The COVID-19 pandemic has unveiled the importance of health data and its exchange across health systems. It has also increased the use of tech-based virtual healthcare solutions for efficient and advanced treatment solutions, which has led to exponential growth in healthcare IT. The global healthcare IT market is expected to reach $1305.1 billion in 2030, growing at a CAGR of 29.3% from 2022 to 2030.
Advanced healthcare IT solutions are facilitating the exchange of health data across health systems to provide better patient outcomes, leading to increased emphasis on data standards in healthcare.
This article covers critical health data standards followed globally and will also touch upon the importance of these standards in healthcare.
Health data standards and formats
Let’s start by understanding the basics of data standards in healthcare.
What are health data standards?
Health data standards are agreed-upon terms which lay the foundation for clinical information systems, clinical data exchange, and system integration. They cover the methods, procedures, terminologies, specifications, and protocols for collection, storage, exchange, and retrieval of health data.
Health data includes all information associated with health applications which include but are not limited to medical records, health metrics, radiology and diagnostic images or reports, medications, payment and reimbursement, medical devices and monitoring systems, and administrative systems.
Who creates data standards in healthcare?
Standard Development Organisations (SDOs) define, update and maintain standards through a collaborative process that involves health IT users. SDOs are non-profit entities and receive no payment.
An SDO can develop and maintain one or more standards based on its mission and interests. The success of a standard depends upon SDO’s credibility.
Over 40 SDOs operate in the US healthcare field and are accredited by the International Organisation of Standardization (ISO) or American National Standards Institute (ANSI). Some of the most recognised ones are:
- Health Level 7 International (HL7)
- DirectTrust Standards
- National Council for Prescription Drug Programs (NCPDP)
- International Health Terminology Standards Development Organisation (IHTSDO)
- Clinical Data Interchange Standards Consortium (CDISC)
- Systematized Nomenclature of Medicine (SNOMED) International
- Digital Imaging and Communications in Medicine (DICOM)
Benefits and importance of health data standards
Data standards in healthcare are the backbone for ‘health data interoperability’—the holy grail of healthcare IT. They facilitate interoperability by ensuring all health systems use the same language and approach for collecting, storing and exchanging data irrespective of domain or software provider. Standardised and interoperable health data has several benefits:
- They streamline data requirements and ensure a smooth flow of health data between different health systems.
- They strive for better patient outcomes through integrated care and personalised medicines.
- Facilitate combining data for health research and innovation
- Improve patient monitoring and repetition of unsuccessful treatments and medications
- Enhanced health data privacy and security
- Increases efficiency of health institutions and reduces costs
- Enhanced public health surveillance and strategy
- Optimised health services and resource planning
Categories of health data standards
Data standards in healthcare are divided into four main categories:
- Terminology standards
- Content Standards
- Data exchange standards
- Privacy and security standards
Let’s understand each one in detail.
Terminology standards
Same disease or medications can have different names. For example, one doctor might use ‘high blood pressure’ whereas the other may prefer ‘hypertension’. While this happens in the same language, how do you understand health data collected in another language? And how to deal with the same medication sold under different brand names? This is where terminology standards play a crucial role.
Terminology standards are a set of unique codes and classification systems that represent different health concepts. They allow health information systems to communicate, removing the barrier of language. Different terminology standards are in place for different purposes. Here are some of them:
Systemised Nomenclature of Medicine – Clinical Terms (SNOMED CT)
SNOMED CT is clinical terminology maintained by the International Health Terminology Standards Development Organisation (IHTSDO). It comprises all concepts related to healthcare delivery and is recognised by more than 50 countries.
SNOMED CT is used to record patient data in EHR systems and exchange the aggregated information across other health systems. It covers all the symptoms, clinical findings, family history, medical procedures, devices, etc., and is more expansive than ICD-11.
However, it is too vast for health institutions. So, they use ICD-11 and CPT/HCPCS coding systems for billing and reimbursement.
International Classification of Diseases (ICD-11) 11th revision
ICD-11 is a set of codes created and maintained by the World Health Organisation (WHO). ICD-11 focuses on disease and diagnosis. Every disease or health issue has a unique alpha-numeric code under ICD. It is the global standard for diagnostic health information.
In October 2020, the 10th revision of ICD had over 500 updates, including new codes for COVID-19. In February 2022, WHO released the 11th revision, which includes aligning classifications with the latest knowledge of disease treatment and prevention.
ICD-11 has 17,000 unique codes and 120,000 codable terms. It is digital health ready with a new API and has improved the ease and accuracy of coding, reducing user training requirements.
ICD-11 is used globally for tracking statistics—morbidity and mortality. Hospitals use it for billing and reimbursement purposes.
Current Procedural Terminology (CPT)
CPT are codes that provide uniform language for coding medical services and procedures. Developed and maintained by the American Medical Association (AMA), CPT codes describe outpatient services and procedures. They are used to track treatment, billing, and reimbursement.
Hospitals use these codes to describe outpatient services. Insurance providers pair the CPT code on the bill for reimbursement with the ICD-11 code. If the OPD service is irrelevant to diagnosis, insurance providers reject the claim. Say, a doctor cannot send a person with breathing issues for a brain MRI.
Healthcare Common Procedure Coding System (HCPCS)
HCPCS are codes for all kinds of health-related services. Maintained by the Centers for Medicare and Medicaid Services (CMS), they are an extension of CPT used for billing Medicare, Medicaid, and other health plans to ensure efficient claim processing.
HCPCS has two levels. Level 1 is a duplicate of CPT used to identify and relate diagnoses and procedures prescribed by doctors. Level 2 identifies supplies or products not included in CPT, like medical equipment or drugs.
If the service prescribed by the doctor is the same in both systems, CPT is given priority. If additional information is required, HCPCS is considered.
Current Dental Terminology (CDT)
Developed and maintained by the American Dental Association (ADA), CDT is a terminology standard for dental services. It covers all diagnosis and OPD services related to oral health.
All CDT codes start with ‘D’ and have a similar CPT code, as several health plans don’t accept CDT for reimbursement. CDT codes are used for documenting dental treatment.
Logical Observation Identifiers Names and Codes (LOINC)
LOINC is a set of universal codes for laboratory tests and clinical observations. They encompass all the lab tests and diagnostic concepts and are widely accepted by commercial laboratories, research institutions and hospitals.
These identifiers were created by the Regenstrief Institute, keeping the HL7 interoperability standard in mind.
National Drug Codes (NDC)
NDC is a coding system for pharmacy products in the US. A unique identifier for human medications, NDC codes are published on all drugs and inserts. It is used to share drug data and facilitate claims processing.
NDC code constitutes labeller (manufacturer, distributor or repackager) code assigned by the FDA, along with product and package code created by the labeller.
RxNorm
RxNorm is a set of codes consisting of all the clinical drugs available in the US. Maintained by the US National Library of Medicine (NLM), the RxNorm code comprises the active ingredients, strength and dosage of the drug.
It ensures interoperability by having similar codes for similar medicine, irrespective of the brand or manufacturing company. While the same drug can have multiple NDC codes depending on the manufacturer, the RxNorm code for them will remain the same.
Content Standards
Imagine different hospitals and diagnostic centres presenting patient and medical information in different documents and forms. It becomes difficult for patients and other healthcare providers to interpret and record the information. Content standards in healthcare address this issue.
Content standards define the structure and data types of electronic medical documents to ensure all medical data is represented in a clear and understandable manner. They are used for clear medical documentation. Some of the content standards are:
Consolidated Clinical Document Architecture (C-CDA)
C-CDA designed by HL7 International provides a framework for creating electronic clinical documents in the US. It specifies the structure of medical records and encoding elements for data exchange.
C-CDA has two parts—a human-readable part for web browser display and a machine-readable part for automated data processing.
The standard provides templates to capture, store, display and exchange health information—both structured and unstructured. Different C-CDA templates are:
- Consultation Note template: for a physician to request an opinion from another physician
- Continuity of Care Document (CCD) template: to exchange critical patient health information like medications, medical history, risk factors, etc., while transferring a patient from one healthcare provider to another.
- Discharge Summary template: to record all the information of a patient from his admission to the hospital to discharge and aftercare.
- Diagnostic Imaging Report template: to provide an interpretation of diagnostic image data.
- And many more.
Health Level 7 Version 2
HL7 V2 is a messaging format used to transfer data from one health system to another. V2 is a widely implemented standard in healthcare across the globe.
Every HL7 message has three characters that define the information they transport:
- VXU messages for vaccination history
- RSP and QBP messages for immunisation history
- ADT messages for demographic history
- And many more
Health Level 7 CDA®
HL7 V3 Clinical Document Architecture (CDA®) is an XML-based markup that specifies the structure and semantics of clinical documents. It says every clinical content must have six characteristics—Persistence, Stewardship, Potential for authentication, Context, Wholeness and Human readability.
CDA® can be any clinical document like discharge summary, imaging report, pathology report, etc.
US Core Data for Interoperability (USCDI)
USCDI is not a document or messaging standard but a content standard that specifies mandatory sets of information a hospital must provide for patient requests via APIs. It also identifies the terminology standards to use—LONIC, SNOMED CT, RxNorm, etc.
Here’s all the information a hospital must provide:
Other content formats in healthcare
- Free text: It is used to note information that cannot be entered in a structured EHR. It also serves as a communication between healthcare providers.
- JSON/REST/XML/SOAP: These are APIs and machine-readable languages and protocols that facilitate documentation and exchange of health data.
- PDFs and documents: for test reports and other clinical documentation
- Flat Files: they are easy to generate files (Excel spreadsheets, database extract etc.) used to transfer information to study teams and have less standardisation.
Transport/Communication Standards
Transport standards specify the flow of information between health systems to ensure interoperability. They define formats, document architecture, methods, APIs etc., to facilitate data exchange. Here are a few transport standards in healthcare:
Fast Healthcare Interoperability Resources (FHIR)
FHIR is an HL7 standard for the electronic exchange of healthcare data. It defines how health data is to be exchanged between different systems, irrespective of how it is stored internally. It is used to transmit EHR information between healthcare providers or between patients and doctors.
FHIR has two primary components—resources and APIs. Resources are standardised and shareable identifiers that enable discrete data sharing rather than document-based exchange. APIs allow developers to create applications that deliver information from EHRs directly.
Direct
Direct is a health data standard maintained by DirectTrust. It is used to exchange personal health information securely. It uses HISP (health information service providers) to provide encryption and digital signing to handle data exchange.
Digital Imaging and Communications in Medicine (DICOM)
DICOM is an international transport standard and file format for exchanging medical images. Commonly used image formats like JPEG, BNP, etc., are incapable of telling anything about patient or image acquisition parameters. Therefore, DICOM is used. DICOM files contain a header with metadata and multiple pages which facilitate easy understanding of medical images.
SCRIPT by National Council for Prescription Drugs Programs (NCPDP)
The Script is a health industry standard for electronic prescription exchange between physicians, patients, pharmacies and health plans. It allows submission of new prescriptions, altering or cancelling prescriptions, refill requests and other functions.
Clinical Data Interchange Standards Consortium (CDISC)
CDISC is a communication standard between pharmaceutical companies and researchers to facilitate the electronic exchange of clinical trial data. CDISC and FDA work together closely. After the 2016 update, it became mandatory for companies to share their clinical trial data with the FDA.
Privacy and Security Standards
These are the most important standards to be followed by healthcare companies. Privacy and Security Standards consist of rules that ensure the protection of sensitive health information from misuse.
Health Insurance Portability and Accountability Act (HIPAA)
HIPAA is a health data standard mandatory in the US for all companies dealing with health data. It defines three rules—privacy rule, security rule and breach notification rule—to protect the privacy and security of e-PHI.
Read our detailed article about HIPAA here.
General Data Protection Regulation (GDPR)
GDPR is a set of rules and regulations framed by the European Union (EU) that regulate data collection, storage, processing and exchange of health data by companies. It aims to protect the sensitive data of EU residents and applies to all the companies dealing with the personal data of EU residents based in the EU or not.
Read our detailed article about GDPR here.
Challenges with health data standards
While several standards are in place to promote interoperability and ensure a smooth flow of data amongst different health systems, they don’t tackle all the problems arising from their implementation. Here are a few challenges related to data standards in healthcare and how they can be addressed:
Heaps of manual work
Recording diagnosis, medical procedures, OPD services, treatment plans, etc., in health systems in the form of medical codes, is a lot of manual work needed to be performed by physicians. While computer-assisted coding systems are available, they are time-consuming and lack translation accuracy.
To reduce the workload on already burnout physicians, health institutions must look forward to AI technologies. Several AI startups are helping healthcare providers with automated medical translations.
No linkage between different codes
There are different codes for different health uses. SNOMED CT defines clinical issues in detail but is not compatible with billing purposes. The data in SNOMED needs to be translated to ICD-11 for administration, billing and reimbursements.
Mapping between different codes can help health institutions to address this. SDOs continually work towards different mapping solutions. Health institutions can make the most of them. For example, Integrating Health Enterprise (IHE) is an initiative that promotes the coordinated use of DICOM and HL7 standards to address specific clinical needs.
Regular new updates
With technology advancing every single day, standards are being updated frequently. However, new standards are not always compatible with older versions, making it difficult for health companies to regularly update hardware and software to meet requirements.
SDOs need to consider this while releasing new updates and creating backwards compatible standards. They also need to build tools and resources that help health companies to transfer data from older versions to newer ones.
Bottom line
Health data standards are essential to enable interoperability between health systems and smooth exchange of health data. However, with ever-evolving technology and standards getting outdated at a faster pace, health companies find it difficult to keep up with the newer versions.
To increase standard adoption and usage, health companies can participate in the standard development process. This will help them understand the standard implementation and provide feedback to improve it.
