Insisting on the Promise of Health Information Technology In 2022.


The passing of the HITECH Act and the 2011 introduction of Medicare and Medicaid E.H.R. Incentive programs (now called the Medicare Promoting Interoperability Program and frequently called Meaningful Utilization) were crucial moments in the history of the field of Health Information Technology (I.T.). They initiated the landmark national effort to swiftly transform our healthcare delivery system from paper-based systems into electronic medical documents (E.H.R.s). Through massive public and private financial investments and huge “sweat capital” from providers’ organizations and developers of technology, over 90% of medical practices and hospitals are now using E.H.R. systems.

This dramatic shift in what is perhaps the most complex and dispersed industry in our society is an incredible achievement. But, E.H.R. adoption was the first step in realizing the promise of a digital, modern health system. Change in processes often comes before technological changes. The health care sector and the interwoven regulations remain embedded in workflows and mental models created by a paper-based culture. While we’re not yet able to get paper (and the fax machine!) entirely out of the health care system and health care, it’s time to focus our efforts on a modern health system free of paper’s limitations. Health system reform must be rethought based on electronic data that could safely, efficiently, quickly, and efficiently flow wherever and whenever needed to improve the quality of healthcare security, cost-effectiveness, efficiency, and accessibility of health care.

This year is going to be an era of change. The policy and infrastructure needed to facilitate information sharing on an international scale will be an actuality. This year, health providers, patients, payers, public health professionals, researchers, technology developers, and others will take the ten years of investments in technology for health to the next step.

The potential for us to invent and use the information to bring benefits in healthcare has never been higher. Some of the most critical provisions in the 21st Century Cures Act (Cures Act) were adopted in 2016 with a bipartisan majority and will be implemented in the coming year and will be essential to improve the quality of care and interoperability between doctors dramatically. This includes:

The continued execution and enforcement of regulations on blocking information will do practices for sharing information (that is, practices that don’t hinder exchange, access, and the use of electronic health information [EHIEHI) top of mind across the entire industry ( 114-255 Sect. 4004, 130 Stat. 1176).

API standardization (API) Standardization of APIs will provide an infrastructure of safe, standard API capabilities to make data sharing simpler through an accredited E.H.R. system (45 C.F.R. Sect. 170.315(g)(10)).

Trusted Exchange Framework and Common Agreement (TEFCA) will provide an all-over infrastructure backbone and policy to make sharing information easier between E.H.R.s and other systems for health information technology ( section 114-255). 4003, 130 Stat. 1165 (2016)).

In the end, the policies will increase the quality of health care by advancing innovation and public health and medical research. Instead of trying to identify or forecast where the field is heading and where it will go, the Office of the National Coordinator for Health I.T.’s (O.N.C.’s) mission is to define and maintain the fundamental principles and foundations to build an open healthcare I.T. ecosystem that is constantly expanding the possibilities in the advancement of health healthcare.

Information Blocking Rule

The Health Insurance Portability and Accountability Act (HIPAA) has served as the federal government’s policy for sharing information since and has defined how HIPAA-regulated health care organizations can share information with other organizations and are required to make the information accessible to patients. Cures Act and the Cures Act and the Cures Act Final Rule published by the O.N.C. include provisions for blocking information which complement HIPAA in various ways, for example:

A broader range of health care providers that are not covered through HIPAA or certified developers of health information technology and health information exchanges/health information networks (importantly that it is essential to note that the Cures Act did not expressly identify payers; however certain may fall under one of the other types) (45 C.F.R. Sect. 171.102).

The ability to direct (rather than simply allowing) data sharing between authorized agencies through setting the penalties (42 U.S.C. Sect. 300jj-52(b)(2)) applicable to those who engage in blocking information methods (45 C.F.R. Sect. 171.102 and 171.103 Also, see 42 U.S.C. Sect. 300jj-52(a)).

They facilitate information sharing with other organizations and patients to better respond to their needs. This is made possible by the latest electronic systems.

At the O.N.C., we don’t have to think of “information blocking” more than we think of “information sharing” because the information blocking penalties enacted in the Cures Act demonstrate Congress’ dedication to sharing information that “allows the full access to, exchange, and utilization of all health information to be used only for authorized users following any applicable State or Federal laws.” Inviting the sharing of “all electronic medical information” is an evolutionary shift in interoperability. Previously, it has been focused on sharing structured, standardized data over unstructured, non-standardized records like notes and transcriptions. This was a common practice when documents that were not structured were heavy to process, extract, store, and then analyze. But, advancements in algorithms, analytics machine learning, analytics, and the use of natural language processors, paired with the development of standard processing capacity and power, provide opportunities to gain valuable insights from records that are not structured and it is no longer making any sense to not include them in standard expectations of sharing information.

Accessing “all” medical information that is electronically available is a challenge because E.H.R. systems usually contain an array of unstructured and structured communication with various formats, which differ across the vendor platform and settings for providers. To make it easier to comply with these new regulations and make it easier for providers to comply, the Cures Act Final Rule allows an incremental approach. This begins with readily shared data today and provides stakeholders more time to design and implement processes, policies, and tools for sharing additional non-standardized and unstructured data.

On May 1, 2020, the O.N.C. released its Cures Act Final Rule in the Federal Register. On April 5, 2021, the information-blocking provisions of the rule came into effect, requiring that all actors covered by the government are required to share information or face sanctions (Pub. L. No. 114-255, Sect. 4004, 130 Stat. 1176 (2016)). From October 5 to October 5, 2022, it is believed that the scope of E.H.I. is restricted to the elements in the United States Core Data for Interoperability V1 (USCDI V1), the O.N.C. standard that a lot of providers and vendors are already utilizing today because it is a requirement of various Centers for Medicare and Medicaid Services payment models as well as it is a requirement for O.N.C. Health I.T. Certification Program. It also serves as the primary data element for many health information networks.

But, beginning on October 6, 2022, all participants — providers and accredited health I.T. professionals and health information networks — will be required to provide all E.H.I., not just the elements of data that are included by USCDI Version 1 (45 C.F.R. Sect. 171.102; 45 C.F.R. Sect. 171.103). In acknowledgment of the reality that E.H.I. is more than just data elements and is usually not standardized, heterogeneous, and, in most cases, not easily transferable, the rules allow some flexibility as to how an entity can provide E.H.I. accessible in various industry-standard formats and, as a last resort in the “machine-readable” file format (45 C.F.R. Sect. 171.301).

Intending the scope of interoperability to encompass the most feasible electronic data will give more data to aid in patient care and lessen the burden for patients needing to gather manually and carry vast piles of paper documents from one provider to another. It also opens new possibilities for modernization across the health care system.

FHIR API Certification

The Cures Act Final Rule creates the framework that regulates blocking information; the rule additionally takes essential steps to allow the developers of certified health I.T. to share data by reducing differences in the business practices and technological methods for exchange. There are two important dates in 2022 that require these developers to create the same level of competition for sharing information and provide access to data via applications programming interfaces (APIs) “without any effort,” as stipulated in the Cures Act.

From April 1, 2022, health I.T. developers who meet one of these API certification requirements will be required to prove the compliance of specific standards for API access in the Conditions and Maintenance of Certification of the Cures Act Final Rule (45 C.F.R. Sect. 170.406). These guidelines enhance competition in pricing contracts, non-discrimination, and contracting concerning competitors. In short, the Cures Act Final Rule helps ensure that the specific commercial terms and conditions for certified technology developers aren’t restrictions that stop suppliers from using certified APIs in any way they choose and with whomever they choose (45 C.F.R. Sect. 170.404).

Setting these standards creates the foundation for the introduction of standard APIs throughout the sector in the coming months. HL7(r) Fast Healthcare Interoperability Resources (FHIR(r)) is an evolving interoperability standard built on the latest technologies for the internet. O.N.C. certification has mandated the use of APIs in 2015 but did not need FHIR APIs due to the lack of maturity that the standards were. This has intended to encourage rapid growth in APIs available and allow us to concentrate on removing the flaws between the different fundamental API standards that limit scaling across E.H.R. platforms.

With the help of technology developers and members of the HL7(r) community, FHIR is now prepared to go live. Health I.T. developers seeking certification for the criteria for application programming interfaces are now required to offer an FHIR API standard to all companies that use the developer-certified API technology until December 31, 2022. (45 C.F.R. Sect. 170.404(b)(3); 45 C.F.R. Sect. 170.404(c)). This creates a climate of innovation, permitting technology developers to develop using a standard industry specification. APIs that are open and accessible to the public is the key to allowing you to examine your bank account or take orders for food delivery directly through a mobile application regardless of your device. We want providers and patients to enjoy the same ease and flexibility of accessing medical records regardless of what technology platform they choose to use. The Cures Act Final Rule will make the technological and business advances brought into reality this year and establish APIs and applications as the primary drivers for improved accessibility, functionality, and user experience healthcare interoperability.

The Trusted Exchange Framework And Common Agreement (TEFCA)

The development of a united national clinical interoperability network has been a part of the O.N.C.’s mission since its inception in 2004. We aim to create interoperability networks to ensure that medical records flow safely and safely behind the background in the same way the back-end banking systems of banks ensure that the financial information you have is always current.

The health care sector has made substantial progress in developing exchange networks. Numerous networks are operating today at local and state levels, performing millions of secured medical record transactions every day between health care providers for treatment purposes. But, progress has slowed in recent years because reaching more significant levels of exchange requires solving problems in business that competitors are unable to reach a consensus on or complicated regulatory and legal questions that are difficult to resolve without the assistance of the federal government.

In recognition of this Recognizing this, the Cures Act called on the O.N.C. to “develop or promote a trust exchange framework, which includes the common agreement [TEFCA] between health information networks across the country” (Cures Act Pub. L. No. 114-255, Sect. 4003(b), 130 Stat. 1165 (2016)). Working with The Sequoia Project, TEFCA was inaugurated on January 18, 2022. The goal was to establish an agreement that is a legal standard and technical standard that allows networks to be more easily connected. The primary objectives of TEFCA are to accelerate the enormous progress made by the market and establish a common ground of interoperability across the nation that is based on standard exchange contracts, open industry technical standards, and clear guidelines for the road. Develop the policy and technological infrastructure that allows organizations to securely exchange data to enhance patient care and create health care benefits. It will also let individuals access their health-related information at any location. TEFCA can also play a key role in expanding the scale of FHIR APIs designed for businesses-to-business and consumer-to-business uses.

Enforcement of The Cures Act Rule

O.N.C. has the responsibility of defining the rules that govern information blocking and creating a complaint procedure, as well as it is the H.H.S. Office of Inspector General (OIG) is charged with conducting investigations and assessing any required penalties on health I.T. professionals who are certified or health information exchanges or networks. In March 2022, the OIG is scheduled to issue its final rule to start the application of the O.N.C.’s policy on information blocking.

2022 and Beyond

Cures Act Cures Act helps bring needed uniformity across the entire industry by encouraging health care providers and creators of certified health I.T. and health information exchanges to elevate information sharing to the top of their priority lists from “may” to the status of a “must.” It has seen considerable improvements in transmitting information over a short time. However, in the highly dispersed system, the pace of progress is not consistent and is influenced by the distinct priorities of different industry actors. The Cures Act is a significant shift in thought and requires a substantial overhaul of the existing policies and procedures. But, it’s crucial to keep in mind your responsibility to ensure that every obligation to comply with you also puts a burden on other organizations to share their information with you.

It has been stated that technological advancements increase over time. We overestimate the potential of technology in the near term. Still, We underestimate what it can achieve in the long run since possibilities adjacent to it expand exponentially and are challenging to forecast. The last decade has been dedicated to laying the base for implementing E.H.R.s. In 2022, the Cures Act’s goal will become a reality, and we will be able to take advantage of the full benefit of the benefits that an entirely digital health care system can provide to enhance patient lives.

Brian Santiago

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