Running head: INTEROPERABILITY 1

INTEROPERABILITY 2

Table of Contents

Introduction 4

Background of the Problem 6

Purpose of the Study 7

Significance of the Study 8

Theoretical Framework 9

Research Questions 12

Limitations 13
INTEROPERABILITY 3

What is EHR Interoperability, and Is It Important to Embrace It?

Introduction

Interoperability is the capability of two or more applications, components, or computer

systems to access and share information ( Magnuson & In 2014). Health records have been

digitized in the recent past and have grown to become the backbone of the Hospital Information

System. The full use of Electronic Health Records (EHR) can be realized in an interoperable

environment. Further, in the future, substantial growth in sharing EHR is expected. To further

define the term Electronic Health Records, according to ISO, it is the ability of two or more

applications, which can communicate effectively without compromising any content that is being

shared or transmitted. Maximum usage of Electronic Health Records may be achieved by

ensuring both patients and doctors have access to these systems or any other third party. The

Electronic Health Records may be shared within the units of the hospital, which is referred to as

intra-sharing. It can also be shared between different hospitals, which is then referred to as

(inter sharing). Laboratories and various other external agencies like the government and

insurance providers should also have access. The path to interoperability in computer systems

(EHR) is a matter that is not decided by one organization alone but by several organizations to

enhance quality healthcare.

Interoperability has been a major achievement within healthcare services (quality and

accessibility) as other changes are implemented to enhance interoperability with the dynamic

nature of healthcare provision. Most importantly, organizations responsible for promoting

interoperability are always striving to be effective across several systems within healthcare. The
INTEROPERABILITY 4

U.S. The Department of Health and Human Services is always seeking opportunities to foster,

promote, and accelerate interoperability development across several healthcare systems. To

achieve the best results from interoperability it is important to optimize and adopt health

information systems and electronic health records. The essence of adoption and optimization is

to make EHI available in EHRs at every time as opposed to paper-based health records which

cannot be used simultaneously in many places and by distinguished players in the health

industry. Some of the information shared among healthcare centers, doctors, and physicians

include patients admission, transfer alerts, and discharge; other past health records about the

patient's health medical practitioners to have sufficient information about the patient's health

issues and associated criteria to make quality health provision.

Through the path to interoperability, several organizations and bodies must work together

within a set of standards, policies, and regulatory guidelines. Office of the National Coordinator

for Health Information (ONC) is the body that ensures that interoperability is accelerated within

the right/standard adoption. ONC works alongside other organizations and bodies in the

healthcare environment to make sure that there exists an interoperable framework to share and

solve issues in health information. Another function of ONC is to provide support in testing

software applications through the provision of standardized tools, and the appropriate guidelines

for software development. Another support by ONC to the EHRs develops is policies,

workflows, packaging standards, and cases; this ensures that certification in health IT systems is

followed to avoid lack of proper communication among providers who might be competing.

Medicaid and Medicare EHR incentive programs are essential in providing financial incentives

to all eligible healthcare providers. The programs are important in providing up-to-date and

evidence-based regulations within the healthcare environment. Medicaid and medicare financial
INTEROPERABILITY 5

incentives programs also coordinate patients' care with healthcare providers through a private

and secure sharing of clinical information. For instance, in the United States, 49 states already

have an exchange service that allows transitions of care safer as more others (30 states) have

allowed providers access patients' EHI even if they are unsure about their last places and time

they previously received care. Privacy and security are seen as the most vital elements to keep

patients' information secure and safe. In fact, in the year 2014, ONC provided a set of security-

related capabilities necessary for standardization and certification in developing EHRs systems.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is the core

federal law that protected EHI; this law also aligns with the requirements of the ONC. The main

significance of the body is to keep the privacy and security of the patients and their families top

priority. The HIPAA- security laws cover all electronic protected EHI (ePHI) while HIPAA-

privacy covers all protected EHI in any given medium. Health Information Technology Advisory

Committee (HITAC), a body that was established in the 21st century is governed by the Federal

Advisory Committee Act (FACA) and recommended appropriate certification criteria, standards,

implementation specifications, and IT policies to ONC. Virtually, all the bodies and

organizations in the healthcare and interoperability environment work alongside each other to

provide the most effective care to patients and providers. Patients have the right to access their

health information at any time with ease. When developing EHRs, software developers take into

account security and privacy obligations, including easy accessibility and usage of patients' data.

A patient may not know about the technical terms used by developers including the related APIs

but security and privacy should be kept constant. ONC has adopted API certification for EHR to

encourage accessibility of health information for patient-facing and clinical uses.

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The 21st Century Cures Act is aligned with APIs to enable people to downland, view,

and transmit health information. In 2015, ONC provided criteria aligning with the 21st care act

and which requires certified health information technology to demonstrate the ability to offer

software applications that could access (Continuity of Care Document) CCDS via API.

Moreover, Medicaid and Medicare EHR incentive programs provided a set of given objectives

referencing change usability of APIs for support care and individuals electronic access to health

information all through individual engagement. There are security and technical considerations

in place in the usability of APIs. For instance, Transport Layer Security(with strong ciphers

suites) has always been required to protect the information in transit through APIs against access

by third-party EHRs. Additionally, the development of technical authorization controls that can

easily support personal privacy preferences limiting API accessibility, disclosure, and use.

However, API can also pose some risks and vulnerabilities as information is exchanged between

health systems and third-party applications. ONC Health Information System (2017) states that,

"However, in 2016, the Joint API Task Force of the Health IT Policy and Standards Federal

Advisory Committees (FACA) recommended to ONC that the benefits of API-enabled health

information exchange outweigh potential security risks;" this vulnerability can sometimes go

unnoticed by some users since others are dynamic. API vulnerabilities and risks can happen if a

provider using EHRs and patients adapts outdated web, internet, and imperfect API security

specifications. Moreover, vulnerabilities could occur due to human-led errors such as poorly

designed API, ignoring security practices, and unintended functionalities.

While interoperability has been useful in healthcare services, several people believe that

accessibility to their information jeopardizes their security and privacy. More providers and

patients are already using Fast Healthcare Interoperability Resources (FHIR) APIs although a
INTEROPERABILITY 7

higher percentage is predicted to use such technologies widely by 2024. In 2020 and 2021,

pandemic-led disruptions have confirmed the need for interoperability for EHRs. In July 2021,

Goggle Inc updated its passes to APIs allowing more people to enjoy secure ways to share, store,

and access Coronavirus testing and vaccination data on Android devices. According to The Pew

Charitable Trusts, more Americans want to use and access electronic health data. However,

several issues are noted and which show a lack of alignment in interoperability, APIs, current

policies (long-standing vs current), what-data-t-be-shared, data format, and Syndromic

surveillance among others.

Background of the Problem

Over the last few decades, much has changed regarding interoperability including the

uses of electronic health information. secure access, information blocking, correction of errors,

and updates. most importantly. changes that have been applied have affected organizations and

the use of information differently during the Covid-19 pandemic (especially in 2020 and 2021).

The significance of the EHRs interoperability is to empower patients to participate in care,

improving coordination, reducing medical errors, and optimizing care. However, there are some

challenges seen before the pandemic and during the pandemic which need to align with current

policies; the two main challenges are the exchange of EHI among different health facilities and

usability and patient safety. Some of the barriers to interoperability are the lack of patient

identification which could make a health provider adopt other inappropriate ways as alternatives

to access patients' data. Patient matching is another problem that has been discussed but never

sufficiently addressed in the USA for more than 20 years.

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Congress has invested billions of dollars (taxpayers' money) to accelerate the transition of

EHRs (from paper-based to digitization recording), coordinating patient care, enabling clinicians

to share data, and through the authorization of federal rules. According to a survey conducted by

PEW in 2020, 81% of adults in the USA support increased health information between providers

and patients. Also, more than two-thirds of adults want an exchange of information to include

some data sharing policies and regulations which conflicts with long-standing policies; some of

those conflicting issues are related to family medical; histories, images (e.g. X Rays), and end of

life preferences, and advanced care plans. Interoperability has been working effectively in

banking and other industry systems but the gap in healthcare is widened by privacy and security.

Many people have raised concerns about data privacy especially after it was noted that federal

privacy protection does not include data covered in applications. Therefore, enhancing

interoperability through APIs would still be a problem as many people may choose other

alternative methods to share patient information. While APIs have proved to be effective amid

the pandemic as made possible by companies like Google, many people still worry about their

privacy where long-standing policies still exist; this has also been the case among political

parties. A long-standing challenge is that there are no unique identifiers for patients to perfectly

match records in different EHR systems. APIs have not been widely adopted as per

expectations after the passing of the 21st Century Cures Act because of conflicting policies and

data sharing.

Following the final rule updates on the 2015 edition; adding to new technical certification

and removing several other certifications, some definition of Common Critical Data Set has been

noted to take away that is away from regulatory context. The set of information to be shared in

EHRs is defined in US Core Data for Interoperability (USCDI), which unfortunately does not
INTEROPERABILITY 9

include all parts of patients' medical records such as X-rays. A final rule introduced in 2020 to

take effect in 2022, requires that EHRs would make EHI available to patients and health

providers via APIs. The type of data to be included in USCDI includes allergy information,

clinical notes, medication, and demographic details but other crucial medical information will be

lacking. More than 2 in 3 individuals feel that it is essential for providers to share specific

information in health recipes such as family records, images, and end-of-life preferences which

is not currently aligning with federal policies. Such issues lead to social economic and racially

related inequalities leading to more barriers to interoperability. The current policies in

interoperability do not allow sharing of social determinants to healths such as exposure to

violence, hunger, and homelessness which may enhance better health care services among all

people in the United States. Some long-standing policies may lead to many inequalities among

people from distinguished backgrounds and also associated some providers with specific

demographic and ethnic groups.

New versions of USCDI may be emerging between 2020 and 2022 to include data

elements that are consistent in supporting interoperability and aligning with the 21st Cures Act.

As new versions are introduced into the EHRs environment the more the delays and uncertainty

about the final rules as expected in 2022. There might lack of a collaborative and predictable

process among organizations so that they have a common way of accessing patients' data without

forcing them to use alternative approaches. it is also a problem for software developers who may

find it difficult to make changes to applications. For instance, USCGI Version 2 added the

attributes of identity, sexual orientation/gender as data elements in USCDI and as a

recommendation by the ONC Health Information Technology Advisory Committee (HITAC).

However, many health facilities have not developed systems that would collect structured sexual
INTEROPERABILITY 10

orientation information among patients and exchange other social determinants. Without such

information, long standing policies would not match the current policies and people in the LGBT

community would not have their health information, addressed, identified, or targeted. Therefore,

newer versions of applications in EHRs may fail to align with the updated certified Health

Information Technology.

Another issue in interoperability is the exportation of EHI so that providers can determine

the type of data to share with others providers and single patient EHI export data. The final rule

edition in interoperability fails to specify the format of the data to be exported leaving a wide gap

in data usability and accessibility. During the pandemic, other providers have been reported to

use non-standardized formats (such as Fax) in exchanging patients' data. In the future providers

may use formats that do not align with USCDI leaving a major challenge in privacy and security.

Purpose of the Study

As noted earlier, interoperability is the capability of two or more applications,

components, or systems to access and share information. Moreover, interoperability has done

extremely well in other fields and health provision but some barriers still exist. Therefore, this

study explores the issues in interoperability in EHRs while examining sharing of information,

security, privacy, social determinants, organizational alignment, and policies (longstanding and

current ones). More specifically, the study strives to make interoperability examine the nature of

interoperability, determine the barriers, assess its significance/importance, and provide

recommendations for its improvement.

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Significance of the Study

Over the past year, the federal government has used a lot of taxpayers' money to enhance

interoperability, sharing of information, and authorization and policies. However, many issues

have been pointed out like EHRs and their interoperability. Moreover, the dynamic nature of

technology and changes in the policies need to match with the regulations and rules provided by

ONC, HIPAA, and other associated bodies. Therefore, the study explores the challenges and

benefits associated with EHRs Interoperability to determine issues that are and which could be

barriers to future interoperability. This is necessary because the final rule is expected to be

effective in 2022 as the updated edition 2015. Also, as the final rules on 21st Century Cures, Act

has been delayed up to Dec. 2022; this study will investigate other changes that need advanced

updates. For instance, the study will dwell on the adoption of APIs as well as incentivizing APIs

by the Centers for Medicare & Medicaid Services and ONC. The study will seek ways to ensure

that patient privacy is kept top priority by responsible bodies such as the Department of Health

and Human Services (HHS).

The paper examines the alignment of governing bodies and organizations; this will ensure

that there are minimal errors in medical records and treatment since providers would be

exchanging data in a manner that does not conflict with policies. The study will also seek to

determine the way long-standing policies conflict with current requirements in EHRs

interoperability including; social determinants, data format, information blocking, and needs in

unique patient identifiers. Finally, the study will cover several scholarly and publication works

that show challenging issues in interoperability.

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Theoretical Framework

● Theory of Technology Adoption

This is the theory that defines how users of a particular system gain a sense of

acceptance and use a given technology. The theory is derived from theories of reasoned

action which influences individual attitudes, behaviors, and decisions as they get to know

new technologies (Kakar & Kakar, 2017). This theory is useful in the study to influence

people, government officials, to closely examine interoperability and make changes

where applicable or embrace it where necessary. This theory is known to provide

empirical evidence while investigating the existing relationship in systems' ease of use,

usefulness, and effectiveness. The study will use the theory to determine the degree of

acceptance of the model of the EHRs system.

● Organization Theory

Organization theory is viewed in the social, traditional, conventional, and

normative institutionalization strategies (Rapoport & Horvath, 2017). For instance,

traditional approaches argue that structural decisions and policies reflect the way

institutions will behave throughout their life; this can help empirically examine the nature

of interoperability viewing the traditional policies. Normative approaches show that an

individual's attitude and behaviors are based on the nature of institutional normative

standards. The empirical strategy shows the impacts of changing policies on the overall

national government and organizational structure. In this study organizational theory is

crucial in understanding the organization, structures, and designs of relationships within

seemingly conflicting bodies and health providers in terms of policies and system use.
INTEROPERABILITY 13

Organization theory will be used in the study to help provide new ways in which

health institutions, developers, and other third-party groups can manage rapid changes to

ensure overall benefits to society. It will enhance collaborative working environments so

that institutions can embrace distributed systems in health care where information is

shared about security and privacy, and minimize the influence on competition.

Research Questions

Through the use of online surveys and conducting interviews, I will ask the following questions

to determine the effectiveness and adaptability of an EHR system in a hospital setting. The

results will be appropriately analyzed and discussed in the methodology section.

Survey Questions

1. How familiar are you with patient access and interoperability rules?

2. Does the EHR vendor adhere to industry standards?

3. Does the EHR Vendor work with interoperability services providers?

4. Does the EHR product's level of interoperability align with organizational needs?

5. Is your organization staying current on interoperability-related regulations?

6. Is your organization addressing non-technical aspects of interoperability and the policies and

procedures that encourage data exchange?

7. Is your organization addressing technical aspects that advance interoperability and medical

data sharing?

8. Is your organization aligning technology plans with its interoperability goals?

9. Is the organization staying up-to-date on changing regulations related to interoperability?

INTEROPERABILITY 14

10. Is the organization adequately addressing the non-technical aspects of interoperability?

11. Is the organization adequately addressing the technical aspects necessary to advance

interoperability, including data standards and formats?

12. Are the organizations successful in sharing data within their health systems?

13. Are organizations successful in sharing data with payers

14. Are the health systems successfully sharing information with their patients?

15. Is the health system successfully sharing data with pharmaceutical departments?

16. Is your organization successful in sharing data with other partners?

17. Do interoperability problems limit efforts to improve workflow?

18. Do interoperability problems limit efforts to improve new models of care?

19. Is your organization leveraging innovative tools like application programming interfaces

(APIs), artificial intelligence, and blockchain to improve interoperability?

20. Do technologies (like application programming interfaces (APIs), artificial intelligence, and

blockchain) lead to greater interoperability?

21. Does senior leadership's commitment to interoperability improve challenges?

22. Will financial incentives or penalties be the answer to data sharing problems?

Limitations

The theory of technology adoption is limited to several issues. One of the limitations in

the study section is determining the user's intentions to suggest the best technologies for them. It

is important to note that some people do not have adequate knowledge about certain technologies

and others might be having a negative attitude towards them. Also, a limitation in organization

theory is that it is based on a simple-structured organization but not the entangled ones.
INTEROPERABILITY 15

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