You know that not doing Meaningful Use correctly can impact your incentives. In this Webcast you'll learn what is needed to support HL7 v2.5.1 and its impact on Meaningful Use data exchange.
Easy! Have a look at our diagram on how the submission process looks like. It is never been easier - with Cunesoft you are prepared for upcoming submission mandates. Check our eCTD submission software cune-eCTD here: https://cunesoft.com/en/products/ectd/
The aim is to be a one stop service provider for consulting and support services related to compliance, validation, Computerized System Validation, IT Infrastructure Qualification and IT Solutions catering to clients in the life sciences industry. The main objective is to provide services that enhance current operations and bring the knowledge and experience needed to maintain, manage and control related services.
The philosophy of IVY Works is to be transparent, open and work with our Clients as part of their teams to achieve set objectives and goals.
Experience: Extensive experience among the founders in regulatory compliance, validation, CSV and IT Solutions. All consultants have relevant experiences in the life sciences industries with exposure to the whole gamut of operations (manufacturing, labs, IT, regulatory).
Exposure: Founders and Consultants have worked with a majority of the top ten Pharmaceutical companies in lead roles to manage and also better develop, implement and validate compliance processes. Have worked with clients in North America, Europe & Asia.
Performance: Proven track record of delivering ahead of budget and timelines for a variety of projects/ programs
Delivery: Ability to take on projects of any size – with the same emphasis on project delivery and management
Strategies for Conducting GxP Vendor Assessment of Cloud Service Providers - ...Montrium
Want to deploy a new technology solution but not sure where to begin? These slides cover key considerations for choosing a vendor with cloud compliance and validation in mind. With the Office 365 subscription-based service gaining considerable momentum in the life sciences, it's important to stay ahead of the technological and regulatory curve and consider how an EDMS system will bring improvements to managing your GxP content.
Here we cover the following topics:
-Vendor assessment of Microsoft
-Subscription basics of Office 365
-Review of ISO/SOC audit reports
-Ensuring that no critical observations are made
-Security and quality controls in place
You can follow along with this presentation via webinar format:
https://info.montrium.com/strategies-for-conducting-gxp-vendor-assessment-of-cloud-service-providers
Easy! Have a look at our diagram on how the submission process looks like. It is never been easier - with Cunesoft you are prepared for upcoming submission mandates. Check our eCTD submission software cune-eCTD here: https://cunesoft.com/en/products/ectd/
The aim is to be a one stop service provider for consulting and support services related to compliance, validation, Computerized System Validation, IT Infrastructure Qualification and IT Solutions catering to clients in the life sciences industry. The main objective is to provide services that enhance current operations and bring the knowledge and experience needed to maintain, manage and control related services.
The philosophy of IVY Works is to be transparent, open and work with our Clients as part of their teams to achieve set objectives and goals.
Experience: Extensive experience among the founders in regulatory compliance, validation, CSV and IT Solutions. All consultants have relevant experiences in the life sciences industries with exposure to the whole gamut of operations (manufacturing, labs, IT, regulatory).
Exposure: Founders and Consultants have worked with a majority of the top ten Pharmaceutical companies in lead roles to manage and also better develop, implement and validate compliance processes. Have worked with clients in North America, Europe & Asia.
Performance: Proven track record of delivering ahead of budget and timelines for a variety of projects/ programs
Delivery: Ability to take on projects of any size – with the same emphasis on project delivery and management
Strategies for Conducting GxP Vendor Assessment of Cloud Service Providers - ...Montrium
Want to deploy a new technology solution but not sure where to begin? These slides cover key considerations for choosing a vendor with cloud compliance and validation in mind. With the Office 365 subscription-based service gaining considerable momentum in the life sciences, it's important to stay ahead of the technological and regulatory curve and consider how an EDMS system will bring improvements to managing your GxP content.
Here we cover the following topics:
-Vendor assessment of Microsoft
-Subscription basics of Office 365
-Review of ISO/SOC audit reports
-Ensuring that no critical observations are made
-Security and quality controls in place
You can follow along with this presentation via webinar format:
https://info.montrium.com/strategies-for-conducting-gxp-vendor-assessment-of-cloud-service-providers
This Presentation gives an idea about validation and different type of validation and overview of computer system/software validation and basics steps for computer system validations as per the regulatory and user requirement specifications.
How Oracle Argus Safety 8.x Supports Product Safety NeedsPerficient, Inc.
Pharmaceutical, biotechnology, medical device, and contract research organizations (CROs) have many reasons to use a safety and pharmacovigilance system, such as Oracle's Argus Safety. From capturing adverse events and product complaints to reporting individual case safety reports (ICSRs) to regulatory authorities, a comprehensive solution can address most needs.
In our webinar, Perficient’s Dr. Rodney Lemery, Director of Safety and Pharmacovigilance, reviewed the newest release of Argus Safety. This presentation demonstrated both the basic and complex needs of life sciences companies that can be supported through the implementation or upgrade of the system.
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
Six Elements of the QC Process.
To learn more about the QC Process join us for a complimentary webinar ( March 29 @11am EST) where we will follow a TMF document through its life cycle from creation through inspection: Learn how TMF documents should maneuver through TMF submissions and quality checks utilizing well-developed processes, tools and metrics to ensure the TMF is ready when the inspectors come knocking.
Presented by: Jackie Morrill - Director of Clinical Operations
Register Here: http://bit.ly/2kqA6s8
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
Management of e-SOP in GxP environment .Anand Pandya
Management and use of electronic SOP for use in GxP environment . How can electronic version of SOP be prepared and used in compliance with regulatory environment .
This presentation is about the validation of software. It focus on the validation of software used in pharmacy. It contains definition of validation, computer system and validation of computer system. It explains the models which are used for software validation and on example i.e. HPLC software validation.
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
Migrating from Oracle AERS to Argus Safety: Reasons for the MovePerficient, Inc.
Not too long ago, Oracle AERS was the most widely-used adverse event report system. However, with the acquisition of Relsys and its safety and pharmacovigilance system in 2009, Argus Safety quickly became the go-to software for most life sciences companies. Its capabilities and comprehensiveness are unmatched.
Companies currently using Oracle AERS have expressed interest in moving to Argus Safety, but want to know more before making the jump. This webinar is meant to do just that – answer your common questions.
Please join Perficient's Dr. Rodney Lemery, director of safety and pharmacovigilance, as he will:
Compare Argus Safety to AERS
Cover the options of effectively migrating to Argus Safety
Process and Regulated Processes Software Validation ElementsArta Doci
Medical device manufacturers operate in a competitive marketplace with increasing end-user demands for features and usability and in a highly regulated environment.
Regulatory bodies look for evidence that medical devices are developed under a structured, quality-oriented development process. By following software validation and verification best practices, one can not only increase the likelihood that they will meet their compliance goals, they can also enhance developer productivity.
Scenario:
Midwest Regional Health is one of Wisconsin's largest and most sophisticated hospitals, is Implementing a new EHR system that will better their services to their internal and external customers. They are asking ITMC (I-Tech Medical Consortium) to help them navigate through this long term project, thereby improving their commitment to their surrounding community.
This Presentation gives an idea about validation and different type of validation and overview of computer system/software validation and basics steps for computer system validations as per the regulatory and user requirement specifications.
How Oracle Argus Safety 8.x Supports Product Safety NeedsPerficient, Inc.
Pharmaceutical, biotechnology, medical device, and contract research organizations (CROs) have many reasons to use a safety and pharmacovigilance system, such as Oracle's Argus Safety. From capturing adverse events and product complaints to reporting individual case safety reports (ICSRs) to regulatory authorities, a comprehensive solution can address most needs.
In our webinar, Perficient’s Dr. Rodney Lemery, Director of Safety and Pharmacovigilance, reviewed the newest release of Argus Safety. This presentation demonstrated both the basic and complex needs of life sciences companies that can be supported through the implementation or upgrade of the system.
Overview on “Computer System Validation” CSVAnil Sharma
HI this is Anil Sharma, Executive Compliance in USV LTD. I want to share my brief knowledge on CSV with you. I hope my presentation will help you to understand basics of CSV.
Six Elements of the QC Process.
To learn more about the QC Process join us for a complimentary webinar ( March 29 @11am EST) where we will follow a TMF document through its life cycle from creation through inspection: Learn how TMF documents should maneuver through TMF submissions and quality checks utilizing well-developed processes, tools and metrics to ensure the TMF is ready when the inspectors come knocking.
Presented by: Jackie Morrill - Director of Clinical Operations
Register Here: http://bit.ly/2kqA6s8
This document covers most of the topics in the CSV like Importance of CVS, Why to perform CSV, Validation Deliverables, Part 11 and Annex 11 Diferences
Management of e-SOP in GxP environment .Anand Pandya
Management and use of electronic SOP for use in GxP environment . How can electronic version of SOP be prepared and used in compliance with regulatory environment .
This presentation is about the validation of software. It focus on the validation of software used in pharmacy. It contains definition of validation, computer system and validation of computer system. It explains the models which are used for software validation and on example i.e. HPLC software validation.
An introduction to Life Sciences Computer System Validation, applicable regulation, SDLC phases, software categorisation, risk/ change/ deviation management, validation deliverable, risk based approach, regulatory inspection, audit findings, causes of compliance failure, key concepts in CSV etc.
Migrating from Oracle AERS to Argus Safety: Reasons for the MovePerficient, Inc.
Not too long ago, Oracle AERS was the most widely-used adverse event report system. However, with the acquisition of Relsys and its safety and pharmacovigilance system in 2009, Argus Safety quickly became the go-to software for most life sciences companies. Its capabilities and comprehensiveness are unmatched.
Companies currently using Oracle AERS have expressed interest in moving to Argus Safety, but want to know more before making the jump. This webinar is meant to do just that – answer your common questions.
Please join Perficient's Dr. Rodney Lemery, director of safety and pharmacovigilance, as he will:
Compare Argus Safety to AERS
Cover the options of effectively migrating to Argus Safety
Process and Regulated Processes Software Validation ElementsArta Doci
Medical device manufacturers operate in a competitive marketplace with increasing end-user demands for features and usability and in a highly regulated environment.
Regulatory bodies look for evidence that medical devices are developed under a structured, quality-oriented development process. By following software validation and verification best practices, one can not only increase the likelihood that they will meet their compliance goals, they can also enhance developer productivity.
Scenario:
Midwest Regional Health is one of Wisconsin's largest and most sophisticated hospitals, is Implementing a new EHR system that will better their services to their internal and external customers. They are asking ITMC (I-Tech Medical Consortium) to help them navigate through this long term project, thereby improving their commitment to their surrounding community.
The slides of the presentation I gave to the GNU Health community on December 11, 2013.
Video of the presentation, including question from the audience, is available on YouTube:
https://www.youtube.com/watch?v=t5LxER0Fbm0
A Baptism of FHIR - The Layman's intro to HL7 FHIRMark Scrimshire
As I work on #BlueButton on #FHIR I find people struggling to understand how FHIR works. I am still learning myself. This was a short introductory session I gave to colleagues at CMS about the underlying mechanics of FHIR and how it can benefit Healthcare interoperability.
HL7
Health level 7
What is HL7?
What does it stand for
HL7 Mission
HL7 contains message standards
HL7 in HealthcareManagement System
Standards
Limitations of HL7
Health IT has a Big Data opportunity with HL7 analytics. Learn about what is possible from Wes Wright, CIO at Seattle Children's Hospital, and Erik Giesa, SVP of Marketing and Business Development at ExtraHop.
Theera-Ampornpunt N. HL7 Clinical Document Architecture: overview and applications. Presented at: HL7 CDA Workshop at the Faculty of Medicine Ramathibodi Hospital; 2013 Jun 20-21; Bangkok, Thailand. Invited speaker, in Thai.
In this tutorial participants will learn the history of the RIM, the method by which the RIM is maintained, and key characteristics of the RIM that make it the premier information model in healthcare.
Topics Covered:
1. Introduction to HL7: who, what, and why
2. Introduction to HL7 v3: what and why
3. History of the HL7 Reference Information Model
4. HL7 RIM Subjects, Core Classes, and Structural Attributes
5. State Machines of RIM Core Classes
6. HL7 v3 Datatypes
7. HL7 v3 Vocabulary
This tutorial will assist in preparation for the HL7 v3 Certification exam.
2015 Edition Proposed RuleModifications to the ONC Health IT Certification ...Brian Ahier
Presentation to April 7, 2015 Health IT Policy Committee:
2015 Edition Proposed RuleModifications to the ONC Health IT Certification Program and 2015 Edition Health IT Certification Criteria
Presented at the 8th Healthcare CIO Certificate Program, Hospital Administration School, Faculty of Medicine Ramathibodi Hospital, Mahidol University on March 21, 2018
Importance of data standards and system validation of software for clinical r...Wolfgang Kuchinke
We present our evaluation of existing data standards for clinical trials. For this purpose a survey about the importance of data standards for clinical trials centers and EDC software companies were conducted. Electronic data capture in clinical trials uses a computerized system designed for the collection of clinical data in electronic form in Case Report Forms (CRF). It also covers medical data captured during clinical trials, safety data related to clinical trials, and patient reported outcome. The degree of implementation of standards, like CDISC ODM in available EDC software products was evaluated. Failure to establish data standards will make it difficult or impossible to connect data between different systems for efficient clinical study execution. The next step after purchasing a software solution is the computer system validation. Validation is about bringing computerized systems into regulatory compliance and making them compliant with GCP, GLP and GMP and other regulations (e.g. data protection). The basis standard for validation is provided by the GAMP Good Practice Guide, which provides a framework of best practices to ensure that computer systems are suitable for use and compliant with the legislation. The newest version uses a risk-based approach to computer system validation A system is evaluated and assigned to a predefined category based on its intended use and complexity. For validation one should define how all elements of the computer system are supposed to work (functional requirements), develop corresponding scripts and test routines to validate it is functioning as it should.
HANDI Summit 18 - Introducing HANDI-HOPD - Ewan DavisHANDI HEALTH
NHS England hosted the HANDI-HOPD Summit in London on the 18th September. This was attended by an invited audience of around 40 people to discuss plans to take the HANDI-HOPD platform forward to the NHS England Open Source Open Day on the 26th of November in Newcastle-Upon-Tyne where is will be launched as the Platform for NHS Code4Health.
HANDI-HOPD The HANDI Open Platform Demonstrator provides an experimental platform to demonstrate the power of emerging open standards and APIs to deliver the transformational power of the Internet to support digital health and care.
Ewan Davis introduced the HOPD, described where it fitted in the global development of open health platforms what had already been deployed and our plans for it’s development.
Microsoft HDInsight as a Big Data and Interoperability Platform to Drive Poin...DataWorks Summit
Learn how a small team of 3-4 technology and subject matter experts developed an Azure HDInsight solution. The solution captures genomics data for solid tumors, summary data from a third party and various internal sources, and does genomic Clinical Trial matching. This was done strictly using the Azure cloud and interactions with cloud-based Office 365 SharePoint web applications utilizing only batch scripting, Hive, and Sqoop. HD Insights is the data munging layer and SharePoint is the user access layer.
The process was stood up in a 6-8 week period, while doing our day jobs. The business benefit is to enable providers, at the point of care, to suggest clinical trials for oncology patients based on genomic matches (Molecular Tumor Board). This has increased participation rates in clinical trials with the goal to improve the survival rates and quality of life for patients. The success of this project has spread to capturing local home grown registries in data silos to share with other like-minded providers within Levine Cancer Institute.
The Prototype of Standalone Diagnostic Report Editor as a Proof-of-Concept for an Interoperable Implementation of Health Level Seven Clinical Document Architecture Standard (HL7 CDA) not Integrated with Electronic Health Record (EHR) System
The next wave: understanding how IT developments are changing the future of m...Erin Lyons
Demand is exploding in the field of medical translation with the pharmaceutical, biotechnology, and medical device sectors representing the second-largest market share in the industry. Despite fast-growing demand and higher volumes of translation services in both traditional and emerging markets, the life sciences vertical is set to face new challenges in an expanding geographic environment that has become increasingly regulated and quality-driven.
We will take a closer look at the trends currently driving the medical translation industry, including the recent push towards multilingual harmonization through controlled language and the implementation of common technological applications. Recent changes in the regulatory environment, transitions to e-documentation, and new approaches to terminology management as determinants of quality and consistency will also be explored.
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Understanding HL7 version 2.5.1 and Meaningful Use data considerations
1. Presented By:
Rich Murphy, VP, Interface Software
July, 2015
HL7: Version 2.5.1 and
Meaningful Use data
considerations
2. Topics
• Brief overview of HL7 v2.5.1
• Codification Standards and
considerations
• Clinical Document Exchange
considerations
• XML and Clinical Documents
• Looking forward with FHIR
3. What is HL7?
HL7 Organization definition: Health Level Seven is one of
several American National Standards Institute (ANSI)
accredited Standards Developing Organizations (SDOs)
operating in the healthcare arena. Most SDOs produce
standards (sometimes called specifications or protocols)
for a particular healthcare domain such as pharmacy,
medical devices, imaging or insurance (claims processing)
transactions. Health Level Seven’s domain is clinical and
administrative data. www.hl7.org
HL7 develops standards to improve information sharing
and provides interoperability to allow information
exchange between disparate systems.
4. HL7 Version 2
• HL7 version 2 messaging standard
was created in 1987
• The standard has evolved since that
time, current version is v2.7
• 95% of US healthcare organizations
use HL7 version 2 in some capacity*
• More than 35 countries have HL7
version 2 implementations in place*
*From hl7.org Primary Standards version
2 product suite brief
5. HL7 Version 2
• Version 2.3 approved as ANSI standard in
1997. Most common version in use with
healthcare interfacing at this time
• Version 2.5.1 approved as an ANSI standard
in 2007
• Version 3 approved in 2003
(Reference Information Model Release 1)
• Version 3 is a complete departure from
previous versions and is much more complex
• Even with version 3, HL7.org envisions
version 2 continuing to play a critical role in
healthcare interoperability well into the future
6. Why Use version 2.5.1?
• Required version for Meaningful Use Stage 1
objectives:
• Reportable LABs
• Clinical Document (codified values)
• Required version for Meaningful Use Stage 2
objectives:
• Reportable LABs
• Syndromic Surveillance (v2.3 no longer allowed)
• Immunizations (v2.3 no longer allowed)
• Transmit LAB tests/results
• Clinical Document data transfer (codified values)
HL7 Version 2.5.1
7. Why Use version 2.5.1?
• Required version for Meaningful Use Stage 3
objectives (tentative, still in comment phase):
• Public Health Interfaces (expanded to include
bidirectional data transfer for Immunizations)
• Clinical Documents (codified values)
• LAB Orders Interface (CPOE)
• eDOS (electronic Directory of Services) (LAB
test compendium) (CPOE and LAB Results)
HL7 Version 2.5.1
8. Why Use version 2.5.1?
• In addition to Meaningful use, mandated by many
State agencies as part of grant requirements
• Growing acceptance in HIE data exchange
• Interface vendors must conform to receiving system
specifications, if these require v2.5.1 these interfaces
must be designed to match these requirements for
proper communications
• In order to certify each solution, Interface vendors
must confirm to all Meaningful Use requirements,
vendors have to be able to send/receive v2.5.1 if they
want to operate in the Meaningful Use space
HL7 Version 2.5.1
9. HL7 Version 2.5.1
Overview
• Build upon previous versions of HL7 v2
and takes advantage of some of the
same core concepts:
• Messages used as the data transfer
mechanism between systems
• Segments and Fields used to create
each message
• Message Type used to define intent of
each message
• Control Characters/Delimiters/Data
Types
• ACKnowledgments
11. HL7 Version 2.5.1
Codified Values
LOINC
• Logical Observation Identifiers Names
and Codes (www.loinc.org)
• Global system for identifying tests
and observations
• Used to identify resulted LAB test
value in messages
• Local coding system (ex: MT value)
can be sent along with the LOINC
code to assist with data mapping
between the two systems if needed
12. HL7 Version 2.5.1
Codified Values
SNOMED CT
• Systematized Nomenclature of Medicine
• Global clinical content terminology
• Used with LAB and Microbiology results
• Organisms
(ex: 38907003 = Varicella (chicken pox))
• Specimen Type
(ex: 119297000 = Blood Specimen)
• Procedures
(ex: 252417001 = 24 hour EKG)
• Can be part of patient Problem List
(ex: 418799008 = Symptom)
13. HL7 Version 2.5.1
Codified Values
UCUM
• Unified Code for Units of Measure
• Encompasses all units of measure
being used in international science,
engineering and business
• Focus is on electronic exchange of
these units
• Used to report units of measure
throughout various interfaces
(examples)
mL = milliliter
ug/mL = microgram per milliliter
[degF] = degrees Farhenheit
14. HL7 Version 2.5.1
Codified Values
CVX/MVX
• CDC Vaccine Administered code set
(Immunizations)
(ex: 141 = influenza seasonal injectable)
• CDC Manufacturers of Vaccines codes
(Immunizations)
(ex: PFR = Pfizer, Inc)
ICD9/ICD10
• Problem List
• Public Health Interfaces
• Clinical Documents
15. Sample OBX Segment
with Codified Values
OBX|7|SN|108-1^Cefotaxime Islt MIC^LN^M600.212^CEFOTAXIME
OTHER^L^2.40^5.66||=^0.5^^^|ug/mL^microgram per milliliter^UCUM^
mcg/ml^microgram per milliliter^L^1.1^5.66||S^Susceptible. for microbiology
susceptibilities only^HL70078^^^^HL7 v2.5.1|||F|||20150506084800-0500|
|1112223334^TESTDR^MARK^^^^^^NPI&2.16.840.1.113883.4.6&ISO^L^
^^NPI^IL&2.16.840.1.113883.3.229&ISO^^^^^^^|||201505060925-0500|||
|IATRIC HEALTH SYSTEM^L^^^^CLIA&2.16.840.1.113883.4.7&ISO^XX
^^^11D0224433|300 SINGLE RIDGE RD^^SOMEWHERE^MA^01001^
^L^^SPM|1|M51996.110.0300&IL&2.16.840.1.113883.3.229&ISO^
M51996.110.0300&IL&2.16.840.1.113883.3.229&ISO||258580003^Whole blood
sample^SCT^BLD^BLOOD^L^20120731^5.66|||||||P^Patient^
HL70369^P^Patient^L^HL7 v2.5.1^5.66||||||20150506084800-0500
|20150506084800-0500||||||||||
16. Codified Values Impact
What does this mean for vendors?
• Software products cannot be certified as
Meaningful Use compliant unless these
match proper specifications (the right
data must be sent)
• Interface vendors need to ensure that all
software offerings meet Meaningful Use
requirements and must receive
certification from an accredited
organization for each solution
• Data validation tools are available and
must be used to confirm all data is in
acceptable format and model before
certification can be scheduled
17. Codified Values Impact
What does this mean for
vendors?
• National Institute of Standards and
Technology (NIST) provides a testing
validation tool for this purpose and
this is widely used and modified
• Once certified, vendors can change
some items within each offering but
must evaluate all change requests to
prevent “breaking” an offering
• All change requests must be
reviewed in this light to ensure
continued v2.5.1 compliance
18. Codified Values Impact
What does this mean for
vendors?
• Mapping utilities may be needed to
map each non codified value to its
required codified counterpart
• Home medications (drug, route,
frequency, dose)
• Allergies (value, severity, type)
• Problems
• LOINC/SNOMED/UCUM/CVX/MVX
19. Codified Values Impact
What does this mean for
vendors?
Outbound:
• Data is collected electronically from
the Hospital HIS system using that
system’s dictionaries/values
• Mapping utility is applied for fields
requiring codified mapping
• Output is now compliant with
necessary data requirements and can
be transmitted to receiving system
• Receiving system may or may not be
aware that this mapping took place
20. Codified Values Impact
Example:
HL7 v2.5.1 message created with Meditech standard
source data, IMO mapping and 3rd party mapping
process
Meditech
Data
IMO Mapping
Tables
HL7
Message
3rd Party
Mapping
Tables
Final HL7
Output
containing v2.5.1
codified data
21. Codified Values Impact
What does this mean for
vendors?
Inbound:
• Data is received from outside system
matching codified data requirements
• Mapping utility is applied for fields
requiring codified mapping to
determine local HIS system value to
use
• Output is now compliant with
necessary HIS system data
requirements
22. Codified Values Impact
Example:
HL7 v2.5.1 message received, 3rd party mapping tables
and IMO mapping used to create final Meditech codified
value
HL7 v2.5.1
compliant
message received
3rd party
Mapping
Tables
IMO
Mapping
tables
Final Meditech
data set
23. Codified Values Impact
What does this mean for
vendors?
• We’re seeing mixed adoption so far
with vendors
• Some are ready for v2.5.1 while
others are years away
• Some vendors are not HL7 compliant
and are planning on going right to
web service and API type
programming w/o supporting HL7
24. Codified Values Impact
What does this mean for Hospital staff?
• Dictionaries – The following Meditech Dictionaries are impacted
and require seasoned staff for data entry to provide the necessary
codified content:
• Customer Defined Queries - Used to capture data values
which may not always have a predefined location within
Meditech
• LAB Tests
• LAB Specimen Type
• LAB Site
• Microorganisms
• Micro Procedures and Source
25. Codified Values Impact
What does this mean for Hospital staff?
• Dictionaries – The following Meditech Dictionaries are impacted
and require seasoned staff for data entry to provide the necessary
codified content:
• Nomenclature
• Antibiotics
• MIS Provider
• Other MIS and NMI Dictionaries
26. Codified Values Impact
What does this mean for Hospital staff?
• Mapping
• Can involve thousands of entries and can
take quite a bit of time to complete
• Needs to be completed before proper
testing can begin (timeline impact and
consideration)
• Requires clinical knowledge and
expertize to properly complete
• IMO Mapping – IMO tables are typically used
as well to help address the mapping issues
but these need to be reviewed, approved and
maintained over time.
27. Codified Values Impact
What does this mean for Hospital staff?
• Mapping
• Hospitals need to be prepared to set
seasoned staff aside for a fair amount of
time to complete the codified data
mapping and data entry, no small effort
• Hospitals need to be prepared to
coordinate these activities months in
advance of testing/attestation dates
28. Codified Values Impact
Impact on Hospital staff (continued):
• Change requests – Software vendors may be
unable to change Meaningful Use certified items
once these have been certified to preserve their
structure and intent. Each change request needs to
be closely reviewed and approved.
• Timeline coordination – Software vendors may need
to provide software updates to be Meaningful Use
compliant before testing can begin, this activity
needs to be coordinated between all parties and
needs to be factored into the larger project timeline
• Vendor delays can have large timeline
consequences (firm go LIVE dates)
29. Clinical Documents
Clinical Documents:
• There are many different types of Clinical
Documents, these also take advantage of codified
data values
• These are typically made up of sections with each
specification defining allowable sections and proper
use of these sections for a document to be
considered a proper document per spec
• These are typically created in XML (Extensible
Markup Language) with style sheet applied to make
each document more human readable
30. FHIR
Looking forward with FHIR
• Fast Healthcare Interoperability Resources
(FHIR)
• Next generation standards framework
containing significant improvements over
previous standards
• Takes advantage of lessons learned with
previous HL7 versions and offerings (v2, v3
Clinical Document Architecture CDA) and the
latest web standards
• Can be used as a stand-alone data exchange
standard and can also be used in partnership
with prior HL7 standards as there is overlap
31. FHIR
• Currently in the Draft Standard for Trial Use (DSTU)
level. Content has been well reviewed, is considered
ready for use in production systems and currently slated
for Normative (“locked”) release in 2017.
• Designed to allow fast and easy implementations!
• Solutions are created from a set of modular components
called Resources
• All exchangeable content is defined as a Resource
• The Specification contains general documentation
describing how Resources are defined, a list of available
Resources as defined by HL7 and Implementation
requirements for using these Resources
32. FHIR
• The majority of common use cases can be satisfied
by using Resources either by themselves or by
combining Resources
• FHIR contains Resource relationships to satisfy the
majority of common implementations as well as
built-in extension mechanism which allows
implementers to expand Resources to cover
remaining content as the need arises
33. FHIR
Advantages with FHIR:
• Strong focus on implementation and ease of use
• Concise and easy to understand specification
• Specification is free for use with no restrictions
• Interoperability “out of the box”, large set of base resources
provided to solve most common healthcare integration challenges
• Expandability – Items can be added as needed to cover use cases
which are not provided in the standard set
• Strong foundation on web standards
• Suitable for wide range of contexts requiring healthcare data for
integration – mobile apps, cloud based communications, EHR
based data sharing, server to server communications in large
settings
34. FHIR
Resources:
• All Resources share common characteristics:
• A common way to define and represent them
• Built from data types that define common reusable
patterns of data elements
• Common set of metadata (version information)
• Human readable component (documentation) (XHTML)
• Has a url by which it can be addressed
• Allowable Resource Types are defined in the specification
• Identified version which is updated as the content is
updated
35. FHIR
Resources:
• Represented in either XML (Extensible Markup Language) or JSON
(JavaScript Object Notation), end users can decide which
implementation to use
• References – Elements within Resources can contain links to
elements contained within other Resources, allowing these to be
combined together to build a rich collection of healthcare information
to solve complex problems
• References – These are provided as a url and always flow in one
direction from the source Resource to the target Resource
• Extensibility - Every element in a resource can be expanded (via the
specification rules and requirements) to represent additional
information above and beyond the basic definition for the resource
37. FHIR
RESTful API:
• Defines a set of operations (interactions) which may be
performed on Resources
• Organizations can choose which of these are supported
read – Read the current state of the Resource
update – Update a Resource by its id
delete – Delete a Resource
history – Retrieve update history for the Resource
create – Create a new Resource with a server assigned id
search – Search the resource type based on some filter criteria
validate – Check that the content would be acceptable
conformance – Get conformance statement for the system
transaction – Update, create or delete a set of resources
40. FHIR Example Use Case 1
Accessing patient health record via a portal or mobile app:
• RESTful API provided (exposed) by Healthcare organization
• This would support the search and read operations on these
Resources:
• Patient – to provide demographic info
• Document Reference – to provide access to patient
documents
• Clinical Resources – to provide patient clinical data
• Patient portal/mobile app would interact via this API to perform
proper patient validation and present the user with the patient’s
information as a result of the search/read operation interaction
with the Healthcare organization
41. FHIR Example Use Case 2
Document sharing:
(Using a repository of documents around a patient record via XDS
(Cross-Enterprise Document Sharing) framework)
• DocumentReference Resource – describes a document stored
within the network
• Binary Resource - used to store the actual documents on a FHIR
supported server
• Patient/Practitioner/Organization Resources – used to provide
proper identification and indexing links per document
• SecurityEvent Resource – tracks usage of documents
• These Resources can be combined to create a Clinical Document
query/retrieval mechanism specific to each organization
42. FHIR
Looking forward with FHIR
• Application Access to Common
Clinical Data Set item for Stage 3
(§170.315(g)(7))
• Calls for API to be used to provide
various patient data to an outside
calling system, CMS wants the
patient to have access to this data
via API
• FHIR could be used here to
accomplish this via Resources (proper
Patient Identification, data collection
for specific patient, return to calling
system via API and logging of
actions)
FHIR – What’s All
the FHUSS Webcast
August 11th at 2pm ET
http://bit.ly/1IFT18H
43. Summary
• HL7 version 2.5.1 is built upon previous versions and
contains many similarities to previous versions but contains
stricter codified values
• HL7 version 2.5.1 is required for several Meaningful Use
objectives across all Stages
• Software vendors must conform to this version for these
objectives and must be able to send/receive the correct
codified values
• Some changes may be made to these items solutions
without having a negative impact on certification standing
or HL7 version requirements
• But, all changes need to be reviewed to confirm these can
be made without negative impact for all parties
44. Summary
• Mapping utilities may be required to properly transform
each Hospital’s non codified data to the proper v2.5.1
codified data set. Hospital staff will need to be trained on
these tools
• A fair number of Meditech Dictionaries will also require data
entry for proper codification. Hospital staff will most likely
need to spend a fair amount of time on mapping and
Dictionary build activities before testing can begin
• Clinical expertize and knowledge are required to properly
map the required values, this will most likely require
seasoned resources from the Hospital to complete
• These activities need to be coordinated and factored into
the larger project plan to allow sufficient time for mapping/
testing ahead of project go LIVE
45. Summary
• There are many different types of Clinical Documents, these
are typically created using pre-defined sections
• These are typically programmed using XML and a style
sheet for easier human readability
• Fast Healthcare Interoperability Resources (FHIR) is a next
generation standards framework containing significant
improvements over previous standards
• FHIR Resources should start to become more common
moving forward and are called for as part of Meaningful Use
Stage 3 (tentative)
46. Question? We Can Help!
Rich Murphy
Vice President, Interface/Integration
Division
Iatric Systems, Inc.
(978) 805-4151
Rich.Murphy@iatric.com
48. HL7 Version 2.5.1 & Meaningful Use
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