Authorities regularly adopt interoperability regulations to optimize healthcare services and improve patients’ access to personal data. They are and will be mandatory to comply with. Around 47% of technology executives from health companies believe that regulations are the primary driver making businesses pursue interoperability in healthcare.
Unfortunately, interoperability requirements may be challenging to navigate and implement. That’s why we want to share our healthcare regulatory experience with you.
Read our guide to know the purpose of interoperability rules, reasons to follow them, and ways to achieve healthcare regulatory compliance.
Healthcare Interoperability Regulations: Purpose, Main Actors, and Types
Before we dive into the topic, let’s take a short look at the history behind interoperability healthcare IT regulations. For a long time, healthcare companies have failed to take full advantage of digital technologies. By 2017, around 20% of EHR system installations were unsuccessful. Besides, patients had limited access to their medical information. The main problems were the inefficient use of software and healthcare interoperability issues. To accelerate healthcare digitization, the U.S. Congress enacted the 21st Century Cures Act aimed at simplifying the sharing of electronically accessible health information with patients. ONC later expanded it with the Cures Act Final Rule that clarifies the initial regulation and facilitates compliance. The regulations set the following data interoperability and transparency requirements:
The essentials of the ONC Cures Act Final Rule:
Besides, the Final Rule sets the basic interoperability data standards in healthcare. Those are HL7 FHIR and USCDI. These standards are also stipulated in other regulations released by ONC and Centers for Medicare & Medicaid Services.
Even though compliance with all these interoperability rules and standards is difficult, it also brings significant benefits.
Why to Comply with Interoperability Requirements?
Apart from proving your reliability, healthcare regulatory compliance gives you a few practical benefits, including:
- Enhanced collaboration. Data interoperability in healthcare helps you cope with problems that cannot be solved by stand-alone systems. It improves information exchange and systems collaboration. This allows you to use combinations of apps, tools, and databases for solving challenges. For example, smooth connectivity of remote monitoring systems and EHR databases optimizes critical patient management.
- Improved efficiency. Interoperability of health information systems allows you to automate many processes. Therefore, healthcare teams spend less time on routine activities.
- Easier technology adoption. Interoperable systems in healthcare are adaptive to innovation. By using common data formats and standards for health information exchanges (HIEs), you enhance your system’s connectivity.
- Quality mark. Healthcare regulatory compliance can make you an ONC-certified company. As a result, you will receive a quality mark proving your status as a regulation-compliant company. It may become a decisive factor for potential clients.
- Participation in programs. Regulatory compliance in healthcare is an essential demand for companies that aim to participate in Medicare/Medicaid and CMS-initiated insurance programs. It also allows healthcare businesses to earn incentives from Quality Payment Programs.
- Enhanced publicity. Upon achieving medical regulatory compliance, your business will be mentioned in numerous lists of ONC-certified and CMS-certified companies. Its name will also appear in reputable industry press releases more often. This makes your organization more popular and allows you to expand its outreach.
Most importantly, software interoperability enables you to collect all patient data in one place. This allows the healthcare team and patients to access medical records whenever they need and improves healthcare services.
Want to reap these benefits? Get to know about interoperability standards and provisions in our next chapter.
Overview of the Essential Interoperability Standards and Provisions
There are lots of healthcare IT regulations that affect healthcare interoperability. For this material, we have chosen the most valuable health data standards and provisions medical businesses should consider.
Basic Healthcare Interoperability Standards
The two main health data standards regulate the nationwide exchange of medical information. These are HL7 FHIR and USCDI. Let’s take a closer look at both.
The full name of this data interoperability standard is the 4th version of Fast Healthcare Interoperability Resources from HL7 International. It specifies the format for HTTP-based RESTful APIs that ensure healthcare interoperability. One of the basic FHIR standards requires medical businesses to use three basic data formats: XML, JSON, RDF. Therefore, this medical regulation ensures EHR interoperability and seamless exchange of other medical data types.
The US Core Data for Interoperability (USCDI) defines what pieces of information must be shared at a patient’s request. This EHR interoperability standard covers basic classes of medical information. See them in the table below.
The main goal of HL7 FHIR and the USCDI is promoting consumer healthcare through efficient FHIR APIs and enhanced transparency. Meanwhile, these data standards in healthcare are rather general and leave many aspects of interoperability unspecified. Therefore, ONC and CMSs released additional interoperability healthcare provisions to provide a more detailed roadmap to standard compliance. Check them out below.
ONC Interoperability Healthcare Provisions
ONC is one of the most influential actors in digital healthcare. This organization has designed numerous interoperability healthcare provisions that improve healthcare management efficiency. Some of them have become active recently, while others will be enforced within two years. Here are the most valuable ones.
According to this ONC interoperability rule, healthcare businesses have to provide patients with data covered by the USCDI on request. The key requirements to health IT providers are building FHIR APIs and establishing a standard online format in which patients will receive data. At the same time, each case of EHI healthcare blocking will be reviewed individually. It means that, in particular conditions, healthcare providers may avoid fines after withdrawing or declining a patient’s data request.
New Standardized API Functionality
This ONC interoperability provision requires hospitals to use two standardized types of FHIR API-enabled functionality. The first one will be oriented toward single patients. Such APIs will connect EHR systems with third-party apps used to access a patient’s medical data. The second type of APIs will come into action to help hospitals deliver better care for groups of patients. It will connect EHR systems with machine learning and Big Data analytics software. Through standardization of API requests, the provision will eliminate medical information exchange inconsistencies, which are the most common interoperability challenges.
EHI Export Capability Provision
According to this medical regulation, EHR users must be able to create export files with all EHI of a single patient. The provision also specifies the format and the classification for data that can be exported. After its enforcement, healthcare providers will have to classify specific data elements, which are frequently stored and managed outside the core EHR systems, as EHI. This means providing patients with access to the related administrative and billing data upon request.
CMS Interoperability Healthcare Provisions
Centers for Medicare & Medicaid Services play a definitive role in insurance programs. These organizations create regulations aimed at making medical exchange smoother and more transparent. Check the list of the most recent and upcoming CMS interoperability provisions below.
Patient Access API/Provider Directory API Provision
According to this CMS interoperability provision, CMS-regulated payers have to implement two types of FHIR-based APIs in their software. Through the first type, which is the Patient Access API, enrollees can request data on claims, costs, and clinical measures. The second type of such FHIR standard APIs allows patients to access provider directories. The directories provide information on all entities participating in a particular health plan, namely hospitals, third-party administrators, pharmacies, practitioners, etc. It keeps the patients informed about the medical services they receive.
Admission, Discharge, and Transfer Events Notifications Provision
This CMS interoperability rule requires hospitals to send event notifications to practitioners and care managers when a patient is admitted to a hospital, transferred to another facility, or discharged to their home. The ADT Provision determines a fixed format for such notifications necessary for software interoperability. The message has to include the patient’s name, the treating provider’s name, the sending institution’s name, and, optionally, the patient’s diagnosis.
Payer-to-Payer Data Exchange Provision
This provision requires CMS-regulated payers to exchange patient data with other payers upon an enrollee’s request. The regulation helps patients easily coordinate their care and switch between health plans. There are currently no specific demands to EHR APIs applied during such health information exchanges (HIEs). However, in the future, CMS-regulated payers will probably have to align them with FHIR standards.
How to Build Interoperability that Brings Healthcare Regulatory Compliance?
Compliance with interoperability regulations has many obstacles. Building a compliant interoperable system requires thorough preparation and a comprehensive development approach. Here are some general steps you should take to meet regulatory requirements in healthcare interoperability.
- Determine how healthcare interoperability standards and provisions apply to you. Research all EHR interoperability and data standards in healthcare. Make sure to determine those that apply to you and understand how to meet them for regulatory compliance in healthcare.
- Review your existing systems. Focus on improving your existing infrastructure instead of replacing it completely. Review your systems for features that do not comply with interoperability regulations. Make sure to determine possible ways to fix such EHR interoperability issues.
- Build your interoperability strategy. Use the insights from your research to build a clear roadmap to regulatory compliance in healthcare.
- Align interoperability plans with the required functionalities. Do not forget about your business goals. Your infrastructure has to both fit regulatory requirements in healthcare and improve your organizational efficiency.
- Publish the required APIs. Comply with a recent CMS interoperability provision: implement a patient-access EHR API and a provider-directory EHR API.
- Enable payer-to-payer data exchange. Be ready to exchange patient clinical data with other CMS payers at an enrollee’s request.
- Master and implement the HL7 FHIR standard. Learn the essentials of FHIR API management. Implement the basic components of this solution, such as an API Gateway, an orchestration hub, and a privacy engine.
- Structure data according to standard terminologies. Make sure that you use the FHIR standard vocabularies for different types of information.
- Enable top-notch security practices for sensitive data. Label sets of data covered by security-centered healthcare IT regulations, such as HIPAA. Protect them with top-notch access management practices, security safeguards, and threat management tools.
- Train your staff to comply. Educate your staff to handle requests and manage health information exchanges (HIEs) according to regulatory requirements in healthcare.
- Establish a consent management process. Patient consent is essential for any actions with their personal data. Make sure to implement features allowing you to collect and track consent for all EHR APIs within your system.
- Implement auditing and testing tools for your software. Ensure continuous auditing and regularly review your systems for compliance with CMS and ONC interoperability rules.
Best Solution for Meeting Healthcare Interoperability Standards and Provisions
Even if you clearly understand all the rules and have a roadmap for building regulation-compliant interoperability in healthcare, you may still face insurmountable interoperability challenges. The most common one is the lack of technology expertise, essential for building connectivity and APIs that suit the FHIR standard.
This is when outsourcing becomes a solution. A dependable technology partner with solid experience in delivering regulatory-compliant medical software will help you solve the most painful interoperability challenges.
Binariks is here to help you implement your plans. We handle all stages of the software development lifecycle to deliver highly scalable solutions. Our dedicated developers are experienced in building efficient FHIR healthcare APIs that fit the basic health data standards. Learn more about our expertise in our portfolio.
Contact us to discuss your needs. It is just about time to boost your business with state-of-the-art systems that comply with the basic healthcare interoperability standards.