Electronic-Medical-Recording: There are many Electronic Medical Records [EMR] products available on the market Today. There are over 400 electronic medical record products on the market today but many companies prefer customized solutions for their recording requirements.

That the AMA define the critical elements that an electronic Medical record (EMR) system should have the capacity to record, although some of these elements may not be used by all parties and/or may require refinement for effective use. 

The following report, which is presented for the information of the House, summarizes electronic Medical record trends; addresses issues such as health data element standards and data sets; outlines and discusses some of the characteristics and features of key inter-related core components of ambulatory EMRs; reviews the results of the AMA's core clinical data elements survey; discusses some of the barriers or obstacles to implementation of EMRs; and presents current information related to security and interoperability.

When describing an electronic Medical or patient records system, different associations, vendors, and institutions use varying terminology and definitions.  Some organizations make a clear delineation between the definitions, whereas others use terminology interchangeably.   

According to the Medical Records Institute (MRI), the EMR is an upgraded version of the computerized medical record that has essentially the same structure, scope, and information as the paper-based record.  However, the information is rearranged for computer use.  In addition, the MRI believes such a system should be capable of appropriately capturing, processing, and storing information and be interoperable with other related systems such as billing and administration. 

Furthermore, the MRI believes that the electronic Medical record is a concept that has a number of criteria, such as being paperless, complying with documentation rules (e.g., data integrity, authenticity, availability, and auditability, etc.) as well as being platform and institution-independent.  Systems may comply with some or all of these concept requirements. 

A survey of electronic health record trends and usage was recently conducted by the MRI that reveals a number of the following insights into the motivations driving the need for EMRs, the major barriers, and associated security concerns:  

• Major management/administrative factors driving the need for EMRs include the need to share comparable patient data among different sites within a multi-entity health care delivery system as well as the need to establish a more efficient and effective information infrastructure as a competitive advantage.

• Major clinical factors driving the need for EMRs include improving the ability to share patient record information among providers as well as improving the quality of care.

• Major barriers to implementation include lack of adequate funding or resources and inadequate or incomplete health care information standards, data sets, or code sets.

• Major concerns regarding the security of patient record information include access to patient record information by unauthorized users as well as inappropriate access to patient record information by authorized users inside the organization.

Complete results of the survey are available at www.medrecinst.com.

There are few established health data element standards for electronic Medical records are few.  Two known core data sets, each published in 1996, are the National Committee for Vital and Health Statistics (NCVHS) Core Health Data Elements and the American Society for Testing and Materials (ASTM) Minimum Essential Data Set.  The core health data set proposed by NCVHS for standardization consists of 42 elements.  Twenty-six of the 42 elements are identified as being "ready for implementation," whereas "substantial agreement has been reached, but some additional work is needed" on 10 of the elements.  The remaining six are "recognized as significant, but considerable work remains to be undertaken."  The data set, included as part of a complete report on core health data elements, can be downloaded directly from the NCVHS Web site at:  http:// www.ncvhs.hhs.gov/ncvhsr1.htm.  

The ASTM data set is part of the ASTM American National Standard E 1384-96: Standard Guide for Content and Structure of the Computer-Based Patient Record (recently revised to E 1384-99 Standard Guide for Content and Structure of the electronic Health Record) and consists of 116 data elements divided into the following entities: 

• Patient
• Encounter
• Problem
• Order-Care/Treatment Plan
• Provider
• Observation-History
• Observation-Assessment/Exams
• Observations-Diagnostic Tests
• Observation-Encounter/Episode Detail
• Service Instance

Information regarding ASTM standards can be found on its Web site:  http://www.astm.org.  The number of computer software vendors that have incorporated either the ASTM standard or NCVHS data set remains unknown.  In addition, the overall lack of a solution for standards for data recording and transmission, and the assurance of security, privacy, and confidentiality in record storage and transmission, have prohibited professional organizations from endorsing or truly supporting either of these data sets. 

Although the availability of the full range of core clinical data elements is perhaps the area of most concern to practicing physicians as they evaluate potential EMR systems, ambulatory electronic Medical record systems are comprised of a set of several inter-related key components.  These components together form the technical and clinical requirements of an optimal paperless patient record and the evaluation of an EMR system for an ambulatory setting demands attention to each component.  Review of the literature identified a total of seven key component categories of ambulatory electronic Medical record systems as necessary for evaluation: 

1. Data entry

• Provides flexible data entry options
• Supports a choice of data entry devices
• Provides modifiable templates to facilitate direct data entry at the point of care
• Provides pick lists for common responses
• Provides data merging from templates to progress notes
• Provides drawing tools for genograms
• Provides drawing tools with templates to document the presence of lesions, injuries, etc.
• Supports a wide range of coding options
• Provides mechanism for entry and validation of electronic signatures
• Allows direct data entry by physicians, nurses and other providers
• Allows entry of transcribed provider notes
• Allows multiple providers to view and write to the same chart simultaneously

2. Data display

• Provides practical data presentation formats
• Allows automatic text generation
• Provides custom views of results

3. Communications/connectivity

• Standards compliant
• Bi-directional interfaces
• Ability to transmit documents via facsimile
• Ability to transmit documents via email
• Internet capabilities
• Integrated Web browser 
• Technical features:
• Database type
• Structured data content/data elements
• Data warehouse capabilities
• Data access-decision support software
• Network
• Operating system
• Performance
• System security and privacy of data/data integrity

4. Workflow and record management

• Facilitates patient record management
• Supports patient scheduling
• Records patient information and demographics
• Clinical documentation and decision support functions
• Summary screen
• Problem lists
• Clinical decision support tools
• Medications/prescriptions support
• Imaging
• Labs
• Reminders and alerts
• Consultations
• Health care maintenance-preventive care
• Order entry capabilities
• Letters and forms
• Health status and functional level measurement
• Patient educational resources
• Quality management and reporting capability
• Managed care/insurance support

5. Core clinical data elements

• Patient Identification and Demographic Data
• Special Patient Health Conditions
• Allergies
• Immunizations
• Health Promotion/Disease Prevention
• Past medical History
• Family and Social History
• Encounter/Visit Administrative Information
• Encounter/Visit Clinical Information
• Laboratory Tests Orders and Results
• Other Diagnostic Procedures Orders and Results
• Therapeutic Services and Procedures Orders and Results  
• Medications Prescribed and Results
• Consultations and Referrals
• Correspondence/Release of Information

AMA CORE CLINICAL DATA ELEMENTS SURVEY 
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The Council believes that of the key EMR components described in the previous section, the category of most concern to practicing physicians is core clinical data elements.  In addition, this is the area where practice management software vendors continue to fall short in development of their products.  Therefore, on behalf of the AMA, Medical Systems Development, a firm specializing in market analyses of electronic Medical records and practice management systems, developed a report identifying a comprehensive list of core clinical data elements that an electronic Medical record system should have the capacity to record.  These data elements were derived from a large number of diverse resources including uniform data sets, accrediting and licensing agency requirements, industry standards, selected EMR literature, and EMR vendor system specifications. 

The AMA then developed a survey tool based on the market analysis to gather the opinions of 29 external advisors with expertise in paper-based medical record systems, computer applications in clinical care, and experience developing electronic Medical record systems in academia and the government.  The list of core clinical data elements included in the survey was not intended to represent a minimum data set.  In addition, the survey tool indicated that the data for each listed data element did not have to be recorded for every patient.  However, the 500-plus elements included on the survey were intended to represent a comprehensive listing of data elements that should be available in an optimal EMR system.  Therefore, the advisors were asked to review the data elements and assess the appropriateness of each data element for inclusion in a final list of recommended core clinical data elements for an ambulatory EMR system.   

General feedback from the survey revealed that all the presently listed core clinical data elements, along with a few suggestions from the advisors, should be further analyzed by a standards group to determine their functionality (required or conditional).  The survey tool, including comments to the overall survey, is available on the AMA Web site at http://www.ama-assn.org.  The Council believes that the results of this survey could provide standards development organizations, as well as electronic medical record system software vendors, with a coveted and viable source of information they can use in the development of future standards and products.  Since specific standards work does not exist in this area, two standards development organizations, ASTM and Health Level Seven (HL7), have already expressed interest in the outcome of this survey 

BARRIERS TO EMR IMPLEMENTATION  
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One of the biggest barriers in health care information technology remains the lack of standards. A standard is a clearly defined and agreed-upon convention for the operation and behavior of specific computing functions, formats, and processes. Standards are deficient for an EMR in a number of areas, including but not limited to medical vocabulary, common identifiers, data exchange, and privacy and confidentiality. In addition, standards are lacking in the categories of system interfaces and interoperability.  This latter deficiency is especially troublesome because the underlying technology and infrastructure of an EMR must incorporate the ability to communicate between one system and another.

Many organizations are addressing standards and issues related to the EMR.  However, no organization is focusing on the necessity for vendors to incorporate the specific needs of the practicing physician in the ambulatory care setting.  Since there is no agreed upon standardized EMR system for ambulatory care, the vendor community is creating a variety of EMR systems that are often incompatible.  This situation leaves little guidance for physicians in selecting an EMR.  

As stated previously, the Council believes that the results of the AMA core clinical data elements survey could provide standards development organizations, as well as electronic medical record system software vendors, with a coveted and viable source of information they can use in the development of future standards and products.  Since specific standards work does not exist in this area, and both ASTM and HL7 have expressed interest in the survey outcome, the results will be shared with the standards developing organizations. 

SECURITY AND INTEROPERABILITY 
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In CMS Report 7 (I-98), the Council recommended that the AMA work to establish consensus on industry security guidelines for electronic storage and transmission of medical records as an important means of protecting patient privacy.  The AMA is currently working with Intelâ Corporation on a system to provide digital certificates to physicians for use on the Internet.  It will protect physician and patient privacy and confidentiality when they use the Internet to send and receive medical information.  The AMA will begin issuing digital certificates to physicians by the third quarter of 2000.  The digital certificates will uniquely identify individuals over the Internet, providing a more reliable authentication technique than do passwords for secure Internet transactions.  Digital certificates function in the online world in the same way driver licenses, passports, and other trusted documents function in the paper world.   

The AMA and Intel believe that the potential for physicians to use the Internet as a tool to obtain data such as lab results, or to send prescriptions to pharmacies, in addition to storing and retrieving patient files, makes it vitally important that systems are in place to ensure that the patients privacy and confidentiality are protected.  Furthermore, by authenticating the identity of the physician, this system will allow for a wide and growing variety of routine medical transactions to occur online.  Ultimately, this development will enable better patient care and lessen the administrative burden on busy physicians and their staffs.  

Additional information regarding the AMA and Intel Digital Credential Management System to identify physicians on the Internet can be found in Board of Trustees' Report, "Health Data and Modern medical Professionalism" (A-00).  

CONCLUSION 
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It is clear that physicians and their patients can derive important benefits from broader use of EMR systems that adequately address the dimensions that are identified in this report.  At the same time, the Council recognizes that there are important issues related to potential impact on physician time, cost, patient care, and confidentiality.  In addition, the Council realizes that current EMR systems are not fully supporting physician needs.   

Based on the current marketplace and obstacles, the Council believes that it is premature for the AMA to suggest a specific standardized EMR system for use in the ambulatory setting.  The Council also believes that, based on substantial input from practicing physicians, accelerated progress in the EMR area is imperative.  This progress should address the need for greater standardization and the specific EMR dimensions identified previously in this report.  

Furthermore, the Council believes that the component of the EMR that is of most concern to practicing physicians is in the area of core clinical data elements.  Moreover, this is the area where practice management software vendors continue to fall short in development of their products.  However, as stated previously, standards work presently does not exist in this area.  Therefore, the Council believes that results of the survey tool including the comprehensive list of core clinical data elements should be shared with the appropriate standards development organization(s), since the true functionality of each element could be better determined within the standards community.  AMA participation in this project is crucial in order to make the computer a useful tool for creating a more efficient work environment for the physician.  Without the AMA efforts, standards will be modified to medicine rather than developed specifically for the profession.

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