Networking and Health Information Exchange Unit 5c Health Data Interchange Standards Networking and Health Information Exchange Unit 5c Health Data Interchange Standards

Health IT Workforce Curriculum Version 1.0/Fall 2010 Unit 5c Objectives Understand imaging standards Understand standards for pharmacy services Understand interface standards for medical devices Understanding claims and reimbursement standards Understand concept of profiling Understand the use and value of implementation guides The objectives of this subunit are to understand other standards that are used for data interchange. These standards include DICOM imaging standards, NCPDP pharmacy services standards, IEEE medical device standards, X12N reimbursement standards, and profiling and implementation guide services from IHE. You may encounter one or all of these standards, depending on your job and the size of your facility. At least some knowledge of these standards will be useful. If you need more detail than is included in this subunit, you will need to get copies of the actual standards. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

Health IT Workforce Curriculum Version 1.0/Fall 2010 DICOM Digital Imaging and Communication in Medicine (DICOM) Industry standard for transfer of radiologic images and other medical information between computers Developed by American College of Radiology National Electrical Manufacturers Assn. Current structure developed in 1993; current version 3.0. DICOM is the exclusive international standards body for imaging standards. All PACS systems will use the DICOM standards. DICOM also embraces JPEG and MPEG standards as part of their imaging package, although these standards were created by another group. The global universality of these standards provide a major step toward interoperability. The part of the standard for images specifically has withstood the test of time is truly interoperable. The additional supporting standards that provide information about how the image was taken and specifically about the subject/patient and clinical data overlaps with other standards and does have some variability among different settings. The DICOM standard resulted from a joint effort between the American College of Radiology and the National Electrical Manufacturers Association, starting in 1983. Subsequently, DICOM became an independent organization and a global standards body. The current version of the standard, v3.0, was published in 1993. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

Health IT Workforce Curriculum Version 1.0/Fall 2010 DICOM A single DICOM file contains both a header (which stores information about the patient's name, the type of scan, image dimensions, etc), as well as all of the image data (which can contain information in three dimensions). DICOM is the most common standard for receiving scans from a hospital DICOM v3.0 supports communication services for a point-to-point environment and for a networked environment. The upper-layer service supports the use of a fully conformant stack of OSI protocols to achieve effective communication. It supports a wide variety of international standards-based network technologies using a choice of physical networks such as Ethernet, FDDI, ISDN, X.25, dedicated digital circuits, and other local area network and wide area network technologies. In addition, the same upper-level service can be used in conjunction with TCP/IP transport protocols. DICOM also supports other standards including Structured reports and Web-access to persistent objects. These later standards are also ISO standards. DICOM is a liaison group to ISO. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

National Council for Prescription Drug Programs (NCPDP) Data interchange standards for pharmacy services Standards included in meaningful use criteria Key standards include Telecommunication Standard Batch Standard Script for electronic prescribing Manufacturers Rebate Standard NCPDP is an ANSI-accredited, SDO representing virtually every sector of the pharmacy services industry. The diverse membership provides leadership and healthcare business solutions through education and standards, created using the consensus building process. NCPDP has been named in US federal legislation, including HIPAA, the Medicare Prescription Drug, Improvement, and Modernization Act, and in the meaningful use requirements. These standards are used for the reimbursement of prescription drugs. NCPDP members have created standards such as the Telecommunication Standard and Batch Standard, the SCRIPT Standard for Electronic Prescribing, the Manufacturers Rebate Standard and more to improve communication within the pharmacy industry. The current version of the Telecommunications Standards is Version D, release 0. The Batch standard (which does the same thing) is version 1.1. The SCRIPT standard, current version 10, release 4, is used to exchange prescription information between physician/prescriber and the pharmacy. It is also used for managing refills and for communication information about drugs dispensed. The current version of the manufacturer rebate standard is Version 4, release 1. Other NCPDP standards include a financial information reporting standard, a billing unit standard, a Medicaid subrogation standard (permits Medicaid agency to communicate to a processor for reimbursement), a formulary and benefit standard, a post adjudication standard, and a prescription file transfer standard. NCPDP also works with HL7 for Electronic Prescribing Coordination. This activity correlates portions of NCPDP SCRIPT into HL7 v2.n standards for new prescriptions, changes to prescriptions, refills, cancellation of prescriptions, compliance notification and sharing medication history information. This work is particularly important to improve patient safety. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

Institute of Electrical and Electronic Engineering (IEEE) Standards Developing Organization focused primarily on device standards Works with ISO, HL7, CEN and DICOM to create device standards Standards referred to as point of care standards Also creates waveform standards IEEE creates standards for medical devices. IEEE works collaboratively with ISO, CEN, HL7, and DICOM to create these standard, and, as a result, contribute greatly to interoperability. The following slides identify the IEEE standards that are in use or are being developed. IEEE has created a family of standards the defines the entire seven-layer communications requirements for the medical information bus. IEEE, working with the above groups, is also producing waveform standards. More recently, the group is developing personal device standards. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

Health IT Workforce Curriculum Version 1.0/Fall 2010 IEEE Standards Family of standards labeled 11073 – nnnnn ISO rules – title is Health Informatics – class – purpose All of the IEEE standards are identified by the initial number 11073 and, as such, are often referred to as the 11073 family of standards. The specific identification number is a 5 digit number(nnnnn) that identifies the type of standard. Types include guidelines/information/background, point-of-care standards, transport profile, application profile, interface profile, models, nomenclature, and models. The next series of slides identify the IEEE medical devices by the year in which they were published. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

Health IT Workforce Curriculum Version 1.0/Fall 2010 IEEE - 2000 30200 Transport profile – cable connected The interface profiles deal with every way in which a medical device can be connected to a system – cable, infrared, and wireless. The 30200 is a transport profile for cable connected devices and was published in 2000. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

Health IT Workforce Curriculum Version 1.0/Fall 2010 IEEE - 2008 00101 [TR] – Guidelines for the use of wireless technology 10404 – Pulse Oximeter 10407 – Blood pressure monitor 10408 – Thermometer 10415 – Weighing scale 10441 – Cardiovascular fitness and activity monitor Technical report 00101 is a guideline standard for the use of wireless devices. In 2008, IEEE began to develop a set of personal health devices using the label device specialization. These standards all have the leading category identifier 104 followed by the 2 digit personal device identifier. Appliances covered in 2008 include the pulse oximeter, the blood pressure monitor, the thermometer, the weighing scale, and the cardiovascular fitness and activity monitor. These personal devices standards are increasingly important as we move into personal health records' and personal responsibility for one’s own health. Many of these devices will be found in the homes or worn. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

Health IT Workforce Curriculum Version 1.0/Fall 2010 IEEE – 2008 (cont) 10442 - Strength fitness equipment 10471 – Independent living activity hub 20601 Application profile – Optimized Exchange protocol Other devices include strength fitness equipment (such as treadmills) and independent living activity hub – important for an ageing population. An application profile standards was published in 2008 for an optimized exchange protocol. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

Health IT Workforce Curriculum Version 1.0/Fall 2010 IEEE - 2009 10417 – Glucose monitor In 2009, a standard was published for a glucose monitor as a personal device. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

Health IT Workforce Curriculum Version 1.0/Fall 2010 IEEE - 2010 10420 – Body composition analyzer 10421 – Peak expiratory flow monitor 10472 – Medication monitor 30400 – Interface profile – cabled Ethernet 2010 continued the creation of personal device standards – body composition analyzer, the peak expiratory flow monitor (peak flow), and a medication monitor. Also published in 2008 was an interface profile for cabled Ethernet, so devices could be connected directly to an Ethernet network. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

IEEE Under Development 00103 [TR] – Overview 10101 [rev] – Nomenclature 10102 – Nomenclature – Annotated ECG 10103 – Nomenclature – Implantable device, cardiac 10201 [rev] – domain information model 10202 – domain information model – XML schema format IEEE has a very aggressive agenda. Currently under development are a series of standards, identified on these 3 slides. Some of the standards are revisions of older standards; others are amendments to existing standards. Of an informative nature is an overview standard for the 11073 family of standards and a set of 3 standards for nomenclature – or glossary – for medical device standards, for annotated ECG, and for implantable cardiac devices. The annotated ECG standard defines the set of measurements that accompany the waveform – useful for the EHR or PHR. Other standards include a domain information model for medical devices one of which is XML schema based. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

IEEE Under Development 10404 [rev] – pulse oximeter 10406 – basic electrocardiogram (1 to 3 lead ECG) 10413 – Respiration rate monitor 10417 [rev] – Glucose meter 10418 – International normalized ratio (INR) monitor 10419 – Insulin pump Several other personal device standards are under development – pulse oximeter (revision), basic ECG (1-3 lead, waveform), respiration rate monitor, glucose meter (revision), international normalized ratio (INR) monitor, and an insulin pump. The INR measures the time it takes for blood to clot and compares it to an average. Monitoring the INR can be an important step in managing health. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

IEEE Under Development 10441 [rev] – cardiovascular fitness and activity monitor 20200 –association control function 20201– polling mode 20202 – baseline asynchronous mode 20301 – Optional package, remote control 20401 – Common networking infrastructure Continued personal device standards include a revision of the cardiovascular fitness and activity monitor. The 20nnn codes are application profiles and include standards for association control function, polling mode, baseline asynchronous mode, remote control, and a common network infrastructure. These standards deal with applications interfacing with medical devices. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

IEEE Under Development 20601a [amendment] – optimized exchange protocol 30200a [amendment] – Transport profile – cable connected 30503 – Transport profile – RF wireless – local area network (wLAN) Two amendments to standards are under development: for optimized exchange protocol (to be published in 2011) and transport profile for cable connected devices. The last standards under development is a transport profile for RF wireless in a local area network. The time to publication for these standards will vary from 1- 3 years. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

Health IT Workforce Curriculum Version 1.0/Fall 2010 IEEE 2004 10101 – nomenclature 10201 – domain information model 20101 Application profile – base standard 30300 – Interface profile – cabled Ethernet The IEEE 2004 standard is also being developed. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

Health IT Workforce Curriculum Version 1.0/Fall 2010 X12N Creates EDI standards related to claims and reimbursement Use required by HIPAA Standards available from Washington Publishing Company or buy CD version X12 has developed standards for the exchange of purchase-order data, invoice data, and other commonly used business documents. The X12N subcommittee is responsible for business standards that are related to healthcare – specifically standards that deal with claims and the reimbursement process. The X12N standards use an EDI structure called transaction sets. Each transaction set is composed of a header and one or more control segments that relate to the purpose of the standard. Data segments are defined in a data segment dictionary; data elements are defined in a data element dictionary; composite data structures are defined in a composite data dictionary, and control segments and binary segments are defined in a data-segment dictionary. X12N standards are required by HIPAA and are mentioned in the final rule for meaningful use. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

The HIPAA Standard Transactions HIPAA - What's Happening The HIPAA Standard Transactions 5/23/2000 This slide illustrates the family of X12n standards that support the exchange of data among providers and payers as well as data exchange with employers related to reimbursement. 270 is an Eligibility Inquiry from the provider and 271 is the payer’s response. 837 is the payer’s claim submission and 835 is the payer’s claim payment/advice. 276 is a claim status request from the provider and 277 is the claim status notification or a request for additional information from the payer. 275 is additional information from the provider. 278 is healthcare review from payer. Coupled to the employer or sponsor are 834 for benefits enrollment and 829 for premium payment. Claims attachments – the clinical data that supports the claim – standards have been jointly developed by X12N and HL7. The current version uses the HL7 CDA. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

Integrating the Healthcare Enterprise (IHE) Is not a standards developing organization Use standards developed by other SDOs Provides a common framework for passing health information seamlessly: within the healthcare enterprise across multiple healthcare enterprises for local, regional & national health information networks. Drives standards adoption to address specific clinical needs. The goal of the Integrating the Healthcare Environment (IHE) is to stimulate the integration of healthcare information resources and promote the adoption of standards. It is not a standards developing organization – it identifies and promotes the use of other SDOs. IHE works with specific clinical domain organizations to understand requirements and develops profiles and implementation guides to support those requirements. In many cases the profile requires the use of several standards. This approach does enable interoperability in a controlled way. IHE has value locally, across multiple enterprises, regionally, nationally and globally. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

Health IT Workforce Curriculum Version 1.0/Fall 2010 IHE Drives standards adoption to address specific clinical needs Coordinates implementation of standards to meet clinical and administrative needs Creates integration profiles to provide end-to-end interoperability Sponsor annual Connectathon at HIMSS Provides opportunity for vendors to test and demonstrate interoperability of their products IHE has played a major role in defining requirements and promoting the development of standards to meet those requirements. Their incentive for participation is the opportunity to demonstrate that their systems can operate efficiently in standards-based, multi-vendor environments with the functionality of real hospital and clinic information systems. IHE enables vendors to direct product development resources toward building increased functionality. The IHE Connectathon, held annually at HIMSS and also at other locations internationally, provides the opportunity for vendors to test and prove their ability to work with other systems. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

Health IT Workforce Curriculum Version 1.0/Fall 2010 Domains of Activity IT Infrastructure Radiology Laboratory Cardiology Patient care coordination Patient care devices Radiation Oncology Eye This slides shows activity with IHE working with medical specialty groups create profile/implementation guides for specific domains. Domains currently addressed include radiology, cardiology, laboratory, patient care coordination, patient care devices, radiation oncology, and eye. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

Document Exchange Profiles XDS –document sharing XDR – document reliable interchange XDM – document media interchange PIX – patient identifier cross reference manager PDQ – patient demographic supplier XCA – cross-community access All of these services/products are cross enterprise XDS supports records sharing. XDS typically uses HL7 CDA documents. XDS supports a document registry with queryable index of metadata and references to all documents shared within a connected enterprise. Using XDS, IHE provides for storage and retrieval of clinical data (usually documents. XDR (Cross-Enterprise Document Reliable Interchange) is intended to be a light-weight, point-to-point introduction to XDS. It uses the Provide and Register Document Set transaction, originally defined in XDS, to move documents and associated metadata between two systems. It does not use the Document Repository and Document Registry actors from XDS. In short, it does not define an environment for sharing (that would be XDS) but instead a way of transporting documents and metadata about documents from one system to another. Cross-Enterprise Document Media Interchange (XDM) provides document interchange using a common file and directory structure over several standard media. This permits the patient to use physical media to carry medical documents. This also permits the use of person-to-person email to convey medical documents. PIX reconciles information on patients from multiple domains to a single cross-referenced set of IDs for each patient. PDQ – returns demographic information and identifiers of patients based on specified demographic criteria. XCA supports the means to query and retrieve patient relevant data held by other communities – i.e. another RHIO. These products work together to support interoperability and the sharing of data among sites. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010

Health IT Workforce Curriculum Version 1.0/Fall 2010 Summary This unit has introduced you to a series of standards are used for networking between sites at all levels. Much of the focus was on clinical messaging standards – namely HL7 version 2.n and v3. standards. You were also introduced in imaging standards, pharmacy services standards, medical device standards, and claims and reimbursement standards,. Finally we looked at an organization that provided profiles and implementation guides that put these standards together to support end-to-end interoperability. This unit has introduced you to a series of standards that are used for networking between sites at all levels. Much of the focus was on clinical messaging standards – namely HL7 version 2.n and v3. standards. You were also introduced in imaging standards, pharmacy services standards, medical device standards, and claims and reimbursement standards. Finally we looked at an organization that provided profiles and implementation guides that put these standards together to support end-to-end interoperability. Component 9/Unit 5c Health IT Workforce Curriculum Version 1.0/Fall 2010