practices that make doing so more costly or difficult.

2.   Knowledge: The decision to engage in information blocking must be made knowingly. An individual or entity does not engage in information blocking unless it knows (or should know under the circumstances) that its conduct is likely to interfere with the exchange or use of electronic health information.

3.   No reasonable justification: Not all conduct that knowingly interferes with electronic health information exchange is information blocking. Accusations of information blocking are serious and should be reserved for conduct that is objectively unreasonable in light of public policy (Report to Congress: Report on Health Information Blocking, 2015).

Following this report and 21st Century Cures, ONC published a Notice of Proposed Rulemaking (NPRM) in March 2019 which addresses several provisions outlined in the law.

Sec. 4002 Conditions and Maintenance of Certification identifies initial and ongoing requirements for health IT developers and certified Health IT Modules.

Sec. 4003 Interoperability Definition is consistent with the Cures Act definition; ONC proposes interoperability to mean secure exchange and use of electronic health information with and from other health IT without special effort, allows for complete access, exchange, and use of electronically accessible health information for authorized use, and does not constitute information blocking.

Sec. 4004 Information Blocking is defined through seven proposed categories of practice that are reasonable and necessary whereby certain conditions are met, and does not constitute information blocking. If a regulated actor (provider, health IT developer, etc.) meets certain exceptions, his/her actions would not be subject to penalties under the law.

MAKING IT EASIER TO SHARE DATA—ADDITIONAL POLICY FRAMEWORKS

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