Key Takeaways
- FHIR was developed by HL7 and is an interoperability standard for healthcare data exchange. FHIR made it easy to create applications for EHRs and to retrieve and exchange data at a faster rate.
- HIPAA regulations protect the privacy and security of ePHI. The security rule protects health data that is created, received, or transmitted by covered entities, which primarily includes healthcare providers.
- SCRIPT is a standard for exchanging e-prescriptions and medical data between pharmacies, care providers, and health plans. It supports the submission of new prescriptions.
Healthcare data standards define protocols, methods, terms, and specifications required for data exchange and storage. These standards ensure the security and privacy of ePHI, which gives reassurance to patients that their data is in safe hands. As of 2022, more than 500 healthcare data breaches were reported due to the disclosure of ePHI without authorization. Healthcare data standards such as HIPAA prevent such data breaches and also give direction on how to handle medical data. This article highlights every data standard used in the healthcare sector.
4 Categories of Healthcare Data Standards
1. Data Exchange Standards
a. Direct
Direct standard is used for exchanging health data between healthcare providers, hospitals, clinics, and labs over a secure network. It is inexpensive and easy to use. Further, Direct messaging operates like a regular e-mail with security measures. It is maintained by DirectTrust since 2010 and is widely adopted by EHR software for data exchange. Direct messaging uses HISPs (Health Information Service Providers), instead of SMPT (Simple Mail Transfer Protocol). This is so because HISPs offer digital signing and encryption of every message exchanged.
b. FHIR
FHIR (Fast Healthcare Interoperability Resources) was developed by HL7 (Health Level Seven) and is an interoperability standard for healthcare data exchange. It was launched in 2014 and was quickly adopted by healthcare vendors. FHIR made it easy to create applications for EHRs and to retrieve and exchange data at a faster rate. Recently, SMART on FHIR was introduced for seamless data access between different EHRs. It is a set of guidelines to integrate portals and apps with EHRs.
c. DICOM
DICOM (Digital Imaging and Communications in Medicine) is an international communication standard and file format for exchanging medical images and data across software and hardware tools from multiple vendors. It provides interconnectivity between medical systems and it supports all medical branches such as radiology, pathology, orthopedics, etc.
d. CDISC
CDISC (Clinical Data Interchange Standards Consortium) communicates and creates standards for the exchange, acquisition, archive, and submission of data for biopharmaceutical and medical product development. It works in collaboration with global agencies such as the FDA (U.S. Food and Drug Administration), PMDA (Japan’s Pharmaceuticals and Medical Devices Agency), and EMA (European Medicines Agency). Incorporation of CDISC decreases expenses during drug development, leading to quick marketing authorization.
e. SCRIPT
SCRIPT is a standard for exchanging e-prescriptions and medical data between pharmacies, care providers, and health plans. It supports the submission of new prescriptions, changing and canceling prescriptions, and refilling. This standard uses RxNorm codes for drug information and SNOMED codes for explaining allergies.
2. Security Standards
a. HIPAA
HIPAA (Health Insurance Portability and Accountability Act) regulations protect the privacy and security of ePHI (Protected Health Information). The security rule protects health data that is created, received, or transmitted by covered entities, which primarily includes healthcare providers. The covered entities under the security rule of HIPAA ensure the integrity, confidentiality, and availability of ePHI.
The data is protected against cyber security threats like fraud, ransomware attacks, and data breaches. All healthcare software applications, websites, portals, APIs, etc. are made HIPAA compliant. Failure to do so results in penalties and criminal charges which is harmful to the reputation of a company and healthcare facility.
3. Terminology Standards
a. SNOMED CT
SNOMED CT (Systematized Nomenclature of Medicine – Clinical Terms) is recognized as a common language for medical terminologies in 50 different countries. It helps providers to input medical data into the EHR system, share it, and aggregate it. SNOMED CT was needed for Stage 2 Meaningful Use for documenting problems. Today it is an excellent method put forth by Medicare and Medicaid’s Promoting Interoperability Programs. It can be mapped with other standards such as ICD-9, ICD-10, and CPT to facilitate semantic interoperability.
b. ICD-10-CM
ICD-10-CM (Clinical Modification) signifies the US version of the International Classification of Diseases, which is maintained by the WHO. The ICD codes are revised by the CMS (Centers for Medicare and Medicaid) and the NCHS (National Center for Health Statistics). Healthcare facilities used ICD codes for billing and reimbursement and serve as a universal tool to track mortality and morbidity statistics.
c. LOINC
LOINC (Logical Observation Identifiers Names and Codes) are a set of identifiers for clinical observations and laboratory tests. It covers existing labs and a range of clinical concepts and measurements. LOINC codes are adopted by hospitals, commercial laboratories, government agencies, and research institutions.
d. CPT
CPT (Current Procedure Terminology) is a code system that is maintained by the AMA (American Medical Association). It explains outpatient services and processes for billing and tracking treatment. In a bill for reimbursement, a CPT code is paired with an ICD-10-CM code. The insurance company can reject the claim if any irrelevant document is offered.
e. NDC
NDC (National Drug Code) is an authentic identifier for human medications in the United States. The NDC codes were created to facilitate drug data storing and claims processing. These codes are published on all drug packages.
f. HCPCS
HCPCS (Healthcare Common Procedure Coding System) is an extended version of the CPT code. It has two levels:
- Level 1: This duplicates CPT codes and identifies procedures and services delivered or ordered by physicians.
- Level 2: It is supported by the CMS and it supplies and identifies products and services which aren’t included in the CPT code such as drugs, prosthetics, or medical equipment.
i. RxNorm
RxNorm is a catalog of drug delivery devices and clinical drugs which are available in the USA. It is handled by the NLM (US National Library of Medicine) and it helps to improve interoperability and enable clear communication between healthcare systems.
j. CDT
CDT (Current Dental Terminology) is maintained and developed by the ADA (American Dental Association) for electronic communication of dental services. It covers oral health and is used in the same way as the CPT code for general healthcare.
4. Content Standards
a. USCDI
USCDI (US Core Data for Interoperability) is a set of mandatory content pieces that healthcare facilities must share on patients’ requests via APIs. It aggregates information such as health concerns, patient demographics, medications, treatment procedures, etc. into large data sets.
b. HL7 v2 and v3
One of the key differences between HL7 messaging and HL7 documents is that the former is a set of data sent from one system to another, while the latter is just an electronic document. The healthcare facilities rely on 2 and 2. x messaging versions that are supported by every EHR software.
c. C-CDA
C-CDA (Consolidated Clinical Document Architecture) is designed by the HL7 and is used for creating electronic clinical documents. It determines how to structure medical records and encode data for exchange. C-CDA allows data capture, storage, access, and transfers (both structured and unstructured).
Wrapping Up
Healthcare data standards change every time and new regulations are constantly coming up. It’s quite hard to keep up with the changing regulations and some may be missed out too. So, it is necessary to collaborate with HealthTech companies who are aware of these healthcare data standards and other regulations. These companies will help you to develop healthcare software that complies with all the regulations and protocols. This will help you to save tons of time in going through surplus rules created by data standards.
Arkenea, a healthcare software development company offers services that not only align with data standards but also meet industry standards. Get in touch for a quote.